Florida Senate - 2018 COMMITTEE AMENDMENT Bill No. CS for SB 710 Ì717750(Î717750 LEGISLATIVE ACTION Senate . House . . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— Appropriations Subcommittee on Health and Human Services (Book) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 6 Section 1. Section 465.1902, Florida Statutes, is created 7 to read: 8 465.1902 Prescription Drug Donation Repository Program.— 9 (1) SHORT TITLE.—This section may be cited as the 10 “Prescription Drug Donation Repository Program Act.” 11 (2) PRESCRIPTION DRUG DONATION REPOSITORY PROGRAM.—The 12 Prescription Drug Donation Repository Program is created within 13 the Department of Health for the purpose of authorizing and 14 facilitating the donation of prescription drugs and supplies to 15 eligible patients. The department may contract with a third 16 party to implement and administer the program. 17 (3) DEFINITIONS.—As used in this section, the term: 18 (a) “Centralized repository” means a distributor permitted 19 pursuant to chapter 499 which is approved by the department or 20 the contractor to accept, inspect, inventory, and distribute 21 donated drugs and supplies under this section. 22 (b) “Closed drug delivery system” means a system in which 23 the actual control of the unit-dose medication package is 24 maintained by the facility rather than by the individual 25 patient. 26 (c) “Contractor” means the third-party vendor approved by 27 the department to implement and administer the program. 28 (d) “Controlled substance” means any substance listed under 29 Schedule II, Schedule III, Schedule IV, or Schedule V of s. 30 893.03. 31 (e) “Department” means Department of Health. 32 (f) “Direct-support organization” means an entity that is 33 established pursuant to s. 20.058 and is: 34 1. A Florida corporation not for profit incorporated under 35 chapter 617, exempted from filing fees, and approved by the 36 Department of State. 37 2. Organized and operated to conduct programs and 38 activities; raise funds and request and receive grants, gifts, 39 and bequests of moneys; acquire, receive, hold, and invest, in 40 its own name, securities, funds, objects of value, or other 41 property, either real or personal; and make expenditures or 42 provide funding to or for the direct or indirect benefit of the 43 program. 44 (g) “Dispenser” means a dispensing health care practitioner 45 or pharmacist licensed to dispense medicinal drugs in the state. 46 (h) “Donor” means an entity that meets the requirements of 47 subsection (4). 48 (i) “Eligible patient” means a Florida resident who is 49 indigent, uninsured, or underinsured and has a valid 50 prescription for a prescription drug or supply that is eligible 51 for dispensing under the program. 52 (j) “Free clinic” means a clinic that delivers only medical 53 diagnostic services or nonsurgical medical treatment free of 54 charge to all low-income recipients. 55 (k) “Health care practitioner” or “practitioner” means a 56 practitioner licensed under chapter 458, chapter 459, chapter 57 461, chapter 463, chapter 464, chapter 465, or chapter 466. 58 (l) “Indigent” means a person with an income that is below 59 200 percent of the federal poverty level as defined by the most 60 recently revised poverty income guidelines published by the 61 United States Department of Health and Human Services. 62 (m) “Local repository” means a health care practitioner’s 63 office, a pharmacy, a hospital with a closed drug delivery 64 system, a nursing home facility with a closed drug delivery 65 system, a free clinic, or a nonprofit health clinic that is 66 licensed or permitted to dispense medicinal drugs in the state. 67 (n) “Nonprofit health clinic” means a nonprofit legal 68 entity that provides medical care to patients who are indigent, 69 uninsured, or underinsured, including, but not limited to, a 70 federally qualified health center as defined in 42 U.S.C. s. 71 1396d(l)(2)(B) and a rural health clinic as defined in 42 U.S.C. 72 s. 1396d(l)(1). 73 (o) “Nursing home facility” has the same meaning as in s. 74 400.021(12). 75 (p) “Prescriber” means a prescribing physician, prescribing 76 practitioner, or other health care practitioner authorized by 77 the laws of this state to prescribe medicinal drugs. 78 (q) “Prescription drug” has the same meaning as defined in 79 s. 465.003(8), but does not include controlled substances or 80 cancer drugs donated under s. 499.029. 81 (r) “Program” means the Prescription Drug Donation 82 Repository Program created by this section. 83 (s) “Supplies” means any supply used in the administration 84 of a prescription drug. 85 (t) “Tamper-evident packaging” means a package that has one 86 or more indicators or barriers to entry which, if breached or 87 missing, can reasonably be expected to provide visible evidence 88 to consumers that tampering has occurred. 89 (u) “Underinsured” means a person who has third-party 90 insurance or is eligible to receive prescription drugs or 91 supplies through the Medicaid program or any other prescription 92 drug program funded in whole or in part by the Federal 93 Government, but has exhausted these benefits or does not have 94 prescription drug coverage for the drug prescribed. 95 (v) “Uninsured” means a person who has no third-party 96 insurance and is not eligible to receive prescription drugs or 97 supplies through the Medicaid program or any other prescription 98 drug program funded in whole or in part by the Federal 99 Government. 100 (4) DONOR ELIGIBILITY.—The program may only accept a 101 donation of a prescription drug or supply from: 102 (a) Nursing home facilities with closed drug delivery 103 systems. 104 (b) Hospices that have maintained control of a patient’s 105 prescription drug. 106 (c) Hospitals with closed drug delivery systems. 107 (d) Pharmacies. 108 (e) Drug manufacturers or wholesale distributors. 109 (f) Medical device manufacturers or suppliers. 110 (g) Prescribers who receive prescription drugs or supplies 111 directly from a drug manufacturer, wholesale distributor, or 112 pharmacy. 113 (5) PRESCRIPTION DRUGS AND SUPPLIES ELIGIBLE FOR DONATION.— 114 (a) All prescription drugs and supplies that have been 115 approved for medical use in the United States and meet the 116 criteria for donation established by this section may be 117 accepted for donation under the program. 118 (b) The centralized repository or a local repository may 119 accept a prescription drug only if: 120 1. The drug is in its original sealed and tamper-evident 121 packaging. Single-unit-dose drugs may be accepted if the single 122 unit-dose packaging is unopened. 123 2. The drug requires storage at normal room temperature per 124 the manufacturer or the United States Pharmacopeia. 125 3. The drug has been stored according to manufacturer or 126 United States Pharmacopeia storage requirements. 127 4. The drug does not have any physical signs of tampering 128 or adulteration and there is no reason to believe that the drug 129 is adulterated. 130 5. The packaging does not have any physical signs of 131 tampering, misbranding, deterioration, compromised integrity, or 132 adulteration. 133 6. The packaging contains the lot number and expiration 134 date of the drug. If the lot number is not retrievable, all 135 specified medications must be destroyed in the event of a 136 recall. 137 7. The drug has an expiration date that is more than 3 138 months after the date that the drug was donated. 139 (c) The central repository or a local repository may only 140 accept supplies that are in their original, unopened, sealed 141 packaging and have not been adulterated or misbranded. 142 (d) Prescription drugs and supplies may be donated on the 143 premises of the centralized repository or a local repository to 144 a person designated by the repository. A drop box may not be 145 used to accept donations. 146 (e) Prescription drugs or supplies may not be donated to a 147 specific patient. 148 (f) Prescription drugs billed to and paid for by Medicaid 149 in long-term care facilities which are eligible for return to 150 stock under federal Medicaid regulations must be credited to 151 Medicaid and are not eligible for donation under the program. 152 (g) Prescription drugs that are subject to a Federal Food 153 and Drug Administration Risk Evaluation and Mitigation Strategy 154 with Elements to Assure Safe Use are not eligible for donation 155 under the program. 156 (h) Nothing in this section requires the central repository 157 or a local repository to accept a donation of a prescription 158 drug or supplies. 159 (6) INSPECTION AND STORAGE.— 160 (a) A licensed pharmacist employed by or under contract 161 with the centralized repository or a local repository shall 162 inspect donated prescription drugs and supplies to determine 163 whether the donated prescription drugs or supplies: 164 1. Are eligible for donation under the program; 165 2. Have been adulterated or misbranded; and 166 3. Are safe and suitable for dispensing. 167 (b) The pharmacist who inspects the donated prescription 168 drugs or supplies shall sign an inspection record on a form 169 prescribed by the department and adopted in rule verifying that 170 the criteria of paragraph (a) have been met and attach such 171 record to the copy of the inventory record. If a local 172 repository receives drugs and supplies from the centralized 173 repository, the local repository is not required to reinspect 174 the drugs and supplies. 175 (c) The centralized repository and local repositories shall 176 store donated prescription drugs and supplies in a secure 177 storage area under the environmental conditions specified by the 178 manufacturer or United States Pharmacopeia for the prescription 179 drugs or supplies being stored. Donated prescription drugs and 180 supplies may not be stored with nondonated inventory. A local 181 repository shall quarantine any donated prescription drugs or 182 supplies from all dispensing stock until the donated 183 prescription drugs or supplies are inspected and approved for 184 dispensing under the program. 185 (d) A local repository shall maintain an inventory of all 186 donated prescription drugs or supplies it receives. Such 187 inventory shall be recorded on a form prescribed by the 188 department and adopted in rule. 189 (e) A local repository shall notify the centralized 190 repository within 5 days after receipt of any donation of 191 prescription drugs or supplies to the program. The notification 192 shall be on a form prescribed by the department and adopted by 193 rule. 194 (f) The centralized repository shall maintain an inventory 195 of all prescription drugs and supplies donated to the program. 196 (g) The centralized repository may redistribute 197 prescription drugs and supplies to facilitate dispensing to 198 either the centralized repository or to a local repository, as 199 needed. 200 (7) LOCAL REPOSITORY NOTICE OF PARTICIPATION.— 201 (a) A local repository must notify the department of its 202 intent to participate in the program before accepting or 203 dispensing any prescription drugs or supplies pursuant to this 204 section. The notification shall be on a form prescribed by the 205 department and adopted by rule and must, at a minimum, include: 206 1. The name, street address, website, and telephone number 207 of the local repository and any state-issued license or 208 registration number issued to the local repository, including 209 the name of the issuing agency. 210 2. The name and telephone number of the pharmacist employed 211 by or under contract with the local repository who is 212 responsible for the inspection of donated prescription drugs and 213 supplies. 214 3. A statement signed and dated by the responsible 215 pharmacist affirming that the local repository meets the 216 eligibility requirements of this section. 217 (b) A local repository may withdraw from participation in 218 the program at any time by providing written notice to the 219 department or contractor on a form prescribed by the department 220 and adopted by rule. The department shall adopt rules addressing 221 the disposition of any prescription drugs in the possession of 222 the local repository. 223 (8) DISPENSING.— 224 (a) Each eligible patient without a program identification 225 card must submit an intake collection form to a local repository 226 before receiving prescription drugs or supplies under the 227 program. The form shall be prescribed by the department and 228 adopted by rule and, at a minimum, must include: 229 1. The name, street address, and telephone number of the 230 eligible patient. 231 2. The basis for eligibility, which must specify that the 232 patient is indigent, uninsured, or underinsured. 233 3. A statement signed and dated by the eligible patient 234 affirming that he or she meets the eligibility requirements of 235 this section. 236 (b) A local repository shall collect a signed and dated 237 intake collection form from each eligible patient receiving 238 prescription drugs or supplies under the program. The local 239 repository must issue a program identification card upon receipt 240 of a duly executed intake collection form. The program 241 identification card is valid for 1 year after issuance and must 242 be in a form prescribed by the department and adopted in rule. 243 (c) A local repository must send a summary of the intake 244 collection form data to the centralized pharmacy within 5 days 245 after receipt of a duly executed intake collection form. 246 (d) A dispenser may only dispense a donated prescription 247 drug or supplies, if available, to an eligible patient with a 248 program identification card or a duly executed intake collection 249 form. 250 (e) A dispenser shall inspect the donated prescription 251 drugs or supplies prior to dispensing such drugs or supplies. 252 (f) A dispenser may provide dispensing and consulting 253 services to an eligible patient. 254 (g) Donated prescription drugs and supplies may not be sold 255 or resold under this program. 256 (h) A dispenser of donated prescription drugs or supplies 257 may not submit a claim or otherwise seek reimbursement from any 258 public or private third-party payor for donated prescription 259 drugs or supplies dispensed to any patient under this program. 260 However, a repository may charge a nominal handling fee, 261 established by department rule, for the preparation and 262 dispensing of prescription drugs or supplies under the program. 263 (i) A local repository that receives donated prescription 264 drugs or supplies may, with authorization from the centralized 265 repository, distribute the prescription drugs or supplies to 266 another local repository. 267 (9) RECALL AND DESTRUCTION OF PRESCRIPTION DRUGS AND 268 SUPPLIES.— 269 (a) The centralized repository and a local repository shall 270 be responsible for drug recalls and shall have an established 271 protocol to notify recipients in the event of a prescription 272 drug recall. 273 (b) Local repositories shall destroy all of the recalled or 274 expired prescription drugs or prescription drugs that are not 275 suitable for dispensing in the repository and complete a 276 destruction information form for all donated prescription drugs 277 destroyed, in accordance with rules adopted by the department. 278 (10) RECORDKEEPING.— 279 (a) Local repositories shall maintain records of 280 prescription drugs and supplies that were accepted, donated, 281 dispensed, distributed, or destroyed under the program. 282 (b) All records required to be maintained as a part of the 283 program shall be maintained in accordance with any applicable 284 practice acts. Local repositories shall submit these records 285 quarterly to the centralized repository for data collection, and 286 the centralized repository shall submit these records and the 287 collected data in annual reports to the department. 288 (11) REGISTRIES AND FORMS.— 289 (a) The department shall establish and maintain registries 290 of all local repositories and available drugs and supplies under 291 the program. The registry of local repositories must include the 292 repository’s name, address, website, and telephone number. The 293 registry of available drugs and supplies must include the name, 294 strength, available quantity, and expiration date of the drug or 295 supply and the name and contact information of the repositories 296 where such drug or supply is available. The department shall 297 publish the registries on its website. 298 (b) The department shall publish all forms required by this 299 section on its website. 300 (12) IMMUNITY.— 301 (a) Any donor of prescription drugs or supplies, or any 302 participant in the program, who exercises reasonable care in 303 donating, accepting, distributing, or dispensing prescription 304 drugs or supplies under the program, and the rules adopted 305 pursuant thereto, is immune from civil or criminal liability and 306 from professional disciplinary action of any kind for any 307 injury, death, or loss to person or property relating to such 308 activities. 309 (b) A pharmaceutical manufacturer who exercises reasonable 310 care is not liable for any claim or injury arising from the 311 transfer of any prescription drug under this section, including 312 but not limited to, liability for failure to transfer or 313 communicate product or consumer information regarding the 314 transferred drug, including the expiration date of the 315 transferred drug. 316 (13) NOTICE TO PATIENTS.–Before dispensing a prescription 317 drug that has been donated under this program, the dispenser 318 must provide written notification to the patient, or to his or 319 her legal representative, receipt of which must be acknowledged 320 in writing, that: 321 (a) The prescription drug was donated to the program; 322 (b) The donors and participants in the program are granted 323 certain immunities as described in subsection (12); and 324 (c) The patient may not be required to pay for the 325 prescription drug, except for a nominal handling fee which may 326 not exceed the amount established by department rule. 327 (14) DIRECT-SUPPORT ORGANIZATION.-The department may 328 establish a direct-support organization to provide assistance, 329 funding, and promotional support for the activities authorized 330 for the program. 331 (a) Purposes and objectives.-The purposes and objectives of 332 the direct-support organization of the program must be 333 consistent with the goals of the department, in the best 334 interest of the state, and in accordance with the adopted goals 335 and mission of the department. 336 (b) Prohibition against lobbying.–The direct-support 337 organization is not considered a lobbying firm within the 338 meaning of s. 11.045. All expenditures of the direct-support 339 organization must be used for the program. No expenditures of 340 the direct-support organization may be used for the purpose of 341 lobbying as defined in s. 11.045. 342 (c) Contract.—The direct-support organization shall operate 343 under a written contract with the department. The contract must 344 provide for a submission by the direct-support organization to 345 the department, by each August 1, and posting on the direct 346 support organization’s and department’s websites, the following 347 information: 348 1. The articles of incorporation and bylaws of the direct 349 support organization as approved by the department. 350 2. An annual budget for the approval of the department. 351 3. The code of ethics of the direct-support organization. 352 4. The statutory authority or executive order that created 353 the direct-support organization. 354 5. A brief description of the direct-support organization’s 355 mission and any results obtained by the direct-support 356 organization. 357 6. A brief description of the direct-support organization’s 358 plans for the next 3 fiscal years. 359 7. A copy of the direct-support organization’s most recent 360 federal Internal Revenue Service Return Organization Exempt from 361 Income Tax form (Form 990). 362 8. Certification by the department that the direct-support 363 organization is complying with the terms of the contract and 364 operating in a manner consistent with the goals and purposes of 365 the department and the best interest of the program and the 366 state. Such certification must be made annually and reported in 367 the official minutes of a meeting of the direct-support 368 organization. 369 9. The reversion, without penalty, of moneys and property 370 held in trust by the direct-support organization for the benefit 371 of the program to the state if the department ceases to exist; 372 or reversion to the department if the direct-support 373 organization is no longer approved to operate or ceases to 374 exist. 375 10. The fiscal year of the direct-support organization, 376 which must begin on July 1 of each year and end on June 30 of 377 the following year. 378 11. The disclosure of material provisions of the contract, 379 and the distinction between the department and the direct 380 support organization, to donors of gifts, contributions, or 381 bequests, including such disclosure on all promotional and 382 fundraising publications. 383 12. All prescription drugs solicited by the direct-support 384 organization to be distributed to the centralized repository or 385 a local repository. The direct-support organization may not 386 possess any prescription drugs on behalf of the program. 387 (d) Board of directors.—The State Surgeon General shall 388 appoint a board of directors of the direct-support organization. 389 The board of directors shall consist of at least 5 members, but 390 not more than 15 members, who serve at the pleasure of the State 391 Surgeon General. The board members must elect a chair from among 392 its members. Board members must serve without compensation but 393 may be entitled to reimbursement of travel and per diem expenses 394 in accordance with s. 112.061, if funds are available for this 395 purpose. 396 (e) Use of property.—The department may allow, without 397 charge, appropriate use of fixed property, facilities, and 398 personnel services of the department by the direct-support 399 organization, subject to this subsection. For the purposes of 400 this paragraph, the term “personnel services” includes full-time 401 or part-time personnel, as well as payroll processing services. 402 1. The department may prescribe any condition with which 403 the direct-support organization must comply in order to use 404 fixed property or facilities of the department. 405 2. The department may not permit the use of any fixed 406 property or facilities of the department by the direct-support 407 organization if it does not provide equal membership and 408 employment opportunities to all persons regardless of race, 409 color, religion, sex, age, or national origin. 410 3. The department shall adopt rules prescribing the 411 procedures by which the direct-support organization is governed 412 and any conditions with which a direct-support organization must 413 comply to use property or facilities of the department. 414 (f) Deposit of funds.—Any moneys may be held in a separate 415 depository account in the name of the direct-support 416 organization and subject to the provisions of the contract with 417 the department. 418 (g) Use of funds.-Funds designated for the direct-support 419 organization must be used for the enhancement of the projects of 420 the program and used in a manner consistent with that purpose. 421 Any administrative costs of running and promoting the purposes 422 of the corporation or program must be paid by private funds. 423 (h) Audit.—The direct-support organization shall provide 424 for an annual financial audit in accordance with s. 215.981. 425 (i) Repeal.—This subsection shall stand repealed on October 426 1, 2023, unless reviewed and saved from repeal by the 427 Legislature. 428 (15) RULEMAKING.—The department shall adopt rules necessary 429 to implement the requirements of this section. When applicable, 430 the rules may provide for the use of electronic forms, 431 recordkeeping, and meeting by teleconference. 432 Section 2. Paragraph (o) is added to subsection (5) of 433 section 252.36, Florida Statutes, to read: 434 252.36 Emergency management powers of the Governor.— 435 (5) In addition to any other powers conferred upon the 436 Governor by law, she or he may: 437 (o) Waive the patient eligibility requirements of s. 438 465.1902. 439 Section 3. This act shall take effect July 1, 2018. 440 441 ================= T I T L E A M E N D M E N T ================ 442 And the title is amended as follows: 443 Delete everything before the enacting clause 444 and insert: 445 A bill to be entitled 446 An act relating to the Prescription Drug Donation 447 Repository Program; creating s. 465.1902, F.S.; 448 providing a short title; creating the Prescription 449 Drug Donation Repository Program within the Department 450 of Health; providing purpose; authorizing the 451 department to contract with a third party to implement 452 and administer the program; providing definitions; 453 specifying entities that are eligible donors; 454 providing criteria for eligible donations; prohibiting 455 donations to specific patients; providing that certain 456 prescription drugs eligible for return to stock must 457 be credited to Medicaid under specified conditions and 458 are not program eligible; prohibiting the donation of 459 certain drugs pursuant to federal restrictions; 460 authorizing repositories to refuse to accept donations 461 of prescription drugs or supplies; providing 462 inspection, inventory, and storage requirements for 463 centralized and local repositories; requiring 464 inspection of donated prescription drugs and supplies 465 by a licensed pharmacist; requiring a local repository 466 to notify the centralized repository within a 467 specified timeframe after receiving a donation of 468 prescription drugs or supplies; authorizing a 469 centralized repository to redistribute prescription 470 drugs or supplies; requiring local repositories to 471 notify the department regarding participation in the 472 program; providing conditions for dispensing donated 473 prescription drugs and supplies to eligible patients; 474 requiring repositories to establish a protocol for 475 notifying recipients of a prescription drug recall; 476 providing for destruction of donated prescription 477 drugs in the event of a drug recall; providing 478 recordkeeping requirements; requiring the department 479 to maintain and publish a registry of participating 480 local repositories and available donated prescription 481 drugs and supplies; specifying certain notice to 482 patients; providing immunity from civil and criminal 483 liability for participants under certain 484 circumstances; authorizing the department to establish 485 a direct-support organization to provide assistance 486 funding and promotional support for program 487 activities; specifying direct-support organization 488 purposes and objectives; prohibiting such direct 489 support organization from lobbying and specifying that 490 such direct-support organization is not a lobbying 491 firm; specifying that the direct-support organization 492 mush operate under contract with the department; 493 specifying required contract terms; providing for the 494 direct-support organization board of directors; 495 specifying the membership of such board; specifying 496 requirements relating to a direct-support 497 organization’s use of department property; specifying 498 requirements for the deposit of funds by the direct 499 support organization; providing for audits of a 500 direct-support organization; specifying a repeal, 501 unless reviewed and saved from repeal by the 502 Legislature on a specified date; requiring the 503 department to adopt rules; amending s. 252.36, F.S.; 504 authorizing the Governor to waive the patient 505 eligibility requirements of s. 465.1902, F.S., during 506 a declared state of emergency; providing an effective 507 date.