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Massachusetts House Bill H1125

Massachusetts 2025-2026 Regular Session

Massachusetts House Bill H1125 Compare Versions

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22 HOUSE DOCKET, NO. 3340 FILED ON: 1/17/2025
33 HOUSE . . . . . . . . . . . . . . . No. 1125
44 The Commonwealth of Massachusetts
55 _________________
66 PRESENTED BY:
77 Michael S. Day
88 _________________
99 To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
1010 Court assembled:
1111 The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
1212 An Act relative to non-medical switching.
1313 _______________
1414 PETITION OF:
1515 NAME:DISTRICT/ADDRESS :DATE ADDED:Michael S. Day31st Middlesex1/17/2025 1 of 25
1616 HOUSE DOCKET, NO. 3340 FILED ON: 1/17/2025
1717 HOUSE . . . . . . . . . . . . . . . No. 1125
1818 By Representative Day of Stoneham, a petition (accompanied by bill, House, No. 1125) of
1919 Michael S. Day relative to changes to health benefit plans that cause certain covered persons to
2020 switch to less costly alternate prescription drugs. Financial Services.
2121 [SIMILAR MATTER FILED IN PREVIOUS SESSION
2222 SEE HOUSE, NO. 982 OF 2023-2024.]
2323 The Commonwealth of Massachusetts
2424 _______________
2525 In the One Hundred and Ninety-Fourth General Court
2626 (2025-2026)
2727 _______________
2828 An Act relative to non-medical switching.
2929 Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
3030 of the same, as follows:
3131 1 Section 1. Chapter 175 of the General Laws, as appearing in the 2022 Official Edition, is
3232 2hereby amended by inserting after section 230 the following section:-
3333 3 Section 231.
3434 4 1. Definitions. For the purpose of this section:
3535 5 a. “Commissioner” means the commissioner of insurance.
3636 6 b. “Cost sharing” means any coverage limit, copayment, coinsurance, deductible, or
3737 7other out-of-pocket expense requirement. 2 of 25
3838 8 c. “Coverage exemption” means a determination made by a health carrier, health benefit
3939 9plan, or utilization review organization to cover a prescription drug that is otherwise excluded
4040 10from coverage.
4141 11 d. “Coverage exemption determination” means a determination made by a health carrier,
4242 12health benefit plan, or utilization review organization whether to cover a prescription drug that is
4343 13otherwise excluded from coverage.
4444 14 e. “Covered person” means the same as defined in section 1 of Chapter 176J.
4545 15 f. “Discontinued health benefit plan” means a covered person’s existing health benefit
4646 16plan that is discontinued by a health carrier during open enrollment for the next plan year.
4747 17 g. “Formulary” means a complete list of prescription drugs eligible for coverage under a
4848 18health benefit plan.
4949 19 h. “Health benefit plan” means the same as defined in section 1 of Chapter 176 J.
5050 20 i. “Health care professional” means the same as defined in section 1 of Chapter 176O.
5151 21 j. “Health care services” means the same as defined in section 1 of Chapter 176O.
5252 22 k. “Health carrier” means the same as defined in section 1 of Chapter 176O.
5353 23 l. “Nonmedical switching” means a health benefit plan’s restrictive changes to the health
5454 24benefit plan’s formulary after the current plan year has begun or during the open enrollment
5555 25period for the upcoming plan year, causing a covered person who is medically stable on the
5656 26covered person’s current prescribed drug, inclusive of changes to the drug dosage, as determined
5757 27by the prescribing health care professional, to switch to a less costly alternate prescription drug. 3 of 25
5858 28 m. “Open enrollment” means the yearly time period an individual can enroll in a health
5959 29benefit plan.
6060 30 n. “Utilization review” means the same as defined in section 1 of Chapter 176O.
6161 31 o. “Utilization review organization” means the same as defined in section 1 1 of Chapter
6262 32176O.
6363 33 2. Nonmedical switching. With respect to a health carrier that has entered into a health
6464 34benefit plan with a covered person that covers prescription drug benefits, all of the following
6565 35apply:
6666 36 a. A health carrier, health benefit plan, or utilization review organization shall not limit
6767 37or exclude coverage of a prescription drug for any covered person who is medically stable on
6868 38such drug as determined by the prescribing health care professional, if all of the following apply:
6969 39 (1) The prescription drug was previously approved by the health carrier for coverage for
7070 40the covered person.
7171 41 (2) The covered person’s prescribing health care professional has prescribed the drug for
7272 42the medical condition within the previous six months.
7373 43 (3) The covered person continues to be an enrollee of the health benefit plan.
7474 44 b. Coverage of a covered person’s prescription drug, as described in paragraph “a”, shall
7575 45continue through the last day of the covered person’s eligibility under the health benefit plan,
7676 46inclusive of any open enrollment period. 4 of 25
7777 47 c. Prohibited limitations and exclusions referred to in paragraph “a” include but are not
7878 48limited to the following:
7979 49 (1) Limiting or reducing the maximum coverage of prescription drug benefits.
8080 50 (2) Increasing cost sharing for a covered prescription drug.
8181 51 (3) Moving a prescription drug to a more restrictive tier if the health carrier uses a
8282 52formulary with tiers.
8383 53 (4) Removing a prescription drug from a formulary, unless the United States food and
8484 54drug administration has issued a statement about the drug that calls into question the clinical
8585 55safety of the drug, or the manufacturer of the drug has notified the United States food and drug
8686 56administration of a manufacturing discontinuance or potential discontinuance of the drug as
8787 57required by section 506C of the Federal Food, Drug, and Cosmetic Act, as codified in 21 U.S.C.
8888 58§356c.
8989 59 3. Coverage exemption determination process.
9090 60 a. To ensure continuity of care, a health carrier, health plan, or utilization review
9191 61organization shall provide a covered person and prescribing health care professional with access
9292 62to a clear and convenient process to request a coverage exemption determination. A health
9393 63carrier, health plan, or utilization review organization may use its existing medical exceptions
9494 64process to satisfy this requirement. The process used shall be easily accessible on the internet site
9595 65of the health carrier, health benefit plan, or utilization review organization.
9696 66 b. A health carrier, health benefit plan, or utilization review organization shall respond to
9797 67a coverage exemption determination request within seventy-two hours of receipt. In cases where 5 of 25
9898 68exigent circumstances exist, a health carrier, health benefit plan, or utilization review
9999 69organization shall respond within twenty-four hours of receipt. If a response by a health carrier,
100100 70health benefit plan, or utilization review organization is not received within the applicable time
101101 71period, the coverage exemption shall be deemed granted.
102102 72 (1) A coverage exemption shall be expeditiously granted for a discontinued health
103103 73benefit plan if a covered person enrolls in a comparable plan offered by the same health carrier,
104104 74and all of the following conditions apply:
105105 75 (a) The covered person is medically stable on a prescription drug as determined by the
106106 76prescribing health care professional.
107107 77 (b) The prescribing health care professional continues to prescribe the drug for the
108108 78covered person for the medical condition.
109109 79 (c) In comparison to the discontinued health benefit plan, the new health benefit plan
110110 80does any of the following:
111111 81 (i) Limits or reduces the maximum coverage of prescription drug benefits.
112112 82 (ii) Increases cost sharing for the prescription drug.
113113 83 (iii) Moves the prescription drug to a more restrictive tier if the health carrier uses a
114114 84formulary with tiers.
115115 85 (iv) Excludes the prescription drug from the formulary.
116116 86 c. Upon granting of a coverage exemption for a drug prescribed by a covered person’s
117117 87prescribing health care professional, a health carrier, health benefit plan, or utilization review 6 of 25
118118 88organization shall authorize coverage no more restrictive than that offered in a discontinued
119119 89health benefit plan, or than that offered prior to implementation of restrictive changes to the
120120 90health benefit plan’s formulary after the current plan year began.
121121 91 d. If a determination is made to deny a request for a coverage exemption, the health
122122 92carrier, health benefit plan, or utilization review organization shall provide the covered person or
123123 93the covered person’s authorized representative and the authorized person’s prescribing health
124124 94care professional with the reason for denial and information regarding the procedure to appeal
125125 95the denial. Any determination to deny a coverage exemption may be appealed by a covered
126126 96person or the covered person’s authorized representative.
127127 97 e. A health carrier, health benefit plan, or utilization review organization shall uphold or
128128 98reverse a determination to deny a coverage exemption within seventy-two hours of receipt of an
129129 99appeal of denial. In cases where exigent circumstances exist, a health carrier, health benefit plan,
130130 100or utilization review organization shall uphold or reverse a determination to deny a coverage
131131 101exemption within twenty-four hours of receipt. If the determination to deny a coverage
132132 102exemption is not upheld or reversed on appeal within the applicable time period, the denial shall
133133 103be deemed reversed and the coverage exemption shall be deemed approved.
134134 104 f. If a determination to deny a coverage exemption is upheld on appeal, the health
135135 105carrier, health benefit plan, or utilization review organization shall provide the covered person or
136136 106covered person’s authorized representative and the covered person’s prescribing health care
137137 107professional with the reason for upholding the denial on appeal and information regarding the
138138 108procedure to request external review of the denial pursuant to chapter 514J. Any denial of a
139139 109request for a coverage exemption that is upheld on appeal shall be considered a final adverse 7 of 25
140140 110determination for purposes of chapter 514J and is eligible for a request for external review by a
141141 111covered person or the covered person’s authorized representative pursuant to chapter 514J.
142142 112 4. Limitations. This section shall not be construed to do any of the following:
143143 113 a. Prevent a health care professional from prescribing another drug covered by the health
144144 114carrier that the health care professional deems medically necessary for the covered person.
145145 115 b. Prevent a health carrier from doing any of the following:
146146 116 (1) Adding a prescription drug to its formulary.
147147 117 (2) Removing a prescription drug from its formulary if the drug manufacturer has
148148 118removed the drug for sale in the United States.
149149 119 (3) Requiring a pharmacist to effect a substitution of a generic or interchangeable
150150 120biological drug product pursuant to section 12EE Chapter 112.
151151 121 5. Enforcement. The commissioner may take any enforcement action under the
152152 122commissioner’s authority to enforce compliance with this section.
153153 123 6. Applicability. This section is applicable to a health benefit plan that is delivered,
154154 124issued for delivery, continued, or renewed in this state on or after January 1, 2026.
155155 125 Section 2. Chapter 176A of the General Laws, as appearing in the 2022 Official Edition,
156156 126is hereby amended by inserting after section 38 the following section:-
157157 127 Section 39.
158158 128 1. Definitions. For the purpose of this section: 8 of 25
159159 129 a. “Commissioner” means the commissioner of insurance.
160160 130 b. “Cost sharing” means any coverage limit, copayment, coinsurance, deductible, or
161161 131other out-of-pocket expense requirement.
162162 132 c. “Coverage exemption” means a determination made by a health carrier, health benefit
163163 133plan, or utilization review organization to cover a prescription drug that is otherwise excluded
164164 134from coverage.
165165 135 d. “Coverage exemption determination” means a determination made by a health carrier,
166166 136health benefit plan, or utilization review organization whether to cover a prescription drug that is
167167 137otherwise excluded from coverage.
168168 138 e. “Covered person” means the same as defined in section 1 of Chapter 176I.
169169 139 f. “Discontinued health benefit plan” means a covered person’s existing health benefit
170170 140plan that is discontinued by a health carrier during open enrollment for the next plan year.
171171 141 g. “Formulary” means a complete list of prescription drugs eligible for coverage under a
172172 142health benefit plan.
173173 143 h. “Health benefit plan” means the same as defined in section 1 of Chapter 176I.
174174 144 i. “Health care professional” means the same as defined in section 1 of Chapter 176O.
175175 145 j. “Health care services” means the same as defined in section 1 of Chapter 176O.
176176 146 k. “Health carrier” means the same as defined in section 1 of Chapter 176O. 9 of 25
177177 147 l. “Nonmedical switching” means a health benefit plan’s restrictive changes to the health
178178 148benefit plan’s formulary after the current plan year has begun or during the open enrollment
179179 149period for the upcoming plan year, causing a covered person who is medically stable on the
180180 150covered person’s current prescribed drug, inclusive of changes to the drug dosage, as determined
181181 151by the prescribing health care professional, to switch to a less costly alternate prescription drug.
182182 152 m. “Open enrollment” means the yearly time period an individual can enroll in a health
183183 153benefit plan.
184184 154 n. “Utilization review” means the same as defined in section 1 of Chapter 176O.
185185 155 o. “Utilization review organization” means the same as defined in section 1 of Chapter
186186 156176O.
187187 157 2. Nonmedical switching. With respect to a health carrier that has entered into a health
188188 158benefit plan with a covered person that covers prescription drug benefits, all of the following
189189 159apply:
190190 160 a. A health carrier, health benefit plan, or utilization review organization shall not limit
191191 161or exclude coverage of a prescription drug for any covered person who is medically stable on
192192 162such drug as determined by the prescribing health care professional, if all of the following apply:
193193 163 (1) The prescription drug was previously approved by the health carrier for coverage for
194194 164the covered person.
195195 165 (2) The covered person’s prescribing health care professional has prescribed the drug for
196196 166the medical condition within the previous six months.
197197 167 (3) The covered person continues to be an enrollee of the health benefit plan. 10 of 25
198198 168 b. Coverage of a covered person’s prescription drug, as described in paragraph “a”, shall
199199 169continue through the last day of the covered person’s eligibility under the health benefit plan,
200200 170inclusive of any open enrollment period.
201201 171 c. Prohibited limitations and exclusions referred to in paragraph “a” include but are not
202202 172limited to the following:
203203 173 (1) Limiting or reducing the maximum coverage of prescription drug benefits.
204204 174 (2) Increasing cost sharing for a covered prescription drug.
205205 175 (3) Moving a prescription drug to a more restrictive tier if the health carrier uses a
206206 176formulary with tiers.
207207 177 (4) Removing a prescription drug from a formulary, unless the United States food and
208208 178drug administration has issued a statement about the drug that calls into question the clinical
209209 179safety of the drug, or the manufacturer of the drug has notified the United States food and drug
210210 180administration of a manufacturing discontinuance or potential discontinuance of the drug as
211211 181required by section 506C of the Federal Food, Drug, and Cosmetic Act, as codified in 21 U.S.C.
212212 182§356c.
213213 183 3. Coverage exemption determination process.
214214 184 a. To ensure continuity of care, a health carrier, health plan, or utilization review
215215 185organization shall provide a covered person and prescribing health care professional with access
216216 186to a clear and convenient process to request a coverage exemption determination. A health
217217 187carrier, health plan, or utilization review organization may use its existing medical exceptions 11 of 25
218218 188process to satisfy this requirement. The process used shall be easily accessible on the internet site
219219 189of the health carrier, health benefit plan, or utilization review organization.
220220 190 b. A health carrier, health benefit plan, or utilization review organization shall respond to
221221 191a coverage exemption determination request within seventy-two hours of receipt. In cases where
222222 192exigent circumstances exist, a health carrier, health benefit plan, or utilization review
223223 193organization shall respond within twenty-four hours of receipt. If a response by a health carrier,
224224 194health benefit plan, or utilization review organization is not received within the applicable time
225225 195period, the coverage exemption shall be deemed granted.
226226 196 (1) A coverage exemption shall be expeditiously granted for a discontinued health
227227 197benefit plan if a covered person enrolls in a comparable plan offered by the same health carrier,
228228 198and all of the following conditions apply:
229229 199 (a) The covered person is medically stable on a prescription drug as determined by the
230230 200prescribing health care professional.
231231 201 (b) The prescribing health care professional continues to prescribe the drug for the
232232 202covered person for the medical condition.
233233 203 (c) In comparison to the discontinued health benefit plan, the new health benefit plan
234234 204does any of the following:
235235 205 (i) Limits or reduces the maximum coverage of prescription drug benefits.
236236 206 (ii) Increases cost sharing for the prescription drug.
237237 207 (iii) Moves the prescription drug to a more restrictive tier if the health carrier uses a
238238 208formulary with tiers. 12 of 25
239239 209 (iv) Excludes the prescription drug from the formulary.
240240 210 c. Upon granting of a coverage exemption for a drug prescribed by a covered person’s
241241 211prescribing health care professional, a health carrier, health benefit plan, or utilization review
242242 212organization shall authorize coverage no more restrictive than that offered in a discontinued
243243 213health benefit plan, or than that offered prior to implementation of restrictive changes to the
244244 214health benefit plan’s formulary after the current plan year began.
245245 215 d. If a determination is made to deny a request for a coverage exemption, the health
246246 216carrier, health benefit plan, or utilization review organization shall provide the covered person or
247247 217the covered person’s authorized representative and the authorized person’s prescribing health
248248 218care professional with the reason for denial and information regarding the procedure to appeal
249249 219the denial. Any determination to deny a coverage exemption may be appealed by a covered
250250 220person or the covered person’s authorized representative.
251251 221 e. A health carrier, health benefit plan, or utilization review organization shall uphold or
252252 222reverse a determination to deny a coverage exemption within seventy-two hours of receipt of an
253253 223appeal of denial. In cases where exigent circumstances exist, a health carrier, health benefit plan,
254254 224or utilization review organization shall uphold or reverse a determination to deny a coverage
255255 225exemption within twenty-four hours of receipt. If the determination to deny a coverage
256256 226exemption is not upheld or reversed on appeal within the applicable time period, the denial shall
257257 227be deemed reversed and the coverage exemption shall be deemed approved.
258258 228 f. If a determination to deny a coverage exemption is upheld on appeal, the health
259259 229carrier, health benefit plan, or utilization review organization shall provide the covered person or
260260 230covered person’s authorized representative and the covered person’s prescribing health care 13 of 25
261261 231professional with the reason for upholding the denial on appeal and information regarding the
262262 232procedure to request external review of the denial pursuant to chapter 514J. Any denial of a
263263 233request for a coverage exemption that is upheld on appeal shall be considered a final adverse
264264 234determination for purposes of chapter 514J and is eligible for a request for external review by a
265265 235covered person or the covered person’s authorized representative pursuant to chapter 514J.
266266 236 4. Limitations. This section shall not be construed to do any of the following:
267267 237 a. Prevent a health care professional from prescribing another drug covered by the health
268268 238carrier that the health care professional deems medically necessary for the covered person.
269269 239 b. Prevent a health carrier from doing any of the following:
270270 240 (1) Adding a prescription drug to its formulary.
271271 241 (2) Removing a prescription drug from its formulary if the drug manufacturer has
272272 242removed the drug for sale in the United States.
273273 243 (3) Requiring a pharmacist to effect a substitution of a generic or interchangeable
274274 244biological drug product pursuant to section section 12EE of Chapter 112.
275275 245 5. Enforcement. The commissioner may take any enforcement action under the
276276 246commissioner’s authority to enforce compliance with this section.
277277 247 6. Applicability. This section is applicable to a health benefit plan that is delivered,
278278 248issued for delivery, continued, or renewed in this state on or after January 1, 2026.
279279 249 Section 3. Chapter 176B of the General Laws, as appearing in the 2022 Official Edition,
280280 250is hereby amended by inserting after section 25 the following section:- 14 of 25
281281 251 Section 26.
282282 252 1. Definitions. For the purpose of this section:
283283 253 a. “Commissioner” means the commissioner of insurance.
284284 254 b. “Cost sharing” means any coverage limit, copayment, coinsurance, deductible, or
285285 255other out-of-pocket expense requirement.
286286 256 c. “Coverage exemption” means a determination made by a health carrier, health benefit
287287 257plan, or utilization review organization to cover a prescription drug that is otherwise excluded
288288 258from coverage.
289289 259 d. “Coverage exemption determination” means a determination made by a health carrier,
290290 260health benefit plan, or utilization review organization whether to cover a prescription drug that is
291291 261otherwise excluded from coverage.
292292 262 e. “Covered person” means the same as defined in section 1 of Chapter 176I.
293293 263 f. “Discontinued health benefit plan” means a covered person’s existing health benefit
294294 264plan that is discontinued by a health carrier during open enrollment for the next plan year.
295295 265 g. “Formulary” means a complete list of prescription drugs eligible for coverage under a
296296 266health benefit plan.
297297 267 h. “Health benefit plan” means the same as defined in section 1 of Chapter 176I.
298298 268 i. “Health care professional” means the same as defined in section 1 of Chapter 176O.
299299 269 j. “Health care services” means the same as defined in section 1 of Chapter 176O. 15 of 25
300300 270 k. “Health carrier” means the same as defined in section 1 of Chapter 176O.
301301 271 l. “Nonmedical switching” means a health benefit plan’s restrictive changes to the health
302302 272benefit plan’s formulary after the current plan year has begun or during the open enrollment
303303 273period for the upcoming plan year, causing a covered person who is medically stable on the
304304 274covered person’s current prescribed drug, inclusive of changes to the drug dosage, as determined
305305 275by the prescribing health care professional, to switch to a less costly alternate prescription drug.
306306 276 m. “Open enrollment” means the yearly time period an individual can enroll in a health
307307 277benefit plan.
308308 278 n. “Utilization review” means the same as defined in section 1 of Chapter 176O.
309309 279 o. “Utilization review organization” means the same as defined in section 1 of Chapter
310310 280176O.
311311 281 2. Nonmedical switching. With respect to a health carrier that has entered into a health
312312 282benefit plan with a covered person that covers prescription drug benefits, all of the following
313313 283apply:
314314 284 a. A health carrier, health benefit plan, or utilization review organization shall not limit
315315 285or exclude coverage of a prescription drug for any covered person who is medically stable on
316316 286such drug as determined by the prescribing health care professional, if all of the following apply:
317317 287 (1) The prescription drug was previously approved by the health carrier for coverage for
318318 288the covered person.
319319 289 (2) The covered person’s prescribing health care professional has prescribed the drug for
320320 290the medical condition within the previous six months. 16 of 25
321321 291 (3) The covered person continues to be an enrollee of the health benefit plan.
322322 292 b. Coverage of a covered person’s prescription drug, as described in paragraph “a”, shall
323323 293continue through the last day of the covered person’s eligibility under the health benefit plan,
324324 294inclusive of any open enrollment period.
325325 295 c. Prohibited limitations and exclusions referred to in paragraph “a” include but are not
326326 296limited to the following:
327327 297 (1) Limiting or reducing the maximum coverage of prescription drug benefits.
328328 298 (2) Increasing cost sharing for a covered prescription drug.
329329 299 (3) Moving a prescription drug to a more restrictive tier if the health carrier uses a
330330 300formulary with tiers.
331331 301 (4) Removing a prescription drug from a formulary, unless the United States food and
332332 302drug administration has issued a statement about the drug that calls into question the clinical
333333 303safety of the drug, or the manufacturer of the drug has notified the United States food and drug
334334 304administration of a manufacturing discontinuance or potential discontinuance of the drug as
335335 305required by section 506C of the Federal Food, Drug, and Cosmetic Act, as codified in 21 U.S.C.
336336 306§356c.
337337 307 3. Coverage exemption determination process.
338338 308 a. To ensure continuity of care, a health carrier, health plan, or utilization review
339339 309organization shall provide a covered person and prescribing health care professional with access
340340 310to a clear and convenient process to request a coverage exemption determination. A health
341341 311carrier, health plan, or utilization review organization may use its existing medical exceptions 17 of 25
342342 312process to satisfy this requirement. The process used shall be easily accessible on the internet site
343343 313of the health carrier, health benefit plan, or utilization review organization.
344344 314 b. A health carrier, health benefit plan, or utilization review organization shall respond to
345345 315a coverage exemption determination request within seventy-two hours of receipt. In cases where
346346 316exigent circumstances exist, a health carrier, health benefit plan, or utilization review
347347 317organization shall respond within twenty-four hours of receipt. If a response by a health carrier,
348348 318health benefit plan, or utilization review organization is not received within the applicable time
349349 319period, the coverage exemption shall be deemed granted.
350350 320 (1) A coverage exemption shall be expeditiously granted for a discontinued health
351351 321benefit plan if a covered person enrolls in a comparable plan offered by the same health carrier,
352352 322and all of the following conditions apply:
353353 323 (a) The covered person is medically stable on a prescription drug as determined by the
354354 324prescribing health care professional.
355355 325 (b) The prescribing health care professional continues to prescribe the drug for the
356356 326covered person for the medical condition.
357357 327 (c) In comparison to the discontinued health benefit plan, the new health benefit plan
358358 328does any of the following:
359359 329 (i) Limits or reduces the maximum coverage of prescription drug benefits.
360360 330 (ii) Increases cost sharing for the prescription drug.
361361 331 (iii) Moves the prescription drug to a more restrictive tier if the health carrier uses a
362362 332formulary with tiers. 18 of 25
363363 333 (iv) Excludes the prescription drug from the formulary.
364364 334 c. Upon granting of a coverage exemption for a drug prescribed by a covered person’s
365365 335prescribing health care professional, a health carrier, health benefit plan, or utilization review
366366 336organization shall authorize coverage no more restrictive than that offered in a discontinued
367367 337health benefit plan, or than that offered prior to implementation of restrictive changes to the
368368 338health benefit plan’s formulary after the current plan year began.
369369 339 d. If a determination is made to deny a request for a coverage exemption, the health
370370 340carrier, health benefit plan, or utilization review organization shall provide the covered person or
371371 341the covered person’s authorized representative and the authorized person’s prescribing health
372372 342care professional with the reason for denial and information regarding the procedure to appeal
373373 343the denial. Any determination to deny a coverage exemption may be appealed by a covered
374374 344person or the covered person’s authorized representative.
375375 345 e. A health carrier, health benefit plan, or utilization review organization shall uphold or
376376 346reverse a determination to deny a coverage exemption within seventy-two hours of receipt of an
377377 347appeal of denial. In cases where exigent circumstances exist, a health carrier, health benefit plan,
378378 348or utilization review organization shall uphold or reverse a determination to deny a coverage
379379 349exemption within twenty-four hours of receipt. If the determination to deny a coverage
380380 350exemption is not upheld or reversed on appeal within the applicable time period, the denial shall
381381 351be deemed reversed and the coverage exemption shall be deemed approved.
382382 352 f. If a determination to deny a coverage exemption is upheld on appeal, the health
383383 353carrier, health benefit plan, or utilization review organization shall provide the covered person or
384384 354covered person’s authorized representative and the covered person’s prescribing health care 19 of 25
385385 355professional with the reason for upholding the denial on appeal and information regarding the
386386 356procedure to request external review of the denial pursuant to chapter 514J. Any denial of a
387387 357request for a coverage exemption that is upheld on appeal shall be considered a final adverse
388388 358determination for purposes of chapter 514J and is eligible for a request for external review by a
389389 359covered person or the covered person’s authorized representative pursuant to chapter 514J.
390390 360 4. Limitations. This section shall not be construed to do any of the following:
391391 361 a. Prevent a health care professional from prescribing another drug covered by the health
392392 362carrier that the health care professional deems medically necessary for the covered person.
393393 363 b. Prevent a health carrier from doing any of the following:
394394 364 (1) Adding a prescription drug to its formulary.
395395 365 (2) Removing a prescription drug from its formulary if the drug manufacturer has
396396 366removed the drug for sale in the United States.
397397 367 (3) Requiring a pharmacist to effect a substitution of a generic or interchangeable
398398 368biological drug product pursuant to section 12EE of Chapter 112.
399399 369 5. Enforcement. The commissioner may take any enforcement action under the
400400 370commissioner’s authority to enforce compliance with this section.
401401 371 6. Applicability. This section is applicable to a health benefit plan that is delivered,
402402 372issued for delivery, continued, or renewed in this state on or after January 1, 2026.
403403 373 Section 4. Chapter 176G of the General Laws, as appearing in the 2022 Official Edition,
404404 374is hereby amended by inserting after section 33 the following section:- 20 of 25
405405 375 Section 34.
406406 376 1. Definitions. For the purpose of this section:
407407 377 a. “Commissioner” means the commissioner of insurance.
408408 378 b. “Cost sharing” means any coverage limit, copayment, coinsurance, deductible, or
409409 379other out-of-pocket expense requirement.
410410 380 c. “Coverage exemption” means a determination made by a health carrier, health benefit
411411 381plan, or utilization review organization to cover a prescription drug that is otherwise excluded
412412 382from coverage.
413413 383 d. “Coverage exemption determination” means a determination made by a health carrier,
414414 384health benefit plan, or utilization review organization whether to cover a prescription drug that is
415415 385otherwise excluded from coverage.
416416 386 e. “Covered person” means the same as defined in section 1 of Chapter 176J.
417417 387 f. “Discontinued health benefit plan” means a covered person’s existing health benefit
418418 388plan that is discontinued by a health carrier during open enrollment for the next plan year.
419419 389 g. “Formulary” means a complete list of prescription drugs eligible for coverage under a
420420 390health benefit plan.
421421 391 h. “Health benefit plan” means the same as defined in section 1 of Chapter 176J.
422422 392 i. “Health care professional” means the same as defined in section 1 of Chapter 176O.
423423 393 j. “Health care services” means the same as defined in section 1 of Chapter 176O. 21 of 25
424424 394 k. “Health carrier” means the same as defined in section 1 of Chapter 176O.
425425 395 l. “Nonmedical switching” means a health benefit plan’s restrictive changes to the health
426426 396benefit plan’s formulary after the current plan year has begun or during the open enrollment
427427 397period for the upcoming plan year, causing a covered person who is medically stable on the
428428 398covered person’s current prescribed drug, inclusive of changes to the drug dosage, as determined
429429 399by the prescribing health care professional, to switch to a less costly alternate prescription drug.
430430 400 m. “Open enrollment” means the yearly time period an individual can enroll in a health
431431 401benefit plan.
432432 402 n. “Utilization review” means the same as defined in section 1 of Chapter 176O.
433433 403 o. “Utilization review organization” means the same as defined in section 1 of Chapter
434434 404176O.
435435 405 2. Nonmedical switching. With respect to a health carrier that has entered into a health
436436 406benefit plan with a covered person that covers prescription drug benefits, all of the following
437437 407apply:
438438 408 a. A health carrier, health benefit plan, or utilization review organization shall not limit
439439 409or exclude coverage of a prescription drug for any covered person who is medically stable on
440440 410such drug as determined by the prescribing health care professional, if all of the following apply:
441441 411 (1) The prescription drug was previously approved by the health carrier for coverage for
442442 412the covered person.
443443 413 (2) The covered person’s prescribing health care professional has prescribed the drug for
444444 414the medical condition within the previous six months. 22 of 25
445445 415 (3) The covered person continues to be an enrollee of the health benefit plan.
446446 416 b. Coverage of a covered person’s prescription drug, as described in paragraph “a”, shall
447447 417continue through the last day of the covered person’s eligibility under the health benefit plan,
448448 418inclusive of any open enrollment period.
449449 419 c. Prohibited limitations and exclusions referred to in paragraph “a” include but are not
450450 420limited to the following:
451451 421 (1) Limiting or reducing the maximum coverage of prescription drug benefits.
452452 422 (2) Increasing cost sharing for a covered prescription drug.
453453 423 (3) Moving a prescription drug to a more restrictive tier if the health carrier uses a
454454 424formulary with tiers.
455455 425 (4) Removing a prescription drug from a formulary, unless the United States food and
456456 426drug administration has issued a statement about the drug that calls into question the clinical
457457 427safety of the drug, or the manufacturer of the drug has notified the United States food and drug
458458 428administration of a manufacturing discontinuance or potential discontinuance of the drug as
459459 429required by section 506C of the Federal Food, Drug, and Cosmetic Act, as codified in 21 U.S.C.
460460 430§356c.
461461 431 3. Coverage exemption determination process.
462462 432 a. To ensure continuity of care, a health carrier, health plan, or utilization review
463463 433organization shall provide a covered person and prescribing health care professional with access
464464 434to a clear and convenient process to request a coverage exemption determination. A health
465465 435carrier, health plan, or utilization review organization may use its existing medical exceptions 23 of 25
466466 436process to satisfy this requirement. The process used shall be easily accessible on the internet site
467467 437of the health carrier, health benefit plan, or utilization review organization.
468468 438 b. A health carrier, health benefit plan, or utilization review organization shall respond to
469469 439a coverage exemption determination request within seventy-two hours of receipt. In cases where
470470 440exigent circumstances exist, a health carrier, health benefit plan, or utilization review
471471 441organization shall respond within twenty-four hours of receipt. If a response by a health carrier,
472472 442health benefit plan, or utilization review organization is not received within the applicable time
473473 443period, the coverage exemption shall be deemed granted.
474474 444 (1) A coverage exemption shall be expeditiously granted for a discontinued health
475475 445benefit plan if a covered person enrolls in a comparable plan offered by the same health carrier,
476476 446and all of the following conditions apply:
477477 447 (a) The covered person is medically stable on a prescription drug as determined by the
478478 448prescribing health care professional.
479479 449 (b) The prescribing health care professional continues to prescribe the drug for the
480480 450covered person for the medical condition.
481481 451 (c) In comparison to the discontinued health benefit plan, the new health benefit plan
482482 452does any of the following:
483483 453 (i) Limits or reduces the maximum coverage of prescription drug benefits.
484484 454 (ii) Increases cost sharing for the prescription drug.
485485 455 (iii) Moves the prescription drug to a more restrictive tier if the health carrier uses a
486486 456formulary with tiers. 24 of 25
487487 457 (iv) Excludes the prescription drug from the formulary.
488488 458 c. Upon granting of a coverage exemption for a drug prescribed by a covered person’s
489489 459prescribing health care professional, a health carrier, health benefit plan, or utilization review
490490 460organization shall authorize coverage no more restrictive than that offered in a discontinued
491491 461health benefit plan, or than that offered prior to implementation of restrictive changes to the
492492 462health benefit plan’s formulary after the current plan year began.
493493 463 d. If a determination is made to deny a request for a coverage exemption, the health
494494 464carrier, health benefit plan, or utilization review organization shall provide the covered person or
495495 465the covered person’s authorized representative and the authorized person’s prescribing health
496496 466care professional with the reason for denial and information regarding the procedure to appeal
497497 467the denial. Any determination to deny a coverage exemption may be appealed by a covered
498498 468person or the covered person’s authorized representative.
499499 469 e. A health carrier, health benefit plan, or utilization review organization shall uphold or
500500 470reverse a determination to deny a coverage exemption within seventy-two hours of receipt of an
501501 471appeal of denial. In cases where exigent circumstances exist, a health carrier, health benefit plan,
502502 472or utilization review organization shall uphold or reverse a determination to deny a coverage
503503 473exemption within twenty-four hours of receipt. If the determination to deny a coverage
504504 474exemption is not upheld or reversed on appeal within the applicable time period, the denial shall
505505 475be deemed reversed and the coverage exemption shall be deemed approved.
506506 476 f. If a determination to deny a coverage exemption is upheld on appeal, the health
507507 477carrier, health benefit plan, or utilization review organization shall provide the covered person or
508508 478covered person’s authorized representative and the covered person’s prescribing health care 25 of 25
509509 479professional with the reason for upholding the denial on appeal and information regarding the
510510 480procedure to request external review of the denial pursuant to chapter 514J. Any denial of a
511511 481request for a coverage exemption that is upheld on appeal shall be considered a final adverse
512512 482determination for purposes of chapter 514J and is eligible for a request for external review by a
513513 483covered person or the covered person’s authorized representative pursuant to chapter 514J.
514514 484 4. Limitations. This section shall not be construed to do any of the following:
515515 485 a. Prevent a health care professional from prescribing another drug covered by the health
516516 486carrier that the health care professional deems medically necessary for the covered person.
517517 487 b. Prevent a health carrier from doing any of the following:
518518 488 (1) Adding a prescription drug to its formulary.
519519 489 (2) Removing a prescription drug from its formulary if the drug manufacturer has
520520 490removed the drug for sale in the United States.
521521 491 (3) Requiring a pharmacist to effect a substitution of a generic or interchangeable
522522 492biological drug product pursuant to section 12EE of Chapter 112.
523523 493 5. Enforcement. The commissioner may take any enforcement action under the
524524 494commissioner’s authority to enforce compliance with this section.
525525 495 6. Applicability. This section is applicable to a health benefit plan that is delivered,
526526 496issued for delivery, continued, or renewed in this state on or after January 1, 2026.