Bill Text: FL S1722 | 2010 | Regular Session | Comm Sub
Bill Title: Prescription Drug Monitoring Program [SPSC]
Spectrum: Partisan Bill (Republican 2-0)
Status: (Failed) 2010-04-30 - Died in Committee on Criminal Justice, companion bill(s) passed, see CS/CS/SB 2272 (Ch. 2010-211) [S1722 Detail]
Download: Florida-2010-S1722-Comm_Sub.html
Florida Senate - 2010 CS for SB 1722 By the Committee on Health Regulation; and Senators Fasano and Gaetz 588-02727A-10 20101722c1 1 A bill to be entitled 2 An act relating to the prescription drug monitoring 3 program; amending s. 893.055, F.S.; requiring that the 4 comprehensive electronic database system containing 5 information concerning prescriptions of controlled 6 substances comply with the minimum requirements for 7 authentication and certification of the National All 8 Schedules Prescription Electronic Reporting Act; 9 requiring the Department of Health to provide reports 10 from the prescription drug monitoring program to the 11 Department of Law Enforcement; requiring the 12 Department of Health, after consultation with the 13 Department of Law Enforcement and other associations, 14 to adopt rules; requiring the Department of Health to 15 establish a method to allow corrections to the program 16 database; revising the information to be submitted to 17 the program database by a pharmacy or prescriber; 18 revising the acts of dispensing or administering 19 controlled substances which are exempt from reporting; 20 requiring a pharmacy, prescriber, practitioner, or 21 dispenser to register with the Department of Health in 22 order to obtain certain information from the 23 prescription drug monitoring program; requiring the 24 program manager and certain other individuals who have 25 access to the prescription drug monitoring program 26 database to submit fingerprints to the Department of 27 Health; requiring the Department of Health to follow 28 the proper procedures established by the Department of 29 Law Enforcement to request state and national criminal 30 history record checks; prohibiting the Agency for 31 Health Care Administration from having direct access 32 to information in the prescription drug monitoring 33 program database for purposes of Medicaid fraud cases 34 or investigations; requiring a patient, legal 35 guardian, or designated health care surrogate to 36 provide the patient’s phone number and a copy of a 37 government-issued photo identification in order to 38 verify information in the prescription drug monitoring 39 program database; authorizing the State Surgeon 40 General to enter into agreements with other states to 41 exchange prescription drug monitoring information 42 after specified conditions are met; providing factors 43 for considering such agreements; limiting the purposes 44 for which information may be shared under such 45 agreements; amending s. 893.0551, F.S.; authorizing 46 the disclosure of information in the prescription drug 47 monitoring program under certain conditions; providing 48 an effective date. 49 50 Be It Enacted by the Legislature of the State of Florida: 51 52 Section 1. Subsections (2), (3), (5), and (7) of section 53 893.055, Florida Statutes, are amended, and subsection (8) is 54 added to that section, to read: 55 893.055 Prescription drug monitoring program.— 56 (2)(a) By December 1, 2010, the department shall design and 57 establish a comprehensive electronic database system that has 58 controlled substance prescriptions provided to it and that 59 provides prescription information to a patient’s health care 60 practitioner and pharmacist who inform the department that they 61 wish the patient advisory report provided to them. Otherwise, 62 the patient advisory report will not be sent to the 63 practitioner, pharmacy, or pharmacist. The system shall be 64 designed to provide information regarding dispensed 65 prescriptions of controlled substances and shall not infringe 66 upon the legitimate prescribing or dispensing of a controlled 67 substance by a prescriber or dispenser acting in good faith and 68 in the course of professional practice. The system shall be 69 consistent with standards of the American Society for Automation 70 in Pharmacy (ASAP). The electronic system shall also comply with 71 the Health Insurance Portability and Accountability Act (HIPAA) 72 as it pertains to protected health information (PHI), electronic 73 protected health information (EPHI), the National All Schedules 74 Prescription Electronic Reporting (NASPER) Act’s minimum 75 requirements for authentication of a practitioner that requests 76 information in the prescription drug monitoring program database 77 and certification of the purpose for which information is 78 requested, and all other relevant state and federal privacy and 79 security laws and regulations. The department shall establish 80 policies and procedures as appropriate regarding the reporting, 81 accessing the database, evaluation, management, development, 82 implementation, operation, storage, and security of information 83 within the system. The reporting of prescribed controlled 84 substances shall include a dispensing transaction with a 85 dispenser pursuant to chapter 465 or through a dispensing 86 transaction to an individual or address in this state with a 87 pharmacy that is not located in this state but that is otherwise 88 subject to the jurisdiction of this state as to that dispensing 89 transaction. The reporting of patient advisory reports refers 90 only to reports to patients, pharmacies, and practitioners. 91 Separate reports that contain patient prescription history 92 information and that are not patient advisory reports are 93 provided to persons and entities as authorized in paragraphs 94 (7)(b) and (c) and s. 893.0551. 95 (b)1. The department’s prescription drug monitoring program 96 shall: 97 a. Provide reports directly to the Department of Law 98 Enforcement without review by the department or a regulatory 99 board so that the Department of Law Enforcement may investigate 100 whether any violation of law has occurred regarding controlled 101 substances in Schedule II, Schedule III, or Schedule IV; and 102 b. Report, if applicable, the information to the 103 appropriate state attorney or other law enforcement agency in 104 accordance with state law. 105 106 The parameters for such reports shall be adopted by rule of the 107 department and developed after consultation with the Department 108 of Law Enforcement, the Florida Medical Association, and the 109 Florida Osteopathic Medical Association. 110 2. The department, when the direct support organization 111 receives at least $20,000 in nonstate moneys or the state 112 receives at least $20,000 in federal grants for the prescription 113 drug monitoring program, and in consultation with the Office of 114 Drug Control, shall adopt rules as necessary concerning the 115 reporting, accessing the database, evaluation, management, 116 development, implementation, operation, security, and storage of 117 information within the system, including rules for when patient 118 advisory reports are provided to pharmacies and prescribers. The 119 patient advisory report shall be provided in accordance with s. 120 893.13(7)(a)8. The department shall work with the professional 121 health care licensure boards, such as the Board of Medicine, the 122 Board of Osteopathic Medicine, and the Board of Pharmacy; other 123 appropriate organizations, such as the Florida Pharmacy 124 Association, the Office of Drug Control, the Florida Medical 125 Association, the Florida Retail Federation, and the Florida 126 Osteopathic Medical Association, including those relating to 127 pain management; and the Attorney General, the Department of Law 128 Enforcement, and the Agency for Health Care Administration to 129 develop rules appropriate for the prescription drug monitoring 130 program. 131 (c) All dispensers and prescribers subject to these 132 reporting requirements shall be notified by the department of 133 the implementation date for such reporting requirements. 134 (d) The department shall establish a method to allow 135 corrections to the database when notified by a health care 136 practitioner or pharmacist. 137 (3) The pharmacy dispensing the controlled substance and 138 each prescriber who directly dispenses a controlled substance 139 shall submit to the electronic system, by a procedure and in a 140 format established by the department and consistent with an 141 ASAP-approved format, the following information for inclusion in 142 the database: 143 (a) The name of the prescribing practitioner, the 144 practitioner’s federal Drug Enforcement Administration 145 registration number, the practitioner’s National Provider 146 Identification (NPI) or other appropriate identifier, and the 147 date of the prescription. 148 (b) The date the prescription was filled and the method of 149 payment, such as cash by an individual, insurance coverage 150 through a third party, or Medicaid payment. This paragraph does 151 not authorize the department to include individual credit card 152 numbers or other account numbers in the database. 153 (c) The full name, address, and date of birth of the person 154 for whom the prescription was written. 155 (d) The name, national drug code, quantity, and strength of 156 the controlled substance dispensed. 157 (e) The full name, federal Drug Enforcement Administration 158 registration number, and address of the pharmacy or other 159 location from which the controlled substance was dispensed. If 160 the controlled substance was dispensed by a practitioner other 161 than a pharmacist, the practitioner’s full name, federal Drug 162 Enforcement Administration registration number, and address. 163 (f) The name of the pharmacy or practitioner, other than a 164 pharmacist, dispensing the controlled substance and the 165 practitioner’s National Provider Identification (NPI). 166 (g) Other appropriate identifying information as determined 167 by department rule. 168 (h) The number of refills ordered and whether the drug was 169 dispensed as a refill of a prescription or was a first-time 170 request. 171 (5) When the following acts of dispensing or administering 172 occur, the following are exempt from reporting under this 173 section for that specific act of dispensing or administration: 174 (a) A health care practitioner when administering a 175 controlled substance directly to a patient if the amount of the 176 controlled substance is adequate to treat the patient during 177 that particular treatment session. 178 (b) A pharmacist or health care practitioner when 179 administering a controlled substance to a patient or resident 180 receiving care as a patient at a hospital, nursing home, 181 ambulatory surgical center, hospice, or intermediate care 182 facility for the developmentally disabled which is licensed in 183 this state. 184(c)A practitioner when administering or dispensing a185controlled substance in the health care system of the Department186of Corrections.187 (c)(d)A practitioner when administering a controlled 188 substance in the emergency room of a licensed hospital. 189 (d)(e)A health care practitioner when administeringor190dispensinga controlled substance directly to a patientperson191 under the age of 16 if the amount of the controlled substance is 192 adequate to treat the patient during that particular treatment 193 session. 194 (e)(f)A pharmacist or a dispensing practitioner when 195 dispensing a one-time, 48-hour72-houremergency resupply of a 196 controlled substance to a patient. 197 (7)(a) A practitioner or pharmacist who dispenses a 198 controlled substance must submit the information required by 199 this section in an electronic or other method in an ASAP format 200 approved by rule of the department unless otherwise provided in 201 this section. The cost to the dispenser in submitting the 202 information required by this section may not be material or 203 extraordinary. Costs not considered to be material or 204 extraordinary include, but are not limited to, regular postage, 205 electronic media, regular electronic mail, and facsimile 206 charges. 207 (b)1. In order for a pharmacy, prescriber, practitioner, or 208 dispenser toshallhave access to information in the 209 prescription drug monitoring program’s database which relates to 210 a patient of that pharmacy, prescriber, practitioner, or 211 dispenser, the pharmacy, prescriber, practitioner, or dispenser 212 shall register with the department by submitting a registration 213 document provided by the departmentin a manner established by214the department as needed for the purpose of reviewing the215patient’s controlled substance prescription history. The 216 registration document must be notarized before it is submitted 217 to the department. Before a pharmacy, prescriber, practitioner, 218 or dispenser is granted access to information in the 219 prescription drug monitoring program’s database, the submitted 220 document must be approved by the department. Upon approval, the 221 department shall grant the registrant access to the appropriate 222 information in the prescription drug monitoring program’s 223 database. 224 2. Other access to the program’s database shall be limited 225 to the programprogram’smanager and to the designated program 226 and support staff, who may act only at the direction of the 227 program manager or, in the absence of the program manager, as 228 authorized. Access by the program manager or such designated 229 staff is for prescription drug program management only or for 230 management of the program’s database and its system in support 231 of the requirements of this section and in furtherance of the 232 prescription drug monitoring program. Confidential and exempt 233 information in the database shall be released only as provided 234 in paragraph (c) and s. 893.0551. The program manager, 235 designated program and support staff who act at the direction of 236 or in the absence of the program manager, and any individual who 237 has similar access regarding the management of the prescription 238 drug monitoring program database must submit fingerprints to the 239 department for background screening. The department shall follow 240 the procedure established by the Department of Law Enforcement 241 to request a statewide criminal history record check and to 242 request that the Department of Law Enforcement forward the 243 fingerprints to the Federal Bureau of Investigation for a 244 national criminal history record check. 245 (c) Except as provided in subparagraph (2)(b)1., the 246 following entities shall not be allowed direct access to 247 information in the prescription drug monitoring program database 248 but may request from the program manager and, when authorized by 249 the program manager, the program manager’s program and support 250 staff, information that is confidential and exempt under s. 251 893.0551. Prior to release, the request shall be verified as 252 authentic and authorized with the requesting organization by the 253 program manager, the program manager’s program and support 254 staff, or as determined in rules by the department as being 255 authentic and as having been authorized by the requesting 256 entity: 257 1. The department or its relevant health care regulatory 258 boards responsible for the licensure, regulation, or discipline 259 of practitioners, pharmacists, or other persons who are 260 authorized to prescribe, administer, or dispense controlled 261 substances and who are involved in a specific controlled 262 substance investigation involving a designated person for one or 263 more prescribed controlled substances. 264 2. The Attorney General or the Agency for Health Care 265 Administration for Medicaid fraud cases or Medicaid 266 investigations involving prescribed controlled substances. 267 3. A law enforcement agency during active investigations 268 regarding potential criminal activity, fraud, or theft regarding 269 prescribed controlled substances. 270 4. A patient or the legal guardian or designated health 271 care surrogate of an incapacitated patient as described in s. 272 893.0551 who, for the purpose of verifying the accuracy of the 273 database information, submits a written and notarized request 274 that includes the patient’s full name, address, and date of 275 birth, and includes the same information if the legal guardian 276 or health care surrogate submits the request. The patient’s 277 phone number and a copy of a government-issued photo 278 identification must be provided in person to the program manager 279 along with the notarized request. The request shall be validated 280 by the department to verify the identity of the patient and the 281 legal guardian or health care surrogate, if the patient’s legal 282 guardian or health care surrogate is the requestor. Such 283 verification is also required for any request to change a 284 patient’s prescription history or other information related to 285 his or her information in the electronic database. 286 287 Information in the database for the electronic prescription drug 288 monitoring system is not discoverable or admissible in any civil 289 or administrative action, except in an investigation and 290 disciplinary proceeding by the department or the appropriate 291 regulatory board. 292 (d) The following entities shall not be allowed direct 293 access to information in the prescription drug monitoring 294 program database but may request from the program manager and, 295 when authorized by the program manager, the program manager’s 296 program and support staff, information that contains no 297 identifying information of any patient, physician, health care 298 practitioner, prescriber, or dispenser and that is not 299 confidential and exempt: 300 1. Department staff for the purpose of calculating 301 performance measures pursuant to subsection (8). 302 2. The Program Implementation and Oversight Task Force for 303 its reporting to the Governor, the President of the Senate, and 304 the Speaker of the House of Representatives regarding the 305 prescription drug monitoring program. This subparagraph expires 306 July 1, 2012. 307 (e) All transmissions of data required by this section must 308 comply with relevant state and federal privacy and security laws 309 and regulations. However, any authorized agency or person under 310 s. 893.0551 receiving such information as allowed by s. 893.0551 311 may maintain the information received for up to 24 months before 312 purging it from his or her records or maintain it for longer 313 than 24 months if the information is pertinent to ongoing health 314 care or an active law enforcement investigation or prosecution. 315 (8) After the prescription drug monitoring system has been 316 operational for 18 months, the State Surgeon General shall enter 317 into reciprocal agreements for the sharing of prescription drug 318 monitoring information with any other state or states that have 319 compatible prescription drug monitoring programs. If the State 320 Surgeon General evaluates the prescription drug monitoring 321 program of another state as authorized in this subsection, 322 priority shall be given to a state that is contiguous with the 323 borders of this state. 324 (a) In determining compatibility, the State Surgeon General 325 shall consider: 326 1. The essential purposes of the program and the success of 327 the program in fulfilling those purposes. 328 2. The safeguards for privacy of patient records and the 329 success of the program in protecting patient privacy. 330 3. The persons authorized to view the data collected by the 331 program. 332 4. The schedules of the controlled substances monitored. 333 5. The data required to be submitted on each prescription. 334 6. Any implementation criteria deemed essential for a 335 thorough comparison. 336 (b) The State Surgeon General shall review any agreement on 337 an annual basis to determine its continued compatibility with 338 the prescription drug monitoring program in this state. 339 (c) Any agreement between the State Surgeon General and 340 another state shall prohibit the sharing of information about a 341 resident of this state or a practitioner, pharmacist, or other 342 prescriber for any purposes not otherwise authorized by this 343 section or s. 893.0551. 344 Section 2. Present subsections (4), (5), and (6) of section 345 893.0551, Florida Statutes, are renumbered as subsections (5), 346 (6), and (7), respectively, and a new subsection (4) is added to 347 that section, to read: 348 893.0551 Public records exemption for the prescription drug 349 monitoring program.— 350 (4) The department may disclose confidential and exempt 351 information contained in records held by the department under s. 352 893.055 if the State Surgeon General has entered into a 353 reciprocal agreement for the sharing of prescription drug 354 monitoring information with any other state that has compatible 355 prescription drug monitoring programs, as provided under s. 356 893.055(8). 357 Section 3. This act shall take effect July 1, 2010.