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Massachusetts House Bill H1144

Massachusetts 2023-2024 Regular Session

Massachusetts House Bill H1144 Compare Versions

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22 HOUSE DOCKET, NO. 3795 FILED ON: 1/20/2023
33 HOUSE . . . . . . . . . . . . . . . No. 1144
44 The Commonwealth of Massachusetts
55 _________________
66 PRESENTED BY:
77 Jon Santiago
88 _________________
99 To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
1010 Court assembled:
1111 The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
1212 An Act relative to specialty medications and patient safety.
1313 _______________
1414 PETITION OF:
1515 NAME:DISTRICT/ADDRESS :DATE ADDED:Jon Santiago9th Suffolk1/17/2023 1 of 21
1616 HOUSE DOCKET, NO. 3795 FILED ON: 1/20/2023
1717 HOUSE . . . . . . . . . . . . . . . No. 1144
1818 By Representative Santiago of Boston, a petition (accompanied by bill, House, No. 1144) of Jon
1919 Santiago relative to specialty medications and patient safety. Financial Services.
2020 The Commonwealth of Massachusetts
2121 _______________
2222 In the One Hundred and Ninety-Third General Court
2323 (2023-2024)
2424 _______________
2525 An Act relative to specialty medications and patient safety.
2626 Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
2727 of the same, as follows:
2828 1 SECTION 1. Chapter 32A of the General Laws is hereby amended by inserting after
2929 2section 17R the following new section:-
3030 3 Section 17S. a) The following words as used in this section shall have the following
3131 4meanings:
3232 5 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
3333 6services and where drugs, devices, and other materials used in the diagnosis and treatment of
3434 7injury, illness, and disease are dispensed and compounded.
3535 8 “Specialty pharmacy practice” means the provision of pharmacist care services, which
3636 9involves drugs used to treat chronic or specific diseases and conditions that require frequent
3737 10communication with other health care providers, extensive patient monitoring and case
3838 11management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed 2 of 21
3939 12by a specialty pharmacy may also require instruction and training on complex administration
4040 13processes and/or handling and storage considerations.
4141 14 b) Any coverage offered by the commission to an active or retired employee of the
4242 15commonwealth insured under the group insurance commission shall not require a specialty
4343 16pharmacy to dispense a medication directly to a patient with the intention that the patient will
4444 17transport the medication to a healthcare provider for administration.
4545 18 c) Any coverage offered by the commission to an active or retired employee of the
4646 19commonwealth insured under the group insurance commission may offer but shall not require
4747 20the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by physicians
4848 21to patients in their homes or the use of an infusion site external to a patient’s provider office or
4949 22clinic.
5050 23 d) Any coverage offered by the commission to an active or retired employee of the
5151 24commonwealth insured under the group insurance commission shall, when requiring the
5252 25distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
5353 26hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients
5454 27from the insurer prior to the implementation of such a requirement; ii) a patient-specific
5555 28expedited exception process for cases in which a provider certifies that it is unsafe for a patient
5656 29to receive medication from a third party specialty pharmacy or to have the drug administered in
5757 30the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
5858 31call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
5959 32that a drug remains at the appropriate temperature through all stages of supply and storage; vi)
6060 33the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was 3 of 21
6161 34handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
6262 35risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
6363 36demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
6464 37deliver medications to a health system pharmacy in a ready-to-administer dosage form and
6565 38clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
6666 39with hospitals responsible for receiving and administering medications dispensed by the
6767 40specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
6868 41prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
6969 42pharmacy for the purposes of this paragraph.
7070 43 e) Any coverage offered by the commission to an active or retired employee of the
7171 44commonwealth insured under the group insurance commission shall not require a medication
7272 45requiring sterile compounding by health system pharmacy staff or a medication with a patient-
7373 46specific dosage requirement dependent upon lab or test results on the day of the clinic visit, or a
7474 47federally controlled substance, to be distributed from a specialty pharmacy to a physician’s
7575 48office, hospital or clinic for administration.
7676 49 f) Any coverage offered by the commission to an active or retired employee of the
7777 50commonwealth insured under the group insurance commission shall, when requiring the
7878 51distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
7979 52hospital or clinic for administration, shall offer site neutral payment for such medication to the
8080 53healthcare providers administering the medication. Such payment shall include the costs for the
8181 54providers to intake, store and dispose of such medications. 4 of 21
8282 55 SECTION 2. Chapter 118E of the General Laws is hereby amended by inserting after
8383 56section 10N the following new section:-
8484 57 Section 10O. a) The following words as used in this section shall have the following
8585 58meanings:
8686 59 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
8787 60services and where Drugs, Devices, and other materials used in the diagnosis and treatment of
8888 61injury, illness, and disease are Dispensed and Compounded.
8989 62 “Specialty pharmacy practice” means the provision of pharmacist care services, which
9090 63involves drugs used to treat chronic or specific diseases and conditions that require frequent
9191 64communication with other health care providers, extensive patient monitoring and case
9292 65management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
9393 66by a specialty pharmacy may also require instruction and training on complex administration
9494 67processes and/or handling and storage considerations.
9595 68 b) The division, its Medicaid contracted health insurers, health plans, health maintenance
9696 69organizations, behavioral health management firms and third party administrators under contract
9797 70to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
9898 71accountable care organizations shall not require coverage for a specialty pharmacy that dispenses
9999 72a medication directly to a patient with the intention that the patient will transport the medication
100100 73to a healthcare provider for administration.
101101 74 c) The division, its Medicaid contracted health insurers, health plans, health maintenance
102102 75organizations, behavioral health management firms and third party administrators under contract
103103 76to a Medicaid managed care organization, the Medicaid primary care clinician plan, and 5 of 21
104104 77accountable care organizations may offer coverage for but shall not require the use of a home
105105 78infusion pharmacy to dispense sterile intravenous drugs ordered by physicians to patients in their
106106 79homes or the use of an infusion site external to a patient’s provider office or clinic.
107107 80 d) The division, its Medicaid contracted health insurers, health plans, health maintenance
108108 81organizations, behavioral health management firms and third party administrators under contract
109109 82to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
110110 83accountable care organizations shall when requiring the distribution of patient-specific
111111 84medication from a specialty pharmacy to a physician’s office, hospital or clinic for
112112 85administration, require: i) at least 60 days’ notice to providers and patients from the insurer prior
113113 86to the implementation of such a requirement; ii) a patient-specific expedited exception process
114114 87for cases in which a provider certifies that it is unsafe for a patient to receive medication from a
115115 88third party specialty pharmacy or to have the drug administered in the home setting; iii) same day
116116 89delivery of medications; iv) 24 hour per day, 7 day per week on-call access to a pharmacist or
117117 90nurse; v) provision of cold chain logistics or other ability to ensure that a drug remains at the
118118 91appropriate temperature through all stages of supply and storage; vi) the provision of a
119119 92medication’s pedigree to certify to the hospital pharmacy that the drug was handled appropriately
120120 93through the supply chain; vii) demonstration of expertise and reliability in risk evaluation and
121121 94mitigation strategy to comply with USFDA reporting requirements; viii) demonstrated
122122 95accreditation from a national accreditation organization; ix) demonstrated ability to deliver
123123 96medications to a health system pharmacy in a ready-to-administer dosage form and clinically
124124 97appropriate dosage; and x) third-party specialty pharmacies to establish agreements with
125125 98hospitals responsible for receiving and administering medications dispensed by the specialty
126126 99pharmacy to ensure proper receipt, transfer, handling, and storage of the medication prior to 6 of 21
127127 100administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
128128 101pharmacy for the purposes of this paragraph.
129129 102 e) The division, its Medicaid contracted health insurers, health plans, health maintenance
130130 103organizations, behavioral health management firms and third party administrators under contract
131131 104to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
132132 105accountable care organizations shall not require a medication requiring sterile compounding by
133133 106health system pharmacy staff or a medication with a patient-specific dosage requirement
134134 107dependent upon lab or test results on the day of the clinic visit, or a federally controlled
135135 108substance, to be distributed from a specialty pharmacy to a physician’s office, hospital or clinic
136136 109for administration.
137137 110 f) The division, its Medicaid contracted health insurers, health plans, health maintenance
138138 111organizations, behavioral health management firms and third party administrators under contract
139139 112to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
140140 113accountable care organizations, shall, when requiring the distribution of patient-specific
141141 114medication from a specialty pharmacy to a physician’s office, hospital or clinic for
142142 115administration, shall offer site neutral payment for such medication to the healthcare providers
143143 116administering the medication. Such payment shall include the costs for the providers to intake,
144144 117store and dispose of such medications.
145145 118 SECTION 3. Chapter 175 of the General Laws is hereby amended by inserting after
146146 119section 47PP the following new section:-
147147 120 Section 47QQ. a) The following words as used in this section shall have the following
148148 121meanings: 7 of 21
149149 122 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
150150 123services and where drugs, devices, and other materials used in the diagnosis and treatment of
151151 124injury, illness, and disease are dispensed and compounded.
152152 125 “Specialty pharmacy practice” means the provision of pharmacist care services, which
153153 126involves drugs used to treat chronic or specific diseases and conditions that require frequent
154154 127communication with other health care providers, extensive patient monitoring and case
155155 128management, and comprehensive counseling with the patient and/or caregiver.Drugs dispensed
156156 129by a specialty pharmacy may also require instruction and training on complex administration
157157 130processes and/or handling and storage considerations.
158158 131 b) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
159159 132renewed within the commonwealth that provides medical expense coverage shall not require a
160160 133specialty pharmacy to dispense a medication directly to a patient with the intention that the
161161 134patient will transport the medication to a healthcare provider for administration.
162162 135 c) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
163163 136renewed within the commonwealth that provides medical expense coverage may offer coverage
164164 137for but shall not require the use of a home infusion pharmacy to dispense sterile intravenous
165165 138drugs ordered by physicians to patient in their homes or the use of an infusion site external to a
166166 139patient’s provider office or clinic.
167167 140 d) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
168168 141renewed within the commonwealth that provides medical expense coverage shall, when requiring
169169 142the distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
170170 143hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients 8 of 21
171171 144from the insurer prior to the implementation of such a requirement; ii) a patient-specific
172172 145expedited exception process for cases in which a provider certifies that it is unsafe for a patient
173173 146to receive medication from a third party specialty pharmacy or to have the drug administered in
174174 147the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
175175 148call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
176176 149that a drug remains at the appropriate temperature through all stages of supply and storage; vi)
177177 150the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was
178178 151handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
179179 152risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
180180 153demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
181181 154deliver medications to a health system pharmacy in a ready-to-administer dosage form and
182182 155clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
183183 156with hospitals responsible for receiving and administering medications dispensed by the
184184 157specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
185185 158prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
186186 159pharmacy for the purposes of this paragraph.
187187 160 e) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
188188 161renewed within the commonwealth that provides medical expense coverage shall not require a
189189 162medication requiring sterile compounding by health system pharmacy staff or a medication with
190190 163a patient-specific dosage requirement dependent upon lab or test results on the day of the clinic
191191 164visit, or a federally controlled substance, to be distributed from a specialty pharmacy to a
192192 165physician’s office, hospital or clinic for administration. 9 of 21
193193 166 f) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
194194 167renewed within the commonwealth that provides medical expense coverage shall, when requiring
195195 168the distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
196196 169hospital or clinic for administration, offer site neutral payment for such medication to the
197197 170healthcare providers administering the medication. Such payment shall include the costs for the
198198 171providers to intake, store and dispose of such medications.
199199 172 SECTION 4. Chapter 176A of the General Laws is hereby amended by inserting after
200200 173section 8QQ the following new section:-
201201 174 Section 8RR. a) The following words as used in this section shall have the following
202202 175meanings:
203203 176 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
204204 177services and where drugs, devices, and other materials used in the diagnosis and treatment of
205205 178injury, illness, and disease are dispensed and compounded.
206206 179 “Specialty pharmacy practice” means the provision of pharmacist care services, which
207207 180involves drugs used to treat chronic or specific diseases and conditions that require frequent
208208 181communication with other health care providers, extensive patient monitoring and case
209209 182management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
210210 183by a specialty pharmacy may also require instruction and training on complex administration
211211 184processes and/or handling and storage considerations.
212212 185 b) Any contracts, except contracts providing supplemental coverage to Medicare or other
213213 186governmental programs, between a subscriber and the corporation under an individual or group
214214 187hospital service plan which is delivered, issued or renewed in the commonwealth shall not 10 of 21
215215 188require a specialty pharmacy to dispense a medication directly to a patient with the intention that
216216 189the patient will transport the medication to a healthcare provider for administration.
217217 190 c) Any contracts, except contracts providing supplemental coverage to Medicare or other
218218 191governmental programs, between a subscriber and the corporation under an individual or group
219219 192hospital service plan which is delivered, issued or renewed in the commonwealth may offer
220220 193coverage for but shall not require the use of a home infusion pharmacy to dispense sterile
221221 194intravenous drugs ordered by physicians to patient in their homes or the use of an infusion site
222222 195external to a patient’s provider office or clinic..
223223 196 d) Any contracts, except contracts providing supplemental coverage to Medicare or other
224224 197governmental programs, between a subscriber and the corporation under an individual or group
225225 198hospital service plan which is delivered, issued or renewed in the commonwealth shall when
226226 199requiring the distribution of patient-specific medication from a specialty pharmacy to a
227227 200physician’s office, hospital or clinic for administration, require: i) at least 60 days’ notice to
228228 201providers and patients from the insurer prior to the implementation of such a requirement; ii) a
229229 202patient-specific expedited exception process for cases in which a provider certifies that it is
230230 203unsafe for a patient to receive medication from a third party specialty pharmacy or to have the
231231 204drug administered in the home setting; iii) same day delivery of medications; iv) 24 hour per day,
232232 2057 day per week on-call access to a pharmacist or nurse; v) provision of cold chain logistics or
233233 206other ability to ensure that a drug remains at the appropriate temperature through all stages of
234234 207supply and storage; vi) the provision of a medication’s pedigree to certify to the hospital
235235 208pharmacy that the drug was handled appropriately through the supply chain; vii) demonstration
236236 209of expertise and reliability in risk evaluation and mitigation strategy to comply with USFDA
237237 210reporting requirements; viii) demonstrated accreditation from a national accreditation 11 of 21
238238 211organization; ix) demonstrated ability to deliver medications to a health system pharmacy in a
239239 212ready-to-administer dosage form and clinically appropriate dosage; and x) third-party specialty
240240 213pharmacies to establish agreements with hospitals responsible for receiving and administering
241241 214medications dispensed by the specialty pharmacy to ensure proper receipt, transfer, handling, and
242242 215storage of the medication prior to administration. A pharmacy owned or affiliated with a hospital
243243 216may serve as specialty pharmacy for the purposes of this paragraph.
244244 217 e) Any contracts, except contracts providing supplemental coverage to Medicare or other
245245 218governmental programs, between a subscriber and the corporation under an individual or group
246246 219hospital service plan which is delivered, issued or renewed in the commonwealth shall not
247247 220require a medication requiring sterile compounding by health system pharmacy staff or a
248248 221medication with a patient-specific dosage requirement dependent upon lab or test results on the
249249 222day of the clinic visit, or a federally controlled substance, to be distributed from a specialty
250250 223pharmacy to a physician’s office, hospital or clinic for administration.
251251 224 f) Any contracts, except contracts providing supplemental coverage to Medicare or other
252252 225governmental programs, between a subscriber and the corporation under an individual or group
253253 226hospital service plan which is delivered, issued or renewed in the commonwealth shall, when
254254 227requiring the distribution of patient-specific medication from a specialty pharmacy to a
255255 228physician’s office, hospital or clinic for administration, offer site neutral payment for such
256256 229medication to the healthcare providers administering the medication. Such payment shall include
257257 230the costs for the providers to intake, store and dispose of such medications.
258258 231 SECTION 5. Chapter 176B of the General Laws is hereby amended by inserting after
259259 232section 4QQ the following new section:- 12 of 21
260260 233 Section 4RR. a) The following words as used in this section shall have the following
261261 234meanings:
262262 235 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
263263 236services and where drugs, devices, and other materials used in the diagnosis and treatment of
264264 237injury, illness, and disease are dispensed and compounded.
265265 238 “Specialty pharmacy practice” means the provision of pharmacist care services, which
266266 239involves drugs used to treat chronic or specific diseases and conditions that require frequent
267267 240communication with other health care providers, extensive patient monitoring and case
268268 241management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
269269 242by a specialty pharmacy may also require instruction and training on complex administration
270270 243processes and/or handling and storage considerations.
271271 244 b) Any subscription certificate under an individual or group medical service agreement
272272 245delivered, issued or renewed within the commonwealth shall not require a specialty pharmacy to
273273 246dispense a medication directly to a patient with the intention that the patient will transport the
274274 247medication to a healthcare provider for administration.
275275 248 c) Any subscription certificate under an individual or group medical service agreement
276276 249delivered, issued or renewed within the commonwealth may offer coverage for but shall not
277277 250require the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by
278278 251physicians to patient in their homes or the use of an infusion site external to a patient’s provider
279279 252office or clinic.
280280 253 d) Any subscription certificate under an individual or group medical service agreement
281281 254delivered, issued or renewed within the commonwealth shall when requiring the distribution of 13 of 21
282282 255patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic
283283 256for administration, require: i) at least 60 days’ notice to providers and patients from the insurer
284284 257prior to the implementation of such a requirement; ii) a patient-specific expedited exception
285285 258process for cases in which a provider certifies that it is unsafe for a patient to receive medication
286286 259from a third party specialty pharmacy or to have the drug administered in the home setting; iii)
287287 260same day delivery of medications; iv) 24 hour per day, 7 day per week on-call access to a
288288 261pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure that a drug
289289 262remains at the appropriate temperature through all stages of supply and storage; vi) the provision
290290 263of a medication’s pedigree to certify to the hospital pharmacy that the drug was handled
291291 264appropriately through the supply chain; vii) demonstration of expertise and reliability in risk
292292 265evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
293293 266demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
294294 267deliver medications to a health system pharmacy in a ready-to-administer dosage form and
295295 268clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
296296 269with hospitals responsible for receiving and administering medications dispensed by the
297297 270specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
298298 271prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
299299 272pharmacy for the purposes of this paragraph.
300300 273 e) Any subscription certificate under an individual or group medical service agreement
301301 274delivered, issued or renewed within the commonwealth shall not require a medication requiring
302302 275sterile compounding by health system pharmacy staff or a medication with a patient-specific
303303 276dosage requirement dependent upon lab or test results on the day of the clinic visit, , or a 14 of 21
304304 277federally controlled substance, to be distributed from a specialty pharmacy to a physician’s
305305 278office, hospital or clinic for administration.
306306 279 f) Any subscription certificate under an individual or group medical service agreement
307307 280delivered, issued or renewed within the commonwealth shall, when requiring the distribution of
308308 281patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic
309309 282for administration, offer site neutral payment for such medication to the healthcare providers
310310 283administering the medication. Such payment shall include the costs for the providers to intake,
311311 284store and dispose of such medications.
312312 285 SECTION 6. Chapter 176G of the General Laws is hereby amended by inserting after
313313 286section 4II the following new section:-
314314 287 Section 4JJ. a) The following words as used in this section shall have the following
315315 288meanings:
316316 289 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
317317 290services and where drugs, devices, and other materials used in the diagnosis and treatment of
318318 291injury, illness, and disease are dispensed and compounded.
319319 292 “Specialty pharmacy practice” means the provision of pharmacist care services, which
320320 293involves drugs used to treat chronic or specific diseases and conditions that require frequent
321321 294communication with other health care providers, extensive patient monitoring and case
322322 295management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
323323 296by a specialty pharmacy may also require instruction and training on complex administration
324324 297processes and/or handling and storage considerations. 15 of 21
325325 298 b) Any individual or group health maintenance contract shall not require a specialty
326326 299pharmacy to dispense a medication directly to a patient with the intention that the patient will
327327 300transport the medication to a healthcare provider for administration.
328328 301 c) Any individual or group health maintenance contract may offer coverage for but shall
329329 302not require the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by
330330 303physicians to patient in their homes or the use of an infusion site external to a patient’s provider
331331 304office or clinic.
332332 305 d) Any individual or group health maintenance contract shall when requiring the
333333 306distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
334334 307hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients
335335 308from the insurer prior to the implementation of such a requirement; ii) a patient-specific
336336 309expedited exception process for cases in which a provider certifies that it is unsafe for a patient
337337 310to receive medication from a third party specialty pharmacy or to have the drug administered in
338338 311the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
339339 312call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
340340 313that a drug remains at the appropriate temperature through all stages of supply and storage; vi)
341341 314the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was
342342 315handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
343343 316risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
344344 317demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
345345 318deliver medications to a health system pharmacy in a ready-to-administer dosage form and
346346 319clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
347347 320with hospitals responsible for receiving and administering medications dispensed by the 16 of 21
348348 321specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
349349 322prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
350350 323pharmacy for the purposes of this paragraph.
351351 324 e) Any individual or group health maintenance contract shall not require a medication
352352 325requiring sterile compounding by health system pharmacy staff or a medication with a patient-
353353 326specific dosage requirement dependent upon lab or test results on the day of the clinic visit, or a
354354 327federally controlled substance, to be distributed from a specialty pharmacy to a physician’s
355355 328office, hospital or clinic for administration.
356356 329 f) Any individual or group health maintenance contract shall when requiring the
357357 330distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
358358 331hospital or clinic for administration, offer site neutral payment for such medication to the
359359 332healthcare providers administering the medication. Such payment shall include the costs for the
360360 333providers to intake, store and dispose of such medications.
361361 334 SECTION 7. Chapter 176I of the General Laws is hereby amended by inserting after
362362 335section 13 the following new section:-
363363 336 Section 14. a) The following words as used in this section shall have the following
364364 337meanings:
365365 338 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
366366 339services and where drugs, devices, and other materials used in the diagnosis and treatment of
367367 340injury, illness, and disease are dispensed and compounded. 17 of 21
368368 341 “Specialty pharmacy practice” means the provision of pharmacist care services, which
369369 342involves drugs used to treat chronic or specific diseases and conditions that require frequent
370370 343communication with other health care providers, extensive patient monitoring and case
371371 344management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
372372 345by a specialty pharmacy may also require instruction and training on complex administration
373373 346processes and/or handling and storage considerations.
374374 347 b) An organization entering into a preferred provider contract shall not require a specialty
375375 348pharmacy to dispense a medication directly to a patient with the intention that the patient will
376376 349transport the medication to a healthcare provider for administration.
377377 350 c) An organization entering into a preferred provider contract may offer coverage for but
378378 351shall not require the use of a home infusion pharmacy to dispense sterile intravenous drugs
379379 352ordered by physicians to patient in their homes or the use of an infusion site external to a
380380 353patient’s provider office or clinic.
381381 354 d) An organization entering into a preferred provider contract shall when requiring the
382382 355distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
383383 356hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients
384384 357from the insurer prior to the implementation of such a requirement; ii) a patient-specific
385385 358expedited exception process for cases in which a provider certifies that it is unsafe for a patient
386386 359to receive medication from a third party specialty pharmacy or to have the drug administered in
387387 360the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
388388 361call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
389389 362that a drug remains at the appropriate temperature through all stages of supply and storage; vi) 18 of 21
390390 363the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was
391391 364handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
392392 365risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
393393 366demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
394394 367deliver medications to a health system pharmacy in a ready-to-administer dosage form and
395395 368clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
396396 369with hospitals responsible for receiving and administering medications dispensed by the
397397 370specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
398398 371prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
399399 372pharmacy for the purposes of this paragraph.
400400 373 e) An organization entering into a preferred provider contract shall not require a
401401 374medication requiring sterile compounding by health system pharmacy staff or a medication with
402402 375a patient-specific dosage requirement dependent upon lab or test results on the day of the clinic
403403 376visit, or a federally controlled substance, to be distributed from a specialty pharmacy to a
404404 377physician’s office, hospital or clinic for administration.
405405 378 f) An organization entering into a preferred provider contract shall, when requiring the
406406 379distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
407407 380hospital or clinic for administration, offer site neutral payment for such medication to the
408408 381healthcare providers administering the medication. Such payment shall include the costs for the
409409 382providers to intake, store and dispose of such medications.
410410 383 SECTION 8. Chapter 176Q of the General Laws is hereby amended in section 1 by
411411 384inserting after the definition of “Rating factor”, the following definitions:- 19 of 21
412412 385 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
413413 386services and where drugs, devices, and other materials used in the diagnosis and treatment of
414414 387injury, illness, and disease are dispensed and compounded.
415415 388 “Specialty pharmacy practice” means the provision of pharmacist care services, which
416416 389involves drugs used to treat chronic or specific diseases and conditions that require frequent
417417 390communication with other health care providers, extensive patient monitoring and case
418418 391management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
419419 392by a specialty pharmacy may also require instruction and training on complex administration
420420 393processes and/or handling and storage considerations.
421421 394 SECTION 9. Chapter 176Q of the General Laws, as appearing in the 2018 Official
422422 395Edition, is hereby amended in section 5 by inserting after subsection d the following 5 new
423423 396subsections:-
424424 397 e) No health plans offered through the connector shall require a specialty pharmacy to
425425 398dispense a medication directly to a patient with the intention that the patient will transport the
426426 399medication to a healthcare provider for administration.
427427 400 f) Health plans offered through the connector may offer coverage for but shall not require
428428 401the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by physicians
429429 402to patient in their homes or the use of an infusion site external to a patient’s provider office or
430430 403clinic.
431431 404 g) Health plans offered through the connector shall when requiring the distribution of
432432 405patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic
433433 406for administration, require: i) at least 60 days’ notice to providers and patients from the insurer 20 of 21
434434 407prior to the implementation of such a requirement; ii) a patient-specific expedited exception
435435 408process for cases in which a provider certifies that it is unsafe for a patient to receive medication
436436 409from a third party specialty pharmacy or to have the drug administered in the home setting; iii)
437437 410same day delivery of medications; iv) 24 hour per day, 7 day per week on-call access to a
438438 411pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure that a drug
439439 412remains at the appropriate temperature through all stages of supply and storage; vi) the provision
440440 413of a medication’s pedigree to certify to the hospital pharmacy that the drug was handled
441441 414appropriately through the supply chain; vii) demonstration of expertise and reliability in risk
442442 415evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
443443 416demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
444444 417deliver medications to a health system pharmacy in a ready-to-administer dosage form and
445445 418clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
446446 419with hospitals responsible for receiving and administering medications dispensed by the
447447 420specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
448448 421prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
449449 422pharmacy for the purposes of this paragraph.
450450 423 h) No health plans offered through the connector shall require a medication requiring
451451 424sterile compounding by health system pharmacy staff or a medication with a patient-specific
452452 425dosage requirement dependent upon lab or test results on the day of the clinic visit to be
453453 426distributed from a specialty pharmacy to a physician’s office, hospital or clinic for
454454 427administration.
455455 428 i) Health plans offered through the connector shall, when requiring the distribution of
456456 429patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic 21 of 21
457457 430for administration, offer site neutral payment for such medication to the healthcare providers
458458 431administering the medication. Such payment shall include the costs for the providers to intake,
459459 432store and dispose of such medications.