This document includes Senate 2nd Reading Floor Amendments incorporated into the bill on Tue, Mar 10, 2020 at 1:46 PM by lpoole.
Representative Norman K. Thurston proposes the following substitute bill:


1     
INSULIN ACCESS AMENDMENTS

2     
2020 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Norman K. Thurston

5     
Senate Sponsor: Deidre M. Henderson

6     Cosponsors:
7     Kay J. Christofferson
8     James A. Dunnigan
9     Suzanne Harrison
Eric K. Hutchings
Marsha Judkins
Lee B. Perry
Marie H. Poulson
Raymond P. Ward
Christine F. Watkins
Mike Winder
10     

11     LONG TITLE
12     General Description:
13          This bill creates mechanisms to increase Utahns' access to affordable insulin.
14     Highlighted Provisions:
15          This bill:
16          ▸     creates an incentive for health benefit plans to reduce the required copayments for
17     insulin;
18          ▸     directs the Insurance Department to conduct a study on insulin pricing;
19          ▸     directs the Public Employees' Benefit and Insurance Program to purchase insulin at
20     discounted prices and to create a program that allows Utahns to purchase the
21     discounted insulin;
22          ▸     increases the number of days for which an insulin prescription can be refilled; and
23          ▸     authorizes a pharmacist to refill an expired insulin prescription.
24     Money Appropriated in this Bill:
25          None
26     Other Special Clauses:
27          This bill provides a special effective date.
28     Utah Code Sections Affected:
29     AMENDS:
30          31A-22-626, as last amended by Laws of Utah 2015, Chapter 258
31          58-17b-609, as last amended by Laws of Utah 2005, Chapter 160
32     ENACTS:
33          31A-22-626.5, Utah Code Annotated 1953
34          49-20-420, Utah Code Annotated 1953
35          58-17b-608.2, Utah Code Annotated 1953
36     

37     Be it enacted by the Legislature of the state of Utah:
38          Section 1. Section 31A-22-626 is amended to read:
39          31A-22-626. Coverage of diabetes.
40          (1) As used in this section[, "diabetes"]:
41          (a) "Diabetes" includes individuals with:
42          [(a)] (i) complete insulin deficiency or type 1 diabetes;
43          [(b)] (ii) insulin resistant with partial insulin deficiency or type 2 diabetes; [and] or
44          [(c)] (iii) elevated blood glucose levels induced by pregnancy or gestational diabetes.
45          (b) "High deductible health plan" means the same as that term is defined in Section
46     223(c)(2), Internal Revenue Code.
47          (c) "Lowest tier" means:
48          (i) the lowest cost tier of a health benefit plan;
49          (ii) the lowest cost-sharing level of a high deductible health plan that preserves the
50     enrollee's ability to claim tax exempt contributions from the enrollee's health savings account
51     under federal laws and regulations; or
52          (iii) a discount or other cost-savings program that has the effect of equating
53     cost-sharing of insulin to the health plan's lowest-cost tier.
54          (d) "Therapy category" means a type of insulin that is distinct from other types of
55     insulin due to a difference in onset, peak time, or duration.
56          (2) The commissioner shall establish, by rule, minimum standards of coverage for
57     diabetes for accident and health insurance policies that provide a health insurance benefit
58     before July 1, 2000.
59          (3) In making rules under Subsection (2), the commissioner shall require rules:
60          (a) with durational limits, amount limits, deductibles, and coinsurance for the treatment
61     of diabetes equitable or identical to coverage provided for the treatment of other illnesses or
62     diseases; and
63          (b) that provide coverage for:
64          (i) diabetes self-management training and patient management, including medical
65     nutrition therapy as defined by rule, provided by an accredited or certified program and referred
66     by an attending physician within the plan and consistent with the health plan provisions for
67     self-management education:
68          (A) recognized by the federal Centers for Medicare and Medicaid Services; or
69          (B) certified by the Department of Health; and
70          (ii) the following equipment, supplies, and appliances to treat diabetes when medically
71     necessary:
72          (A) blood glucose monitors, including those for the legally blind;
73          (B) test strips for blood glucose monitors;
74          (C) visual reading urine and ketone strips;
75          (D) lancets and lancet devices;
76          (E) insulin;
77          (F) injection aides, including those adaptable to meet the needs of the legally blind, and
78     infusion delivery systems;
79          (G) syringes;
80          (H) prescriptive oral agents for controlling blood glucose levels; and
81          (I) glucagon kits.
82          (4) If a health benefit plan entered into or renewed on or after January 1, 2021,
83     provides coverage for insulin for diabetes, the health benefit plan shall:
84          (a) cap the total amount that an insured is required to pay for at least one insulin in
85     each therapy category at an amount not to exceed $30 per prescription of a 30-day supply of
86     insulin for the treatment of diabetes; and
87          (b) apply the cap to an insured regardless of whether the insured has met the plan's
88     deductible.
89          (5) Subsection (4) does not apply to a health benefit plan that:
90          (a) covers at least one insulin for the treatment of diabetes in each therapy category
91     under the lowest tier of drugs; and
92          (b) does not require cost-sharing other than a co-payment of an insured before the plan
93     will cover insulin at the lowest tier.
94          (6) Subsection (4) does not apply to a health benefit plan that:
95          (a) guarantees an insured that the insured will not pay more out-of-pocket for insulin
96     the insured obtains through the health benefit plan than the insured would pay to obtain insulin
97     through the discount program described in Section 49-20-420; and
98          (b) caps the total amount that an insured is required to pay for at least one insulin in
99     each therapy category at an amount not to exceed $100 per prescription of a 30-day supply of
100     insulin for the treatment of diabetes.
101          (7) A health benefit plan that provides coverage for insulin may condition the coverage
102     of insulin at a cost-sharing method described in Subsection (4), (5), or (6) on:
103          (a) the insured's participation in wellness-related activities for diabetes;
104          (b) purchasing the insulin at an in-network pharmacy; or
105          (c) choosing an insulin from the lowest tier of the health benefit plan's formulary.
106          (8) The department may issue a waiver from the requirements described in Subsection
107     (4) to a health benefit plan if the health benefit plan can demonstrate to the department that the
108     plan provides an insured with substantially similar consumer cost reductions to those that result
109     from Subsections (4) and (5).
110          (9) The department shall annually adjust the caps described in Subsections (4)(a) and
111     (6)(b) for inflation based on an index that reflects the change in the previous year in the average
112     wholesale price of insulin sold in Utah.
113          (10) The department shall annually provide the price of insulin available under the
114     discount program described in Section 49-20-420 to a health benefit plan that adopts the
115     cost-sharing method described in Subsection (6).
116          (11) A health benefit plan entered into or renewed on or after January 1, 2021, that
117     provides coverage of insulin is not required to reimburse a participant, as that term is defined in
118     Subsection 49-20-420(1), for insulin the participant obtains through the discount program
119     described in Section 49-20-420.
120          (12) The department may request information from insurers to monitor the impact of
121     the requirements of this section on insulin prices charged by pharmaceutical manufacturers.
122          (13) The department shall classify records provided in response to the request
123     described in Subsection (12) as protected records under Title 63G, Chapter 2, Government
124     Records Access and Management Act.
125          (14) The department may not publish information submitted in response to the request
126     described in Subsection (12) in a manner that:
127          (a) makes a specific submission from a contracting insurer identifiable; or
128          (b) discloses information that is a trade secret, as defined in Section 13-24-2.
129          Section 2. Section 31A-22-626.5 is enacted to read:
130          31A-22-626.5. Affordable insulin study.
131          (1) As used in this section, "insulin" means a prescription drug that contains insulin.
132          (2) The department shall obtain funding through grants to fund a study on insulin costs.
133          (3) If the department obtains the funding described in Subsection (2), the department
134     shall, on or before October 30, 2020, complete a study on the cost of insulin manufacturing and
135     factors that determine the price of insulin.
136          (4) The department shall use public, readily available data accessible to the department
137     to conduct the study described in Subsection (3).
138          (5) The study described in Subsection (3) shall investigate:
139          (a) current and historical trend information about the wholesale acquisition cost of
140     insulin;
141          (b) the cost to produce insulin;
142          (c) explanations for increases in insulin costs;
143          (d) expenditures of drug manufacturers in marketing insulin;
144          (e) manufacturers' net profits from insulin;
145          (f) the portion of a drug manufacturers' total net profits that is composed of insulin net
146     profits;
147          (g) financial assistance currently available to individuals who use insulin through
148     patient prescription assistance programs;
149          (h) value to individuals who use insulin benefits including:
150          (i) coupons provided directly to individuals who use insulin; and
151          (ii) programs to assist individuals who use insulin in paying co-payments and
152     coinsurance;
153          (i) costs to drug manufacturers of the programs described in Subsection (5)(h);
154          (j) total value of benefits manufacturers provide in the form of rebates for insulin to
155     health plans or pharmacy benefit managers in Utah; and
156          (k) additional information that the department determines will aid the Legislature in
157     developing policy to reduce insulin prices in Utah.
158          (6) (a) On or before October 30, 2020, the department shall submit a final report on the
159     study described in Subsection (3) to the Health and Human Services Interim Committee and
160     the Business and Labor Interim Committee.
161          (b) The department's report may include recommendations on legislation for:
162          (i) increased drug pricing transparency; and
163          (ii) programs that would meaningfully reduce the cost of insulin.
164          (c) The final report shall include references to all sources of information and data used
165     in the report and study, except the department may not disclose information that is proprietary
166     or protected under state law or federal law or regulation.
167          Section 3. Section 49-20-420 is enacted to read:
168          49-20-420. Insulin discount program.
169          (1) As used in this section:
170          (a) "Diabetes" means:
171          (i) complete insulin deficiency or type 1 diabetes;
172          (ii) insulin resistant with partial insulin deficiency or type 2 diabetes; or
173          (iii) elevated blood glucose levels induced by pregnancy or gestational diabetes.
174          (b) "Discount program" means a process developed by the program that allows
175     participants to purchase insulin at a discounted, post-rebate rate.
176          (c) "Individual with diabetes" means an individual who has been diagnosed with
177     diabetes and who uses insulin to treat diabetes.
178          (d) "Insulin" means a prescription drug that contains insulin.
179          (e) "Participant" means a resident of Utah who:
180          (i) uses insulin to treat diabetes;
181          (ii) does not receive health coverage under the program; and
182          (iii) enrolls in the discount program.
183          (f) "Prescription drug" means the same as that term is defined in Section 58-17b-102.
184          (g) "Rebate" means the same as that term is defined in Section 31A-46-102.
185          (2) Notwithstanding Subsection 49-20-201(1), and for the purpose of the insulin
186     discount program only, the program shall offer an insulin discount program that allows
187     participants to purchase insulin at a discounted, post-rebate price.
188          (3) The discount program described in Subsection (2) shall:
189          (a) provide a participant with a card or electronic document that identifies the
190     participant as eligible for the discount;
191          (b) provide a participant with information about pharmacies that will honor the
192     discount;
193          (c) allow a participant to purchase insulin at a discounted, post-rebate price; and
194          (d) provide a participant with instructions to pursue a reimbursement of the purchase
195     price from the participant's health insurer.
196          (4) The discount program shall charge a price for insulin that allows the program to
197     retain only enough of any rebate for the insulin to make the state risk pool whole for providing
198     discounted insulin to participants.
199          Section 4. Section 58-17b-608.2 is enacted to read:
200          58-17b-608.2. Insulin prescriptions and diabetes supplies.
201          (1) As used in this section, "exhausted prescription" means a prescription for an insulin
202     that the patient is currently using that:
203          (a) expired no earlier than six months before the patient requests the pharmacist for a
204     refill; or
205          (b) is not expired and has no refills remaining.
206          (2) If a valid prescription for insulin includes an authorization for one or more refills, a
207     pharmacist may combine refills to dispense a supply for 90 days but may not exceed the total
208     supply authorized by the refills.
209          (3) Notwithstanding Section 58-17b-608 and Subsection (2), a pharmacist may, on an
210     emergency basis, dispense a refill for an exhausted prescription based on the prescribing
211     practitioner's instructions for the exhausted prescription in an amount up to a supply for Ŝ→ [90]
211a     60 ←Ŝ
212     days.
213          (4) A pharmacist may dispense insulin for an exhausted prescription described in
214     Subsection (3) no more than one time per exhausted prescription.
215          (5) Before a pharmacist may dispense insulin under Subsection (3), the pharmacist
216     shall:
217          (a) attempt to contact the prescribing practitioner to inform the prescribing practitioner
218     that the patient's prescription has expired; and
219          (b) notify the patient of the outcome of the attempt described in Subsection (5)(a).
220          (6) Within 30 days after the day on which a pharmacist dispenses insulin under
221     Subsection (3), the pharmacist shall inform the prescribing practitioner of:
222          (a) the amount of insulin dispensed; and
223          (b) the type of insulin dispensed.
224          (7) The division, in consultation with the Board of Pharmacy and the Physicians
225     Licensing Board, shall make rules in accordance with Title 63G, Chapter 3, Utah
226     Administrative Rulemaking Act, to ensure the safe dispensing of insulin under Subsection (3).
227          (8) Notwithstanding Section 58-17b-605.5, a pharmacist, when filling a prescription
228     for insulin, may dispense an interchangeable biological product, as defined in Subsection
229     58-17b-605.5(1), except that the pharmacist may not dispense an interchangeable biological
230     product if a prescribing practitioner prohibits the substitution through a method described in
231     Subsection 58-17b-605.5(6).
232          (9) A pharmacist may dispense the therapeutic equivalent when filling a prescription
233     for:
234          (a) a glucometer;
235          (b) diabetes test strips;
236          (c) lancets; or
237          (d) syringes.
238          Section 5. Section 58-17b-609 is amended to read:
239          58-17b-609. Limitation on prescriptions and refills -- Controlled Substances Act
240     not affected -- Legend drugs.
241          (1) Except as provided in [Section] Sections 58-16a-102 and 58-17b-608.2, a
242     prescription for any prescription drug or device may not be dispensed after one year from the
243     date it was initiated except as otherwise provided in Chapter 37, Utah Controlled Substances
244     Act.
245          (2) [A] Except as provided in Section 58-17b-608.2, a prescription authorized to be
246     refilled may not be refilled after one year from the original issue date.
247          (3) A practitioner may not be prohibited from issuing a new prescription for the same
248     drug orally, in writing, or by electronic transmission.
249          (4) Nothing in this chapter affects Chapter 37, Utah Controlled Substances Act.
250          (5) A prescription for a legend drug written by a licensed prescribing practitioner in
251     another state may be filled or refilled by a pharmacist or pharmacy intern in this state if the
252     pharmacist or pharmacy intern verifies that the prescription is valid.
253          Section 6. Effective date.
254          This bill takes effect on May 12, 2020, except that the amendments to Sections
255     31A-22-626 and 49-20-420 take effect on January 1, 2021.