Massachusetts 2023-2024 Regular Session

Massachusetts House Bill H945 Compare Versions

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22 HOUSE DOCKET, NO. 2503 FILED ON: 1/19/2023
33 HOUSE . . . . . . . . . . . . . . . No. 945
44 The Commonwealth of Massachusetts
55 _________________
66 PRESENTED BY:
77 Christine P. Barber and 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 to ensure prescription drug cost transparency and affordability.
1313 _______________
1414 PETITION OF:
1515 NAME:DISTRICT/ADDRESS :DATE ADDED:Christine P. Barber34th Middlesex1/19/2023Jon Santiago9th Suffolk1/19/2023Lindsay N. Sabadosa1st Hampshire1/19/2023Mindy Domb3rd Hampshire1/19/2023Carmine Lawrence Gentile13th Middlesex1/25/2023David Paul Linsky5th Middlesex1/26/2023Lenny Mirra2nd Essex1/26/2023Peter Capano11th Essex1/27/2023Susannah M. Whipps2nd Franklin1/27/2023Brian W. Murray10th Worcester1/29/2023Jack Patrick Lewis7th Middlesex2/1/2023Vanna Howard17th Middlesex2/1/2023Patricia A. Duffy5th Hampden2/2/2023Kevin G. Honan17th Suffolk2/3/2023Jennifer Balinsky Armini8th Essex2/4/2023David Henry Argosky LeBoeuf17th Worcester2/6/2023Jason M. LewisFifth Middlesex2/7/2023Patrick M. O'ConnorFirst Plymouth and Norfolk2/8/2023 2 of 2
1616 Colleen M. Garry36th Middlesex2/13/2023James C. Arena-DeRosa8th Middlesex2/13/2023James B. EldridgeMiddlesex and Worcester2/16/2023Kate Lipper-Garabedian32nd Middlesex2/22/2023Natalie M. Higgins4th Worcester2/23/2023Tram T. Nguyen18th Essex2/27/2023 1 of 29
1717 HOUSE DOCKET, NO. 2503 FILED ON: 1/19/2023
1818 HOUSE . . . . . . . . . . . . . . . No. 945
1919 By Representatives Barber of Somerville and Santiago of Boston, a petition (accompanied by
2020 bill, House, No. 945) of Christine P. Barber, Jon Santiago and others for legislation to ensure
2121 prescription drug cost transparency and affordability. Financial Services.
2222 The Commonwealth of Massachusetts
2323 _______________
2424 In the One Hundred and Ninety-Third General Court
2525 (2023-2024)
2626 _______________
2727 An Act to ensure prescription drug cost transparency and affordability.
2828 Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
2929 of the same, as follows:
3030 1 SECTION 1. Section 1 of chapter 6D of the General Laws, as appearing so appearing, is
3131 2hereby amended by inserting after the definition of “Alternative payment methodologies or
3232 3methods” the following 2 definitions:-
3333 4 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
3434 5application approved under 42 U.S.C. 262(k)(3).
3535 6 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
3636 7drug application approved under 21 U.S.C. 355(c) except for an authorized generic as defined by
3737 842 C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application
3838 9approved under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand
3939 10name drug based on available data resources such as Medi-Span.
4040 11 SECTION 2. Said section 1 of said chapter 6D, as so appearing, is hereby further
4141 12amended by inserting after the definition of “Fiscal year” the following definition:- 2 of 29
4242 13 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
4343 14abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic as
4444 15defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 and
4545 16was not originally marketed under a new drug application; or (iv) identified by the health benefit
4646 17plan as a generic drug based on available data resources such as Medi-Span.
4747 18 SECTION 3. Said section 1 of said chapter 6D, as so appearing, is hereby further
4848 19amended by striking out, in line 189, the words “not include excludes ERISA plans” and
4949 20inserting in place thereof the following words:- include self-insured plans to the extent allowed
5050 21under the federal Employee Retirement Income Security Act of 1974.
5151 22 SECTION 4. Said section 1 of said chapter 6D, as so appearing, is hereby further
5252 23amended by inserting after the definition of “Performance penalty” the following 2 definitions:-
5353 24 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
5454 25preparation, propagation, compounding, conversion or processing of prescription drugs, directly
5555 26or indirectly, by extraction from substances of natural origin, independently by means of
5656 27chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
5757 28repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
5858 29“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
5959 30under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
6060 31chapter 112.
6161 32 “Pharmacy benefit manager”, a person, business or other entity, however organized, that
6262 33directly or through a subsidiary provides pharmacy benefit management services for prescription
6363 34drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- 3 of 29
6464 35insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
6565 36management services shall include, but not be limited to, the processing and payment of claims
6666 37for prescription drugs, the performance of drug utilization review, the processing of drug prior
6767 38authorization requests, pharmacy contracting, the adjudication of appeals or grievances related to
6868 39prescription drug coverage contracts, formulary administration, drug benefit design, mail and
6969 40specialty drug pharmacy services, cost containment, clinical, safety and adherence programs for
7070 41pharmacy services and managing the cost of covered prescription drugs; provided further, that
7171 42“pharmacy benefit manager” shall include a health benefit plan that does not contract with a
7272 43pharmacy benefit manager and manages its own prescription drug benefits unless specifically
7373 44exempted by the commission.
7474 45 SECTION 5. Said section 1 of said chapter 6D, as so appearing, is hereby further
7575 46amended by adding the following definition:-
7676 47 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C.
7777 481395w-3a(c)(6)(B).
7878 49 SECTION 6. Said chapter 6D is hereby further amended by striking out section 2A, as so
7979 50appearing, and inserting in place thereof the following section:-
8080 51 Section 2A. The commission shall keep confidential all nonpublic clinical, financial,
8181 52strategic or operational documents or information provided or reported to the commission in
8282 53connection with any care delivery, quality improvement process, performance improvement plan
8383 54authorized under sections 7, 10, 14, 15 or 20 of this chapter or under section 2GGGG of chapter
8484 5529 and shall not disclose the information or documents to any person without the consent of the
8585 56payer, provider or pharmaceutical manufacturing company providing or reporting the 4 of 29
8686 57information or documents under said sections 7, 10, 14, 15, or 20 of this chapter or under said
8787 58section 2GGGG of said chapter 29, except in summary form in evaluative reports of such
8888 59activities or when the commission believes that such disclosure should be made in the public
8989 60interest after taking into account any privacy, trade secret or anticompetitive considerations. The
9090 61confidential information and documents shall not be public records and shall be exempt from
9191 62disclosure under clause Twenty sixth of section 7 of chapter 4 or section 10 of chapter 66.
9292 63 SECTION 7. Section 6 of said chapter 6D, as so appearing, is hereby amended by
9393 64inserting after the word “center”, in line 1, the following words:- , pharmaceutical and
9494 65biopharmaceutical manufacturing company, pharmacy benefit manager.
9595 66 SECTION 8. Said section 6 of said chapter 6D, as so appearing, is hereby further
9696 67amended by striking out, in lines 5 and 36, the figure “33” and inserting in place thereof, in each
9797 68instance, the following figure:- 25.
9898 69 SECTION 9. Said section 6 of said chapter 6D, as so appearing, is hereby further
9999 70amended by adding the following paragraph:-
100100 71 The assessed amount for pharmaceutical and biopharmaceutical manufacturing
101101 72companies and pharmacy benefit managers shall be not less than 25 per cent of the amount
102102 73appropriated by the general court for the expenses of the commission minus amounts collected
103103 74from: (i) filing fees; (ii) fees and charges generated by the commission's publication or
104104 75dissemination of reports and information; and (iii) federal matching revenues received for these
105105 76expenses or received retroactively for expenses of predecessor agencies. Pharmaceutical and
106106 77biopharmaceutical manufacturing companies and pharmacy benefit managers shall, in a manner
107107 78and distribution determined by the commission, pay to the commonwealth an amount of the 5 of 29
108108 79estimated expenses of the commission attributable to the commission’s activities under sections
109109 808, 9 and 20. A pharmacy benefit manager that is a surcharge payor subject to the preceding
110110 81paragraph and manages its own prescription drug benefits shall not be subject to additional
111111 82assessment under this paragraph.
112112 83 SECTION 10. Section 8 of said chapter 6D, as so appearing, is hereby amended by
113113 84inserting after the word “organization”, in lines 6 and 7, the following words:- , pharmacy benefit
114114 85manager, pharmaceutical manufacturing company.
115115 86 SECTION 11. Said section 8 of said chapter 6D, as so appearing, is hereby further
116116 87amended by inserting after the word “organizations”, in line 14, the following words:- ,
117117 88pharmacy benefit managers, pharmaceutical manufacturing companies.
118118 89 SECTION 12. Said section 8 of said chapter 6D, as so appearing, is hereby further
119119 90amended by striking out, in line 32, the words “and (xi)” and inserting in place thereof the
120120 91following words:- (xi) at least 3 representatives of the pharmaceutical industry; (xii) at least 1
121121 92pharmacy benefit manager; and (xiii).
122122 93 SECTION 13. Said section 8 of said chapter 6D, as so appearing, is hereby further
123123 94amended by inserting after the word “commission”, in line 59, the first time it appears, the
124124 95following words:- ; and (iii) in the case of pharmacy benefit managers and pharmaceutical
125125 96manufacturing companies, testimony concerning factors underlying prescription drug costs and
126126 97price increases including, but not limited to, the initial prices of drugs coming to market and
127127 98subsequent price increases, changes in industry profit levels, marketing expenses, reverse
128128 99payment patent settlements, the impact of manufacturer rebates, discounts and other price 6 of 29
129129 100concessions on net pricing, the availability of alternative drugs or treatments and any other
130130 101matters as determined by the commission.
131131 102 SECTION 14. Subsection (g) of said section 8 of said chapter 6D, as so appearing, is
132132 103hereby amended by striking out the second sentence and inserting in place thereof the following
133133 104sentence:- The report shall be based on the commission’s analysis of information provided at the
134134 105hearings by witnesses, providers, provider organizations, payers, pharmaceutical manufacturing
135135 106companies and pharmacy benefit managers, registration data collected under section 11, data
136136 107collected or analyzed by the center under sections 8, 9, 10, and 10A of chapter 12C and any other
137137 108available information that the commission considers necessary to fulfill its duties under this
138138 109section as defined in regulations promulgated by the commission.
139139 110 SECTION 15. Section 9 of said chapter 6D, as so appearing, is hereby amended by
140140 111inserting after the word “organization”, in line 72, the following words:- , pharmacy benefit
141141 112manager, pharmaceutical manufacturing company.
142142 113 SECTION 16. Said chapter 6D, as so appearing, is hereby further amended by adding the
143143 114following section:
144144 115 Section 20. (a) For the purposes of this section, “Manufacturer” shall mean an entity that
145145 116manufactures a pharmaceutical drug.
146146 117 (b) The commission may require a manufacturer specified in subsection (c) to disclose to
147147 118the commission within a reasonable time information relating to the manufacturer’s pricing of
148148 119that drug, on a standard reporting form developed by the commission with the input of the
149149 120manufacturers, which includes, but shall not be limited to, the following: 7 of 29
150150 121 (1) A schedule of the drug’s wholesale acquisition cost increases over the previous 5
151151 122calendar years;
152152 123 (2) The manufacturer’s aggregate, company-level research and development and other
153153 124relevant capital expenditures, including facility construction, for the most recent year for which
154154 125final audited data are available;
155155 126 (3) A written, narrative description, suitable for public release, of factors that contributed
156156 127to reported changes in wholesale acquisition cost during the previous 5 calendar years; and
157157 128 (4) Any other information that the manufacturer wishes to provide to the commission.
158158 129 Based on the records furnished, the commission may identify a proposed value for a
159159 130prescribed drug specified in subsection (c). The Commission may request additional relevant
160160 131information that it deems necessary.
161161 132 (c) A manufacturer of a drug for which the commission has received a referral from the
162162 133center under subsection (b) of section 25 of chapter 12C shall comply with the requirements set
163163 134forth in this section; provided that the commission may select or prioritize a subset of the
164164 135referred drugs for the commission’s review.
165165 136 (d) Records disclosed by a manufacturer under this section shall: (i) be accompanied by
166166 137an attestation that all information provided is true and correct; (ii) not be public records under
167167 138section 7 of chapter 4 or chapter 66; and (iii) remain confidential; provided, however, that the
168168 139commission may produce reports summarizing any findings; provided that any such report shall
169169 140not be in a form that identifies specific prices charged for or rebate amounts associated with 8 of 29
170170 141drugs by a manufacturer, or in a manner that is likely to compromise the financial, competitive or
171171 142proprietary nature of the information.
172172 143 (e) If, after review of any records furnished to the commission under subsection (b), the
173173 144commission determines that the manufacturer’s pricing of the drug is potentially unreasonable or
174174 145excessive in relation to the commission’s proposed value under subsection (b), the commission
175175 146shall require that the manufacturer provide within 30 days further information related to the
176176 147pricing of the prescribed drug and the manufacturer’s justification for the pricing. In addition to
177177 148the manufacturer, the commission may identify other relevant parties including but not limited to
178178 149patients, providers, provider organizations and payers who may provide information to the
179179 150commission.
180180 151 (f) The commission shall provide to the manufacturer for review and input any
181181 152information, analyses or reports regarding a particular drug reviewed or relied on by the
182182 153commission in assessing the proposed value of the drug shall be provided to the manufacturer.
183183 154The commission shall consider any clarifications or data provided by the manufacturer with
184184 155respect to its drug. The commission may not rely solely on the analysis or research of an outside
185185 156third party in reaching its determination regarding the proposed value or the reasonableness of
186186 157the drug pricing.
187187 158 (g) If the commission relies upon a third party to provide cost-effectiveness analysis or
188188 159research related to the proposed value, such analysis or research shall also provide, without
189189 160limitation (i) a description of the methodologies and models used by the third party in its
190190 161analysis; (ii) any assumptions and potential limitations of research findings in the context of the
191191 162results; and (iii) outcomes for affected subpopulations that utilize the drug, including but not 9 of 29
192192 163limited to potential impacts on individuals of minority racial or ethnic groups, and on individuals
193193 164with specific disabilities or health conditions who regularly utilize the eligible drug.
194194 165 (h) Not later than 60 days after receiving information from the manufacturer, as required
195195 166under subsections (b) or (e), the commission shall issue a determination on whether the
196196 167manufacturer’s pricing of a drug is unreasonable or excessive in relation to the commission’s
197197 168proposed value of the drug. Following the determination, the commission shall issue
198198 169recommendations on measures to reduce the cost of the drug and to improve the affordability of
199199 170the drug for patients. Recommendations may include, but not be limited to: (i) an alternative
200200 171purchasing plan or value-based payment methodology; (ii) a bulk purchasing program; (iii)
201201 172changes to co-pay, deductibles, coinsurance or other cost-sharing requirements; or (iv) a
202202 173reinsurance program to subsidize the cost of the eligible drug. The commission shall make its
203203 174determination and recommendations public and shall post them on its website and shall provide
204204 175them to private and public health care payers.
205205 176 (i) If the manufacturer fails to timely comply with the commission’s request for records
206206 177under subsections (b) or (e), or otherwise knowingly obstructs the commission’s ability to issue
207207 178its determination under subsection (h), including, but not limited to, providing incomplete, false
208208 179or misleading information, the commission may assess a civil penalty to a manufacturer of not
209209 180more than $500,000. A civil penalty assessed under this subsection shall be deposited into the
210210 181Payment Reform Fund established pursuant to section 100 of chapter 194 of the acts of 2011.
211211 182The commission shall seek to promote compliance with this section and shall only impose a civil
212212 183penalty on the manufacturer as a last resort. 10 of 29
213213 184 (j) Neither the proposed value, nor the analysis produced via the process to determine a
214214 185proposed value, is intended to be used by MassHealth, health insurance carriers, managed care
215215 186organizations, accountable care organizations, hospitals or pharmacies to determine whether a
216216 187treatment should be approved for an individual patient, whether any individual patient should be
217217 188subjected to step therapy or other utilization management methodology,
218218 189 (k) The commission shall adopt any written policies, procedures or regulations that the
219219 190commission determines necessary to implement this section.
220220 191 SECTION 17. Section 11N of chapter 12 of the General Laws, as so appearing, is hereby
221221 192amended by striking out subsection (a) and inserting in place thereof the following subsection:-
222222 193 (a) The attorney general shall monitor trends in the health care market including, but not
223223 194limited to, trends in provider organization size and composition, consolidation in the provider
224224 195market, payer contracting trends, patient access and quality issues in the health care market and
225225 196prescription drug cost trends. The attorney general may obtain the following information from a
226226 197private health care payer, public health care payer, pharmaceutical manufacturing company,
227227 198pharmacy benefit manager, provider or provider organization as any of those terms may be
228228 199defined in section 1 of chapter 6D: (i) any information that is required to be submitted under
229229 200sections 8, 9 10 and 10A of chapter 12C; (ii) filings, applications and supporting documentation
230230 201related to any cost and market impact review under section 13 of said chapter 6D; (iii) filings,
231231 202applications and supporting documentation related to a determination of need application filed
232232 203under section 25C of chapter 111; and (iv) filings, applications and supporting documentation
233233 204submitted to the federal Centers for Medicare and Medicaid Services or the Office of the
234234 205Inspector General for any demonstration project. Under section 17 of said chapter 12C and 11 of 29
235235 206section 8 of said chapter 6D and subject to the limitations stated in those sections, the attorney
236236 207general may require that any provider, provider organization, pharmaceutical manufacturing
237237 208company, pharmacy benefit manager, private health care payer or public health care payer
238238 209produce documents, answer interrogatories and provide testimony under oath related to health
239239 210care costs and cost trends, pharmaceutical costs, pharmaceutical cost trends, the factors that
240240 211contribute to cost growth within the commonwealth's health care system and the relationship
241241 212between provider costs and payer premium rates and the relationship between pharmaceutical
242242 213drug costs and payer premium rates.
243243 214 SECTION 18. Section 1 of chapter 12C of the General Laws, as so appearing, is hereby
244244 215amended by inserting after the definition of “Ambulatory surgical center services” the following
245245 2163 definitions:-
246246 217 “Average manufacturer price”, the average price paid to a manufacturer for a drug in the
247247 218commonwealth by a wholesaler for drugs distributed to pharmacies and by a pharmacy that
248248 219purchases drugs directly from the manufacturer.
249249 220 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
250250 221application approved under 42 U.S.C. 262(k)(3).
251251 222 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
252252 223drug application approved under 21 U.S.C. §355(c) except for an authorized generic as defined
253253 224by 42 C.F.R. § 447.502; (ii) produced or distributed pursuant to a biologics license application
254254 225approved under 42 U.S.C. § 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand
255255 226name drug based on available data resources such as Medi-Span. 12 of 29
256256 227 SECTION 19. Said section 1 of said chapter 12C, as so appearing, is hereby further
257257 228amended by inserting after the definition of “General health supplies, care or rehabilitative
258258 229services and accommodations” the following definition:-
259259 230 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
260260 231abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic as
261261 232defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 that
262262 233was not originally marketed under a new drug application; or (iv) identified by the health benefit
263263 234plan as a generic drug based on available data resources such as Medi-Span.
264264 235 SECTION 20. Said section 1 of said chapter 12C, as so appearing, is hereby further
265265 236amended by inserting after the definition of “Patient-centered medical home” the following 2
266266 237definitions:-
267267 238 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
268268 239preparation, propagation, compounding, conversion or processing of prescription drugs, directly
269269 240or indirectly, by extraction from substances of natural origin, independently by means of
270270 241chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
271271 242repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
272272 243“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
273273 244under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
274274 245chapter 112.
275275 246 “Pharmacy benefit manager”, a person, business or other entity, however organized, that,
276276 247directly or through a subsidiary, provides pharmacy benefit management services for prescription
277277 248drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- 13 of 29
278278 249insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
279279 250management services shall include, but not be limited to, the processing and payment of claims
280280 251for prescription drugs, the performance of drug utilization review, the processing of drug prior
281281 252authorization requests, pharmacy contracting, the adjudication of appeals or grievances related to
282282 253prescription drug coverage contracts, formulary administration, drug benefit design, mail and
283283 254specialty drug pharmacy services, cost containment, clinical, safety and adherence programs for
284284 255pharmacy services and managing the cost of covered prescription drugs; provided further, that
285285 256“pharmacy benefit manager” shall include a health benefit plan that does not contract with a
286286 257pharmacy benefit manager and manages its own prescription drug benefits unless specifically
287287 258exempted by the commission.
288288 259 SECTION 21. Said section 1 of said chapter 12C, as so appearing, is hereby further
289289 260amended by adding the following definition:-
290290 261 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C.
291291 2621395w-3a(c)(6)(B).
292292 263 SECTION 22. Section 3 of said chapter 12C, as so appearing, is hereby amended by
293293 264inserting after the word “organizations”, in lines 13 and 14, the following words:- ,
294294 265pharmaceutical manufacturing companies, pharmacy benefit managers.
295295 266 SECTION 23. Said section 3 of said chapter 12C, as so appearing, is hereby further
296296 267amended by striking out, in line 24, the words “and payer” and inserting in place thereof the
297297 268following words:- , payer, pharmaceutical manufacturing company and pharmacy benefit
298298 269manager. 14 of 29
299299 270 SECTION 24. Section 5 of said chapter 12C, as so appearing, is hereby amended by
300300 271striking out, in lines 11 and 12, the words “and public health care payers” and inserting in place
301301 272thereof the following words:- , public health care payers, pharmaceutical manufacturing
302302 273companies and pharmacy benefit managers.
303303 274 SECTION 25. Said section 5 of said chapter 12C, as so appearing, is hereby further
304304 275amended by striking out, in line 15, the words “and affected payers” and inserting in place
305305 276thereof the following words:- affected payers, affected pharmaceutical manufacturing companies
306306 277and affected pharmacy benefit managers.
307307 278 SECTION 26. The first paragraph of section 7 of said chapter 12C, as so appearing, is
308308 279hereby amended by adding the following sentence:-
309309 280 Each pharmaceutical and biopharmaceutical manufacturing company and pharmacy
310310 281benefit manager shall pay to the commonwealth an amount for the estimated expenses of the
311311 282center and for the other purposes described in this chapter.
312312 283 SECTION 27. Said section 7 of said chapter 12C, as so appearing, is hereby further
313313 284amended by striking out, in lines 8 and 42, the figure “33” and inserting in place thereof, in each
314314 285instance, the following figure:- 25.
315315 286 SECTION 28. Said section 7 of said chapter 12C, as so appearing, is hereby further
316316 287amended by adding the following paragraph:-
317317 288 The assessed amount for pharmaceutical and biopharmaceutical manufacturing
318318 289companies and pharmacy benefit managers shall be not less than 25 per cent of the amount
319319 290appropriated by the general court for the expenses of the center minus amounts collected from: 15 of 29
320320 291(i) filing fees; (ii) fees and charges generated by the commission's publication or dissemination
321321 292of reports and information; and (iii) federal matching revenues received for these expenses or
322322 293received retroactively for expenses of predecessor agencies. Pharmaceutical and
323323 294biopharmaceutical manufacturing companies and pharmacy benefit managers shall, in a manner
324324 295and distribution determined by the center, pay to the commonwealth an amount of the estimated
325325 296expenses of the center attributable to the center’s activities under sections 3, 10A, 12 and 16. A
326326 297pharmacy benefit manager that is a surcharge payor subject to the preceding paragraph and
327327 298manages its own prescription drug benefits shall not be subject to additional assessment under
328328 299this paragraph.
329329 300 SECTION 29. Subsection (b) of section 10 of chapter 12C of the General Laws, as so
330330 301appearing, is hereby amended by striking out, in line 55, the word “and”.
331331 302 SECTION 30. Said subsection (b) of said section 10 of said chapter 12C is hereby further
332332 303amended by adding the following words:- ; (12) information about prescription drug utilization
333333 304and spending for all covered drugs, including for generic drugs, brand-name drugs, and specialty
334334 305drugs provided in an outpatient setting or sold in a retail setting, including but not limited to
335335 306information sufficient to show (i) highest utilization drugs, (ii) drugs with the greatest increases
336336 307in utilization, (iii) drugs that are most impactful on plan spending, net of rebates, and (iv) drugs
337337 308with the highest year-over-year price increases, net of rebates; and (13) information on claims
338338 309and non-claims based payments to providers for the provision of primary care and behavioral
339339 310health, including mental health and substance use disorder, services, as defined by the center. 16 of 29
340340 311 SECTION 31. Subsection (c) of said section 10 of said chapter 12C, as so appearing, is
341341 312hereby amended by striking out, in line 91, the words “()” and inserting in place thereof the
342342 313following words:- (10).
343343 314 SECTION 32. Said subsection (c) of said section 10 of said chapter 12C, as so appearing,
344344 315is hereby further amended by striking out, in line 99, the word “and”.
345345 316 SECTION 33. Said subsection (c) of said section 10 of said chapter 12C, as so appearing,
346346 317is hereby further amended by adding the following words:- ; (12) information, to the extent
347347 318permissible under 42 U.S.C. 1396r-8(b)(3)(D), about prescription drug utilization and spending
348348 319for all covered drugs, including for generic drugs, brand-name drugs, and specialty drugs
349349 320provided in an outpatient setting or sold in a retail setting, including but not limited to
350350 321information sufficient to show (i) highest utilization drugs, (ii) drugs with the greatest increases
351351 322in utilization, (iii) drugs that are most impactful on plan spending, net of rebates, and (iv) drugs
352352 323with the highest year-over-year price increases, net of rebates; and (13) information on claims
353353 324and non-claims based payments to providers for the provision of primary care and behavioral
354354 325health, including mental health and substance use disorder services, as defined by the center.
355355 326 SECTION 34. Said chapter 12C is hereby further amended by inserting after section 10
356356 327the following section:-
357357 328 Section 10A. (a) The center shall promulgate regulations necessary to ensure the uniform
358358 329annual reporting of information from pharmacy benefit managers certified under chapter 175N,
359359 330including but not limited to information on: (1) prices charged to payers on average by pharmacy
360360 331benefits managers for select prescription drug products, net of any rebate, discounts, fees or other
361361 332payments from the manufacturer to the pharmacy benefits manager and from the pharmacy 17 of 29
362362 333benefits manager to the manufacturer; (2) payments received by pharmacy benefit managers by
363363 334payers related to drugs provided to Massachusetts residents; (3) payments made by pharmacy
364364 335benefit managers to pharmacies related to drugs provided to Massachusetts residents; (4) rebates
365365 336received by pharmacy benefit managers from drug manufacturers related to drugs provided to
366366 337Massachusetts residents; (5) rebates paid by pharmacy benefit managers to payers related to
367367 338drugs provided to Massachusetts residents; (6) other payments made or received by pharmacy
368368 339benefit managers by payers or pharmacies, including but not limited to administrative or
369369 340performance-based payments, related to doing business in Massachusetts; (7) other rebates paid
370370 341to or received by pharmacy benefit managers by drug manufacturers or payers related to doing
371371 342business in Massachusetts; (8) information about prescription drug utilization and spending for
372372 343all covered drugs, including for generic drugs, brand-name drugs, and specialty drugs provided
373373 344in an outpatient setting or sold in a retail setting, including but not limited to information
374374 345sufficient to show: (i) highest utilization drugs; (ii) drugs with the greatest increases in
375375 346utilization; (iii) drugs that are most impactful on plan spending, net of rebates; and (iv) drugs
376376 347with the highest year-over-year price increases, net of rebates; (9) the Medicare Maximum Fair
377377 348Price (42USC Sec 1191(c)) for a prescription drug; and (10) any other information deemed
378378 349necessary by the center.
379379 350 (b) The center shall analyze the information and data collected under subsection (a) and
380380 351shall publish an annual report summarizing, at minimum, the information collected under
381381 352subsection (a) and comparing the information as it relates to each pharmacy benefit manager
382382 353certified under chapter 175N with respect to drugs provided to Massachusetts residents. The
383383 354center may also consult with other states collecting similar data to inform their analysis and
384384 355annual report. 18 of 29
385385 356 (c) Except as provided otherwise by the center or under this chapter, pharmacy benefit
386386 357manager data collected by the center under this section shall not be a public record under clause
387387 358Twenty-sixth of section 7 of chapter 4 or under chapter 66. The center may confidentially
388388 359provide pharmacy benefit manager data collected by the center under this section to the health
389389 360policy commission.
390390 361 SECTION 35. Said chapter 12C is hereby further amended by striking out section 11, as
391391 362so appearing, and inserting in place thereof the following section:-
392392 363 Section 11. The center shall ensure the timely reporting of information required under
393393 364sections 8, 9, 10 and 10A. The center shall notify payers, providers, provider organizations,
394394 365pharmacy benefit managers and pharmaceutical manufacturing companies of any applicable
395395 366reporting deadlines. The center shall notify, in writing, a private health care payer, provider,
396396 367provider organization, pharmacy benefit manager or pharmaceutical manufacturing company that
397397 368it has failed to meet a reporting deadline and that failure to respond within 2 weeks of the receipt
398398 369of the notice may result in penalties. The center may assess a penalty against a private health care
399399 370payer, provider, provider organization, pharmacy benefit manager or pharmaceutical
400400 371manufacturing company that fails, without just cause, to provide the requested information
401401 372within 2 weeks following receipt of the written notice required under this section of not more
402402 373than $2,000 per week for each week of delay after the 2-week period following receipt of the
403403 374written notice. Amounts collected under this section shall be deposited in the Healthcare
404404 375Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011. 19 of 29
405405 376 SECTION 36. Section 12 of said chapter 12C, as so appearing, is hereby amended by
406406 377striking out, in line 2, the words “and 10” and inserting in place thereof the following words:- ,
407407 37810 and 10A.
408408 379 SECTION 37. Subsection (a) of section 16 of said chapter 12C, as so appearing, is hereby
409409 380amended by striking out the first sentence and inserting in place thereof the following sentence:-
410410 381 The center shall publish an annual report based on the information submitted under: (i)
411411 382sections 8, 9, 10 and 10A concerning health care provider, provider organization, private and
412412 383public health care payer, pharmaceutical manufacturing company and pharmacy benefit manager
413413 384costs and cost and price trends; (ii) section 13 of chapter 6D relative to market power reviews;
414414 385and (iii) section 15 of said chapter 6D relative to quality data.
415415 386 SECTION 38. Said chapter 12C is hereby further amended by striking out section 17, as
416416 387so appearing, and inserting in place thereof the following section:-
417417 388 Section 17. The attorney general may review and analyze any information submitted to
418418 389the center under sections 8, 9, 10 and 10A and the health policy commission under section 8 of
419419 390chapter 6D. The attorney general may require that any provider, provider organization,
420420 391pharmaceutical manufacturing company, pharmacy benefit manager or payer produce
421421 392documents, answer interrogatories and provide testimony under oath related to health care costs
422422 393and cost trends, pharmaceutical cost trends, factors that contribute to cost growth within the
423423 394commonwealth's health care system and the relationship between provider costs and payer
424424 395premium rates. The attorney general shall keep confidential all nonpublic information and
425425 396documents obtained under this section and shall not disclose the information or documents to any
426426 397person without the consent of the provider, pharmaceutical manufacturing company, pharmacy 20 of 29
427427 398benefit manager or payer that produced the information or documents except in a public hearing
428428 399under said section 8 of said chapter 6D, a rate hearing before the division of insurance or in a
429429 400case brought by the attorney general, if the attorney general believes that such disclosure will
430430 401promote the health care cost containment goals of the commonwealth and that the disclosure
431431 402shall be made in the public interest after taking into account any privacy, trade secret or
432432 403anticompetitive considerations. The confidential information and documents shall not be public
433433 404records and shall be exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4
434434 405or section 10 of chapter 66.
435435 406 SECTION 39. Said chapter 12C is hereby further amended by adding the following
436436 407section:-
437437 408 Section 25. (a) The center shall analyze data on Massachusetts drug utilization and
438438 409spending, including but not limited to data reported under Sections 10 and 10A. Annually, the
439439 410center shall refer drugs to the health policy commission for review under section 8B of chapter
440440 4116D that meet any of the following criteria: (i) a current average annual gross cost per utilizer for
441441 412public and private health care payers in Massachusetts of greater than $50,000; (ii) a biosimilar
442442 413drug that has a launch wholesale acquisition cost that is not at least 15 per cent lower than the
443443 414referenced brand biologic at the time the biosimilar is launched; or (iii) among the 25 drugs
444444 415determined by the center to have the most impact on health care spending in the most recent year
445445 416of available data, based upon utilization, price, utilization and price growth, patient cost sharing
446446 417amounts, net spending and other factors as determined by the center. The center shall provide
447447 418notice of the referral to the manufacturer of the drug. 21 of 29
448448 419 (b) Not later than May 1, the center shall publish an annual report detailing, at minimum,
449449 420each drug referred to the health policy commission under subsection (a).
450450 421 (c) The center shall adopt any written policies, procedures or regulations necessary to
451451 422implement this section.
452452 423 SECTION 40. Chapter 94C of the General Laws is hereby amended by inserting after
453453 424section 21B the following section:-
454454 425 Section 21C. (a) For the purposes of this section, the following words shall, unless the
455455 426context clearly requires otherwise, have the following meanings:-
456456 427 “Cost-sharing”, the amount owed by an insured under the terms of the insured’s health
457457 428benefit plan or as required by a pharmacy benefit manager, including any copayment,
458458 429coinsurance or deductible.
459459 430 “Pharmacy retail price”, the amount a pharmacy bills for a prescription medication
460460 431regardless of whether the individual purchases that prescription medication at that pharmacy
461461 432using a health benefit plan or any other prescription medication benefit or discount.
462462 433 “Registered pharmacist”, a pharmacist who holds a valid certificate of registration issued
463463 434by the board of registration in pharmacy pursuant to section 24 of chapter 112.
464464 435 (b) A health benefit plan shall (1) not restrict, directly or indirectly, any pharmacy that
465465 436dispenses a prescription drug to an insured in the plan from informing, or penalize such
466466 437pharmacy for informing, an insured of any differential between the insured’s cost-sharing
467467 438amount under the plan with respect to acquisition of the drug and the amount an individual
468468 439would pay for acquisition of the drug without using any health plan or health insurance coverage; 22 of 29
469469 440and (2) ensure that any pharmacy benefit manager under a contract with any such health benefit
470470 441plan does not, with respect to such plan, restrict, directly or indirectly, a pharmacy that dispenses
471471 442a prescription drug from informing, or penalize such pharmacy for informing, an insured of any
472472 443differential between the insured's cost-sharing amount under the plan with respect to acquisition
473473 444of the drug and the amount an individual would pay for acquisition of the drug without using any
474474 445health plan or health insurance coverage.
475475 446 (c) A health benefit plan or a pharmacy benefit manager may not require an insured to
476476 447make a payment at the point of sale for a covered prescription medication in an amount greater
477477 448than the lesser of: (i) the applicable copayment for the prescription medication; (ii) the allowable
478478 449claim amount for the prescription medication; (iii) the amount an insured would pay for the
479479 450prescription medication if the insured purchased the prescription medication without using a
480480 451health benefit plan or any other source of prescription medication benefits or discounts, to the
481481 452extent this information is available to the health benefit plan; or (iv) the amount the pharmacy
482482 453will be reimbursed for the drug from pharmacy benefit manager or health benefit plan.
483483 454 (d) A pharmacy shall affirmatively inform consumers that a consumer may request, at the
484484 455point of sale, the current pharmacy retail price for each prescription medication the consumer
485485 456intends to purchase. The pharmacy shall provide the information through verbal indication,
486486 457posting of a notice, or other methods. If the consumer’s cost-sharing amount for a prescription
487487 458medication exceeds the current pharmacy retail price, the pharmacist, or an authorized individual
488488 459at the direction of a pharmacist, shall notify the consumer that the pharmacy retail price is less
489489 460than the patient’s cost-sharing amount. The pharmacist shall charge the consumer the applicable
490490 461cost-sharing amount or the current pharmacy retail price for that prescription medication, as
491491 462directed by the consumer. 23 of 29
492492 463 (e) A contractual obligation shall not prohibit a pharmacist from complying with this
493493 464section; provided, however, that a pharmacist shall submit a claim to the insured’s health benefit
494494 465plan or its pharmacy benefit manager if the pharmacist has knowledge that the prescription
495495 466medication is covered under the insured’s health benefit plan.
496496 467 (f) A health benefit plan or pharmacy benefit manager shall not penalize, require, or
497497 468provide financial incentives, including variations in premiums, deductibles, copayments, or
498498 469coinsurance, to insureds as incentives to use specific retail, mail order pharmacy, or other
499499 470network pharmacy provider in which a pharmacy benefit manager has an ownership interest or
500500 471that has an ownership interest in a pharmacy benefit manager.
501501 472 (g) A violation of this section shall be an unfair or deceptive act or practice under chapter
502502 47393A.
503503 474 SECTION 41. Section 226 of chapter 175 of the General Laws, as appearing in the 2018
504504 475Official Edition, is hereby amended by striking out subsection (a) and inserting in place thereof
505505 476the following subsection:-
506506 477 (a) For the purposes of this section, the term “pharmacy benefit manager” shall mean a
507507 478person, business or other entity, however organized, that, directly or through a subsidiary,
508508 479provides pharmacy benefit management services for prescription drugs and devices on behalf of
509509 480a health benefit plan sponsor, including, but not limited to, a self-insurance plan, labor union or
510510 481other third-party payer; provided, however, that pharmacy benefit management services shall
511511 482include, but not be limited to, the processing and payment of claims for prescription drugs, the
512512 483performance of drug utilization review, the processing of drug prior authorization requests,
513513 484pharmacy contracting, the adjudication of appeals or grievances related to prescription drug 24 of 29
514514 485coverage contracts, formulary administration, drug benefit design, mail and specialty drug
515515 486pharmacy services, cost containment, clinical, safety and adherence programs for pharmacy
516516 487services and managing the cost of covered prescription drugs; provided further, that “pharmacy
517517 488benefit manager” shall include a health benefit plan that does not contract with a pharmacy
518518 489benefit manager and manages its own prescription drug benefits unless specifically exempted.
519519 490 SECTION 42. Section 2 of Chapter 176O of the General Laws, as so appearing, is hereby
520520 491amended by adding the following subsection:-
521521 492 (i) At least annually, a carrier that contracts with a pharmacy benefit manager shall
522522 493coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with
523523 494this chapter and to examine the pricing and rebates applicable to prescription drugs that are
524524 495provided to the carrier’s covered persons.
525525 496 SECTION 43. Said chapter 176O of the General Laws is hereby further amended by
526526 497inserting after section 22 the following section:-
527527 498 Section 22A. Notwithstanding any other general or special law to the contrary, each
528528 499carrier shall require that a pharmacy benefit manager receive a license from the division under
529529 500chapter 176X as a condition of contracting with that carrier.
530530 501 SECTION 44. The General Laws are hereby amended by inserting after chapter 176W
531531 502the following chapter:-
532532 503 Chapter 176X.
533533 504 LICENSING AND REGULATION OF PHARMACY BENEFIT MANAGERS. 25 of 29
534534 505 Section 1. As used in this chapter, the following words shall have the following meanings
535535 506unless the context clearly requires otherwise:
536536 507 “Carrier”, an insurer licensed or otherwise authorized to transact accident or health
537537 508insurance under chapter 175, a nonprofit hospital service corporation organized under chapter
538538 509176A, a non-profit medical service corporation organized under chapter 176B, a health
539539 510maintenance organization organized under chapter 176G and an organization entering into a
540540 511preferred provider arrangement under chapter 176I; provided, however, that the term “carrier”
541541 512shall not include an employer purchasing coverage or acting on behalf of its employees or the
542542 513employees of any subsidiary or affiliated corporation of the employer; provided further, that
543543 514unless otherwise noted the term “carrier” shall not include any entity to the extent it offers a
544544 515policy, certificate or contract that provides coverage solely for dental care services or vision care
545545 516services.
546546 517 “Center”, the center for health information and analysis established in chapter 12C.
547547 518 “Commissioner”, the commissioner of insurance.
548548 519 “Division”, the division of insurance.
549549 520 “Health benefit plan”, a contract, certificate or agreement entered into, offered or issued
550550 521by a carrier to provide, deliver, arrange for, pay for or reimburse any of the costs of health care
551551 522services; provided, however, that the commissioner may by regulation define other health
552552 523coverage as a health benefit plan for the purposes of this chapter. 26 of 29
553553 524 “Pharmacy”, a physical or electronic facility under the direction or supervision of a
554554 525registered pharmacist that is authorized to dispense prescription drugs and has entered into a
555555 526network contract with a pharmacy benefit manager or a carrier.
556556 527 “Pharmacy benefit manager”, a person, business or other entity, however organized, that,
557557 528directly or through a subsidiary, provides pharmacy benefit management services for prescription
558558 529drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
559559 530insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
560560 531management services shall include, but not be limited to, the processing and payment of claims
561561 532for prescription drugs, the performance of drug utilization review, the processing of drug prior
562562 533authorization requests, pharmacy contracting, the adjudication of appeals or grievances related to
563563 534prescription drug coverage contracts, formulary administration, drug benefit design, mail and
564564 535specialty drug pharmacy services, cost containment, clinical, safety and adherence programs for
565565 536pharmacy services and managing the cost of covered prescription drugs; provided further, that
566566 537“pharmacy benefit manager” shall not include a health benefit plan unless otherwise specified by
567567 538the division.
568568 539 Section 2. (a) A person, business or other entity shall not establish or operate as a
569569 540pharmacy benefit manager in the commonwealth without obtaining a license from the division
570570 541pursuant to this section. The division shall issue a pharmacy benefit manager license to a person,
571571 542business or other entity that demonstrates to the division that it has the necessary organization,
572572 543background expertise and financial integrity to maintain such a license. A pharmacy benefit
573573 544manager license shall be valid for a period of 3 years and shall be renewable for additional 3-
574574 545year periods. Initial application and renewal fees for the license shall be established pursuant to
575575 546section 3B of chapter 7. 27 of 29
576576 547 (b) A license granted pursuant to this section and any rights or interests therein shall not
577577 548be transferable.
578578 549 (c) A person, business or other entity licensed as a pharmacy benefit manager shall
579579 550submit data and reporting information to the center according to the standards and methods
580580 551specified by the center pursuant to section 10A of chapter 12C.
581581 552 (d) The division may issue or renew a license subject to restrictions in order to protect the
582582 553interests of consumers. Such restrictions may include limiting the type of services that a license
583583 554holder may provide, limiting the activities in which the license holder may be engaged or
584584 555addressing conflicts of interest between pharmacy benefit managers and health plan sponsors.
585585 556 (e) The division shall develop an application for licensure that shall include, but not be
586586 557limited to: (1) the name of the pharmacy benefit manager; (2) the address and contact telephone
587587 558number for the pharmacy benefit manager; (3) the name and address of the pharmacy benefit
588588 559manager’s agent for service of process in the commonwealth; (4) the name and address of each
589589 560person with management or control over the pharmacy benefit manager; and (5) any audited
590590 561financial statements specific to the pharmacy benefit manager. A pharmacy benefit manager
591591 562shall report to the division any material change to the information contained in its application,
592592 563certified by an officer of the pharmacy benefit manager, within 30 days of such a change.
593593 564 (f) The division may suspend, revoke, refuse to issue or renew or place on probation a
594594 565pharmacy benefit manager license for cause, which shall include, but not be limited to: (1) the
595595 566pharmacy benefit manager engaging in fraudulent activity that constitutes a violation of state or
596596 567federal law; (2) the division receiving consumer complaints that justify an action under this
597597 568chapter to protect the health, safety and interests of consumers; (3) the pharmacy benefit 28 of 29
598598 569manager failing to pay an application or renewal fee for a license; (4) the pharmacy benefit
599599 570manager failing to comply with reporting requirements of the center under section 10A of
600600 571chapter 12C; or (5) the pharmacy benefit manager failing to comply with a requirement of this
601601 572chapter.
602602 573 The division shall provide written notice to the pharmacy benefit manager and advise in
603603 574writing of the reason for any suspension, revocation, refusal to issue or renew or placement on
604604 575probation of a pharmacy benefit manager license under this chapter. A copy of the notice shall be
605605 576forwarded to the center. The applicant or pharmacy benefit manager may make written demand
606606 577upon the division within 30 days of receipt of such notification for a hearing before the division
607607 578to determine the reasonableness of the division’s action. The hearing shall be held pursuant to
608608 579chapter 30A.
609609 580 The division shall not suspend or cancel a license unless the division has first afforded
610610 581the pharmacy benefit manager an opportunity for a hearing pursuant to said chapter 30A.
611611 582 (g) If a person, business or other entity performs the functions of a pharmacy benefit
612612 583manager in violation of this chapter, the person, business or other entity shall be subject to a fine
613613 584of $5,000 per day for each day that the person, business or other entity is found to be in violation.
614614 585 (h) A pharmacy benefit manager shall be required to submit to periodic audits by a carrier
615615 586licensed under chapters 175, 176A, 176B or 176G if the pharmacy benefit manager has entered
616616 587into a contract with the carrier to provide pharmacy benefit services to the carrier or its members.
617617 588The division may direct or provide specifications for such audits.
618618 589 (i) A pharmacy benefit manager licensed under this section shall notify a health carrier
619619 590client in writing of any activity, policy, practice contract or arrangement of the pharmacy benefit 29 of 29
620620 591manager that directly or indirectly presents any conflict of interest with the pharmacy benefit
621621 592manager’s relationship with or obligation to the health carrier client.