Florida Senate - 2016 (PROPOSED BILL) SPB 7038 FOR CONSIDERATION By the Committee on Health Policy 588-01843A-16 20167038pb 1 A bill to be entitled 2 An act relating to controlled substances; amending s. 3 456.42, F.S.; authorizing certain controlled 4 substances to be electronically prescribed; amending 5 s. 499.0121, F.S.; deleting a specified requirement in 6 the performance of due diligence of purchasers by 7 prescription drug wholesalers; amending s. 893.055, 8 F.S.; authorizing the designee of a pharmacy, 9 prescriber, or dispenser to access a patient’s record 10 in the prescription drug monitoring program’s database 11 for a specified purpose; authorizing an impaired 12 practitioner consultant to access an impaired 13 practitioner program participant’s or referral’s 14 record in the prescription drug monitoring program’s 15 database; reenacting and amending s. 893.0551, F.S.; 16 authorizing the designee of a health care 17 practitioner, pharmacist, pharmacy, prescriber, or 18 dispenser and an impaired practitioner consultant to 19 receive certain information from the prescription drug 20 monitoring program; providing an effective date. 21 22 Be It Enacted by the Legislature of the State of Florida: 23 24 Section 1. Subsection (2) of section 456.42, Florida 25 Statutes, is amended to read: 26 456.42 Written prescriptions for medicinal drugs.— 27 (2) A written prescription for a controlled substance 28 listed in chapter 893 must have the quantity of the drug 29 prescribed in both textual and numerical formats, must be dated 30 in numerical, month/day/year format, or with the abbreviated 31 month written out, or the month written out in whole, and must 32 be either written on a standardized counterfeit-proof 33 prescription pad produced by a vendor approved by the department 34 or electronically prescribed as that term is used in s. 35 408.0611. All controlled substances listed in Schedule II, 36 Schedule III, Schedule IV, and Schedule V may be electronically 37 prescribed pursuant to applicable federal law. As a condition of 38 being an approved vendor, a prescription pad vendor must submit 39 a monthly report to the department that, at a minimum, documents 40 the number of prescription pads sold and identifies the 41 purchasers. The department may, by rule, require the reporting 42 of additional information. 43 Section 2. Paragraph (b) of subsection (15) of section 44 499.0121, Florida Statutes, is amended to read: 45 499.0121 Storage and handling of prescription drugs; 46 recordkeeping.—The department shall adopt rules to implement 47 this section as necessary to protect the public health, safety, 48 and welfare. Such rules shall include, but not be limited to, 49 requirements for the storage and handling of prescription drugs 50 and for the establishment and maintenance of prescription drug 51 distribution records. 52 (15) DUE DILIGENCE OF PURCHASERS.— 53 (b) A wholesale distributor must take reasonable measures 54 to identify its customers, understand the normal and expected 55 transactions conducted by those customers, and identify those 56 transactions that are suspicious in nature. A wholesale 57 distributor must establish internal policies and procedures for 58 identifying suspicious orders and preventing suspicious 59 transactions.
A wholesale distributor must assess orders for60 greater than 5,000 unit doses of any one controlled substance in61 any one month to determine whether the purchase is reasonable.62 In making such assessments, a wholesale distributor may consider 63 the purchasing entity’s clinical business needs, location, and 64 population served, in addition to other factors established in 65 the distributor’s policies and procedures. A wholesale 66 distributor must report to the department any regulated 67 transaction involving an extraordinary quantity of a listed 68 chemical, an uncommon method of payment or delivery, or any 69 other circumstance that the regulated person believes may 70 indicate that the listed chemical will be used in violation of 71 the law. The wholesale distributor shall maintain records that 72 document the report submitted to the department in compliance 73 with this paragraph. 74 Section 3. Paragraphs (b) and (c) of subsection (7) and 75 subsection (12) of section 893.055, Florida Statutes, are 76 amended to read: 77 893.055 Prescription drug monitoring program.— 78 (7) 79 (b) A pharmacy, prescriber, or dispenser, or the designee 80 of a pharmacy, prescriber, or dispenser, shall have access to 81 information in the prescription drug monitoring program’s 82 database which relates to a patient of that pharmacy, 83 prescriber, or dispenser in a manner established by the 84 department as needed for the purpose of reviewing the patient’s 85 controlled substance prescription history. Other access to the 86 program’s database shall be limited to the program’s manager and 87 to the designated program and support staff, who may act only at 88 the direction of the program manager or, in the absence of the 89 program manager, as authorized. Access by the program manager or 90 such designated staff is for prescription drug program 91 management only or for management of the program’s database and 92 its system in support of the requirements of this section and in 93 furtherance of the prescription drug monitoring program. 94 Confidential and exempt information in the database shall be 95 released only as provided in paragraph (c) and s. 893.0551. The 96 program manager, designated program and support staff who act at 97 the direction of or in the absence of the program manager, and 98 any individual who has similar access regarding the management 99 of the database from the prescription drug monitoring program 100 shall submit fingerprints to the department for background 101 screening. The department shall follow the procedure established 102 by the Department of Law Enforcement to request a statewide 103 criminal history record check and to request that the Department 104 of Law Enforcement forward the fingerprints to the Federal 105 Bureau of Investigation for a national criminal history record 106 check. 107 (c) The following entities are shallnot beallowed direct 108 access to information in the prescription drug monitoring 109 program database but may request from the program manager and, 110 when authorized by the program manager, the program manager’s 111 program and support staff, information that is confidential and 112 exempt under s. 893.0551. Before Prior torelease, a therequest 113 by the following entities shall be verified as authentic and 114 authorized with the requesting organization by the program 115 manager, the program manager’s program and support staff, or as 116 determined in rules by the department as being authentic and as 117 having been authorized by the requesting entity: 118 1. The department or its relevant health care regulatory 119 boards responsible for the licensure, regulation, or discipline 120 of practitioners, pharmacists, or other persons who are 121 authorized to prescribe, administer, or dispense controlled 122 substances and who are involved in a specific controlled 123 substance investigation involving a designated person for one or 124 more prescribed controlled substances. 125 2. The Attorney General for Medicaid fraud cases involving 126 prescribed controlled substances. 127 3. A law enforcement agency during active investigations of 128 regardingpotential criminal activity, fraud, or theft regarding 129 prescribed controlled substances. 130 4. A patient or the legal guardian or designated health 131 care surrogate of an incapacitated patient as described in s. 132 893.0551 who, for the purpose of verifying the accuracy of the 133 database information, submits a written and notarized request 134 that includes the patient’s full name, address, and date of 135 birth, and includes the same information if the legal guardian 136 or health care surrogate submits the request. The request shall 137 be validated by the department to verify the identity of the 138 patient and the legal guardian or health care surrogate, if the 139 patient’s legal guardian or health care surrogate is the 140 requestor. Such verification is also required for any request to 141 change a patient’s prescription history or other information 142 related to his or her information in the electronic database. 143 5. An impaired practitioner consultant who is retained by 144 the department under s. 456.076 for the purpose of reviewing the 145 database information of an impaired practitioner program 146 participant or a referral who has agreed to be evaluated or 147 monitored through the program and who has separately agreed in 148 writing to the consultant’s access to and review of such 149 information. 150 151 Information in the database for the electronic prescription drug 152 monitoring system is not discoverable or admissible in any civil 153 or administrative action, except in an investigation and 154 disciplinary proceeding by the department or the appropriate 155 regulatory board. 156 (12) A prescriber or dispenser, or his or her designee, may 157 have access to the information under this section which relates 158 to a patient of that prescriber or dispenser as needed for the 159 purpose of reviewing the patient’s controlled drug prescription 160 history. A prescriber or dispenser acting in good faith is 161 immune from any civil, criminal, or administrative liability 162 that might otherwise be incurred or imposed for receiving or 163 using information from the prescription drug monitoring program. 164 This subsection does not create a private cause of action, and a 165 person may not recover damages against a prescriber or dispenser 166 authorized to access information under this subsection for 167 accessing or failing to access such information. 168 Section 4. Section 893.0551, Florida Statutes, is reenacted 169 and amended to read: 170 893.0551 Public records exemption for the prescription drug 171 monitoring program.— 172 (1) For purposes of this section, the terms used in this 173 section have the same meanings as provided in s. 893.055. 174 (2) The following information of a patient or patient’s 175 agent, a health care practitioner, a dispenser, an employee of 176 the practitioner who is acting on behalf of and at the direction 177 of the practitioner, a pharmacist, or a pharmacy that is 178 contained in records held by the department under s. 893.055 is 179 confidential and exempt from s. 119.07(1) and s. 24(a), Art. I 180 of the State Constitution: 181 (a) Name. 182 (b) Address. 183 (c) Telephone number. 184 (d) Insurance plan number. 185 (e) Government-issued identification number. 186 (f) Provider number. 187 (g) Drug Enforcement Administration number. 188 (h) Any other unique identifying information or number. 189 (3) The department shall disclose such confidential and 190 exempt information to the following persons or entities upon 191 request and after using a verification process to ensure the 192 legitimacy of the request as provided in s. 893.055: 193 (a) The Attorney General, or his or her designee, when 194 working on Medicaid fraud cases involving prescription drugs or 195 when the Attorney General has initiated a review of specific 196 identifiers of Medicaid fraud regarding prescription drugs. The 197 Attorney General’s Medicaid fraud investigators may not have 198 direct access to the department’s database. The Attorney 199 General, or his or her designee, may disclose to a criminal 200 justice agency, as defined in s. 119.011, only the confidential 201 and exempt information received from the department that is 202 relevant to an identified active investigation that prompted the 203 request for the information. 204 (b) The department’s relevant health care regulatory boards 205 responsible for the licensure, regulation, or discipline of a 206 practitioner, pharmacist, or other person who is authorized to 207 prescribe, administer, or dispense controlled substances and who 208 is involved in a specific controlled substances investigation 209 for prescription drugs involving a designated person. The health 210 care regulatory boards may request information from the 211 department but may not have direct access to its database. The 212 health care regulatory boards may provide to a law enforcement 213 agency pursuant to ss. 456.066 and 456.073 only information that 214 is relevant to the specific controlled substances investigation 215 that prompted the request for the information. 216 (c) A law enforcement agency that has initiated an active 217 investigation involving a specific violation of law regarding 218 prescription drug abuse or diversion of prescribed controlled 219 substances and that has entered into a user agreement with the 220 department. A law enforcement agency may request information 221 from the department but may not have direct access to its 222 database. The law enforcement agency may disclose to a criminal 223 justice agency, as defined in s. 119.011, only confidential and 224 exempt information received from the department that is relevant 225 to an identified active investigation that prompted the request 226 for such information. 227 (d) A health care practitioner, or his or her designee, who 228 certifies that the information is necessary to provide medical 229 treatment to a current patient in accordance with ss. 893.05 and 230 893.055. 231 (e) A pharmacist, or his or her designee, who certifies 232 that the requested information will be used to dispense 233 controlled substances to a current patient in accordance with 234 ss. 893.04 and 893.055. 235 (f) A patient or the legal guardian or designated health 236 care surrogate for an incapacitated patient, if applicable, 237 making a request as provided in s. 893.055(7)(c)4. 238 (g) The patient’s pharmacy, prescriber, or dispenser, or 239 the designee of the pharmacy, prescriber, or dispenser, who 240 certifies that the information is necessary to provide medical 241 treatment to his or her current patient in accordance with s. 242 893.055. 243 (h) An impaired practitioner consultant who has been 244 authorized in writing by a participant in or referral to the 245 impaired practitioner program to access and review information 246 as provided in s. 893.055(7)(c)5. 247 (4) If the department determines consistent with its rules 248 that a pattern of controlled substance abuse exists, the 249 department may disclose such confidential and exempt information 250 to the applicable law enforcement agency in accordance with s. 251 893.055. The law enforcement agency may disclose to a criminal 252 justice agency, as defined in s. 119.011, only confidential and 253 exempt information received from the department that is relevant 254 to an identified active investigation that is specific to a 255 violation of s. 893.13(7)(a)8., s. 893.13(8)(a), or s. 256 893.13(8)(b). 257 (5) Before disclosing confidential and exempt information 258 to a criminal justice agency or a law enforcement agency 259 pursuant to this section, the disclosing person or entity must 260 take steps to ensure the continued confidentiality of all 261 confidential and exempt information. At a minimum, these steps 262 must include redacting any nonrelevant information. 263 (6) An agency or person who obtains any confidential and 264 exempt information pursuant to this section must maintain the 265 confidential and exempt status of that information and may not 266 disclose such information unless authorized by law. Information 267 shared with a state attorney pursuant to paragraph (3)(a) or 268 paragraph (3)(c) may be released only in response to a discovery 269 demand if such information is directly related to the criminal 270 case for which the information was requested. Unrelated 271 information may be released only upon an order of a court of 272 competent jurisdiction. 273 (7) A person who willfully and knowingly violates this 274 section commits a felony of the third degree, punishable as 275 provided in s. 775.082, s. 775.083, or s. 775.084. 276 Section 5. This act shall take effect upon becoming a law.