An Act To Promote Prescription Drug Price Transparency
Maine Legislature, Session 128, LD 1406
Committee Amendment CA_A_S451 (Senate)
Amends: 22 MRSA §8702, 22 MRSA §8703, 22 MRSA §8704, 22 MRSA §8710-A

COMMITTEE AMENDMENT "ff" to S.P. 484, L.D. 1406, Bill, "An Act To 
Promote Prescription Drug Price Transparency" 
Amend the bill by striking out everything after the enacting clause and before the 
summary and inserting the following: 
'Sec. 1. 22 MRSA §8702, sub-§5-C is enacted to read: 
5-C. Manufacturer. "Manufacturer" means a manufacturer of prescription drugs. 
Sec. 2. 22 MRSA §8702, sub-§12 is enacted to read: 
12. Wholesale acquisition cost. "Wholesale acquisition cost" means the list price of 
a manufacturer to a wholesaler or direct purchaser in the United States, not including 
prompt pay or other discounts, rebates or reductions in price, as reported in wholesale 
price guides or other publications of pharmaceutical pricing data or as estimated by the 
organization using the all-payer claims data and the ingredient cost and list price and 
dispensing fee information that is submitted to the organization. 
Sec. 3. 22 MRSA §8703, sub-§1, as amended by PL 2003, c. 469, Pt. C, §22, is 
further amended to read: 
1. Objective. The purposes of the organization are to create and maintain a useful, 
objective, reliable and comprehensive health information database that is used to improve 
the health of Maine citizens and to issue reports, as provided in section 8712. This 
database must be publicly accessible while protecting patient confidentiality and 
respecting providers of care. The organization shall collect, process, analyze and report 
clinical, fmancial, quality and .. restructuring and prescription drug price data as defined in 
this chapter. 
Sec. 4. 22 MRSA §8704, sub-§1, ,fA, as amended by PL 2003, c. 469, Pt. C, 
§23, is further amended to read: 
A. The board shall develop and implement policies and procedures for the collection, 
processing, storage and analysis of clinical, fmancial, quality and .. restructuring and 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A" to S.P. 484, L.D. 1406 
prescription drug price data in accordance with this subsection for the following 
purposes: 
(1) To use, build and improve upon and coordinate existing data sources and 
measurement efforts through the integration of data systems and standardization 
of concepts; 
(2) 
To coordinate the development of a linked public and private sector 
information system; 
(3) To emphasize data that is useful, relevant and not duplicative of existing 
data; 
( 4) To minimize the burden on those providing data; and 
(5) To preserve the reliability, accuracy and integrity of collected data while 
ensuring that the data is available in the public domain. 
Sec. 5. 22 MRSA §8710-A is enacted to read: 
§8710-A. Prescription drug price transparency 
1. Annual identification; list. The organization shall annually identify and compile 
a list of the following prescription drugs, including brand name and generic drugs: 
A. The 25 most frequently prescribed drugs in the State; 
B. The 25 costliest drugs as determined by the total amount spent on those drugs in 
the State; and 
C. The 25 drugs with the highest year-over-year cost increases as determined by the 
total amount spent on those drugs in the State. 
The list must also include along with each identified prescription drug the corresponding 
wholesale acquisition cost and the percentage of wholesale acquisition cost increase, if 
applicable. The organization shall make the list and cost information compiled pursuant 
to this section available to the public and post it on the publicly accessible website of the 
organization. 
2. Required information. Beginning July 1, 2019 and annually thereafter. the 
organization shall require the manufacturer of each of the drugs listed in subsection 1 to 
provide to the organization, in such form and format and on a schedule determined by the 
organization, information to explain prescription drug prices. including but not limited to 
the following: 
A. Total cost of production and total cost per dose of the drug; 
B. Research and development costs of the drug. including those costs paid with 
public funds. those costs reported as after-tax costs and those costs paid by 3rd 
parties; 
C. Marketing and advertising costs of the drug. including those costs directed to 
consumers. those costs directed to prescribers and the total of those costs directed to 
consumers and prescribers in the State; 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT 'A "to S.P. 484, L.D. 1406 
D. The retail prices of the drug charged to purchasers outside the United States in 
countries that are members of the Organisation of Economic Co-operation and 
Development or successor organization; and 
E. The retail prices of the drug typically charged to purchasers in the State, including 
but not limited to pharmacies. pharmacy wholesalers and other direct purchasers. 
A manufacturer of a brand-name drug or a generic drug directed to provide information 
under this section shall provide the information within 60 days after the information is 
requested by the organization and shall certify as accurate the information provided. The 
organization may request that a manufacturer provide additional information related to 
the information required in this subsection. 
3. Additional information. A manufacturer of each of the drugs listed in subsection 
may voluntarily provide any other information the manufacturer determines relevant to 
the increase in wholesale acquisition cost. including but not limited to a description of all 
manufacturer-sponsored assistance programs for a drug identified in subsection 1 in the 
previous year, including the terms of the programs, the total amount of financial 
assistance provided to residents of the State and the average amount of assistance per 
resident of the State for whom assistance was provided. 
Information provided by 
manufacturers pursuant to this subsection is not confidential and may be released in a 
manner that identifies both the individual drug to which the information pertains as well 
as the manufacturer. 
4. Reports to Legislature. Beginning December 1. 2018 and annually thereafter. 
the organization shall submit a written report to the Legislature that includes the list of 
prescription drugs compiled pursuant to subsection 1 and their wholesale acquisition cost 
and cost increases. if any. The organization may include in the report recommendations 
for improving the transparency of prescription drug pricing. Beginning December 1. 
2019. the report must include a summary of the information provided by manufacturers 
pursuant to this section. The organization shall post the report on the publicly accessible 
website of the organization. 
5. Confidentiality; exceptions. Information provided by manufacturers pursuant to 
subsection 2, unless already publicly accessible or available or previously released in the 
public domain, must, at the request of the manufacturer, be held as confidential and not 
subject to public inspection and copying under the Freedom of Access Act. 
The 
organization may release information that was previously accessible or available or 
released in the public domain. The organization may release other information provided 
pursuant to subsection 2 except for information that is a trade secret as defmed in Title 
10, section 1542, subsection 4. The organization shall treat information submitted by 
manufacturers as Level II data in accordance with 90-590 CMR. Chapter 120, Release of 
Data to the Public. 
6. Penalties for noncompliance. When a manufacturer violates the requirements of 
this section. the board may impose a fme of not more than $10,000 per day after the 
deadline for reporting required information. If the manufacturer fails to pay a fine, or if 
an injunction is necessary. the board may refer the matter to the Attorney General. The 
Attorney General may bring an action in Superior Court for injunctive relief, enforcement 
of fines, costs, attorney's fees and any other appropriate remedy. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A" to S.P. 484, L.D. 1406 
7. Legal ability to change prices. Nothing in this section may be construed to 
restrict the legal ability of a manufacturer to change prices to the extent permitted under 
federal law. 
Sec. 6. Further data collection by Maine Health Data Organization. The 
Maine Health Data Organization shall develop a plan to collect data from manufacturers 
related to the cost and pricing of prescription drugs in order to provide transparency in 
and accountability for prescription drug pricing as required in the Maine Revised 
Statutes, Title 22, section 8710-A, subsection 2. The organization shall consult with 
other state and national agencies and organizations to determine how to institute the data 
collection. The organization shall submit the plan, its findings and any recommendations 
for suggested legislation to the First Regular Session of the 129th Legislature no later 
than April 1, 2019. The joint standing committee of the Legislature having jurisdiction 
over judiciary matters may report out legislation related to prescription drug price 
transparency and the organization's findings and recommendations to the First or Second 
Regular Session of the 129th Legislature. 
Sec. 7. Appropriations and allocations. 
The following appropriations and 
allocations are made. 
HEALTH DATA ORGANIZATION, MAINE 
Maine Health Data Organization 0848 
Initiative: Provides a one-time allocation to the Maine Health Data Organization to 
collect and present certain data to the Legislature and to develop a plan for further data 
collection. 
OTHER SPECIAL REVENUE FUNDS 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
SUMMARY 
2017-18 
$0 
$0 
2018-19 
$100,000 
$100,000 
This amendment is the majority report of the Joint Standing Committee on Judiciary. 
The amendment replaces the bill and amends the statutes governing the Maine Health 
Data Organization to address the collection and reporting of information about 
prescription drug prices. 
This amendment directs the Maine Health Data Organization, referred to as the 
"organization," to collect and report information with regard to the 25 prescription drugs 
that are the most frequently prescribed in the State, the 25 costliest as determined by the 
total amount spent on those drugs in the State and the 25 drugs that have the highest year-
over-year cost increases in total spending in the State. The organization is required to 
post online a list of the identified prescription drugs, along with the corresponding 
wholesale acquisition cost and the percentage of wholesale acquisition cost increase, if 
applicable, for each identified prescription drug. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A "to S.P. 484, L.D. 1406 
This amendment directs the organization to develop a plan to collect data from 
manufacturers that will help explain how prescription drug prices are established. The 
organization is required to work with other state and national agencies and organizations 
to determine how to conduct the data collection. The organization is required to submit 
the plan as well as any recommendations for legislation to the joint standing committee of 
the Legislature having jurisdiction over judiciary matters by April 1, 2019. 
That 
committee may report out legislation to the First or Second Regular Session of the 129th 
Legislature. 
Using the plan developed and reported to the Legislature, starting in 2019, the 
organization must require the manufacturer of each drug on the list to disclose drug 
production, research and development costs, marketing and advertising costs and actual 
costs paid by purchasers. The manufacturer must certify the accuracy of the information 
and provide it within 60 days after the information is requested by the organization. The 
organization is authorized to request additional information related to the required 
information. 
The information that the manufacturers are directed to provide to the organization, 
unless the information is already publicly accessible or available or previously released in 
the public domain, must be held confidential at the request of the manufacturer. The 
organization may release information that was previously accessible or available or 
released in the public domain. The organization may release additional information as 
long as the information released is not a trade secret. The organization must treat the 
information as "Level II" information as required by rules that have already been adopted 
by the organization. 
This amendment provides that the manufacturer may voluntarily provide any other 
information the manufacturer determines relevant to the increase in wholesale acquisition 
cost, including but not limited to information about all manufacturer-sponsored assistance 
programs for that drug in the previous year, including the terms of the programs, the total 
amount of fmancial assistance provided to residents of the State and the average amount 
of assistance per resident of the State for whom assistance was provided. 
This 
information is not considered confidential and the organization may release it, identifying 
both the manufacturer and the individual drug. 
The organization is required to submit an annual report to the Legislature based on 
the list of up to 75 drugs and the wholesale acquisition cost information. 
The 
organization may include in the report recommendations for increasing prescription drug 
pricing transparency. 
Once the organization starts collecting information from 
manufacturers in 2019, the report must also include at least a summary of the 
manufacturer information. The organization is required to post the report online. 
This amendment replaces the penalties in the bill to provide that when a manufacturer 
violates the reporting requirements, the Board of Directors of the Maine Health Data 
Organization may impose a fme of not more than $10,000 per day after the deadline for 
reporting required information. If the manufacturer fails to pay a fine, or if an injunction 
is necessary, the board may refer the matter to the Attorney General. The Attorney 
General may bring an action in Superior Court for injunctive relief, enforcement of fines, 
costs, attorney's fees and any other appropriate remedy. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A "to S.P. 484, L.D. 1406 
The legislation does not restrict the legal ability of a prescription drug manufacturer 
to change prices to the extent permitted under federal law. 
The amendment includes an appropriations and allocations section. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 04/03/18 fea~ 
LD 1406 
LR994(02) 
An Act To Promote Prescription Drug Price Transparency 
Fiscal Note for Bill as Amended by Committee Amendment /J" ( S-45!) 
Committee: Judiciary 
Fiscal Note Required: Yes 
Fiscal Note 
Minor cost increase - General Fund 
Minor revenue increase - General Fund 
FY 2017-18 
FY 2018-19 
Projections 
FY 2019-20 
Projections 
FY 2020-21 
Appropriations/ Allocations 
Other Special Revenue Funds 
Revenue 
Other Special Revenue Funds 
Correctional and Judicial Impact Statements 
Increases the number of civil suits 
$0 
$0 
$100,000 
$0 
$0 
$100,000 
$0 
$0 
The additional workload associated with the minimal number of new cases filed in the court system does not require 
additional funding at this time. 
The collection of additional filing fees may increase General Fund revenue by minor amounts. 
Fiscal Detail and Notes 
The bill includes a one-time allocation to the Maine Health Data Organization of $100,000 to collect and present 
certain data to the legislature and to develop a plan for further data collection. The Maine Health Data Organization 
has sufficient resources available to fund the allocation. 
Additional costs to the Department of the Attorney General are expected to be minor and can be absorbed within 
existing budgeted resources. 
LR0994(02) - Fiscal Note - Page 1 of 1