An Act To Create the Insulin Safety Net Program
Maine Legislature, Session 130, LD 0673
Committee: Health Coverage, Insurance and Financial Services
Sponsors: BREEN, MADIGAN, CLAXTON, JACKSON, MAXMIN, RAFFERTY, McDONALD, WHITE, WILLIAMS
Amends: 32 MRSA §13725

Legislative Document
No. 673
S.P. 260
In Senate, March 4, 2021
An Act To Create the Insulin Safety Net Program
Received by the Secretary of the Senate on March 2, 2021.  Referred to the Committee on 
Health Coverage, Insurance and Financial Services pursuant to Joint Rule 308.2 and ordered 
printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator BREEN of Cumberland.
Cosponsored by Representative MADIGAN of Waterville and
Senators: CLAXTON of Androscoggin, President JACKSON of Aroostook, MAXMIN of 
Lincoln, RAFFERTY of York, Representatives: McDONALD of Stonington, WHITE of 
Waterville, WILLIAMS of Bar Harbor.
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 January 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.
3.  Urgent need safety net.  The board shall, through the program, authorize a 
pharmacy to dispense a 30-day supply of insulin 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.
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 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 auditing purposes.
4.  Manufacturer's patient assistance.  Pursuant to the requirements of the program, 
as established by the board, 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 board with 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 
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 
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 the use of a 3-person 
panel to review eligibility.  The panel is composed of 3 members of the board.  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 panel with the documents submitted by the individual. The panel shall render a 
decision within 10 business days of receipt of all the necessary documents from the 
individual.  The decision of the panel is final.  If the panel 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 panel 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.  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.
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 subsection to the joint standing committee of the Legislature having jurisdiction over 
health coverage, insurance and financial services matters.
10.  Repeal.  This section is repealed January 1, 2027.
SUMMARY
This bill establishes the Insulin Safety Net Program, which is modeled after a similar 
program in Minnesota.  The bill requires the Maine Board of Pharmacy to oversee the 
program.  The bill requires that, by January 1, 2022, manufacturers of insulin establish 
procedures to make insulin available to pharmacies for dispensing to eligible individuals 
who are in urgent need of insulin or who need access to an affordable insulin supply.  The 
bill requires annual reporting to the Legislature on the number of Maine residents accessing 
insulin through the program and the cost to manufacturers.  The bill includes provision to 
repeal the program in 5 years.