Florida Senate - 2018 PROPOSED COMMITTEE SUBSTITUTE Bill No. CS for SB 710 Ì471064ÂÎ471064 576-03267-18 Proposed Committee Substitute by the Committee on Appropriations (Appropriations Subcommittee on Health and Human Services) 1 A bill to be entitled 2 An act relating to the Prescription Drug Donation 3 Repository Program; creating s. 465.1902, F.S.; 4 providing a short title; creating the Prescription 5 Drug Donation Repository Program within the Department 6 of Health; providing purpose; authorizing the 7 department to contract with a third party to implement 8 and administer the program; providing definitions; 9 specifying entities that are eligible donors; 10 providing criteria for eligible donations; prohibiting 11 donations to specific patients; providing that certain 12 prescription drugs eligible for return to stock must 13 be credited to Medicaid under specified conditions and 14 are not program eligible; prohibiting the donation of 15 certain drugs pursuant to federal restrictions; 16 authorizing repositories to refuse to accept donations 17 of prescription drugs or supplies; providing 18 inspection, inventory, and storage requirements for 19 centralized and local repositories; requiring 20 inspection of donated prescription drugs and supplies 21 by a licensed pharmacist; requiring a local repository 22 to notify the centralized repository within a 23 specified timeframe after receiving a donation of 24 prescription drugs or supplies; authorizing a 25 centralized repository to redistribute prescription 26 drugs or supplies; requiring local repositories to 27 notify the department regarding participation in the 28 program; providing conditions for dispensing donated 29 prescription drugs and supplies to eligible patients; 30 requiring repositories to establish a protocol for 31 notifying recipients of a prescription drug recall; 32 providing for destruction of donated prescription 33 drugs in the event of a drug recall; providing 34 recordkeeping requirements; requiring the department 35 to maintain and publish a registry of participating 36 local repositories and available donated prescription 37 drugs and supplies; specifying certain notice to 38 patients; providing immunity from civil and criminal 39 liability for participants under certain 40 circumstances; authorizing the department to establish 41 a direct-support organization to provide assistance 42 funding and promotional support for program 43 activities; specifying direct-support organization 44 purposes and objectives; prohibiting such direct 45 support organization from lobbying and specifying that 46 such direct-support organization is not a lobbying 47 firm; specifying that the direct-support organization 48 mush operate under contract with the department; 49 specifying required contract terms; providing for the 50 direct-support organization board of directors; 51 specifying the membership of such board; specifying 52 requirements relating to a direct-support 53 organization’s use of department property; specifying 54 requirements for the deposit of funds by the direct 55 support organization; providing for audits of a 56 direct-support organization; specifying a repeal, 57 unless reviewed and saved from repeal by the 58 Legislature on a specified date; requiring the 59 department to adopt rules; amending s. 252.36, F.S.; 60 authorizing the Governor to waive the patient 61 eligibility requirements of s. 465.1902, F.S., during 62 a declared state of emergency; providing an effective 63 date. 64 65 Be It Enacted by the Legislature of the State of Florida: 66 67 Section 1. Section 465.1902, Florida Statutes, is created 68 to read: 69 465.1902 Prescription Drug Donation Repository Program.— 70 (1) SHORT TITLE.—This section may be cited as the 71 “Prescription Drug Donation Repository Program Act.” 72 (2) PRESCRIPTION DRUG DONATION REPOSITORY PROGRAM.—The 73 Prescription Drug Donation Repository Program is created within 74 the Department of Health for the purpose of authorizing and 75 facilitating the donation of prescription drugs and supplies to 76 eligible patients. The department may contract with a third 77 party to implement and administer the program. 78 (3) DEFINITIONS.—As used in this section, the term: 79 (a) “Centralized repository” means a distributor permitted 80 pursuant to chapter 499 which is approved by the department or 81 the contractor to accept, inspect, inventory, and distribute 82 donated drugs and supplies under this section. 83 (b) “Closed drug delivery system” means a system in which 84 the actual control of the unit-dose medication package is 85 maintained by the facility rather than by the individual 86 patient. 87 (c) “Contractor” means the third-party vendor approved by 88 the department to implement and administer the program. 89 (d) “Controlled substance” means any substance listed under 90 Schedule II, Schedule III, Schedule IV, or Schedule V of s. 91 893.03. 92 (e) “Department” means Department of Health. 93 (f) “Direct-support organization” means an entity that is 94 established pursuant to s. 20.058 and is: 95 1. A Florida corporation not for profit incorporated under 96 chapter 617, exempted from filing fees, and approved by the 97 Department of State. 98 2. Organized and operated to conduct programs and 99 activities; raise funds and request and receive grants, gifts, 100 and bequests of moneys; acquire, receive, hold, and invest, in 101 its own name, securities, funds, objects of value, or other 102 property, either real or personal; and make expenditures or 103 provide funding to or for the direct or indirect benefit of the 104 program. 105 (g) “Dispenser” means a dispensing health care practitioner 106 or pharmacist licensed to dispense medicinal drugs in the state. 107 (h) “Donor” means an entity that meets the requirements of 108 subsection (4). 109 (i) “Eligible patient” means a Florida resident who is 110 indigent, uninsured, or underinsured and has a valid 111 prescription for a prescription drug or supply that is eligible 112 for dispensing under the program. 113 (j) “Free clinic” means a clinic that delivers only medical 114 diagnostic services or nonsurgical medical treatment free of 115 charge to all low-income recipients. 116 (k) “Health care practitioner” or “practitioner” means a 117 practitioner licensed under chapter 458, chapter 459, chapter 118 461, chapter 463, chapter 464, chapter 465, or chapter 466. 119 (l) “Indigent” means a person with an income that is below 120 200 percent of the federal poverty level as defined by the most 121 recently revised poverty income guidelines published by the 122 United States Department of Health and Human Services. 123 (m) “Local repository” means a health care practitioner’s 124 office, a pharmacy, a hospital with a closed drug delivery 125 system, a nursing home facility with a closed drug delivery 126 system, a free clinic, or a nonprofit health clinic that is 127 licensed or permitted to dispense medicinal drugs in the state. 128 (n) “Nonprofit health clinic” means a nonprofit legal 129 entity that provides medical care to patients who are indigent, 130 uninsured, or underinsured, including, but not limited to, a 131 federally qualified health center as defined in 42 U.S.C. s. 132 1396d(l)(2)(B) and a rural health clinic as defined in 42 U.S.C. 133 s. 1396d(l)(1). 134 (o) “Nursing home facility” has the same meaning as in s. 135 400.021(12). 136 (p) “Prescriber” means a prescribing physician, prescribing 137 practitioner, or other health care practitioner authorized by 138 the laws of this state to prescribe medicinal drugs. 139 (q) “Prescription drug” has the same meaning as defined in 140 s. 465.003(8), but does not include controlled substances or 141 cancer drugs donated under s. 499.029. 142 (r) “Program” means the Prescription Drug Donation 143 Repository Program created by this section. 144 (s) “Supplies” means any supply used in the administration 145 of a prescription drug. 146 (t) “Tamper-evident packaging” means a package that has one 147 or more indicators or barriers to entry which, if breached or 148 missing, can reasonably be expected to provide visible evidence 149 to consumers that tampering has occurred. 150 (u) “Underinsured” means a person who has third-party 151 insurance or is eligible to receive prescription drugs or 152 supplies through the Medicaid program or any other prescription 153 drug program funded in whole or in part by the Federal 154 Government, but has exhausted these benefits or does not have 155 prescription drug coverage for the drug prescribed. 156 (v) “Uninsured” means a person who has no third-party 157 insurance and is not eligible to receive prescription drugs or 158 supplies through the Medicaid program or any other prescription 159 drug program funded in whole or in part by the Federal 160 Government. 161 (4) DONOR ELIGIBILITY.—The program may only accept a 162 donation of a prescription drug or supply from: 163 (a) Nursing home facilities with closed drug delivery 164 systems. 165 (b) Hospices that have maintained control of a patient’s 166 prescription drug. 167 (c) Hospitals with closed drug delivery systems. 168 (d) Pharmacies. 169 (e) Drug manufacturers or wholesale distributors. 170 (f) Medical device manufacturers or suppliers. 171 (g) Prescribers who receive prescription drugs or supplies 172 directly from a drug manufacturer, wholesale distributor, or 173 pharmacy. 174 (5) PRESCRIPTION DRUGS AND SUPPLIES ELIGIBLE FOR DONATION.— 175 (a) All prescription drugs and supplies that have been 176 approved for medical use in the United States and meet the 177 criteria for donation established by this section may be 178 accepted for donation under the program. 179 (b) The centralized repository or a local repository may 180 accept a prescription drug only if: 181 1. The drug is in its original sealed and tamper-evident 182 packaging. Single-unit-dose drugs may be accepted if the single 183 unit-dose packaging is unopened. 184 2. The drug requires storage at normal room temperature per 185 the manufacturer or the United States Pharmacopeia. 186 3. The drug has been stored according to manufacturer or 187 United States Pharmacopeia storage requirements. 188 4. The drug does not have any physical signs of tampering 189 or adulteration and there is no reason to believe that the drug 190 is adulterated. 191 5. The packaging does not have any physical signs of 192 tampering, misbranding, deterioration, compromised integrity, or 193 adulteration. 194 6. The packaging contains the lot number and expiration 195 date of the drug. If the lot number is not retrievable, all 196 specified medications must be destroyed in the event of a 197 recall. 198 7. The drug has an expiration date that is more than 3 199 months after the date that the drug was donated. 200 (c) The central repository or a local repository may only 201 accept supplies that are in their original, unopened, sealed 202 packaging and have not been adulterated or misbranded. 203 (d) Prescription drugs and supplies may be donated on the 204 premises of the centralized repository or a local repository to 205 a person designated by the repository. A drop box may not be 206 used to accept donations. 207 (e) Prescription drugs or supplies may not be donated to a 208 specific patient. 209 (f) Prescription drugs billed to and paid for by Medicaid 210 in long-term care facilities which are eligible for return to 211 stock under federal Medicaid regulations must be credited to 212 Medicaid and are not eligible for donation under the program. 213 (g) Prescription drugs that are subject to a Federal Food 214 and Drug Administration Risk Evaluation and Mitigation Strategy 215 with Elements to Assure Safe Use are not eligible for donation 216 under the program. 217 (h) Nothing in this section requires the central repository 218 or a local repository to accept a donation of a prescription 219 drug or supplies. 220 (6) INSPECTION AND STORAGE.— 221 (a) A licensed pharmacist employed by or under contract 222 with the centralized repository or a local repository shall 223 inspect donated prescription drugs and supplies to determine 224 whether the donated prescription drugs or supplies: 225 1. Are eligible for donation under the program; 226 2. Have been adulterated or misbranded; and 227 3. Are safe and suitable for dispensing. 228 (b) The pharmacist who inspects the donated prescription 229 drugs or supplies shall sign an inspection record on a form 230 prescribed by the department and adopted in rule verifying that 231 the criteria of paragraph (a) have been met and attach such 232 record to the copy of the inventory record. If a local 233 repository receives drugs and supplies from the centralized 234 repository, the local repository is not required to reinspect 235 the drugs and supplies. 236 (c) The centralized repository and local repositories shall 237 store donated prescription drugs and supplies in a secure 238 storage area under the environmental conditions specified by the 239 manufacturer or United States Pharmacopeia for the prescription 240 drugs or supplies being stored. Donated prescription drugs and 241 supplies may not be stored with nondonated inventory. A local 242 repository shall quarantine any donated prescription drugs or 243 supplies from all dispensing stock until the donated 244 prescription drugs or supplies are inspected and approved for 245 dispensing under the program. 246 (d) A local repository shall maintain an inventory of all 247 donated prescription drugs or supplies it receives. Such 248 inventory shall be recorded on a form prescribed by the 249 department and adopted in rule. 250 (e) A local repository shall notify the centralized 251 repository within 5 days after receipt of any donation of 252 prescription drugs or supplies to the program. The notification 253 shall be on a form prescribed by the department and adopted by 254 rule. 255 (f) The centralized repository shall maintain an inventory 256 of all prescription drugs and supplies donated to the program. 257 (g) The centralized repository may redistribute 258 prescription drugs and supplies to facilitate dispensing to 259 either the centralized repository or to a local repository, as 260 needed. 261 (7) LOCAL REPOSITORY NOTICE OF PARTICIPATION.— 262 (a) A local repository must notify the department of its 263 intent to participate in the program before accepting or 264 dispensing any prescription drugs or supplies pursuant to this 265 section. The notification shall be on a form prescribed by the 266 department and adopted by rule and must, at a minimum, include: 267 1. The name, street address, website, and telephone number 268 of the local repository and any state-issued license or 269 registration number issued to the local repository, including 270 the name of the issuing agency. 271 2. The name and telephone number of the pharmacist employed 272 by or under contract with the local repository who is 273 responsible for the inspection of donated prescription drugs and 274 supplies. 275 3. A statement signed and dated by the responsible 276 pharmacist affirming that the local repository meets the 277 eligibility requirements of this section. 278 (b) A local repository may withdraw from participation in 279 the program at any time by providing written notice to the 280 department or contractor on a form prescribed by the department 281 and adopted by rule. The department shall adopt rules addressing 282 the disposition of any prescription drugs in the possession of 283 the local repository. 284 (8) DISPENSING.— 285 (a) Each eligible patient without a program identification 286 card must submit an intake collection form to a local repository 287 before receiving prescription drugs or supplies under the 288 program. The form shall be prescribed by the department and 289 adopted by rule and, at a minimum, must include: 290 1. The name, street address, and telephone number of the 291 eligible patient. 292 2. The basis for eligibility, which must specify that the 293 patient is indigent, uninsured, or underinsured. 294 3. A statement signed and dated by the eligible patient 295 affirming that he or she meets the eligibility requirements of 296 this section. 297 (b) A local repository shall collect a signed and dated 298 intake collection form from each eligible patient receiving 299 prescription drugs or supplies under the program. The local 300 repository must issue a program identification card upon receipt 301 of a duly executed intake collection form. The program 302 identification card is valid for 1 year after issuance and must 303 be in a form prescribed by the department and adopted in rule. 304 (c) A local repository must send a summary of the intake 305 collection form data to the centralized pharmacy within 5 days 306 after receipt of a duly executed intake collection form. 307 (d) A dispenser may only dispense a donated prescription 308 drug or supplies, if available, to an eligible patient with a 309 program identification card or a duly executed intake collection 310 form. 311 (e) A dispenser shall inspect the donated prescription 312 drugs or supplies prior to dispensing such drugs or supplies. 313 (f) A dispenser may provide dispensing and consulting 314 services to an eligible patient. 315 (g) Donated prescription drugs and supplies may not be sold 316 or resold under this program. 317 (h) A dispenser of donated prescription drugs or supplies 318 may not submit a claim or otherwise seek reimbursement from any 319 public or private third-party payor for donated prescription 320 drugs or supplies dispensed to any patient under this program. 321 However, a repository may charge a nominal handling fee, 322 established by department rule, for the preparation and 323 dispensing of prescription drugs or supplies under the program. 324 (i) A local repository that receives donated prescription 325 drugs or supplies may, with authorization from the centralized 326 repository, distribute the prescription drugs or supplies to 327 another local repository. 328 (9) RECALL AND DESTRUCTION OF PRESCRIPTION DRUGS AND 329 SUPPLIES.— 330 (a) The centralized repository and a local repository shall 331 be responsible for drug recalls and shall have an established 332 protocol to notify recipients in the event of a prescription 333 drug recall. 334 (b) Local repositories shall destroy all of the recalled or 335 expired prescription drugs or prescription drugs that are not 336 suitable for dispensing in the repository and complete a 337 destruction information form for all donated prescription drugs 338 destroyed, in accordance with rules adopted by the department. 339 (10) RECORDKEEPING.— 340 (a) Local repositories shall maintain records of 341 prescription drugs and supplies that were accepted, donated, 342 dispensed, distributed, or destroyed under the program. 343 (b) All records required to be maintained as a part of the 344 program shall be maintained in accordance with any applicable 345 practice acts. Local repositories shall submit these records 346 quarterly to the centralized repository for data collection, and 347 the centralized repository shall submit these records and the 348 collected data in annual reports to the department. 349 (11) REGISTRIES AND FORMS.— 350 (a) The department shall establish and maintain registries 351 of all local repositories and available drugs and supplies under 352 the program. The registry of local repositories must include the 353 repository’s name, address, website, and telephone number. The 354 registry of available drugs and supplies must include the name, 355 strength, available quantity, and expiration date of the drug or 356 supply and the name and contact information of the repositories 357 where such drug or supply is available. The department shall 358 publish the registries on its website. 359 (b) The department shall publish all forms required by this 360 section on its website. 361 (12) IMMUNITY.— 362 (a) Any donor of prescription drugs or supplies, or any 363 participant in the program, who exercises reasonable care in 364 donating, accepting, distributing, or dispensing prescription 365 drugs or supplies under the program, and the rules adopted 366 pursuant thereto, is immune from civil or criminal liability and 367 from professional disciplinary action of any kind for any 368 injury, death, or loss to person or property relating to such 369 activities. 370 (b) A pharmaceutical manufacturer who exercises reasonable 371 care is not liable for any claim or injury arising from the 372 transfer of any prescription drug under this section, including 373 but not limited to, liability for failure to transfer or 374 communicate product or consumer information regarding the 375 transferred drug, including the expiration date of the 376 transferred drug. 377 (13) NOTICE TO PATIENTS.–Before dispensing a prescription 378 drug that has been donated under this program, the dispenser 379 must provide written notification to the patient, or to his or 380 her legal representative, receipt of which must be acknowledged 381 in writing, that: 382 (a) The prescription drug was donated to the program; 383 (b) The donors and participants in the program are granted 384 certain immunities as described in subsection (12); and 385 (c) The patient may not be required to pay for the 386 prescription drug, except for a nominal handling fee which may 387 not exceed the amount established by department rule. 388 (14) DIRECT-SUPPORT ORGANIZATION.-The department may 389 establish a direct-support organization to provide assistance, 390 funding, and promotional support for the activities authorized 391 for the program. 392 (a) Purposes and objectives.-The purposes and objectives of 393 the direct-support organization of the program must be 394 consistent with the goals of the department, in the best 395 interest of the state, and in accordance with the adopted goals 396 and mission of the department. 397 (b) Prohibition against lobbying.–The direct-support 398 organization is not considered a lobbying firm within the 399 meaning of s. 11.045. All expenditures of the direct-support 400 organization must be used for the program. No expenditures of 401 the direct-support organization may be used for the purpose of 402 lobbying as defined in s. 11.045. 403 (c) Contract.—The direct-support organization shall operate 404 under a written contract with the department. The contract must 405 provide for a submission by the direct-support organization to 406 the department, by each August 1, and posting on the direct 407 support organization’s and department’s websites, the following 408 information: 409 1. The articles of incorporation and bylaws of the direct 410 support organization as approved by the department. 411 2. An annual budget for the approval of the department. 412 3. The code of ethics of the direct-support organization. 413 4. The statutory authority or executive order that created 414 the direct-support organization. 415 5. A brief description of the direct-support organization’s 416 mission and any results obtained by the direct-support 417 organization. 418 6. A brief description of the direct-support organization’s 419 plans for the next 3 fiscal years. 420 7. A copy of the direct-support organization’s most recent 421 federal Internal Revenue Service Return Organization Exempt from 422 Income Tax form (Form 990). 423 8. Certification by the department that the direct-support 424 organization is complying with the terms of the contract and 425 operating in a manner consistent with the goals and purposes of 426 the department and the best interest of the program and the 427 state. Such certification must be made annually and reported in 428 the official minutes of a meeting of the direct-support 429 organization. 430 9. The reversion, without penalty, of moneys and property 431 held in trust by the direct-support organization for the benefit 432 of the program to the state if the department ceases to exist; 433 or reversion to the department if the direct-support 434 organization is no longer approved to operate or ceases to 435 exist. 436 10. The fiscal year of the direct-support organization, 437 which must begin on July 1 of each year and end on June 30 of 438 the following year. 439 11. The disclosure of material provisions of the contract, 440 and the distinction between the department and the direct 441 support organization, to donors of gifts, contributions, or 442 bequests, including such disclosure on all promotional and 443 fundraising publications. 444 12. All prescription drugs solicited by the direct-support 445 organization to be distributed to the centralized repository or 446 a local repository. The direct-support organization may not 447 possess any prescription drugs on behalf of the program. 448 (d) Board of directors.—The State Surgeon General shall 449 appoint a board of directors of the direct-support organization. 450 The board of directors shall consist of at least 5 members, but 451 not more than 15 members, who serve at the pleasure of the State 452 Surgeon General. The board members must elect a chair from among 453 its members. Board members must serve without compensation but 454 may be entitled to reimbursement of travel and per diem expenses 455 in accordance with s. 112.061, if funds are available for this 456 purpose. 457 (e) Use of property.—The department may allow, without 458 charge, appropriate use of fixed property, facilities, and 459 personnel services of the department by the direct-support 460 organization, subject to this subsection. For the purposes of 461 this paragraph, the term “personnel services” includes full-time 462 or part-time personnel, as well as payroll processing services. 463 1. The department may prescribe any condition with which 464 the direct-support organization must comply in order to use 465 fixed property or facilities of the department. 466 2. The department may not permit the use of any fixed 467 property or facilities of the department by the direct-support 468 organization if it does not provide equal membership and 469 employment opportunities to all persons regardless of race, 470 color, religion, sex, age, or national origin. 471 3. The department shall adopt rules prescribing the 472 procedures by which the direct-support organization is governed 473 and any conditions with which a direct-support organization must 474 comply to use property or facilities of the department. 475 (f) Deposit of funds.—Any moneys may be held in a separate 476 depository account in the name of the direct-support 477 organization and subject to the provisions of the contract with 478 the department. 479 (g) Use of funds.-Funds designated for the direct-support 480 organization must be used for the enhancement of the projects of 481 the program and used in a manner consistent with that purpose. 482 Any administrative costs of running and promoting the purposes 483 of the corporation or program must be paid by private funds. 484 (h) Audit.—The direct-support organization shall provide 485 for an annual financial audit in accordance with s. 215.981. 486 (i) Repeal.—This subsection shall stand repealed on October 487 1, 2023, unless reviewed and saved from repeal by the 488 Legislature. 489 (15) RULEMAKING.—The department shall adopt rules necessary 490 to implement the requirements of this section. When applicable, 491 the rules may provide for the use of electronic forms, 492 recordkeeping, and meeting by teleconference. 493 Section 2. Paragraph (o) is added to subsection (5) of 494 section 252.36, Florida Statutes, to read: 495 252.36 Emergency management powers of the Governor.— 496 (5) In addition to any other powers conferred upon the 497 Governor by law, she or he may: 498 (o) Waive the patient eligibility requirements of s. 499 465.1902. 500 Section 3. This act shall take effect July 1, 2018.