HOUSE DOCKET, NO. 3943 FILED ON: 1/20/2023
HOUSE . . . . . . . . . . . . . . . No. 982
The Commonwealth of Massachusetts
_________________
PRESENTED BY:
Michael S. Day
_________________
To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
Court assembled:
The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
An Act relative to non-medical switching.
_______________
PETITION OF:
NAME: DISTRICT/ADDRESS: DATE ADDED:
Michael S. Day 31st Middlesex 1/20/2023
Carmine Lawrence Gentile 13th Middlesex 7/10/2023
John Barrett, III 1st Berkshire 7/10/2023
David F. DeCoste 5th Plymouth 7/10/2023
Samantha Montaño 15th Suffolk 7/10/2023
Adam Scanlon 14th Bristol 7/10/2023
James C. Arena-DeRosa 8th Middlesex 7/10/2023
Michael O. Moore Second Worcester 7/10/2023
James B. Eldridge Middlesex and Worcester 1/29/2024
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HOUSE DOCKET, NO. 3943 FILED ON: 1/20/2023
HOUSE . . . . . . . . . . . . . . . No. 982
By Representative Day of Stoneham, a petition (accompanied by bill, House, No. 982) of
Michael S. Day relative to changes to health benefit plans that cause certain covered persons to
switch to less costly alternate prescription drugs. Financial Services.
[SIMILAR MATTER FILED IN PREVIOUS SESSION
SEE HOUSE, NO. 1237 OF 2021-2022.]
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Third General Court
(2023-2024)
_______________
An Act relative to non-medical switching.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
of the same, as follows:
1 Section 1. Chapter 175 of the General Laws, as appearing in the 2016 Official Edition, is
2 hereby amended by inserting after section 229 the following section:-
3 Section 230.
4 1. Definitions. For the purpose of this section:
5 a. “Commissioner” means the commissioner of insurance.
6 b. “Cost sharing” means any coverage limit, copayment, coinsurance, deductible, or
7 other out-of-pocket expense requirement.
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8 c. “Coverage exemption” means a determination made by a health carrier, health benefit
9 plan, or utilization review organization to cover a prescription drug that is otherwise excluded
10 from coverage.
11 d. “Coverage exemption determination” means a determination made by a health carrier,
12 health benefit plan, or utilization review organization whether to cover a prescription drug that is
13 otherwise excluded from coverage.
14 e. “Covered person” means the same as defined in section 1 of Chapter 176J.
15 f. “Discontinued health benefit plan” means a covered person’s existing health benefit
16 plan that is discontinued by a health carrier during open enrollment for the next plan year.
17 g. “Formulary” means a complete list of prescription drugs eligible for coverage under a
18 health benefit plan.
19 h. “Health benefit plan” means the same as defined in section 1 of Chapter 176 J.
20 i. “Health care professional” means the same as defined in section 1 of Chapter 176O.
21 j. “Health care services” means the same as defined in section 1 of Chapter 176O.
22 k. “Health carrier” means the same as defined in section 1 of Chapter 176O.
23 l. “Nonmedical switching” means a health benefit plan’s restrictive changes to the health
24 benefit plan’s formulary after the current plan year has begun or during the open enrollment
25 period for the upcoming plan year, causing a covered person who is medically stable on the
26 covered person’s current prescribed drug, inclusive of changes to the drug dosage, as determined
27 by the prescribing health care professional, to switch to a less costly alternate prescription drug.
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28 m. “Open enrollment” means the yearly time period an individual can enroll in a health
29 benefit plan.
30 n. “Utilization review” means the same as defined in section 1 of Chapter 176O.
31 o. “Utilization review organization” means the same as defined in section 1 1 of Chapter
32 176O.
33 2. Nonmedical switching. With respect to a health carrier that has entered into a health
34 benefit plan with a covered person that covers prescription drug benefits, all of the following
35 apply:
36 a. A health carrier, health benefit plan, or utilization review organization shall not limit
37 or exclude coverage of a prescription drug for any covered person who is medically stable on
38 such drug as determined by the prescribing health care professional, if all of the following apply:
39 (1) The prescription drug was previously approved by the health carrier for coverage for
40 the covered person.
41 (2) The covered person’s prescribing health care professional has prescribed the drug for
42 the medical condition within the previous six months.
43 (3) The covered person continues to be an enrollee of the health benefit plan.
44 b. Coverage of a covered person’s prescription drug, as described in paragraph “a”, shall
45 continue through the last day of the covered person’s eligibility under the health benefit plan,
46 inclusive of any open enrollment period.
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47 c. Prohibited limitations and exclusions referred to in paragraph “a” include but are not
48 limited to the following:
49 (1) Limiting or reducing the maximum coverage of prescription drug benefits.
50 (2) Increasing cost sharing for a covered prescription drug.
51 (3) Moving a prescription drug to a more restrictive tier if the health carrier uses a
52 formulary with tiers.
53 (4) Removing a prescription drug from a formulary, unless the United States food and
54 drug administration has issued a statement about the drug that calls into question the clinical
55 safety of the drug, or the manufacturer of the drug has notified the United States food and drug
56 administration of a manufacturing discontinuance or potential discontinuance of the drug as
57 required by section 506C of the Federal Food, Drug, and Cosmetic Act, as codified in 21 U.S.C.
58 §356c.
59 3. Coverage exemption determination process.
60 a. To ensure continuity of care, a health carrier, health plan, or utilization review
61 organization shall provide a covered person and prescribing health care professional with access
62 to a clear and convenient process to request a coverage exemption determination. A health
63 carrier, health plan, or utilization review organization may use its existing medical exceptions
64 process to satisfy this requirement. The process used shall be easily accessible on the internet site
65 of the health carrier, health benefit plan, or utilization review organization.
66 b. A health carrier, health benefit plan, or utilization review organization shall respond to
67 a coverage exemption determination request within seventy-two hours of receipt. In cases where
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68 exigent circumstances exist, a health carrier, health benefit plan, or utilization review
69 organization shall respond within twenty-four hours of receipt. If a response by a health carrier,
70 health benefit plan, or utilization review organization is not received within the applicable time
71 period, the coverage exemption shall be deemed granted.
72 (1) A coverage exemption shall be expeditiously granted for a discontinued health
73 benefit plan if a covered person enrolls in a comparable plan offered by the same health carrier,
74 and all of the following conditions apply:
75 (a) The covered person is medically stable on a prescription drug as determined by the
76 prescribing health care professional.
77 (b) The prescribing health care professional continues to prescribe the drug for the
78 covered person for the medical condition.
79 (c) In comparison to the discontinued health benefit plan, the new health benefit plan
80 does any of the following:
81 (i) Limits or reduces the maximum coverage of prescription drug benefits.
82 (ii) Increases cost sharing for the prescription drug.
83 (iii) Moves the prescription drug to a more restrictive tier if the health carrier uses a
84 formulary with tiers.
85 (iv) Excludes the prescription drug from the formulary.
86 c. Upon granting of a coverage exemption for a drug prescribed by a covered person’s
87 prescribing health care professional, a health carrier, health benefit plan, or utilization review
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88 organization shall authorize coverage no more restrictive than that offered in a discontinued
89 health benefit plan, or than that offered prior to implementation of restrictive changes to the
90 health benefit plan’s formulary after the current plan year began.
91 d. If a determination is made to deny a request for a coverage exemption, the health
92 carrier, health benefit plan, or utilization review organization shall provide the covered person or
93 the covered person’s authorized representative and the authorized person’s prescribing health
94 care professional with the reason for denial and information regarding the procedure to appeal
95 the denial. Any determination to deny a coverage exemption may be appealed by a covered
96 person or the covered person’s authorized representative.
97 e. A health carrier, health benefit plan, or utilization review organization shall uphold or
98 reverse a determination to deny a coverage exemption within seventy-two hours of receipt of an
99 appeal of denial. In cases where exigent circumstances exist, a health carrier, health benefit plan,
100 or utilization review organization shall uphold or reverse a determination to deny a coverage
101 exemption within twenty-four hours of receipt. If the determination to deny a coverage
102 exemption is not upheld or reversed on appeal within the applicable time period, the denial shall
103 be deemed reversed and the coverage exemption shall be deemed approved.
104 f. If a determination to deny a coverage exemption is upheld on appeal, the health
105 carrier, health benefit plan, or utilization review organization shall provide the covered person or
106 covered person’s authorized representative and the covered person’s prescribing health care
107 professional with the reason for upholding the denial on appeal and information regarding the
108 procedure to request external review of the denial pursuant to chapter 514J. Any denial of a
109 request for a coverage exemption that is upheld on appeal shall be considered a final adverse
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110 determination for purposes of chapter 514J and is eligible for a request for external review by a
111 covered person or the covered person’s authorized representative pursuant to chapter 514J.
112 4. Limitations. This section shall not be construed to do any of the following:
113 a. Prevent a health care professional from prescribing another drug covered by the health
114 carrier that the health care professional deems medically necessary for the covered person.
115 b. Prevent a health carrier from doing any of the following:
116 (1) Adding a prescription drug to its formulary.
117 (2) Removing a prescription drug from its formulary if the drug manufacturer has
118 removed the drug for sale in the United States.
119 (3) Requiring a pharmacist to effect a substitution of a generic or interchangeable
120 biological drug product pursuant to section 12EE Chapter 112.
121 5. Enforcement. The commissioner may take any enforcement action under the
122 commissioner’s authority to enforce compliance with this section.
123 6. Applicability. This section is applicable to a health benefit plan that is delivered,
124 issued for delivery, continued, or renewed in this state on or after January 1, 2022.
125 Section 2. Chapter 176A of the General Laws, as appearing in the 2016 Official Edition,
126 is hereby amended by inserting after section 37 the following section:-
127 Section 38.
128 1. Definitions. For the purpose of this section:
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129 a. “Commissioner” means the commissioner of insurance.
130 b. “Cost sharing” means any coverage limit, copayment, coinsurance, deductible, or
131 other out-of-pocket expense requirement.
132 c. “Coverage exemption” means a determination made by a health carrier, health benefit
133 plan, or utilization review organization to cover a prescription drug that is otherwise excluded
134 from coverage.
135 d. “Coverage exemption determination” means a determination made by a health carrier,
136 health benefit plan, or utilization review organization whether to cover a prescription drug that is
137 otherwise excluded from coverage.
138 e. “Covered person” means the same as defined in section 1 of Chapter 176I.
139 f. “Discontinued health benefit plan” means a covered person’s existing health benefit
140 plan that is discontinued by a health carrier during open enrollment for the next plan year.
141 g. “Formulary” means a complete list of prescription drugs eligible for coverage under a
142 health benefit plan.
143 h. “Health benefit plan” means the same as defined in section 1 of Chapter 176I.
144 i. “Health care professional” means the same as defined in section 1 of Chapter 176O.
145 j. “Health care services” means the same as defined in section 1 of Chapter 176O.
146 k. “Health carrier” means the same as defined in section 1 of Chapter 176O.
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147 l. “Nonmedical switching” means a health benefit plan’s restrictive changes to the health
148 benefit plan’s formulary after the current plan year has begun or during the open enrollment
149 period for the upcoming plan year, causing a covered person who is medically stable on the
150 covered person’s current prescribed drug, inclusive of changes to the drug dosage, as determined
151 by the prescribing health care professional, to switch to a less costly alternate prescription drug.
152 m. “Open enrollment” means the yearly time period an individual can enroll in a health
153 benefit plan.
154 n. “Utilization review” means the same as defined in section 1 of Chapter 176O.
155 o. “Utilization review organization” means the same as defined in section 1 of Chapter
156 176O.
157 2. Nonmedical switching. With respect to a health carrier that has entered into a health
158 benefit plan with a covered person that covers prescription drug benefits, all of the following
159 apply:
160 a. A health carrier, health benefit plan, or utilization review organization shall not limit
161 or exclude coverage of a prescription drug for any covered person who is medically stable on
162 such drug as determined by the prescribing health care professional, if all of the following apply:
163 (1) The prescription drug was previously approved by the health carrier for coverage for
164 the covered person.
165 (2) The covered person’s prescribing health care professional has prescribed the drug for
166 the medical condition within the previous six months.
167 (3) The covered person continues to be an enrollee of the health benefit plan.
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168 b. Coverage of a covered person’s prescription drug, as described in paragraph “a”, shall
169 continue through the last day of the covered person’s eligibility under the health benefit plan,
170 inclusive of any open enrollment period.
171 c. Prohibited limitations and exclusions referred to in paragraph “a” include but are not
172 limited to the following:
173 (1) Limiting or reducing the maximum coverage of prescription drug benefits.
174 (2) Increasing cost sharing for a covered prescription drug.
175 (3) Moving a prescription drug to a more restrictive tier if the health carrier uses a
176 formulary with tiers.
177 (4) Removing a prescription drug from a formulary, unless the United States food and
178 drug administration has issued a statement about the drug that calls into question the clinical
179 safety of the drug, or the manufacturer of the drug has noti