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AN ACT relating to the establishment of emergency insulin programs and declaring 1
an emergency. 2
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 3
SECTION 1. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 4
READ AS FOLLOWS: 5
As used in Sections 1 to 7 of this Act, unless the context otherwise requires: 6
(1) "Board" means the Kentucky Board of Pharmacy; 7
(2) "Consumer price index" means the United States Department of Labor's Bureau 8
of Labor Statistics nonseasonally adjusted annual average Consumer Price Index 9
for All Urban Consumers, U.S. City Average, All Items; 10
(3) (a) "Manufacturer" means an entity engaged in the manufacturing of insulin 11
that is self-administered on an outpatient basis and that is made available 12
for sale or distribution in the state. 13
(b) "Manufacturer" shall not include a manufacturer with annual gross 14
revenue of less than two million dollars ($2,000,000) from insulin sales in 15
the state; 16
(4) "Pharmacist" has the same meaning as in KRS 315.010; 17
(5) "Pharmacy" has the same meaning as in KRS 315.010; 18
(6) "Urgent need of insulin" means having readily available for use less than a 19
seven (7) day supply of insulin and in need of insulin in order to avoid the 20
likelihood of negative health consequences; 21
(7) "Urgent-need supply of insulin" means a thirty (30) day supply of an insulin 22
product as prescribed by a healthcare provider; and 23
(8) (a) "Wholesale acquisition cost" means a manufacturer's list price for insulin 24
to wholesalers or direct purchases in the United States for the most recent 25
month for which the information is reported in wholesale price guides or 26
other publication of drug or biological pricing data. 27 UNOFFICIAL COPY 23 RS BR 295
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(b) "Wholesale acquisition cost" shall not include prompt pay or other 1
discounts, rebates, or any other reduction in price. 2
SECTION 2. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 3
READ AS FOLLOWS: 4
(1) The Urgent-Need Insulin Program and the Continuing Access to Insulin 5
Program are hereby established. The Urgent-Need Insulin Program shall ensure 6
affordable access to insulin to eligible individuals who are in urgent need of 7
insulin, and the Continuing Access to Insulin Program shall ensure affordable 8
access to insulin to eligible individuals who have an ongoing need for access to 9
insulin. Both programs shall be administered and overseen by the Kentucky 10
Board of Pharmacy. 11
(2) (a) In order to be eligible to obtain insulin under the Urgent-Need Insulin 12
Program, an individual shall: 13
1. Be a resident of Kentucky; 14
2. Not be enrolled in the state's Medical Assistance Program or the 15
Kentucky Children's Health Insurance Program as established in KRS 16
Chapter 205; 17
3. Not be enrolled in a health benefit plan that limits cost sharing for 18
prescription insulin drugs pursuant to KRS 304.17A-148(3)(b), except 19
as permitted under paragraph (b) of this subsection; 20
4. Not have received an urgent-need supply of insulin through the 21
program within the previous twelve (12) months, except as permitted 22
under paragraph (c) of this subsection; and 23
5. Be in urgent need of insulin. 24
(b) Notwithstanding paragraph (a)3. of this subsection, an individual who is 25
enrolled in a health benefit plan that limits cost sharing for prescription 26
insulin drugs pursuant to KRS 304.17A-148(3)(b) shall be eligible to receive 27 UNOFFICIAL COPY 23 RS BR 295
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insulin under the Urgent-Need Insulin Program if the health benefit plan in 1
which the individual is enrolled does not provide coverage for the specific 2
prescription insulin drug prescribed to the individual by his or her health 3
care provider and the individual meets all other eligibility requirements 4
established in paragraph (a) of this subsection. 5
(c) Notwithstanding paragraph (a)4. of this subsection, an individual may 6
receive an additional urgent-need supply of insulin during a twelve (12) 7
month period if the individual has applied for the state's Medical Assistance 8
Program or the Kentucky Children's Health Insurance Program as 9
established in KRS Chapter 205 but has not been determined eligible or has 10
been determined eligible but coverage has not become effective and the 11
individual meets all other eligibility requirements established in paragraph 12
(a) of this subsection. 13
(3) (a) In order to be eligible to obtain insulin under the Continuing Access to 14
Insulin Program, an individual shall: 15
1. Be a resident of Kentucky; 16
2. Not be enrolled in the state's Medical Assistance Program or the 17
Kentucky Children's Health Insurance Program as established in KRS 18
Chapter 205; 19
3. Not be eligible to receive health care through a federally funded 20
program or receive prescription drug benefits through the federal 21
Department of Veterans Affairs, except as permitted under paragraph 22
(c) of this subsection; and 23
4. Not be enrolled in a health benefit plan that limits cost sharing for 24
prescription insulin drugs pursuant to KRS 304.17A-148(3)(b), except 25
as permitted under paragraph (d) of this subsection. 26
(b) An individual who is eligible to obtain prescription insulin under the 27 UNOFFICIAL COPY 23 RS BR 295
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Continuing Access to Insulin Program may obtain insulin under that 1
program for up to twelve (12) months. 2
(c) Notwithstanding paragraph (a)3. of this subsection, an individual who is 3
enrolled in Medicare Part D shall be eligible for the Continuing Access to 4
Insulin Program if the individual has spent one thousand dollars ($1,000) 5
on prescription drugs in the current calendar year and meets all other 6
eligibility requirements established in paragraph (a) of this subsection. 7
(d) Notwithstanding paragraph (a)4. of this subsection, an individual who is 8
enrolled in a health benefit plan that limits cost sharing for prescription 9
insulin drugs pursuant to KRS 304.17A-148(3)(b) shall be eligible for the 10
Continuing Access to Insulin Program if the health benefit plan in which 11
the individual is enrolled does not provide coverage for the specific 12
prescription insulin drug prescribed to the individual by his or her health 13
care provider and the individual meets the other eligibility requirements 14
established in paragraph (a) of this subsection. 15
(4) Notwithstanding any provision of law to the contrary, an individual who is 16
enrolled in or covered by a health plan or health insurance policy that provides 17
prescription drug benefits that is not subject to the cost sharing limits established 18
in KRS 304.17A-148(3)(b) shall be eligible for: 19
(a) The Urgent-Need Insulin Program if he or she: 20
1. Is a resident of Kentucky; 21
2. Is not enrolled in the state’s Medical Assistance Program or the 22
Kentucky Children’s Health Insurance Program as established in 23
KRS Chapter 205; and 24
3. Has not received an urgent-need supply of insulin through the 25
program within the previous twelve (12) months, except as permitted 26
under subsection (2)(c) of this section; or 27 UNOFFICIAL COPY 23 RS BR 295
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(b) The Continuing Access to Insulin Program if he or she: 1
1. Is a resident of Kentucky; 2
2. Is not enrolled in the state’s Medical Assistance Program or the 3
Kentucky Children’s Health Insurance Program as established in 4
KRS Chapter 205; and 5
3. Is not eligible to receive health care through a federally funded 6
program or receive prescription drug benefits through the federal 7
Department of Veterans Affairs, except as permitted under subsection 8
(3)(d) of this section. 9
SECTION 3. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 10
READ AS FOLLOWS: 11
(1) By July 1, 2023, the board shall: 12
(a) Develop application forms to be used by an individual who is seeking to 13
obtain insulin under either the Urgent-Need Insulin Program or the 14
Continuing Access to Insulin Program. The application forms shall require 15
the individual to show proof that he or she meets the eligibility requirements 16
for the program under which he or she is seeking to obtain insulin as 17
established in Section 2 of this Act; 18
(b) Develop an information sheet on the Urgent-Need Insulin Program and the 19
Continuing Access to Insulin Program. The information sheet shall contain 20
the following: 21
1. A description of the Urgent-Need Insulin Program, including 22
eligibility requirements and information on how to access the 23
program; 24
2. A description of the Continuing Access to Insulin Program, including 25
eligibility requirements and information on how to access the 26
program; 27 UNOFFICIAL COPY 23 RS BR 295
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3. Information on providers who participate in prescription drug 1
discount programs, including providers who are authorized to 2
participate in the 340B program under 42 U.S.C. sec. 256b; 3
4. Information about each manufacturer's consumer insulin programs; 4
5. Information on accessing prescription drug copayment assistance 5
programs; and 6
6. A notification that an individual in need of assistance may contact his 7
or her local health department for more information or assistance in 8
accessing ongoing affordable insulin options; 9
(c) Make the application forms and information sheet developed pursuant to 10
paragraphs (a) and (b) of this subsection accessible on the its website and 11
shall make them available to the Department for Public Health, the 12
Department of Insurance, health care providers, pharmacists, and 13
pharmacies that prescribe or dispense insulin, hospital emergency 14
departments, urgent care clinics, community health clinics, and local health 15
departments; 16
(d) Regularly update the information sheet developed pursuant to paragraph 17
(b) of this subsection; and 18
(e) Promulgate and implement administrative regulations necessary to carry 19
out Sections 1 to 7 of this Act. 20
(2) The Department for Public Health and the Department of Insurance shall make 21
the application forms and information sheet made available to them by the board 22
accessible on their websites. 23
SECTION 4. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 24
READ AS FOLLOWS: 25
(1) An eligible individual seeking to obtain prescription insulin under either the 26
Urgent-Need Insulin Program or the Continuing Access to Insulin Program shall 27 UNOFFICIAL COPY 23 RS BR 295
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submit the following to a pharmacy: 1
(a) A completed, signed, and dated application form developed by the board 2
pursuant to Section 3 of this Act; 3
(b) A valid insulin prescription; and 4
(c) Proof of residency, or if the person in urgent need of insulin is under 5
eighteen (18) years of age, the individual's parent or legal guardian shall 6
provide proof of residency. Proof of residency shall include but not be 7
limited to a valid Kentucky identification card, motor vehicle or motorcycle 8
operator's license or instruction permit, utility agreement or bill, rental 9
housing agreement, or a signed letter from a homeless shelter, health care 10
facility, or social service agency that is currently providing the individual 11
with treatment or services attesting that the applicant is a resident of 12
Kentucky. 13
(2) Upon receipt of the documents identified in subsection (1) of this section: 14
(a) The pharmacist or pharmacy shall: 15
1. Dispense to the individual the prescribed insulin in an amount that 16
will provide the individual with a thirty (30) day supply; 17
2. Within seventy-two (72) hours, notify the health care practitioner who 18
issued the prescription order that the insulin was dispensed under the 19
Urgent-Need Insulin Program or the Continuing Access to Insulin 20
Program; 21
3. Provide the individual with the information sheet developed by the 22
board pursuant to Section 3 of this Act; and 23
4. Retain a copy of the application form and proof of residency submitted 24
by the individual to the pharmacy for reporting and auditing purposes; 25
(b) The pharmacist and pharmacy are encouraged to: 26
1. Inform the individual that he or she may be eligible for the state's 27 UNOFFICIAL COPY 23 RS BR 295
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Medical Assistance Program or Children's Health Insurance Program 1
as established in KRS Chapter 205 or an affordable insurance product 2
on the state-based marketplace; and 3
2. Notify the individual of any manufacturer-sponsored programs that 4
assist individuals who cannot afford their insulin prescriptions; and 5
(c) The pharmacist or pharmacy may: 6
1. Collect from the individual to whom the prescription insulin is 7
dispensed a copayment in an amount not to exceed twenty-five dollars 8
($25) to cover the pharmacy's cost of processing and dispensing; and 9
2. Except as provided in subsection (4) of this section, submit to the 10
manufacturer of the dispensed prescription insulin product or to the 11
manufacturer's vendor an electronic claim for payment that is in 12
accordance with the National Council for Prescription Drug 13
Programs standards for electronic claims processing, unless the 14
manufacturer agrees to send to the pharmacy a replacement supply of 15
the same insulin product that was dispensed in the amount that was 16
dispensed. 17
(3) If a pharmacist or pharmacy submits an electronic claim for payment to the 18
manufacturer or the manufacturer's vendor, the manufacturer or vendor shall, 19
within thirty (30) days after receipt of the claim, either: 20
(a) Reimburse the pharmacy in an amount that is equal to the difference 21
between the pharmacy's wholesale acquisition cost for the insulin product 22
that was dispensed and any amount paid for the insulin pursuant to 23
subsection (2)(c)1. of this section; or 24
(b) Send the pharmacy a replacement supply of the same insulin in an amount 25
equal to or greater than the amount that covers the difference between the 26
pharmacy's wholesale acquisition cost for the insulin product that was 27 UNOFFICIAL COPY 23 RS BR 295
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dispensed and any amount paid for the insulin pursuant to subsection 1
(2)(c)1. of this section. 2
(4) A pharmacy or pharmacist shall not submit a claim for payment for insulin 3
dispensed under either the Urgent-Need Insulin Program or the Continuing 4
Access to Insulin Program if the wholesale acquisition cost of the dispensed 5
insulin is less than or equal to eight dollars ($8) per milliliter, adjusted annually 6
based on the annual percent change in the consumer price index. 7
SECTION 5. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 8
READ AS FOLLOWS: 9
By July 1, 2023, each manufacturer shall establish: 10
(1) A process for a pharmacist or pharmacy to submit an electronic claim for 11
payment as provided in Section 4 of this Act; and 12
(2) Any procedures necessary to make insulin available to eligible individuals in 13
accordance with Sections 1 to 7 of this Act. 14
SECTION 6. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 15
READ AS FOLLOWS: 16
(1) By July 15, 2024, and annually thereafter, each manufacturer shall submit a 17
report to the board containing the following information for the preceding 18
calendar year: 19
(a) The number of Kentucky residents who accessed and received an insulin 20
product produced by the manufacturer through either the Urgent-Need 21
Insulin Program or Continuing Access to Insulin Program; and 22
(b) The value of the insulin provided to residents of Kentucky by the 23
manufacturer under the Urgent-Need Insulin Program and the Continuing 24
Access to Insulin Program. As used in this paragraph, "value" means the 25
wholesale acquisition cost of the insulin provided. 26
(2) Upon receipt of a request from the Legislative Research Commission, the Interim 27 UNOFFICIAL COPY 23 RS BR 295
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Joint Committee on Health, Welfare, and Family Services, or any other 1
committee of the Kentucky General Assembly, the board shall submit a report 2
containing the following information: 3
(a) The information reported under subsection (1) of this section; 4
(b) Any administrative penalties assessed pursuant to Section 7 of this Act, 5
including the name of the manufacturer and the amount of the penalty 6
assessed; and 7
(c) Any other information on the Urgent-Need Insulin Program and the 8
Continuing Access to Insulin Program as requested. 9
SECTION 7. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 10
READ AS FOLLOWS: 11
If a manufacturer fails to comply with Sections 1 to 7 of this Act, the board may assess 12
an administrative penalty of not more than two hundred thousand dollars ($200,000) 13
per month of noncompliance, with the penalty increasing to not more than four 14
hundred thousand dollars ($400,000) per month if the manufacturer continues to be in 15
noncompliance for more than six (6) months, and increasing to not more than six 16
hundred thousand dollars ($600,000) per month if the manufacturer continues to be in 17
noncompliance after one (1) year. 18
Section 8. Whereas there is urgent need to improve affordable access to insulin 19
for the roughly 500,000 Kentuckians diagnosed with diabetes, an emergency is declared 20
to exist, and this Act takes effect upon its passage and approval by the Governor or upon 21
its otherwise becoming a law. 22