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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
For the purposes of 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' Consumer Price Index for all urban consumers for all items; 9
(3) (a) "Manufacturer" means an entity engaged in the manufacturing of insulin 10
that is self-administered on an outpatient basis and that is made available 11
for sale or distribution in the state. 12
(b) "Manufacturer" shall not include a manufacturer with annual gross 13
revenue of less than two million dollars ($2,000,000) from insulin sales in 14
the state; 15
(4) "Pharmacist" has the same meaning as in KRS 315.010; 16
(5) "Pharmacy" has the same meaning as in KRS 315.010; 17
(6) "Urgent need of insulin" means having readily available for use less than a 18
seven (7) day supply of insulin and in need of insulin in order to avoid the 19
likelihood of negative health consequences; 20
(7) "Urgent-need supply of insulin" means a thirty (30) day supply of an insulin 21
product as prescribed by a healthcare provider; and 22
(8) (a) "Wholesale acquisition cost" means a manufacturer's list price for insulin 23
to wholesalers or direct purchases in the United States for the most recent 24
month for which the information is reported in wholesale price guides or 25
other publication of drug or biological pricing data. 26
(b) "Wholesale acquisition cost" shall not include prompt pay or other 27 UNOFFICIAL COPY 22 RS BR 53
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discounts, rebates, or any other reduction in price. 1
SECTION 2. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 2
READ AS FOLLOWS: 3
(1) The Urgent-Need Insulin Program and the Continuing Access to Insulin 4
Program are hereby established. The Urgent-Need Insulin Program shall ensure 5
affordable access to insulin to eligible individuals who are in urgent need of 6
insulin, and the Continuing Access to Insulin Program shall ensure affordable 7
access to insulin to eligible individuals who have an ongoing need for access to 8
insulin. Both programs shall be administered and overseen by the Kentucky 9
Board of Pharmacy. 10
(2) (a) In order to be eligible to obtain insulin under the Urgent-Need Insulin 11
Program, an individual shall: 12
1. Be a resident of Kentucky; 13
2. Not be enrolled in the state's Medical Assistance Program or the 14
Kentucky Children's Health Insurance Program as established in 15
KRS Chapter 205; 16
3. Not be enrolled in a health benefit plan that limits cost sharing for 17
prescription insulin drugs pursuant to KRS 304.17A-148(3)(b), except 18
as permitted under paragraph (b) of this subsection; 19
4. Not have received an urgent-need supply of insulin through the 20
program within the previous twelve (12) months, except as permitted 21
under paragraph (c) of this subsection; and 22
5. Be in urgent need of insulin. 23
(b) Notwithstanding paragraph (a)3. of this subsection, an individual who is 24
enrolled in a health benefit plan that limits cost sharing for prescription 25
insulin drugs pursuant to KRS 304.17A-148(3)(b) shall be eligible to receive 26
insulin under the Urgent-Need Insulin Program if the health benefit plan in 27 UNOFFICIAL COPY 22 RS BR 53
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which the individual is enrolled does not provide coverage for the specific 1
prescription insulin drug prescribed to the individual by his or her 2
healthcare provider and the individual meets all other eligibility 3
requirements established in paragraph (a) of this subsection. 4
(c) Notwithstanding paragraph (a)4. of this subsection, an individual may 5
receive an additional urgent-need supply of insulin during a twelve (12) 6
month period if the individual has applied for the state's Medical Assistance 7
Program or the Kentucky Children's Health Insurance Program as 8
established in KRS Chapter 205 but has not been determined eligible or has 9
been determined eligible but coverage has not become effective and the 10
individual meets all other eligibility requirements established in paragraph 11
(a) of this subsection. 12
(3) (a) In order to be eligible to obtain insulin under the Continuing Access to 13
Insulin 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 eligible to receive health care through a federally funded 19
program or receive prescription drug benefits through the federal 20
Department of Veterans Affairs, except as permitted under paragraph 21
(c) of this subsection; and 22
4. Not be enrolled in a health benefit plan that limits cost sharing for 23
prescription insulin drugs pursuant to KRS 304.17A-148(3)(b), except 24
as permitted under paragraph (d) of this subsection. 25
(b) An individual who is eligible to obtain prescription insulin under the 26
Continuing Access to Insulin Program may obtain insulin under that 27 UNOFFICIAL COPY 22 RS BR 53
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program for up to twelve (12) months. 1
(c) Notwithstanding paragraph (a)3. of this subsection, an individual who is 2
enrolled in Medicare Part D shall be eligible for the Continuing Access to 3
Insulin Program if the individual has spent one thousand dollars ($1,000) 4
on prescription drugs in the current calendar year and meets all other 5
eligibility requirements established in paragraph (a) of this subsection. 6
(d) Notwithstanding paragraph (a)4. of this subsection, an individual who is 7
enrolled in a health benefit plan that limits cost sharing for prescription 8
insulin drugs pursuant to KRS 304.17A-148(3)(b) shall be eligible for the 9
Continuing Access to Insulin Program if the health benefit plan in which 10
the individual is enrolled does not provide coverage for the specific 11
prescription insulin drug prescribed to the individual by his or her 12
healthcare provider and the individual meets the other eligibility 13
requirements established in paragraph (a) of this subsection. 14
(4) Notwithstanding any provision of law to the contrary, an individual who is 15
enrolled in or covered by a health plan or health insurance policy that provides 16
prescription drug benefits that is not subject to the cost sharing limits established 17
in KRS 304.17A-148(3)(b) shall be eligible for: 18
(a) The Urgent-Need Insulin Program if he or she: 19
1. Is a resident of Kentucky; 20
2. Is not enrolled in the state’s Medical Assistance Program or the 21
Kentucky Children’s Health Insurance Program as established in 22
KRS Chapter 205; and 23
3. Has not received an urgent-need supply of insulin through the 24
program within the previous twelve (12) months, except as permitted 25
under subsection (2)(c) of this section; or 26
(b) The Continuing Access to Insulin Program if he or she: 27 UNOFFICIAL COPY 22 RS BR 53
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1. Is a resident of Kentucky; 1
2. Is not enrolled in the state’s Medical Assistance Program or the 2
Kentucky Children’s Health Insurance Program as established in 3
KRS Chapter 205; and 4
3. Is not eligible to receive health care through a federally funded 5
program or receive prescription drug benefits through the federal 6
Department of Veterans Affairs, except as permitted under subsection 7
(3)(d) of this section. 8
SECTION 3. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 9
READ AS FOLLOWS: 10
(1) By July 1, 2022, the board shall: 11
(a) Develop application forms to be used by an individual who is seeking to 12
obtain insulin under either the Urgent-Need Insulin Program or the 13
Continuing Access to Insulin Program. The application forms shall require 14
the individual to show proof that he or she meets the eligibility requirements 15
for the program under which he or she is seeking to obtain insulin as 16
established in Section 2 of this Act; 17
(b) Develop an information sheet on the Urgent-Need Insulin Program and the 18
Continuing Access to Insulin Program. The information sheet shall contain 19
the following: 20
1. A description of the Urgent-Need Insulin Program, including 21
eligibility requirements and information on how to access the 22
program; 23
2. A description of the Continuing Access to Insulin Program, including 24
eligibility requirements and information on how to access the 25
program; 26
3. Information on providers who participate in prescription drug 27 UNOFFICIAL COPY 22 RS BR 53
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discount programs, including providers who are authorized to 1
participate in the 340B program under 42 U.S.C. sec. 256b; 2
4. Information about each manufacturer's consumer insulin programs; 3
5. Information on accessing prescription drug copayment assistance 4
programs; and 5
6 A notification that an individual in need of assistance may contact his 6
or her local health department for more information or assistance in 7
accessing ongoing affordable insulin options; 8
(c) Make the application forms and information sheet developed pursuant to 9
paragraphs (a) and (b) of this subsection accessible on the its Web site and 10
shall make them available to the Department for Public Health, the 11
Department of Insurance, health care providers, pharmacists, and 12
pharmacies that prescribe or dispense insulin, hospital emergency 13
departments, urgent care clinics, community health clinics, and local health 14
departments; 15
(d) Regularly update the information sheet developed pursuant to paragraph 16
(b) of this subsection; and 17
(e) Promulgate and implement administrative regulations necessary to carry 18
out Sections 1 to 7 of this Act. 19
(2) The Department for Public Health and the Department of Insurance shall make 20
the application forms and information sheet made available to them by the board 21
accessible on their Web sites. 22
SECTION 4. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 23
READ AS FOLLOWS: 24
(1) An eligible individual seeking to obtain prescription insulin under either the 25
Urgent-Need Insulin Program or the Continuing Access to Insulin Program shall 26
submit the following to a pharmacy: 27 UNOFFICIAL COPY 22 RS BR 53
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(a) A completed, signed, and dated application form developed by the board 1
pursuant to Section 3 of this Act; 2
(b) A valid insulin prescription; and 3
(c) Proof of residency, or if the person in urgent need of insulin is under 4
eighteen (18) years of age, the individual's parent or legal guardian shall 5
provide proof of residency. Proof of residency shall include but not be 6
limited to a valid Kentucky identification card, motor vehicle or motorcycle 7
operator's license or instruction permit, utility agreement or bill, rental 8
housing agreement, or a signed letter from a homeless shelter, health care 9
facility, or social service agency that is currently providing the individual 10
with treatment or services attesting that the applicant is a resident of 11
Kentucky. 12
(2) Upon receipt of the documents identified in subsection (1) of this section: 13
(a) The pharmacist or pharmacy shall: 14
1. Dispense to the individual the prescribed insulin in an amount that 15
will provide the individual with a thirty (30) day supply; 16
2. Within seventy-two (72) hours, notify the health care practitioner who 17
issued the prescription order that the insulin was dispensed under the 18
Urgent-Need Insulin Program or the Continuing Access to Insulin 19
Program; 20
3. Provide the individual with the information sheet developed by the 21
board pursuant to Section 3 of this Act; and 22
4. Retain a copy of the application form and proof of residency submitted 23
by the individual to the pharmacy for reporting and auditing purposes; 24
(b) The pharmacist and pharmacy are encouraged to: 25
1. Inform the individual that he or she may be eligible for the state's 26
medical assistance program or children's health insurance program 27 UNOFFICIAL COPY 22 RS BR 53
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as established in KRS Chapter 205 or an affordable insurance product 1
on the state-based marketplace; and 2
2. Notify the individual of any manufacturer-sponsored programs that 3
assist individuals who cannot afford their insulin prescriptions; and 4
(c) The pharmacist or pharmacy may: 5
1. Collect from the individual to whom the prescription insulin is 6
dispensed a copayment in an amount not to exceed twenty-five dollars 7
($25) to cover the pharmacy's cost of processing and dispensing; and 8
2. Except as provided in subsection (4) of this section, submit to the 9
manufacturer of the dispensed prescription insulin product or to the 10
manufacturer's vendor an electronic claim for payment that is in 11
accordance with the National Council for Prescription Drug Program 12
standards for electronic claims processing, unless the manufacturer 13
agrees to send to the pharmacy a replacement supply of the same 14
insulin product that was dispensed in the amount that was dispensed. 15
(3) If a pharmacist or pharmacy submits an electronic claim for payment to the 16
manufacturer or the manufacturer's vendor, the manufacturer or vendor shall, 17
within in thirty (30) days after receipt of the claim, either: 18
(a) Reimburse the pharmacy in an amount that is equal to the difference 19
between the pharmacy's wholesale acquisition cost for the insulin product 20
that was dispensed and any amount paid for the insulin pursuant to 21
subsection (2)(c)1. of this section; or 22
(b) Send the pharmacy a replacement supply of the same insulin in an amount 23
equal to or greater than the amount that covers the difference between the 24
pharmacy's wholesale acquisition cost for the insulin product that was 25
dispensed and any amount paid for the insulin pursuant to subsection 26
(2)(c)1. of this section. 27 UNOFFICIAL COPY 22 RS BR 53
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(4) A pharmacy or pharmacist shall not submit a claim for payment for insulin 1
dispensed under either the Urgent-Need Insulin Program or the Continuing 2
Access to Insulin Program if the wholesale acquisition cost of the dispensed 3
insulin is less than or equal to eight dollars ($8) per milliliter, adjusted annually 4
based on the annual percent change in the consumer price index. 5
SECTION 5. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 6
READ AS FOLLOWS: 7
By July 1, 2022, each manufacturer shall establish: 8
(1) A process for a pharmacist or pharmacy to submit an electronic claim for 9
payment as provided in Section 4 of this Act; and 10
(2) Any procedures necessary to make insulin available to eligible individuals in 11
accordance with Sections 1 to 7 of this Act. 12
SECTION 6. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 13
READ AS FOLLOWS: 14
(1) By July 15, 2023, and annually thereafter, each manufacturer shall submit a 15
report to the board containing the following information for the preceding 16
calendar year: 17
(a) The number of Kentucky residents who accessed and received an insulin 18
product produced by the manufacturer through either the Urgent-Need 19
Insulin Program or Continuing Access to Insulin Program; and 20
(b) The value of the insulin provided to residents of Kentucky by the 21
manufacturer under the Urgent-Need Insulin Program and the Continuing 22
Access to Insulin Program. As used in this paragraph, "value" means the 23
wholesale acquisition cost of the insulin provided. 24
(2) Upon receipt of a request from the Legislative Research Commission, the Interim 25
Joint Committee on Health, Welfare, and Family Services, or any other 26
committee of the Kentucky General Assembly, the board shall submit a report 27 UNOFFICIAL COPY 22 RS BR 53
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containing the following information: 1
(a) The information reported under subsection (1) of this section; 2
(b) Any administrative penalties assessed pursuant to Section 7 of this Act, 3
including the name of the manufacturer and the amount of the penalty 4
assessed; and 5
(c) Any other information on the Urgent-Need Insulin Program and the 6
Continuing Access to Insulin Program as requested. 7
SECTION 7. A NEW SECTION OF KRS CHAPTER 211 IS CREATED TO 8
READ AS FOLLOWS: 9
If a manufacturer fails to comply with Sections 1 to 7 of this Act, the board may assess 10
an administrative penalty of not more than two hundred thousand dollars ($200,000) 11
per month of noncompliance, with the penalty increasing to not more than four 12
hundred thousand dollars ($400,000) per month if the manufacturer continues to be in 13
noncompliance for more than six (6) months, and increasing to not more than six 14
hundred thousand dollars ($600,000) per month if the manufacturer continues to be in 15
noncompliance after one (1) year. 16
Section 8. Whereas there is urgent need to improve affordable access to insulin 17
for the roughly 500,000 Kentuckians diagnosed with diabetes, an emergency is declared 18
to exist, and this Act takes effect upon its passage and approval by the Governor or upon 19
its otherwise becoming a law. 20