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HOUSE DOCKET, NO. 3795 FILED ON: 1/20/2023
HOUSE . . . . . . . . . . . . . . . No. 1144
The Commonwealth of Massachusetts
_________________
PRESENTED BY:
Jon Santiago
_________________
To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
Court assembled:
The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
An Act relative to specialty medications and patient safety.
_______________
PETITION OF:
NAME:DISTRICT/ADDRESS :DATE ADDED:Jon Santiago9th Suffolk1/17/2023 1 of 21
HOUSE DOCKET, NO. 3795 FILED ON: 1/20/2023
HOUSE . . . . . . . . . . . . . . . No. 1144
By Representative Santiago of Boston, a petition (accompanied by bill, House, No. 1144) of Jon
Santiago relative to specialty medications and patient safety. Financial Services.
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Third General Court
(2023-2024)
_______________
An Act relative to specialty medications and patient safety.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
of the same, as follows:
1 SECTION 1. Chapter 32A of the General Laws is hereby amended by inserting after
2section 17R the following new section:-
3 Section 17S. a) The following words as used in this section shall have the following
4meanings:
5 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
6services and where drugs, devices, and other materials used in the diagnosis and treatment of
7injury, illness, and disease are dispensed and compounded.
8 “Specialty pharmacy practice” means the provision of pharmacist care services, which
9involves drugs used to treat chronic or specific diseases and conditions that require frequent
10communication with other health care providers, extensive patient monitoring and case
11management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed 2 of 21
12by a specialty pharmacy may also require instruction and training on complex administration
13processes and/or handling and storage considerations.
14 b) Any coverage offered by the commission to an active or retired employee of the
15commonwealth insured under the group insurance commission shall not require a specialty
16pharmacy to dispense a medication directly to a patient with the intention that the patient will
17transport the medication to a healthcare provider for administration.
18 c) Any coverage offered by the commission to an active or retired employee of the
19commonwealth insured under the group insurance commission may offer but shall not require
20the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by physicians
21to patients in their homes or the use of an infusion site external to a patient’s provider office or
22clinic.
23 d) Any coverage offered by the commission to an active or retired employee of the
24commonwealth insured under the group insurance commission shall, when requiring the
25distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
26hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients
27from the insurer prior to the implementation of such a requirement; ii) a patient-specific
28expedited exception process for cases in which a provider certifies that it is unsafe for a patient
29to receive medication from a third party specialty pharmacy or to have the drug administered in
30the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
31call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
32that a drug remains at the appropriate temperature through all stages of supply and storage; vi)
33the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was 3 of 21
34handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
35risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
36demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
37deliver medications to a health system pharmacy in a ready-to-administer dosage form and
38clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
39with hospitals responsible for receiving and administering medications dispensed by the
40specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
41prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
42pharmacy for the purposes of this paragraph.
43 e) Any coverage offered by the commission to an active or retired employee of the
44commonwealth insured under the group insurance commission shall not require a medication
45requiring sterile compounding by health system pharmacy staff or a medication with a patient-
46specific dosage requirement dependent upon lab or test results on the day of the clinic visit, or a
47federally controlled substance, to be distributed from a specialty pharmacy to a physician’s
48office, hospital or clinic for administration.
49 f) Any coverage offered by the commission to an active or retired employee of the
50commonwealth insured under the group insurance commission shall, when requiring the
51distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
52hospital or clinic for administration, shall offer site neutral payment for such medication to the
53healthcare providers administering the medication. Such payment shall include the costs for the
54providers to intake, store and dispose of such medications. 4 of 21
55 SECTION 2. Chapter 118E of the General Laws is hereby amended by inserting after
56section 10N the following new section:-
57 Section 10O. a) The following words as used in this section shall have the following
58meanings:
59 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
60services and where Drugs, Devices, and other materials used in the diagnosis and treatment of
61injury, illness, and disease are Dispensed and Compounded.
62 “Specialty pharmacy practice” means the provision of pharmacist care services, which
63involves drugs used to treat chronic or specific diseases and conditions that require frequent
64communication with other health care providers, extensive patient monitoring and case
65management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
66by a specialty pharmacy may also require instruction and training on complex administration
67processes and/or handling and storage considerations.
68 b) The division, its Medicaid contracted health insurers, health plans, health maintenance
69organizations, behavioral health management firms and third party administrators under contract
70to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
71accountable care organizations shall not require coverage for a specialty pharmacy that dispenses
72a medication directly to a patient with the intention that the patient will transport the medication
73to a healthcare provider for administration.
74 c) The division, its Medicaid contracted health insurers, health plans, health maintenance
75organizations, behavioral health management firms and third party administrators under contract
76to a Medicaid managed care organization, the Medicaid primary care clinician plan, and 5 of 21
77accountable care organizations may offer coverage for but shall not require the use of a home
78infusion pharmacy to dispense sterile intravenous drugs ordered by physicians to patients in their
79homes or the use of an infusion site external to a patient’s provider office or clinic.
80 d) The division, its Medicaid contracted health insurers, health plans, health maintenance
81organizations, behavioral health management firms and third party administrators under contract
82to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
83accountable care organizations shall when requiring the distribution of patient-specific
84medication from a specialty pharmacy to a physician’s office, hospital or clinic for
85administration, require: i) at least 60 days’ notice to providers and patients from the insurer prior
86to the implementation of such a requirement; ii) a patient-specific expedited exception process
87for cases in which a provider certifies that it is unsafe for a patient to receive medication from a
88third party specialty pharmacy or to have the drug administered in the home setting; iii) same day
89delivery of medications; iv) 24 hour per day, 7 day per week on-call access to a pharmacist or
90nurse; v) provision of cold chain logistics or other ability to ensure that a drug remains at the
91appropriate temperature through all stages of supply and storage; vi) the provision of a
92medication’s pedigree to certify to the hospital pharmacy that the drug was handled appropriately
93through the supply chain; vii) demonstration of expertise and reliability in risk evaluation and
94mitigation strategy to comply with USFDA reporting requirements; viii) demonstrated
95accreditation from a national accreditation organization; ix) demonstrated ability to deliver
96medications to a health system pharmacy in a ready-to-administer dosage form and clinically
97appropriate dosage; and x) third-party specialty pharmacies to establish agreements with
98hospitals responsible for receiving and administering medications dispensed by the specialty
99pharmacy to ensure proper receipt, transfer, handling, and storage of the medication prior to 6 of 21
100administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
101pharmacy for the purposes of this paragraph.
102 e) The division, its Medicaid contracted health insurers, health plans, health maintenance
103organizations, behavioral health management firms and third party administrators under contract
104to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
105accountable care organizations shall not require a medication requiring sterile compounding by
106health system pharmacy staff or a medication with a patient-specific dosage requirement
107dependent upon lab or test results on the day of the clinic visit, or a federally controlled
108substance, to be distributed from a specialty pharmacy to a physician’s office, hospital or clinic
109for administration.
110 f) The division, its Medicaid contracted health insurers, health plans, health maintenance
111organizations, behavioral health management firms and third party administrators under contract
112to a Medicaid managed care organization, the Medicaid primary care clinician plan, and
113accountable care organizations, shall, when requiring the distribution of patient-specific
114medication from a specialty pharmacy to a physician’s office, hospital or clinic for
115administration, shall offer site neutral payment for such medication to the healthcare providers
116administering the medication. Such payment shall include the costs for the providers to intake,
117store and dispose of such medications.
118 SECTION 3. Chapter 175 of the General Laws is hereby amended by inserting after
119section 47PP the following new section:-
120 Section 47QQ. a) The following words as used in this section shall have the following
121meanings: 7 of 21
122 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
123services and where drugs, devices, and other materials used in the diagnosis and treatment of
124injury, illness, and disease are dispensed and compounded.
125 “Specialty pharmacy practice” means the provision of pharmacist care services, which
126involves drugs used to treat chronic or specific diseases and conditions that require frequent
127communication with other health care providers, extensive patient monitoring and case
128management, and comprehensive counseling with the patient and/or caregiver.Drugs dispensed
129by a specialty pharmacy may also require instruction and training on complex administration
130processes and/or handling and storage considerations.
131 b) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
132renewed within the commonwealth that provides medical expense coverage shall not require a
133specialty pharmacy to dispense a medication directly to a patient with the intention that the
134patient will transport the medication to a healthcare provider for administration.
135 c) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
136renewed within the commonwealth that provides medical expense coverage may offer coverage
137for but shall not require the use of a home infusion pharmacy to dispense sterile intravenous
138drugs ordered by physicians to patient in their homes or the use of an infusion site external to a
139patient’s provider office or clinic.
140 d) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
141renewed within the commonwealth that provides medical expense coverage shall, when requiring
142the distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
143hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients 8 of 21
144from the insurer prior to the implementation of such a requirement; ii) a patient-specific
145expedited exception process for cases in which a provider certifies that it is unsafe for a patient
146to receive medication from a third party specialty pharmacy or to have the drug administered in
147the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
148call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
149that a drug remains at the appropriate temperature through all stages of supply and storage; vi)
150the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was
151handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
152risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
153demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
154deliver medications to a health system pharmacy in a ready-to-administer dosage form and
155clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
156with hospitals responsible for receiving and administering medications dispensed by the
157specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
158prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
159pharmacy for the purposes of this paragraph.
160 e) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
161renewed within the commonwealth that provides medical expense coverage shall not require a
162medication requiring sterile compounding by health system pharmacy staff or a medication with
163a patient-specific dosage requirement dependent upon lab or test results on the day of the clinic
164visit, or a federally controlled substance, to be distributed from a specialty pharmacy to a
165physician’s office, hospital or clinic for administration. 9 of 21
166 f) A policy, contract, agreement, plan or certificate of insurance issued, delivered or
167renewed within the commonwealth that provides medical expense coverage shall, when requiring
168the distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
169hospital or clinic for administration, offer site neutral payment for such medication to the
170healthcare providers administering the medication. Such payment shall include the costs for the
171providers to intake, store and dispose of such medications.
172 SECTION 4. Chapter 176A of the General Laws is hereby amended by inserting after
173section 8QQ the following new section:-
174 Section 8RR. a) The following words as used in this section shall have the following
175meanings:
176 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
177services and where drugs, devices, and other materials used in the diagnosis and treatment of
178injury, illness, and disease are dispensed and compounded.
179 “Specialty pharmacy practice” means the provision of pharmacist care services, which
180involves drugs used to treat chronic or specific diseases and conditions that require frequent
181communication with other health care providers, extensive patient monitoring and case
182management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
183by a specialty pharmacy may also require instruction and training on complex administration
184processes and/or handling and storage considerations.
185 b) Any contracts, except contracts providing supplemental coverage to Medicare or other
186governmental programs, between a subscriber and the corporation under an individual or group
187hospital service plan which is delivered, issued or renewed in the commonwealth shall not 10 of 21
188require a specialty pharmacy to dispense a medication directly to a patient with the intention that
189the patient will transport the medication to a healthcare provider for administration.
190 c) Any contracts, except contracts providing supplemental coverage to Medicare or other
191governmental programs, between a subscriber and the corporation under an individual or group
192hospital service plan which is delivered, issued or renewed in the commonwealth may offer
193coverage for but shall not require the use of a home infusion pharmacy to dispense sterile
194intravenous drugs ordered by physicians to patient in their homes or the use of an infusion site
195external to a patient’s provider office or clinic..
196 d) Any contracts, except contracts providing supplemental coverage to Medicare or other
197governmental programs, between a subscriber and the corporation under an individual or group
198hospital service plan which is delivered, issued or renewed in the commonwealth shall when
199requiring the distribution of patient-specific medication from a specialty pharmacy to a
200physician’s office, hospital or clinic for administration, require: i) at least 60 days’ notice to
201providers and patients from the insurer prior to the implementation of such a requirement; ii) a
202patient-specific expedited exception process for cases in which a provider certifies that it is
203unsafe for a patient to receive medication from a third party specialty pharmacy or to have the
204drug administered in the home setting; iii) same day delivery of medications; iv) 24 hour per day,
2057 day per week on-call access to a pharmacist or nurse; v) provision of cold chain logistics or
206other ability to ensure that a drug remains at the appropriate temperature through all stages of
207supply and storage; vi) the provision of a medication’s pedigree to certify to the hospital
208pharmacy that the drug was handled appropriately through the supply chain; vii) demonstration
209of expertise and reliability in risk evaluation and mitigation strategy to comply with USFDA
210reporting requirements; viii) demonstrated accreditation from a national accreditation 11 of 21
211organization; ix) demonstrated ability to deliver medications to a health system pharmacy in a
212ready-to-administer dosage form and clinically appropriate dosage; and x) third-party specialty
213pharmacies to establish agreements with hospitals responsible for receiving and administering
214medications dispensed by the specialty pharmacy to ensure proper receipt, transfer, handling, and
215storage of the medication prior to administration. A pharmacy owned or affiliated with a hospital
216may serve as specialty pharmacy for the purposes of this paragraph.
217 e) Any contracts, except contracts providing supplemental coverage to Medicare or other
218governmental programs, between a subscriber and the corporation under an individual or group
219hospital service plan which is delivered, issued or renewed in the commonwealth shall not
220require a medication requiring sterile compounding by health system pharmacy staff or a
221medication with a patient-specific dosage requirement dependent upon lab or test results on the
222day of the clinic visit, or a federally controlled substance, to be distributed from a specialty
223pharmacy to a physician’s office, hospital or clinic for administration.
224 f) Any contracts, except contracts providing supplemental coverage to Medicare or other
225governmental programs, between a subscriber and the corporation under an individual or group
226hospital service plan which is delivered, issued or renewed in the commonwealth shall, when
227requiring the distribution of patient-specific medication from a specialty pharmacy to a
228physician’s office, hospital or clinic for administration, offer site neutral payment for such
229medication to the healthcare providers administering the medication. Such payment shall include
230the costs for the providers to intake, store and dispose of such medications.
231 SECTION 5. Chapter 176B of the General Laws is hereby amended by inserting after
232section 4QQ the following new section:- 12 of 21
233 Section 4RR. a) The following words as used in this section shall have the following
234meanings:
235 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
236services and where drugs, devices, and other materials used in the diagnosis and treatment of
237injury, illness, and disease are dispensed and compounded.
238 “Specialty pharmacy practice” means the provision of pharmacist care services, which
239involves drugs used to treat chronic or specific diseases and conditions that require frequent
240communication with other health care providers, extensive patient monitoring and case
241management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
242by a specialty pharmacy may also require instruction and training on complex administration
243processes and/or handling and storage considerations.
244 b) Any subscription certificate under an individual or group medical service agreement
245delivered, issued or renewed within the commonwealth shall not require a specialty pharmacy to
246dispense a medication directly to a patient with the intention that the patient will transport the
247medication to a healthcare provider for administration.
248 c) Any subscription certificate under an individual or group medical service agreement
249delivered, issued or renewed within the commonwealth may offer coverage for but shall not
250require the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by
251physicians to patient in their homes or the use of an infusion site external to a patient’s provider
252office or clinic.
253 d) Any subscription certificate under an individual or group medical service agreement
254delivered, issued or renewed within the commonwealth shall when requiring the distribution of 13 of 21
255patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic
256for administration, require: i) at least 60 days’ notice to providers and patients from the insurer
257prior to the implementation of such a requirement; ii) a patient-specific expedited exception
258process for cases in which a provider certifies that it is unsafe for a patient to receive medication
259from a third party specialty pharmacy or to have the drug administered in the home setting; iii)
260same day delivery of medications; iv) 24 hour per day, 7 day per week on-call access to a
261pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure that a drug
262remains at the appropriate temperature through all stages of supply and storage; vi) the provision
263of a medication’s pedigree to certify to the hospital pharmacy that the drug was handled
264appropriately through the supply chain; vii) demonstration of expertise and reliability in risk
265evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
266demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
267deliver medications to a health system pharmacy in a ready-to-administer dosage form and
268clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
269with hospitals responsible for receiving and administering medications dispensed by the
270specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
271prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
272pharmacy for the purposes of this paragraph.
273 e) Any subscription certificate under an individual or group medical service agreement
274delivered, issued or renewed within the commonwealth shall not require a medication requiring
275sterile compounding by health system pharmacy staff or a medication with a patient-specific
276dosage requirement dependent upon lab or test results on the day of the clinic visit, , or a 14 of 21
277federally controlled substance, to be distributed from a specialty pharmacy to a physician’s
278office, hospital or clinic for administration.
279 f) Any subscription certificate under an individual or group medical service agreement
280delivered, issued or renewed within the commonwealth shall, when requiring the distribution of
281patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic
282for administration, offer site neutral payment for such medication to the healthcare providers
283administering the medication. Such payment shall include the costs for the providers to intake,
284store and dispose of such medications.
285 SECTION 6. Chapter 176G of the General Laws is hereby amended by inserting after
286section 4II the following new section:-
287 Section 4JJ. a) The following words as used in this section shall have the following
288meanings:
289 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
290services and where drugs, devices, and other materials used in the diagnosis and treatment of
291injury, illness, and disease are dispensed and compounded.
292 “Specialty pharmacy practice” means the provision of pharmacist care services, which
293involves drugs used to treat chronic or specific diseases and conditions that require frequent
294communication with other health care providers, extensive patient monitoring and case
295management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
296by a specialty pharmacy may also require instruction and training on complex administration
297processes and/or handling and storage considerations. 15 of 21
298 b) Any individual or group health maintenance contract shall not require a specialty
299pharmacy to dispense a medication directly to a patient with the intention that the patient will
300transport the medication to a healthcare provider for administration.
301 c) Any individual or group health maintenance contract may offer coverage for but shall
302not require the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by
303physicians to patient in their homes or the use of an infusion site external to a patient’s provider
304office or clinic.
305 d) Any individual or group health maintenance contract shall when requiring the
306distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
307hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients
308from the insurer prior to the implementation of such a requirement; ii) a patient-specific
309expedited exception process for cases in which a provider certifies that it is unsafe for a patient
310to receive medication from a third party specialty pharmacy or to have the drug administered in
311the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
312call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
313that a drug remains at the appropriate temperature through all stages of supply and storage; vi)
314the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was
315handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
316risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
317demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
318deliver medications to a health system pharmacy in a ready-to-administer dosage form and
319clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
320with hospitals responsible for receiving and administering medications dispensed by the 16 of 21
321specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
322prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
323pharmacy for the purposes of this paragraph.
324 e) Any individual or group health maintenance contract shall not require a medication
325requiring sterile compounding by health system pharmacy staff or a medication with a patient-
326specific dosage requirement dependent upon lab or test results on the day of the clinic visit, or a
327federally controlled substance, to be distributed from a specialty pharmacy to a physician’s
328office, hospital or clinic for administration.
329 f) Any individual or group health maintenance contract shall when requiring the
330distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
331hospital or clinic for administration, offer site neutral payment for such medication to the
332healthcare providers administering the medication. Such payment shall include the costs for the
333providers to intake, store and dispose of such medications.
334 SECTION 7. Chapter 176I of the General Laws is hereby amended by inserting after
335section 13 the following new section:-
336 Section 14. a) The following words as used in this section shall have the following
337meanings:
338 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
339services and where drugs, devices, and other materials used in the diagnosis and treatment of
340injury, illness, and disease are dispensed and compounded. 17 of 21
341 “Specialty pharmacy practice” means the provision of pharmacist care services, which
342involves drugs used to treat chronic or specific diseases and conditions that require frequent
343communication with other health care providers, extensive patient monitoring and case
344management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
345by a specialty pharmacy may also require instruction and training on complex administration
346processes and/or handling and storage considerations.
347 b) An organization entering into a preferred provider contract shall not require a specialty
348pharmacy to dispense a medication directly to a patient with the intention that the patient will
349transport the medication to a healthcare provider for administration.
350 c) An organization entering into a preferred provider contract may offer coverage for but
351shall not require the use of a home infusion pharmacy to dispense sterile intravenous drugs
352ordered by physicians to patient in their homes or the use of an infusion site external to a
353patient’s provider office or clinic.
354 d) An organization entering into a preferred provider contract shall when requiring the
355distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
356hospital or clinic for administration, require: i) at least 60 days’ notice to providers and patients
357from the insurer prior to the implementation of such a requirement; ii) a patient-specific
358expedited exception process for cases in which a provider certifies that it is unsafe for a patient
359to receive medication from a third party specialty pharmacy or to have the drug administered in
360the home setting; iii) same day delivery of medications; iv) 24 hour per day, 7 day per week on-
361call access to a pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure
362that a drug remains at the appropriate temperature through all stages of supply and storage; vi) 18 of 21
363the provision of a medication’s pedigree to certify to the hospital pharmacy that the drug was
364handled appropriately through the supply chain; vii) demonstration of expertise and reliability in
365risk evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
366demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
367deliver medications to a health system pharmacy in a ready-to-administer dosage form and
368clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
369with hospitals responsible for receiving and administering medications dispensed by the
370specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
371prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
372pharmacy for the purposes of this paragraph.
373 e) An organization entering into a preferred provider contract shall not require a
374medication requiring sterile compounding by health system pharmacy staff or a medication with
375a patient-specific dosage requirement dependent upon lab or test results on the day of the clinic
376visit, or a federally controlled substance, to be distributed from a specialty pharmacy to a
377physician’s office, hospital or clinic for administration.
378 f) An organization entering into a preferred provider contract shall, when requiring the
379distribution of patient-specific medication from a specialty pharmacy to a physician’s office,
380hospital or clinic for administration, offer site neutral payment for such medication to the
381healthcare providers administering the medication. Such payment shall include the costs for the
382providers to intake, store and dispose of such medications.
383 SECTION 8. Chapter 176Q of the General Laws is hereby amended in section 1 by
384inserting after the definition of “Rating factor”, the following definitions:- 19 of 21
385 “Specialty pharmacy” means a pharmacy that is providing specialty pharmacy practice
386services and where drugs, devices, and other materials used in the diagnosis and treatment of
387injury, illness, and disease are dispensed and compounded.
388 “Specialty pharmacy practice” means the provision of pharmacist care services, which
389involves drugs used to treat chronic or specific diseases and conditions that require frequent
390communication with other health care providers, extensive patient monitoring and case
391management, and comprehensive counseling with the patient and/or caregiver. Drugs dispensed
392by a specialty pharmacy may also require instruction and training on complex administration
393processes and/or handling and storage considerations.
394 SECTION 9. Chapter 176Q of the General Laws, as appearing in the 2018 Official
395Edition, is hereby amended in section 5 by inserting after subsection d the following 5 new
396subsections:-
397 e) No health plans offered through the connector shall require a specialty pharmacy to
398dispense a medication directly to a patient with the intention that the patient will transport the
399medication to a healthcare provider for administration.
400 f) Health plans offered through the connector may offer coverage for but shall not require
401the use of a home infusion pharmacy to dispense sterile intravenous drugs ordered by physicians
402to patient in their homes or the use of an infusion site external to a patient’s provider office or
403clinic.
404 g) Health plans offered through the connector shall when requiring the distribution of
405patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic
406for administration, require: i) at least 60 days’ notice to providers and patients from the insurer 20 of 21
407prior to the implementation of such a requirement; ii) a patient-specific expedited exception
408process for cases in which a provider certifies that it is unsafe for a patient to receive medication
409from a third party specialty pharmacy or to have the drug administered in the home setting; iii)
410same day delivery of medications; iv) 24 hour per day, 7 day per week on-call access to a
411pharmacist or nurse; v) provision of cold chain logistics or other ability to ensure that a drug
412remains at the appropriate temperature through all stages of supply and storage; vi) the provision
413of a medication’s pedigree to certify to the hospital pharmacy that the drug was handled
414appropriately through the supply chain; vii) demonstration of expertise and reliability in risk
415evaluation and mitigation strategy to comply with USFDA reporting requirements; viii)
416demonstrated accreditation from a national accreditation organization; ix) demonstrated ability to
417deliver medications to a health system pharmacy in a ready-to-administer dosage form and
418clinically appropriate dosage; and x) third-party specialty pharmacies to establish agreements
419with hospitals responsible for receiving and administering medications dispensed by the
420specialty pharmacy to ensure proper receipt, transfer, handling, and storage of the medication
421prior to administration. A pharmacy owned or affiliated with a hospital may serve as a specialty
422pharmacy for the purposes of this paragraph.
423 h) No health plans offered through the connector shall require a medication requiring
424sterile compounding by health system pharmacy staff or a medication with a patient-specific
425dosage requirement dependent upon lab or test results on the day of the clinic visit to be
426distributed from a specialty pharmacy to a physician’s office, hospital or clinic for
427administration.
428 i) Health plans offered through the connector shall, when requiring the distribution of
429patient-specific medication from a specialty pharmacy to a physician’s office, hospital or clinic 21 of 21
430for administration, offer site neutral payment for such medication to the healthcare providers
431administering the medication. Such payment shall include the costs for the providers to intake,
432store and dispose of such medications.