APPROVED CHAPTER
JUNE 21, 2021 303
BY GOVERNOR PUBLIC LAW
STATE OF MAINE
_____
IN THE YEAR OF OUR LORD
TWO THOUSAND TWENTY-ONE
_____
S.P. 260 - L.D. 673
An Act To Create the Insulin Safety Net Program
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 32 MRSA §13725 is enacted to read:
§13725. Insulin Safety Net Program
1. Definitions. As used in this section, unless the context otherwise indicates, the
following terms have the following meanings.
A. "Eligible individual" means an individual who has been determined to qualify for
assistance under the program pursuant to subsection 3 or 4.
B. "Insulin" has the same meaning as in section 13786-D, subsection 1, paragraph A,
except for an insulin product that has a wholesale acquisition cost of $8 or less per
milliliter or applicable National Council for Prescription Drug Plan billing unit, for the
entire assessment time period, adjusted annually based on the Consumer Price Index
Annual Average, for All Urban Consumers, CPI-U: U.S. City Averages, All Items
reported by the United States Department of Labor, Bureau of Labor Statistics.
C. "Manufacturer" means a manufacturer engaged in the manufacturing of insulin that
is self-administered on an outpatient basis, except for a manufacturer with an annual
gross revenue of $2,000,000 or less from insulin sales in this State.
D. "Urgent need of insulin" means having readily available for use less than a 7-day
supply of insulin and in need of insulin in order to avoid the likelihood of suffering
significant health consequences.
2. Insulin Safety Net Program established. The board shall establish the Insulin
Safety Net Program, referred to in this section as "the program," in accordance with the
requirements of this section. Under the program, by March 1, 2022, each manufacturer
shall establish procedures to make insulin available in accordance with this section and as
required under subsections 3 and 4 to pharmacies for dispensing to eligible individuals who
are in urgent need of insulin or who need access to an affordable insulin supply.
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 3. Urgent need safety net. A pharmacy shall dispense a 30-day supply of insulin, as
permitted under section 13786-D, to an eligible individual in urgent need of insulin in
accordance with this subsection.
A. To be eligible, an individual must demonstrate on an application form developed
by the board that the individual:
(1) Is a resident of this State;
(2) Is not enrolled in MaineCare or any other health coverage or prescription drug
coverage that limits the total amount of cost-sharing that the enrollee is required to
pay for a 30-day supply of insulin, including copayments, deductibles or
coinsurance, to $75 or less, regardless of the type or amount of insulin prescribed;
(3) Has not received an urgent-need supply of insulin through the program within
the previous 12 months; and
(4) Has an urgent need of insulin.
B. The board shall make the application form accessible through the board's publicly
accessible website and make the form available to pharmacies and health care providers
who prescribe or dispense insulin, hospital emergency departments, urgent care clinics
and community health clinics.
C. In addition to a completed, signed and dated application, an individual shall also
present to a pharmacy a valid insulin prescription and identification indicating
residency in the form of a valid Maine identification card, driver's license or permit. If
the individual in urgent need of insulin is under the age of 18, the individual's parent
or legal guardian shall provide the pharmacy with proof of residency. Upon receipt of
the information required by this paragraph, the pharmacist shall dispense the prescribed
insulin in an amount that will provide the individual a 30-day supply. If an individual
does not have a valid prescription, a pharmacist may dispense an emergency refill of
insulin pursuant to section 13786-D.
D. The pharmacy shall notify the health care practitioner who issued the prescription
order presented under paragraph C no later than 72 hours after the insulin is dispensed.
E. The pharmacy may submit to the manufacturer of the dispensed insulin product or
to the manufacturer's vendor a claim for payment for insulin dispensed under paragraph
C that is in accordance with the standards developed by a national council for
prescription drug programs for electronic claims processing, unless the manufacturer
agrees to send to the pharmacy a replacement supply of the same insulin as dispensed
in the amount dispensed. If the pharmacy submits an electronic claim to the
manufacturer or the manufacturer's vendor, the manufacturer or vendor shall reimburse
the pharmacy in an amount that covers the pharmacy's acquisition cost.
F. The pharmacy may collect an insulin copayment from the eligible individual to
cover the pharmacy's costs of processing and dispensing in an amount not to exceed
$35 for the 30-day supply of insulin dispensed under paragraph C.
G. The pharmacy shall provide each eligible individual an information sheet provided
by the board with contact information for the Health Insurance Consumer Assistance
Program established in Title 24-A, chapter 56-A, subchapter 2-A, including the
program's publicly accessible website, toll-free telephone number and e-mail address,
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 so that the individual may access additional information and assistance related to
ongoing insulin coverage options, including assistance in: applying for MaineCare;
applying for a qualified health plan offered through the federally facilitated
marketplace, subject to open and special enrollment periods; accessing information on
providers who participate in prescription drug discount programs, including providers
who are authorized to participate in the federal program under section 340b of the
federal Public Health Service Act, United States Code, Title 42, section 256b; and
accessing insulin manufacturers' patient assistance programs and other assistance
programs through nonprofit organizations.
H. The pharmacy shall retain a copy of the application form submitted by the
individual under paragraph A to the pharmacy for reporting and compliance purposes.
4. Manufacturer's patient assistance. A manufacturer shall establish a patient
assistance program to provide access to insulin to any eligible individual who meets the
requirements of this subsection and who demonstrates a continued need for insulin. Each
manufacturer's patient assistance program must meet the requirements of this subsection.
A. Each manufacturer shall provide the Health Insurance Consumer Assistance
Program established in Title 24-A, chapter 56-A, subchapter 2-A information regarding
the manufacturer's patient assistance program, including contact information for
individuals to call for assistance in accessing the patient assistance program.
B. To be eligible to participate in a manufacturer's patient assistance program, an
individual must:
(1) Be a Maine resident with a valid identification card that indicates Maine
residency in the form of a Maine identification card or driver's license or permit.
If the individual is under the age of 18, the individual's parent or legal guardian
shall provide proof of residency;
(2) Have a family income that is equal to or less than 400 percent of the federal
poverty guidelines; and
(3) Not be enrolled in MaineCare or eligible to receive health care coverage
through a federally funded program or to receive prescription drug benefits through
the United States Department of Veterans Affairs or not be enrolled in prescription
drug coverage through an individual or group health plan that limits the total
amount of cost-sharing that an enrollee is required to pay for a 30-day supply of
insulin, including copayments, deductibles or coinsurance, to $75 or less,
regardless of the type or amount of insulin needed.
Notwithstanding the requirement in this paragraph, an individual who is enrolled in
Medicare Part D is eligible for a manufacturer's patient assistance program if the
individual has spent $1,000 on prescription drugs in the current calendar year and meets
the eligibility requirements in subparagraphs (1) and (2).
C. An individual who is interested in participating in a manufacturer's patient
assistance program may apply directly to the manufacturer or through the individual's
health care practitioner, if the practitioner participates in the manufacturer's patient
assistance program.
D. Upon receipt of an application for the manufacturer's patient assistance program,
the manufacturer shall process the application and determine eligibility. The
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manufacturer shall notify the applicant of the determination within 10 business days of
receipt of the application. If necessary, the manufacturer may request additional
information from the applicant. If additional information is needed, the manufacturer
shall notify the applicant within 5 business days of receipt of the application as to what
information is being requested. Within 3 business days of receipt of the requested
information, the manufacturer shall determine eligibility and notify the applicant of the
determination. If the individual has been determined to be not eligible, the
manufacturer shall include the reasons for denying eligibility in the notification. The
individual may seek an appeal of the determination in accordance with this section. If
the individual is determined to be eligible, the manufacturer shall provide the
individual with an eligibility statement or other indication that the individual has been
determined eligible for the manufacturer's patient assistance program. An individual's
eligibility is valid for 12 months and is renewable upon a redetermination of eligibility.
E. If the eligible individual has prescription drug coverage through an individual or
group health plan, the manufacturer may determine that the individual's insulin needs
are better addressed by providing financial assistance for copayments and other cost-
sharing requirements of the individual's individual or group health plan. The
manufacturer shall establish a copayment assistance program to provide such financial
assistance. The manufacturer shall inform the individual and provide the individual
with the necessary coupons to submit to a pharmacy. Under the manufacturer's
copayment assistance program, an eligible individual may not be required to pay more
than a copayment of $35 for a 30-day supply of insulin.
F. The eligible individual shall submit to a pharmacy the eligibility statement provided
by the manufacturer under paragraph D. Upon receipt of an individual's eligibility
status, the pharmacy shall dispense insulin in accordance with this paragraph.
(1) The pharmacy shall submit an order containing the name of the insulin product
and the daily dosage amount as contained in a valid prescription to the product's
manufacturer. The pharmacy shall include with the order to the manufacturer the
following information: the pharmacy's name and shipping address; office
telephone number, fax number, e-mail address and contact name; and any specific
days or times when deliveries are not accepted by the pharmacy.
(2) Upon receipt of an order from a pharmacy and the information described in
this paragraph, the manufacturer shall send to the pharmacy a 90-day supply of
insulin as ordered, unless a lesser amount is requested in the order, at no charge to
the individual or pharmacy. Except as authorized under paragraph E, the pharmacy
shall provide the insulin to the individual at no charge to the individual. The
pharmacy may not provide insulin received from the manufacturer to any
individual other than the individual associated with the specific order.
(3) The pharmacy may not seek reimbursement for the insulin received from the
manufacturer or from any 3rd-party payor. The pharmacy may collect a copayment
from the individual to cover the pharmacy's costs for processing and dispensing in
an amount not to exceed $50 for each 90-day supply if the insulin is sent to the
pharmacy.
(4) The pharmacy may submit to a manufacturer a reorder for an individual if the
individual's eligibility statement under paragraph D has not expired. Upon receipt
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 of a reorder from a pharmacy, the manufacturer shall send to the pharmacy an
additional 90-day supply of the product, unless a lesser amount is requested, at no
charge to the individual or pharmacy if the individual's eligibility statement has not
expired.
(5) Notwithstanding subparagraph (2), a manufacturer may send the insulin as
ordered directly to the individual if the manufacturer provides a mail order service
option.
G. If an individual disagrees with a manufacturer's determination of eligibility under
this subsection, the individual may contact the board to request a review of eligibility.
The review of eligibility must be conducted by the board administrator, in consultation
with a board member. The individual requesting the review shall submit to the board,
with the request, all documents submitted by the individual to the manufacturer. The
board shall provide the reviewer or reviewers with the documents submitted by the
individual. The review of eligibility must be completed within 10 business days of
receipt of all the necessary documents from the individual. The review decision is
final. If the review determines that the individual is eligible for the manufacturer's
patient assistance program, the manufacturer shall provide the individual with an
eligibility statement in accordance with this subsection.
5. Additional 30-day urgent-need insulin supply pending eligibility for other
coverage or assistance. If an individual has applied for MaineCare coverage but has not
been determined eligible or has been determined eligible but MaineCare coverage has not
become effective or if the individual has been determined ineligible for the manufacturer's
patient assistance program by the manufacturer and the individual has requested a review
pursuant to subsection 4, paragraph G but the reviewer has not rendered a decision, the
individual is entitled to access insulin under the provisions of subsection 3 if the individual
has an urgent need of insulin. To access insulin under this subsection, the individual must
attest to the pharmacy that the individual meets the requirements of subsection 2.
6. Dissemination of information about program. In consultation with the Health
Insurance Consumer Assistance Program, established in Title 24-A, chapter 56-A,
subchapter 2-A, the board shall develop an information sheet to post on its publicly
accessible website and provide a link to the information sheet on the website to be used by
pharmacies, health care practitioners, hospital emergency departments, urgent care clinics
and community health clinics. The information sheet must contain: a description of the
urgent need insulin safety net, including how to apply for the benefits of the program; a
description of each insulin manufacturer's patient assistance program, including contact
information for accessing the assistance programs for each manufacturer; information on
how to contact the Health Insurance Consumer Assistance Program, established in Title
24-A, chapter 56-A, subchapter 2-A; and information on how to contact the board if a
manufacturer determines that an individual is not eligible for the manufacturer's patient
assistance program.
7. Enforcement; penalty for noncompliance. A person who violates this chapter is
subject to enforcement action by the board through any board action authorized in
accordance with section 13731 or any civil penalty or criminal or civil action authorized in
section 13731.
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 8. Confidential information. Any health information or records provided to the board
under this section are confidential if the information or records identify or permit the
identification of an individual who is seeking to access urgently needed insulin under
subsection 3 or to participate in a manufacturer's patient assistance program under this
section. A manufacturer shall maintain the confidentiality of any information received
from any individual applying for the manufacturer's patient assistance program under this
section and is prohibited from selling, sharing or disseminating data received under this
section unless required to under this section or unless the individual has provided the
manufacturer with a signed authorization.
9. Reports. Beginning February 15, 2023 and annually thereafter, each manufacturer
shall report to the board on the number of Maine residents who accessed and received
insulin on an urgent-need basis in the preceding calendar year; the number of Maine
residents participating in the manufacturer's patient assistance program in the preceding
calendar year, including the number of Maine residents who the manufacturer determined
were ineligible for its patient assistance program; and the total value of the insulin,
determined by the wholesale acquisition cost of the insulin, provided by the manufacturer
in the preceding calendar year. Beginning April 15, 2023 and annually thereafter, the board
shall submit a report of the aggregate information reported by manufacturers pursuant to
this sub