UNOFFICIAL COPY 22 RS BR 1526
Page 1 of 10
XXXX Jacketed
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
For the purposes of Sections 1 to 7 of this Act, unless the context otherwise requires: 6
(1) "Cabinet" means the Cabinet for Health and Family Services; 7
(2) "Consumer price index" means the Consumer Price Index for All Urban 8
Consumers, U.S. City Average, All Items, as published by the United States 9
Bureau of Labor Statistics; 10
(3) "Manufacturer": 11
(a) Means an entity engaged in the manufacturing of insulin that is self-12
administered on an outpatient basis and that is made available for sale or 13
distribution in the state; and 14
(b) Does not include a manufacturer with annual gross revenue of less than 15
two million dollars ($2,000,000) from insulin sales in 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 health care provider; and 23
(8) "Wholesale acquisition cost": 24
(a) Means a manufacturer's list price for insulin to wholesalers or direct 25
purchases in the United States for the most recent month for which the 26
information is reported in wholesale price guides or other publication of 27 UNOFFICIAL COPY 22 RS BR 1526
Page 2 of 10
XXXX Jacketed
drug or biological pricing data; and 1
(b) Does not include prompt pay or other discounts, rebates, or any other 2
reduction in price. 3
SECTION 2. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 4
READ AS FOLLOWS: 5
(1) The Urgent-Need Insulin Program and the Continuing Access to Insulin 6
Program are hereby established. The Urgent-Need Insulin Program shall ensure 7
affordable access to insulin to eligible individuals who are in urgent need of 8
insulin, and the Continuing Access to Insulin Program shall ensure affordable 9
access to insulin to eligible individuals who have an ongoing need for access to 10
insulin. Both programs shall be administered and overseen by the Cabinet for 11
Health and Family Services. 12
(2) (a) In order to be eligible to obtain insulin under the Urgent-Need Insulin 13
Program, an individual shall: 14
1. Be a resident of Kentucky; 15
2. Not be enrolled in the state's Medical Assistance Program or the 16
Kentucky Children's Health Insurance Program as established in 17
KRS Chapter 205; 18
3. Not be enrolled in a health benefit plan that limits cost sharing for 19
prescription insulin drugs pursuant to KRS 304.17A-148(3)(b), except 20
as permitted under paragraph (b) of this subsection; 21
4. Not have received an urgent-need supply of insulin through the 22
program within the previous twelve (12) months, except as permitted 23
under paragraph (c) of this subsection; and 24
5. Be in urgent need of insulin. 25
(b) Notwithstanding paragraph (a)3. of this subsection, an individual who is 26
enrolled in a health benefit plan that limits cost sharing for prescription 27 UNOFFICIAL COPY 22 RS BR 1526
Page 3 of 10
XXXX Jacketed
insulin drugs pursuant to KRS 304.17A-148(3)(b) shall be eligible to receive 1
insulin under the Urgent-Need Insulin Program if the health benefit plan in 2
which the individual is enrolled does not provide coverage for the specific 3
prescription insulin drug prescribed to the individual by his or her health 4
care provider and the individual meets all other eligibility requirements 5
established in paragraph (a) of this subsection. 6
(c) Notwithstanding paragraph (a)4. of this subsection, an individual may 7
receive an additional urgent-need supply of insulin during a twelve (12) 8
month period if the individual has applied for the state's Medical Assistance 9
Program or the Kentucky Children's Health Insurance Program as 10
established in KRS Chapter 205 but has not been determined eligible or has 11
been determined eligible but coverage has not become effective and the 12
individual meets all other eligibility requirements established in paragraph 13
(a) of this subsection. 14
(3) (a) In order to be eligible to obtain insulin under the Continuing Access to 15
Insulin Program, an individual shall: 16
1. Be a resident of Kentucky; 17
2. Not be enrolled in the state's Medical Assistance Program or the 18
Kentucky Children's Health Insurance Program as established in 19
KRS Chapter 205; 20
3. Not be eligible to receive health care through a federally funded 21
program or receive prescription drug benefits through the federal 22
Department of Veterans Affairs, except as permitted under paragraph 23
(c) of this subsection; and 24
4. Not be enrolled in a health benefit plan that limits cost sharing for 25
prescription insulin drugs pursuant to KRS 304.17A-148(3)(b), except 26
as permitted under paragraph (d) of this subsection. 27 UNOFFICIAL COPY 22 RS BR 1526
Page 4 of 10
XXXX Jacketed
(b) An individual who is eligible to obtain prescription insulin under the 1
Continuing Access to Insulin Program may obtain insulin under that 2
program for up to twelve (12) months. 3
(c) Notwithstanding paragraph (a)3. of this subsection, an individual who is 4
enrolled in Medicare Part D shall be eligible for the Continuing Access to 5
Insulin Program if the individual has spent one thousand dollars ($1,000) 6
on prescription drugs in the current calendar year and meets all other 7
eligibility requirements established in paragraph (a) of this subsection. 8
(d) Notwithstanding paragraph (a)4. of this subsection, an individual who is 9
enrolled in a health benefit plan that limits cost sharing for prescription 10
insulin drugs pursuant to KRS 304.17A-148(3)(b) shall be eligible for the 11
Continuing Access to Insulin Program if the health benefit plan in which 12
the individual is enrolled does not provide coverage for the specific 13
prescription insulin drug prescribed to the individual by his or her health 14
care provider and the individual meets the other eligibility requirements 15
established in paragraph (a) of this subsection. 16
(4) Notwithstanding any provision of law to the contrary, an individual who is 17
enrolled in or covered by a health plan or health insurance policy that provides 18
prescription drug benefits that is not subject to the cost-sharing limits established 19
in KRS 304.17A-148(3)(b) shall be eligible for: 20
(a) The Urgent-Need Insulin Program if he or she: 21
1. Is a resident of Kentucky; 22
2. Is not enrolled in the state’s Medical Assistance Program or the 23
Kentucky Children’s Health Insurance Program as established in 24
KRS Chapter 205; and 25
3. Has not received an urgent-need supply of insulin through the 26
program within the previous twelve (12) months, except as permitted 27 UNOFFICIAL COPY 22 RS BR 1526
Page 5 of 10
XXXX Jacketed
under subsection (2)(c) of this section; or 1
(b) The Continuing Access to Insulin Program if he or she is: 2
1. A resident of Kentucky; 3
2. Not enrolled in the state’s Medical Assistance Program or the 4
Kentucky Children’s Health Insurance Program as established in 5
KRS Chapter 205; and 6
3. Not eligible to receive health care through a federally funded program 7
or receive prescription drug benefits through the federal Department 8
of Veterans Affairs, except as permitted under subsection (3)(d) of this 9
section. 10
SECTION 3. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 11
READ AS FOLLOWS: 12
(1) By July 1, 2022, the cabinet shall: 13
(a) Develop application forms to be used by an individual who is seeking to 14
obtain insulin under either the Urgent-Need Insulin Program or the 15
Continuing Access to Insulin Program. The application forms shall require 16
the individual to show proof that he or she meets the eligibility requirements 17
for the program under which he or she is seeking to obtain insulin as 18
established in Section 2 of this Act; 19
(b) Develop an information sheet on the Urgent-Need Insulin Program and the 20
Continuing Access to Insulin Program. The information sheet shall 21
contain: 22
1. A description of the Urgent-Need Insulin Program, including 23
eligibility requirements and information on how to access the 24
program; 25
2. A description of the Continuing Access to Insulin Program, including 26
eligibility requirements and information on how to access the 27 UNOFFICIAL COPY 22 RS BR 1526
Page 6 of 10
XXXX Jacketed
program; 1
3. Information on providers who participate in prescription drug 2
discount programs, including providers who are authorized to 3
participate in the 340B program under 42 U.S.C. sec. 256b; 4
4. Information about each manufacturer's consumer insulin programs; 5
5. Information on accessing prescription drug copayment assistance 6
programs; and 7
6 A notification that an individual in need of assistance may contact his 8
or her local health department for more information or assistance in 9
accessing ongoing affordable insulin options; 10
(c) Make the application forms and information sheet developed pursuant to 11
paragraphs (a) and (b) of this subsection accessible on its Web site and 12
make them available to the Department of Insurance, the Board of 13
Pharmacy, health care providers, pharmacists, and pharmacies that 14
prescribe or dispense insulin, hospital emergency departments, urgent care 15
clinics, community health clinics, and local health 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, in accordance with 19
KRS Chapter 13A, necessary to carry out Sections 1 to 7 of this Act. 20
(2) The Department of Insurance and the Board of Pharmacy shall make the 21
application forms and information sheet made available to them by the cabinet 22
accessible on their Web sites. 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 22 RS BR 1526
Page 7 of 10
XXXX Jacketed
submit the following to a pharmacy: 1
(a) A completed, signed, and dated application form developed by the cabinet 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
cabinet 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 22 RS BR 1526
Page 8 of 10
XXXX Jacketed
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 known manufacturer-sponsored programs 4
that assist individuals who cannot afford their insulin prescriptions; 5
and 6
(c) The pharmacist or pharmacy may: 7
1. Collect from the individual to whom the prescription insulin is 8
dispensed a copayment in an amount not to exceed twenty-five dollars 9
($25) to cover the pharmacy's cost of processing and dispensing; and 10
2. Except as provided in subsection (4) of this section, submit to the 11
manufacturer of the dispensed prescription insulin product or to the 12
manufacturer's vendor an electronic claim for payment that is in 13
accordance with the National Council for Prescription Drug 14
Programs standards for electronic claims processing, unless the 15
manufacturer agrees to send to the pharmacy a replacement supply of 16
the same insulin product that was dispensed in the amount that was 17
dispensed. 18
(3) If a pharmacist or pharmacy submits an electronic claim for payment to the 19
manufacturer or the manufacturer's vendor, the manufacturer or vendor shall, 20
within thirty (30) days after receipt of the claim, either: 21
(a) Reimburse the pharmacy in an amount that is equal to the difference 22
between the pharmacy's wholesale acquisition cost for the insulin product 23
that was dispensed and any amount paid for the insulin pursuant to 24
subsection (2)(c)1. of this section; or 25
(b) Send the pharmacy a replacement supply of the same insulin in an amount 26
equal to or greater than the amount that covers the difference between the 27 UNOFFICIAL COPY 22 RS BR 1526
Page 9 of 10
XXXX Jacketed
pharmacy's wholesale acquisition cost for the insulin product that was 1
dispensed and any amount paid for the insulin pursuant to subsection 2
(2)(c)1. of this section. 3
(4) A pharmacy or pharmacist shall not submit a claim for payment for insulin 4
dispensed under either the Urgent-Need Insulin Program or the Continuing 5
Access to Insulin Program if the wholesale acquisition cost of the dispensed 6
insulin is less than or equal to eight dollars ($8) per milliliter, adjusted annually 7
based on the annual percent change in the consumer price index. 8
SECTION 5. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 9
READ AS FOLLOWS: 10
By July 1, 2022, each manufacturer shall establish: 11
(1) A process for a pharmacist or pharmacy to submit an electronic claim for 12
payment as provided in Section 4 of this Act; and 13
(2) Any procedures necessary to make insulin available to eligible individuals in 14
accordance with Sections 1 to 7 of this Act. 15
SECTION 6. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 16
READ AS FOLLOWS: 17
(1) By July 15, 2023, and annually thereafter, each manufacturer shall submit a 18
report to the cabinet containing the following information for the preceding 19
calendar year: 20
(a) The number of Kentucky residents who accessed and received an insulin 21
product produced by the manufacturer through either the Urgent-Need 22
Insulin Program or the Continuing Access to Insulin Program; and 23
(b) The value of the insulin provided to residents of Kentucky by the 24
manufacturer under the Urgent-Need Insulin Program and the Continuing 25
Access to Insulin Program. As used in this paragraph, "value" means the 26
wholesale acquisition cost of the insulin provided. 27 UNOFFICIAL COPY 22 RS BR 1526
Page 10 of 10
XXXX Jacketed
(2) Upon receipt of a request from the Legislative Research Commission, the Interim 1
Joint Committee on Health, Welfare, and Family Services, or any other 2
committee of the Kentucky General Assembly, the cabinet shall submit a report 3
containing the following information: 4
(a) The information reported under subsection (1) of this section; 5
(b) Any administrative penalties assessed pursuant to Section 7 of this Act, 6
including the name of the manufacturer and the amount of the penalty 7
assessed; and 8
(c) Any other information on the Urgent-Need Insulin Program and the 9
Continuing Access to Insulin Program as requested. 10
SECTION 7. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 11
READ AS FOLLOWS: 12
If a manufacturer fails to comply with Sections 1 to 7 of this Act, the cabinet may 13
assess an administrative penalty of not more than two hundred thousand dollars 14
($200,000) per month of noncompliance, with the penalty increasing to not more than 15
four hundred thousand dollars ($400,000) per month if the manufacturer continues to 16
be in noncompliance for more than six (6) months, and increasing to not more than six 17
hundred thousand dollars ($600,000) per month if the manufacturer continues to be in 18
noncompliance after one (1) year. 19
Section 8. Whereas there is urgent need to improve affordable access to insulin 20
for the roughly 500,000 Kentuckians diagnosed with diabetes, an emergency is declared 21
to exist, and this Act takes effect upon its passage and approval by the Governor or upon 22
its otherwise becoming a law. 23