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| 1 | A bill to be entitled | ||
| 2 | An act relating to pharmacy benefit managers; creating s. | ||
| 3 | 465.189, F.S.; establishing standards and criteria for | ||
| 4 | regulation and licensing of pharmacy benefit managers; | ||
| 5 | providing a popular name; providing purpose, intent, and | ||
| 6 | applicability; providing definitions; requiring a biennial | ||
| 7 | certificate of authority and an annual license; providing | ||
| 8 | rulemaking authority to the Board of Pharmacy and the | ||
| 9 | Office of Insurance Regulation; requiring an annual | ||
| 10 | statement; providing for financial examinations; providing | ||
| 11 | for assessments and fees; providing for pharmacy benefit | ||
| 12 | manager contracts; providing for enforcement; providing | ||
| 13 | for medication reimbursement costs; specifying prohibited | ||
| 14 | practices; preserving existing contracts and providing | ||
| 15 | prospective application for new contracts; providing for | ||
| 16 | control over conflicting provisions of law; providing an | ||
| 17 | effective date. | ||
| 18 | |||
| 19 | Be It Enacted by the Legislature of the State of Florida: | ||
| 20 | |||
| 21 | Section 1. Section 465.189, Florida Statutes, is created | ||
| 22 | to read: | ||
| 23 | 465.189 Pharmacy benefit managers.-- | ||
| 24 | (1) POPULAR NAME.--This section shall be known by the | ||
| 25 | popular name the "Florida Pharmacy Benefit Management Regulation | ||
| 26 | Act." | ||
| 27 | (2) PURPOSE AND INTENT; APPLICABILITY.-- | ||
| 28 | (a)1. This section establishes standards and criteria for | ||
| 29 | the regulation and licensing of pharmacy benefit managers. | ||
| 30 | 2. The purpose of this section is to: | ||
| 31 | a. Promote, preserve, and protect the public health, | ||
| 32 | safety, and welfare through effective regulation and licensing | ||
| 33 | of pharmacy benefit managers. | ||
| 34 | b. Provide for certain powers and duties for certain state | ||
| 35 | agencies and officers. | ||
| 36 | c. Prescribe penalties for violations of this section. | ||
| 37 | (b) A pharmacy benefit manager is subject to this section | ||
| 38 | if the pharmacy benefit manager provides claims-processing | ||
| 39 | services, other prescription drug or device services, or both, | ||
| 40 | to patients who are residents of this state. | ||
| 41 | (c) A pharmacy benefit manager may not do business or | ||
| 42 | provide services in this state unless the pharmacy benefit | ||
| 43 | manager is in full compliance with this section. | ||
| 44 | (3) DEFINITIONS.--For purposes of this section: | ||
| 45 | (a) "Board" means the Board of Pharmacy. | ||
| 46 | (b) "Cease and desist order" means an order of the board | ||
| 47 | or office prohibiting a pharmacy benefit manager or other person | ||
| 48 | or entity from continuing a particular course of conduct that | ||
| 49 | violates this section or rules adopted under this section. | ||
| 50 | (c) "Claims-processing services" means the administrative | ||
| 51 | services performed in connection with the processing and | ||
| 52 | adjudication of claims relating to pharmacist's services, | ||
| 53 | including, but not limited to, making payments to pharmacists | ||
| 54 | and pharmacies. | ||
| 55 | (d) "Maintenance drug" means a drug prescribed by a | ||
| 56 | practitioner who is licensed to prescribe drugs and used to | ||
| 57 | treat a medical condition for a period greater than 30 days. | ||
| 58 | (e) "Multi-source drug" means a drug that is stocked and | ||
| 59 | available from three or more suppliers. | ||
| 60 | (f) "Office" means the Office of Insurance Regulation of | ||
| 61 | the Financial Services Commission. | ||
| 62 | (g) "Other prescription drug or device services" means | ||
| 63 | services other than claims-processing services, provided | ||
| 64 | directly or indirectly by a pharmacy benefit manager, whether in | ||
| 65 | connection with or separate from claims-processing services, | ||
| 66 | including, but not limited to: | ||
| 67 | 1. Negotiating rebates, discounts, or other financial | ||
| 68 | incentives and arrangements with drug companies. | ||
| 69 | 2. Disbursing or distributing rebates. | ||
| 70 | 3. Managing or participating in incentive programs or | ||
| 71 | arrangements for pharmacist's services. | ||
| 72 | 4. Negotiating or entering into contractual arrangements | ||
| 73 | with pharmacists or pharmacies, or both. | ||
| 74 | 5. Developing formularies. | ||
| 75 | 6. Designing prescription benefit programs. | ||
| 76 | 7. Advertising or promoting claims-processing services or | ||
| 77 | other prescription drug or device services. | ||
| 78 | (h) "Pharmacist" means an individual licensed as a | ||
| 79 | pharmacist under this chapter. | ||
| 80 | (i) "Pharmacist's services" means the practice of the | ||
| 81 | profession of pharmacy as defined in s. 465.003. | ||
| 82 | (j) "Pharmacy" means pharmacy as defined in s. 465.003. | ||
| 83 | (k)1. "Pharmacy benefit manager" means a person, business, | ||
| 84 | or other entity, and any wholly or partially owned or controlled | ||
| 85 | subsidiary of a pharmacy benefit manager, that provides claims- | ||
| 86 | processing services or other prescription drug or device | ||
| 87 | services, or both, to third parties. | ||
| 88 | 2. "Pharmacy benefit manager" does not include licensed | ||
| 89 | health care facilities, pharmacies, licensed health care | ||
| 90 | professionals, insurance companies, unions, or health | ||
| 91 | maintenance organizations. | ||
| 92 | (l) "Single-source drug" means a drug that is not a multi- | ||
| 93 | source drug. | ||
| 94 | (m)1. "Third parties" means any person, business, or other | ||
| 95 | entity other than a pharmacy benefit manager. | ||
| 96 | 2. "Third parties" does not include: | ||
| 97 | a. A person, business, or other entity that owns or holds | ||
| 98 | a controlling interest in the pharmacy benefit manager; or | ||
| 99 | b. A person, business, or other entity in which the | ||
| 100 | pharmacy benefit manager owns or holds a controlling interest. | ||
| 101 | (n) "Usual and customary price" means the price that a | ||
| 102 | pharmacist or pharmacy would have charged cash-paying patients, | ||
| 103 | excluding patients for whom reimbursement rates are set by | ||
| 104 | contract, for the same services on the same date. | ||
| 105 | (4) CERTIFICATE OF AUTHORITY.-- | ||
| 106 | (a)1. No person or organization shall establish or operate | ||
| 107 | as a pharmacy benefit manager in this state without obtaining a | ||
| 108 | certificate of authority from the board in accordance with this | ||
| 109 | section and all applicable federal and state laws. | ||
| 110 | 2. A pharmacy benefit manager doing business in this state | ||
| 111 | shall obtain a certificate of authority from the board within | ||
| 112 | 120 days after the effective date of this section and every 2 | ||
| 113 | years thereafter. The certificate of authority shall expire on | ||
| 114 | December 31 in the year following the year the certificate of | ||
| 115 | authority was first issued and then may be renewed for | ||
| 116 | successive 2-year periods. | ||
| 117 | (b)1. Any organization or person may apply to the board to | ||
| 118 | obtain a certificate of authority to establish and operate a | ||
| 119 | pharmacy benefit manager under this section. | ||
| 120 | 2. A nonrefundable application fee of $300, payable to the | ||
| 121 | board, shall accompany each application for a certificate of | ||
| 122 | authority and each application for renewal of a certificate of | ||
| 123 | authority. | ||
| 124 | (c) The board shall not issue a certificate of authority | ||
| 125 | to any pharmacy benefit manager until the board is satisfied | ||
| 126 | that the pharmacy benefit manager: | ||
| 127 | 1. Holds a current license issued by the office to do | ||
| 128 | business in this state as a pharmacy benefit manager. | ||
| 129 | 2. Is ready and able to arrange for pharmacist's services | ||
| 130 | in this state. | ||
| 131 | 3. Meets the requirements set forth in this section and in | ||
| 132 | rules adopted under this section. | ||
| 133 | 4. Is in compliance with all applicable state and federal | ||
| 134 | laws and regulations. | ||
| 135 | (d) The board may suspend or revoke any certificate of | ||
| 136 | authority issued to a pharmacy benefit manager under this | ||
| 137 | section, deny an application for a certificate of authority to | ||
| 138 | an applicant, or deny an application for renewal of a | ||
| 139 | certificate of authority if it finds that: | ||
| 140 | 1. The pharmacy benefit manager is operating materially in | ||
| 141 | contravention of: | ||
| 142 | a. Its application or other information submitted as a | ||
| 143 | part of its application for a certificate of authority or | ||
| 144 | renewal of its certificate of authority; or | ||
| 145 | b. Any condition imposed by the board with regard to the | ||
| 146 | issuance or renewal of its certificate of authority; | ||
| 147 | 2. The pharmacy benefit manager does not arrange for | ||
| 148 | pharmacist's services; | ||
| 149 | 3. The pharmacy benefit manager has failed to continuously | ||
| 150 | meet the requirements for issuance of a certificate of authority | ||
| 151 | as set forth in this section or any rules adopted under this | ||
| 152 | section; | ||
| 153 | 4. The pharmacy benefit manager has otherwise failed to | ||
| 154 | substantially comply with this section or any rules adopted | ||
| 155 | under this section; | ||
| 156 | 5. The continued operation of the pharmacy benefit manager | ||
| 157 | may be hazardous to patients; or | ||
| 158 | 6. The pharmacy benefit manager has failed to | ||
| 159 | substantially comply with any applicable state or federal law or | ||
| 160 | regulation. | ||
| 161 | (e)1. When the certificate of authority of a pharmacy | ||
| 162 | benefit manager is revoked, the manager shall: | ||
| 163 | a. Proceed, immediately following the effective date of | ||
| 164 | the order of revocation, to wind up its affairs. | ||
| 165 | b. Conduct no further business except as may be essential | ||
| 166 | to the orderly conclusion of its affairs. | ||
| 167 | 2. The board may permit any further operation of the | ||
| 168 | pharmacy benefit manager as the board may find to be in the best | ||
| 169 | interest of patients to the end that patients will have the | ||
| 170 | greatest practical opportunity to obtain pharmacist's services. | ||
| 171 | (5) LICENSE TO DO BUSINESS.-- | ||
| 172 | (a)1. No person or organization shall establish or operate | ||
| 173 | as a pharmacy benefit manager in this state without first | ||
| 174 | obtaining a license from the office in accordance with this | ||
| 175 | section and all applicable federal and state laws. | ||
| 176 | 2. A pharmacy benefit manager doing business in this state | ||
| 177 | shall obtain a license from the office within 60 days after the | ||
| 178 | effective date of this section and each year thereafter. | ||
| 179 | (b)1. An application for a license to operate in this | ||
| 180 | state as a pharmacy benefit manager shall be in a form | ||
| 181 | prescribed by the office and shall be verified by an officer or | ||
| 182 | authorized representative of the pharmacy benefit manager. | ||
| 183 | 2. The application shall include at least the following: | ||
| 184 | a. All organizational documents, including, but not | ||
| 185 | limited to, articles of incorporation, bylaws, and other similar | ||
| 186 | documents and any amendments. | ||
| 187 | b. The names, addresses, and titles of individuals | ||
| 188 | responsible for the business and services provided, including | ||
| 189 | all claims-processing services and other prescription drug or | ||
| 190 | device services. | ||
| 191 | c. The names, addresses, titles, and qualifications of the | ||
| 192 | members and officers of the board of directors, board of | ||
| 193 | trustees, or other governing body or committee, or the partners | ||
| 194 | or owners in case of a partnership, other entity, or | ||
| 195 | association. | ||
| 196 | d. A detailed description of the claims-processing | ||
| 197 | services and other prescription drug or device services provided | ||
| 198 | or to be provided. | ||
| 199 | e. The name and address of the agent for service of | ||
| 200 | process in this state. | ||
| 201 | f. Financial statements for the current and the preceding | ||
| 202 | year showing the assets, liabilities, direct or indirect income, | ||
| 203 | and any other sources of financial support sufficient, as deemed | ||
| 204 | by the office, to show financial stability and viability to meet | ||
| 205 | its full obligations to pharmacies and pharmacists. | ||
| 206 | g. A bond in an amount determined by the office by rule to | ||
| 207 | ensure that funds received by the pharmacy benefit manager for | ||
| 208 | pharmacist's services are, in fact, paid to appropriate | ||
| 209 | pharmacies and pharmacists. | ||
| 210 | h. All incentive arrangements or programs such as rebates, | ||
| 211 | discounts, disbursements, or any other similar financial program | ||
| 212 | or arrangement relating to income or consideration received or | ||
| 213 | negotiated, directly or indirectly, with any pharmaceutical | ||
| 214 | company that relates to other prescription drug or device | ||
| 215 | services, including, but not limited to: | ||
| 216 | (I) Information on the formula or other method for | ||
| 217 | calculation and amount of the incentive arrangements, rebates, | ||
| 218 | or other disbursements. | ||
| 219 | (II) The identity of the associated drug or device. | ||
| 220 | (III) The dates and amounts of the disbursements. | ||
| 221 | i. Other information as the office may require. | ||
| 222 | (c) The office shall not issue an annual pharmacy benefit | ||
| 223 | manager license to do business in this state to any pharmacy | ||
| 224 | benefit manager until the office is satisfied that the pharmacy | ||
| 225 | benefit manager has: | ||
| 226 | 1. Paid all fees, taxes, and charges required by law. | ||
| 227 | 2. Filed a financial statement or statements and any | ||
| 228 | reports, certificates, or other documents the office considers | ||
| 229 | necessary to secure a full and accurate knowledge of the | ||
| 230 | pharmacy benefit manager's affairs and financial condition. | ||
| 231 | 3.a. Established its solvency. | ||
| 232 | b. Satisfied the office that the pharmacy benefit | ||
| 233 | manager's financial condition, method of operation, and manner | ||
| 234 | of doing business make it possible for the pharmacy benefit | ||
| 235 | manager to meet its obligations to pharmacies and pharmacists. | ||
| 236 | 4. Otherwise complied with all the requirements of law. | ||
| 237 | 5. Obtained a bond in an amount determined by the office | ||
| 238 | to ensure that funds received by the pharmacy benefit manager | ||
| 239 | for pharmacist's services are, in fact, paid to appropriate | ||
| 240 | pharmacies and pharmacists. | ||
| 241 | (d)1. The annual pharmacy benefit manager license shall be | ||
| 242 | in addition to the certificate of authority issued by the board. | ||
| 243 | 2. A nonrefundable license application fee of $500 shall | ||
| 244 | accompany each application for a license to transact business in | ||
| 245 | this state. | ||
| 246 | 3. The fee shall be collected by the office and paid | ||
| 247 | directly into the Insurance Commissioner's Regulatory Trust Fund | ||
| 248 | to provide expenses for the regulation, supervision, and | ||
| 249 | examination of all entities subject to regulation under this | ||
| 250 | section. | ||
| 251 | (e) The pharmacy benefit manager license shall be signed | ||
| 252 | by the office or an authorized agent of the office and shall | ||
| 253 | expire 1 year after the date the license becomes effective. | ||
| 254 | (f)1. A pharmacy benefit manager transacting business in | ||
| 255 | this state shall obtain an annual renewal of its license from | ||
| 256 | the office. | ||
| 257 | 2. The office may refuse to renew the license of any | ||
| 258 | pharmacy benefit manager or may renew the license, subject to | ||
| 259 | any restrictions considered appropriate by the office, if the | ||
| 260 | office finds that the pharmacy benefit manager has not satisfied | ||
| 261 | all the conditions stated in this section. | ||
| 262 | 3.a. Before denying renewal of a license, the office shall | ||
| 263 | provide the pharmacy benefit manager: | ||
| 264 | (I) At least 10 days' advance notice of the denial. | ||
| 265 | (II) An opportunity to appear at a formal or informal | ||
| 266 | hearing. | ||
| 267 | b. The office and the pharmacy benefit manager may jointly | ||
| 268 | waive the required notice. | ||
| 269 | (6) RULES.-- | ||
| 270 | (a) The board may adopt rules not inconsistent with this | ||
| 271 | section regulating pharmacy benefit managers with regard to | ||
| 272 | professional, public health, and public safety issues. | ||
| 273 | (b) The office may adopt rules not inconsistent with this | ||
| 274 | section regulating pharmacy benefit managers with regard to | ||
| 275 | business and financial issues. | ||
| 276 | (c) Rules adopted under this section may set penalties, | ||
| 277 | including, but not limited to, monetary fines, for violations of | ||
| 278 | this section and rules adopted under this section. | ||
| 279 | (7) ANNUAL STATEMENT.-- | ||
| 280 | (a)1. A pharmacy benefit manager doing business in this | ||
| 281 | state shall file a statement with the office annually by March | ||
| 282 | 1. | ||
| 283 | 2. The statement shall be verified by at least two | ||
| 284 | principal officers of the pharmacy benefit manager and shall | ||
| 285 | cover the preceding calendar year. | ||
| 286 | (b) The statement shall be on forms prescribed by the | ||
| 287 | office and shall include: | ||
| 288 | 1. A financial statement of the organization, including | ||
| 289 | its balance sheet and income statement for the preceding year. | ||
| 290 | 2. The number and dollar value of claims for pharmacist's | ||
| 291 | services processed by the pharmacy benefit manager during the | ||
| 292 | preceding year with respect to patients who are residents of | ||
| 293 | this state. | ||
| 294 | 3. Any other information relating to the operations of the | ||
| 295 | pharmacy benefit manager required by the office. | ||
| 296 | (c) If a pharmacy benefit manager is audited annually by | ||
| 297 | an independent certified public accountant, a copy of each | ||
| 298 | certified audit report shall be promptly filed with the office. | ||
| 299 | (d)1. The office may extend the time prescribed for any | ||
| 300 | pharmacy benefit manager for filing annual statements or other | ||
| 301 | reports or exhibits for good cause shown. | ||
| 302 | 2. The office may not extend the time for filing annual | ||
| 303 | statements beyond 60 days after the time prescribed in this | ||
| 304 | section. | ||
| 305 | 3. Until the annual statement is filed, the office may | ||
| 306 | revoke or suspend the license of a pharmacy benefit manager that | ||
| 307 | fails to file its annual statement within the time prescribed by | ||
| 308 | this section. | ||
| 309 | (8) FINANCIAL EXAMINATION.-- | ||
| 310 | (a)1. The office shall regularly conduct financial | ||
| 311 | examinations of all pharmacy benefit managers doing business in | ||
| 312 | this state pursuant to a schedule and in a manner established by | ||
| 313 | rule. | ||
| 314 | 2. The examination shall verify: | ||
| 315 | a. The financial ability of the pharmacy benefit manager | ||
| 316 | to meet its full obligations to pharmacies and pharmacists. | ||
| 317 | b. Information submitted to the office as a part of an | ||
| 318 | application for a license or renewal of a license. | ||
| 319 | c. Compliance with this section. | ||
| 320 | (b) In lieu of, or in addition to, making the financial | ||
| 321 | examination of a pharmacy benefit manager, the office may accept | ||
| 322 | the report of a financial examination of the pharmacy benefit | ||
| 323 | manager under the laws of another state certified by its | ||
| 324 | insurance office, similar regulatory agency, or state health | ||
| 325 | agency to the extent that the report of financial examination | ||
| 326 | covers the minimum requirements specified in paragraph (a). | ||
| 327 | (c)1. The office shall coordinate financial examinations | ||
| 328 | of pharmacy benefit managers to ensure an appropriate level of | ||
| 329 | regulatory oversight and to avoid any undue duplication of | ||
| 330 | effort or regulation. | ||
| 331 | 2. The pharmacy benefit manager being examined shall pay | ||
| 332 | the cost of the examination. | ||
| 333 | 3. The cost of the examination shall be deposited into the | ||
| 334 | Insurance Commissioner's Regulatory Trust Fund to provide all | ||
| 335 | expenses for the regulation, supervision, and examination of all | ||
| 336 | entities subject to regulation under this section. | ||
| 337 | (9) ASSESSMENT.-- | ||
| 338 | (a) Except as provided in subparagraph (8)(c)3., the | ||
| 339 | expense of administering this section incurred by the office | ||
| 340 | shall be assessed annually by the office against all pharmacy | ||
| 341 | benefit managers operating in this state. | ||
| 342 | (b) The office shall assess each pharmacy benefit manager | ||
| 343 | annually for its share of the office's estimated expenses with | ||
| 344 | regard to this section in proportion to the business done in | ||
| 345 | this state, as determined by the office in the office's | ||
| 346 | reasonable discretion. | ||
| 347 | (c)1. The office shall give each pharmacy benefit manager | ||
| 348 | notice of the assessment, which shall be paid to the office | ||
| 349 | before March 2 of each year. | ||
| 350 | 2. A pharmacy benefit manager that fails to pay the | ||
| 351 | assessment before March 2 of each year shall be subject to a | ||
| 352 | penalty imposed by the office. | ||
| 353 | 3. The penalty shall be 10 percent of the assessment plus | ||
| 354 | interest for the period between the due date and the date of | ||
| 355 | full payment. | ||
| 356 | 4. If a payment is made in an amount later found to be in | ||
| 357 | error, the office shall: | ||
| 358 | a. If an additional amount is due: | ||
| 359 | (I) Notify the pharmacy benefit manager of the additional | ||
| 360 | amount due. | ||
| 361 | (II) Order the pharmacy benefit manager to pay the | ||
| 362 | additional amount within 14 days after the date of the notice. | ||
| 363 | b. If an overpayment is made, order a refund to the | ||
| 364 | pharmacy benefit manager. | ||
| 365 | (d)1. If an assessment made under this section is not paid | ||
| 366 | to the office by the prescribed date, the amount of the | ||
| 367 | assessment, plus any penalty, may be recovered from the | ||
| 368 | defaulting pharmacy benefit manager on motion of the office made | ||
| 369 | in the name and for the use of the State of Florida in the | ||
| 370 | Circuit Court of Leon County, after 10 days' notice to the | ||
| 371 | pharmacy benefit manager. | ||
| 372 | 2. The license of any defaulting pharmacy benefit manager | ||
| 373 | to transact business in this state may be revoked or suspended | ||
| 374 | by the office until the pharmacy benefit manager has paid the | ||
| 375 | assessment. | ||
| 376 | (e) All fees assessed under this section and paid to the | ||
| 377 | office shall be deposited into the Insurance Commissioner's | ||
| 378 | Regulatory Trust Fund to provide all expenses for the | ||
| 379 | regulation, supervision, and examination by the office of all | ||
| 380 | entities subject to regulation under this section. | ||
| 381 | (f) If a pharmacy benefit manager becomes insolvent or | ||
| 382 | ceases to do business in this state in any assessable or license | ||
| 383 | year, the pharmacy benefit manager shall remain liable for the | ||
| 384 | payment of the assessment for the period in which it operated as | ||
| 385 | a pharmacy benefit manager in this state. | ||
| 386 | (10) PHARMACY BENEFIT MANAGER CONTRACTS.-- | ||
| 387 | (a)1. A pharmacy benefit manager that contracts with a | ||
| 388 | pharmacy or pharmacist to provide pharmacist's services in this | ||
| 389 | state shall first inform the pharmacy or pharmacist in writing | ||
| 390 | of the number of, and other relevant information concerning, | ||
| 391 | patients to be served by the pharmacy or pharmacist under the | ||
| 392 | contract. | ||
| 393 | 2. There shall be a separate contract with each pharmacy | ||
| 394 | or pharmacist for each of the pharmacy benefit manager's | ||
| 395 | provider networks. | ||
| 396 | 3. Contracts providing for indemnity of the pharmacy or | ||
| 397 | pharmacist shall be separate from contracts providing for cash | ||
| 398 | discounts. | ||
| 399 | 4. A pharmacy benefit manager shall not require that a | ||
| 400 | pharmacy or pharmacist participate in one contract in order to | ||
| 401 | participate in another contract. | ||
| 402 | (b) Each pharmacy benefit manager shall provide contracts | ||
| 403 | to the pharmacies and pharmacists that are written in plain | ||
| 404 | English, using terms that will be generally understood by | ||
| 405 | pharmacists. | ||
| 406 | (c) All contracts between a pharmacy benefit manager and a | ||
| 407 | pharmacy or pharmacist shall provide specific time limits for | ||
| 408 | the pharmacy benefit manager to pay the pharmacy or pharmacist | ||
| 409 | for pharmacist's services rendered. | ||
| 410 | (d) No pharmacy benefit manager contract may mandate that | ||
| 411 | any pharmacy or pharmacist change a patient's maintenance drug | ||
| 412 | unless the prescribing practitioner so orders. | ||
| 413 | (e)1. In handling moneys received by the pharmacy benefit | ||
| 414 | manager for pharmacist's services, the pharmacy benefit manager | ||
| 415 | acts as a fiduciary of the pharmacy, pharmacist, or both, that | ||
| 416 | provided the pharmacist's services. | ||
| 417 | 2. A pharmacy benefit manager shall distribute all moneys | ||
| 418 | the pharmacy benefit manager receives for pharmacist's services | ||
| 419 | to the pharmacies and pharmacists that provided the pharmacist's | ||
| 420 | services and shall do so within a time established by the | ||
| 421 | office. | ||
| 422 | (f)1. A pharmacy benefit manager that contracts with a | ||
| 423 | pharmacy or pharmacist to provide pharmacist's services in this | ||
| 424 | state shall file the contract forms with the office 30 days | ||
| 425 | before the execution of the contract. | ||
| 426 | 2.a. The contract forms are approved unless the office | ||
| 427 | disapproves the contract forms within 30 days after filing with | ||
| 428 | the office. | ||
| 429 | b. Disapproval shall be in writing, stating the reasons | ||
| 430 | for the disapproval, and a copy shall be delivered to the | ||
| 431 | pharmacy benefit manager. | ||
| 432 | c. The office shall develop formal criteria for the | ||
| 433 | approval and disapproval of pharmacy benefit manager contract | ||
| 434 | forms. | ||
| 435 | (g)1. A pharmacy benefit manager that initiates an audit | ||
| 436 | of a pharmacy or pharmacist under the contract shall limit the | ||
| 437 | audit to methods and procedures that are recognized as fair and | ||
| 438 | equitable for both the pharmacy benefit manager and the pharmacy | ||
| 439 | or pharmacist, or both. | ||
| 440 | 2. Extrapolation calculations in an audit are prohibited. | ||
| 441 | 3. A pharmacy benefit manager may not recoup any moneys | ||
| 442 | due from an audit by setoff from future remittances until the | ||
| 443 | results of the audit are finalized. | ||
| 444 | (h) Before terminating a pharmacy or pharmacist from a | ||
| 445 | pharmacy benefit manager's provider network, the pharmacy | ||
| 446 | benefit manager shall give the pharmacy or pharmacist a written | ||
| 447 | explanation of the reason for the termination 30 days before the | ||
| 448 | actual termination unless the termination is taken in reaction | ||
| 449 | to: | ||
| 450 | 1. Loss of license; | ||
| 451 | 2. Loss of professional liability insurance; or | ||
| 452 | 3. Conviction of fraud or misrepresentation. | ||
| 453 | (i)1. No pharmacy or pharmacist may be held responsible | ||
| 454 | for the acts or omissions of a pharmacy benefit manager. | ||
| 455 | 2. No pharmacy benefit manager may be held responsible for | ||
| 456 | the acts or omissions of a pharmacy or pharmacist. | ||
| 457 | (11) ENFORCEMENT.-- | ||
| 458 | (a)1. Enforcement of this section shall be the | ||
| 459 | responsibility of the board and the office. | ||
| 460 | 2. The board or the office, or both, shall take action or | ||
| 461 | impose appropriate penalties to bring a noncomplying pharmacy | ||
| 462 | benefit manager into full compliance with this section or shall | ||
| 463 | terminate the pharmacy benefit manager's certificate of | ||
| 464 | authority or license. | ||
| 465 | (b)1. The board and the office shall each adopt procedures | ||
| 466 | for formal investigation of complaints concerning the failure of | ||
| 467 | a pharmacy benefit manager to comply with this section. | ||
| 468 | 2.a. The office may refer a complaint received under this | ||
| 469 | section to the board if the complaint involves a professional or | ||
| 470 | patient health or safety issue. | ||
| 471 | b. The board may refer a complaint received under this | ||
| 472 | section to the office if the complaint involves a business or | ||
| 473 | financial issue. | ||
| 474 | 3.a. If the board or the office has reason to believe that | ||
| 475 | there may have been a violation of this section, the board or | ||
| 476 | office shall issue and serve upon the pharmacy benefit manager a | ||
| 477 | statement of the charges and a notice of a hearing. | ||
| 478 | b. The hearing shall be held at a time and place fixed in | ||
| 479 | the notice, and not be less than 30 days after the notice is | ||
| 480 | served. | ||
| 481 | c. At the hearing, the pharmacy benefit manager shall have | ||
| 482 | an opportunity to be heard and to show cause why the board or | ||
| 483 | the office should not: | ||
| 484 | (I) Issue a cease and desist order against the pharmacy | ||
| 485 | benefit manager; or | ||
| 486 | (II) Take any other necessary or appropriate action, | ||
| 487 | including, but not limited to, termination of the pharmacy | ||
| 488 | benefit manager's certificate of authority or license. | ||
| 489 | (c)1. The board may conduct an investigation concerning | ||
| 490 | the quality of services of any pharmacy benefit manager, | ||
| 491 | pharmacy, or pharmacist with whom the pharmacy benefit manager | ||
| 492 | has contracts, as the board deems necessary for the protection | ||
| 493 | of the interests of the residents of this state. | ||
| 494 | 2. In addition to applying penalties and remedies under | ||
| 495 | this section for a pharmacy benefit manager's violation of this | ||
| 496 | section, the board may also apply penalties and remedies under | ||
| 497 | any provision of state law for violation thereof. | ||
| 498 | (12) MEDICATION REIMBURSEMENT COSTS.-- | ||
| 499 | (a) Pharmacy benefit managers shall use a current | ||
| 500 | nationally recognized benchmark to base reimbursements for | ||
| 501 | medications and products dispensed by pharmacies or pharmacists | ||
| 502 | with whom the pharmacy benefit manager contracts as follows: | ||
| 503 | 1. For brand single-source drugs and brand multi-source | ||
| 504 | drugs, either the Average Wholesale Price as listed in First | ||
| 505 | Data Bank (Hearst Publications) or Facts & Comparisons (formerly | ||
| 506 | Medispan) shall be used as an index. | ||
| 507 | 2. For generic multi-source drugs, maximum allowable costs | ||
| 508 | shall be established by referencing the Baseline Price as listed | ||
| 509 | in either First Data Bank or Facts & Comparisons. | ||
| 510 | a. Only products that are in compliance with pharmacy laws | ||
| 511 | as equivalent and generically interchangeable with a United | ||
| 512 | States Food and Drug Administration Orange Book rating of A-B | ||
| 513 | may be reimbursed from a maximum allowable cost price | ||
| 514 | methodology. | ||
| 515 | b. If a generic multi-source drug product has no baseline | ||
| 516 | price, then it shall be treated as a brand single-source drug | ||
| 517 | for the purpose of valuing reimbursement. | ||
| 518 | (b) If the publications specified in paragraph (a) cease | ||
| 519 | to be nationally recognized benchmarks used to base | ||
| 520 | reimbursement for medications and products dispensed by | ||
| 521 | pharmacies and pharmacists, other current nationally recognized | ||
| 522 | benchmarks, as are then current and in effect, may be utilized | ||
| 523 | so long as the benchmark is established and published by a | ||
| 524 | person, business, or other entity with which no pharmacy benefit | ||
| 525 | manager has a financial or business interest or connection. | ||
| 526 | (13) PROHIBITED PRACTICES.-- | ||
| 527 | (a) Neither a pharmacy benefit manager nor a | ||
| 528 | representative of a pharmacy benefit manager may cause or | ||
| 529 | knowingly permit the use of any advertisement, promotion, | ||
| 530 | solicitation, proposal, or offer that is untrue, deceptive, or | ||
| 531 | misleading. | ||
| 532 | (b) A pharmacy benefit manager may not discriminate on the | ||
| 533 | basis of race, creed, color, sex, or religion in the selection | ||
| 534 | of pharmacies or pharmacists with which the pharmacy benefit | ||
| 535 | manager contracts. | ||
| 536 | (c) A pharmacy benefit manager may not unreasonably | ||
| 537 | discriminate against or between pharmacies or pharmacists. | ||
| 538 | (d) A pharmacy benefit manager shall be entitled to access | ||
| 539 | a pharmacy's or pharmacist's usual and customary price only for | ||
| 540 | comparison to specific claims for payment made by the pharmacy | ||
| 541 | or pharmacist to the pharmacy benefit manager, and any other use | ||
| 542 | or disclosure by the pharmacy benefit manager is prohibited. | ||
| 543 | (e) A pharmacy benefit manager may not, directly or | ||
| 544 | indirectly, overtly or covertly, in cash or in kind, receive or | ||
| 545 | accept any rebate, kickback, or any special payment, favor, or | ||
| 546 | advantage of any valuable consideration or inducement for | ||
| 547 | influencing or switching a patient's drug product unless the | ||
| 548 | rebate, kickback, payment, favor, valuable consideration, or | ||
| 549 | inducement is specified in a written contract that has been | ||
| 550 | filed with the office. | ||
| 551 | (f)1. Claims for pharmacist's services paid by a pharmacy | ||
| 552 | benefit manager may not be retroactively denied or adjusted | ||
| 553 | after adjudication of the claims, unless: | ||
| 554 | a. The original claim was submitted fraudulently; | ||
| 555 | b. The original claim payment was incorrect because the | ||
| 556 | pharmacy or pharmacist had already been paid for the | ||
| 557 | pharmacist's services; or | ||
| 558 | c. The pharmacist's services were not, in fact, rendered | ||
| 559 | by the pharmacy or pharmacist. | ||
| 560 | 2. An acknowledgement of eligibility may not be | ||
| 561 | retroactively reversed. | ||
| 562 | (g) A pharmacy benefit manager may not terminate a | ||
| 563 | contract with a pharmacy or pharmacist, or terminate, suspend, | ||
| 564 | or otherwise limit the participation of a pharmacy or pharmacist | ||
| 565 | in a pharmacy benefit manager's provider network, because: | ||
| 566 | 1. The pharmacy or pharmacist expresses disagreement with | ||
| 567 | the pharmacy benefit manager's decision to deny or limit | ||
| 568 | benefits to a patient; | ||
| 569 | 2. The pharmacist discusses with a patient any aspect of | ||
| 570 | the patient's medical condition or treatment alternatives; | ||
| 571 | 3. The pharmacist makes personal recommendations regarding | ||
| 572 | selecting a pharmacy benefit manager based on the pharmacist's | ||
| 573 | personal knowledge of the health needs of the patient; | ||
| 574 | 4. The pharmacy or pharmacist protests or expresses | ||
| 575 | disagreement with a decision, policy, or practice of the | ||
| 576 | pharmacy benefit manager; | ||
| 577 | 5. The pharmacy or pharmacist has in good faith | ||
| 578 | communicated with or advocated on behalf of any patient related | ||
| 579 | to the needs of the patient regarding the method by which the | ||
| 580 | pharmacy or pharmacist is compensated for services provided | ||
| 581 | under the contract with the pharmacy benefit manager; | ||
| 582 | 6. The pharmacy or pharmacist complains to the board or | ||
| 583 | office that the pharmacy benefit manager has failed to comply | ||
| 584 | with this section; or | ||
| 585 | 7. The pharmacy or pharmacist asserts rights under the | ||
| 586 | contract with the pharmacy benefit manager. | ||
| 587 | (h) Termination of a contract between a pharmacy benefit | ||
| 588 | manager and a pharmacy or pharmacist, or termination of a | ||
| 589 | pharmacy or pharmacist from a pharmacy benefit manager's | ||
| 590 | provider network, shall not release the pharmacy benefit manager | ||
| 591 | from the obligation to make any payment due to the pharmacy or | ||
| 592 | pharmacist for pharmacist's services rendered. | ||
| 593 | (i) A pharmacy benefit manager may not intervene in the | ||
| 594 | delivery or transmission of prescriptions from the prescriber to | ||
| 595 | the pharmacist or pharmacy for the purpose of: | ||
| 596 | 1. Influencing the prescriber's choice of therapy; | ||
| 597 | 2. Influencing the patient's choice of pharmacist or | ||
| 598 | pharmacy; or | ||
| 599 | 3. Altering the prescription information, including, but | ||
| 600 | not limited to, switching the prescribed drug without the | ||
| 601 | express written authorization of the prescriber. | ||
| 602 | (j) A pharmacy benefit manager may not engage in or | ||
| 603 | interfere with the practice of medicine or intervene in the | ||
| 604 | practice of medicine between prescribers and their patients. | ||
| 605 | (k) A pharmacy benefit manager may not engage in any | ||
| 606 | activity that violates any requirement of Florida law. | ||
| 607 | (14) NO IMPAIRMENT OF EXISTING CONTRACTS.--To avoid | ||
| 608 | impairment of existing contracts, this section shall apply only | ||
| 609 | to contracts entered into or renewed after the effective date of | ||
| 610 | this section. | ||
| 611 | (15) SUPPLEMENTAL NATURE.--This section is supplemental to | ||
| 612 | all other laws and supersedes only those laws or parts of laws | ||
| 613 | in direct conflict with it. | ||
| 614 | Section 2. This act shall take effect upon becoming a law. | ||
| 615 | |||
| 616 | |||