An Act To Further Expand Drug Price Transparency
Maine Legislature, Session 129, LD 1162
Committee Amendment CA_A_S252 (Senate)
Amends: 22 MRSA §8703, 22 MRSA §8704

COMMITTEE AMENDMENT " ~· to S.P. 350, L.D. 1162, Bill, "An Act To 
Further Expand Drug Price Transparency" 
Amend the bill by striking out everything after the enacting clause and inserting the 
following: 
'Sec. 1. 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 seetion. sections 8712 and 
8736. This database must be publicly accessible while protecting patient confidentiality 
and respecting providers of care. The organization shall collect, process, analyze and 
report clinical, financial, quality and restructuring data as defined in this chapter. 
Sec. 2. 22 MRSA §8704, sub-§1, 1A, 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 an.a~ restructuring and 
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 
COMMITTEE AMENDMENT 
CO:MMITTEEAMENDMENT"A "toS.P.350,L.D.1162 (s-2 S'l.--,) 
(5) To preserve the reliability, accuracy and integrity of collected data while 
ensuring that the data is available in the public domain. 
Sec. 3. 22 MR.SA §8705-A, first ,r, as enacted by PL 2003, c. 659, §2 is further 
amended to read: 
The board shall adopt rules to ensure that payors aru:I .. providers, prescription drug 
manufacturers, wholesale drug distributors and pharmacy benefits managers file data as 
required by section 8704, subsection 1; that users that obtain health data and information 
from the organization safeguard the identification of patients and health care practitioners 
as required by section 8707, subsections 1 and 3; and that payors arui., providers .. 
prescription drug manufacturers, wholesale drug distributors and pharmacy benefits 
managers pay all assessments as required by section 8706, subsection 2. 
Sec. 4. 22 MR.SA §8705-A, first ,r, as amended by PL 2013, c. 528, §6 and 
affected by §12, is further amended to read: 
The board shall adopt rules to ensure that payors aru:I .. providers. prescription drug 
manufacturers, wholesale drug distributors and pharmacy benefits managers file data as 
required by section 8704, subsection 1; that users that obtain health data and information 
from the organization safeguard the identification of patients and health care practitioners 
as required by section 8714, subsections 2, 3 and 4; and that payors arui., providers .. 
prescription drug manufacturers, wholesale drug distributors and pharmacy benefits 
managers pay all assessments as required by section 8706, subsection 2. 
Sec. 5. 22 MR.SA §8705-A, sub-§3, ,rA, as amended by PL 2007, c. 136, §4, is 
further amended to read: 
A. When a person or entity that is a health care facility eF_. payor, prescription drug 
manufacturer, wholesale drug distributor or pharmacy benefits manager violates the 
requirements of this chapter, except for section 8707, that person or entity commits a 
civil violation for which a fine of not more than $1,000 per day may be adjudged. A 
fine imposed under this paragraph may not exceed $25,000 for any one occurrence. 
Sec. 6. 22 MR.SA §8705-A, sub-§3, ,rA, as amended by PL 2013, c. 528, §7 and 
affected by § 12, is further amended to read: 
A. 
When a person or entity that is a health care facility eF_. payor, prescription drug 
manufacturer, wholesale drug distributor or pharmacy benefits manager violates the 
requirements of this chapter, except for section 8714, that person or entity commits a 
civil violation for which a fine of not more than $1,000 per day may be adjudged. A 
fine imposed under this paragraph may not exceed $25,000 for any one occurrence. 
Sec. 7. 22 MR.SA §8706, sub-§2, as amended by PL 2007, c. 136, §5, is further 
amended to read: 
2. Permanent funding. Permanent funding for the organization is provided from 
reasonable costs, user fees and assessments according to this subsection and as provided 
by rules adopted by the board. 
A. Fees may be charged for the reasonable costs of duplicating, mailing, publishing 
and supplies. 
COMMITTEE AMENDMENT 
COMMITTEEAMENDMENT"A "toS.P.350,L.D.1162( {§, ~2S~) 
B. Reasonable user fees must be charged on a sliding scale for the right to access and 
use the health data and information available from the organization. Fees may be 
charged for services provided to the department on a contractual basis. Fees may be 
reduced or waived for users that demonstrate a plan to use the data or information in 
research of general value to the public health or inability to pay the scheduled fees, as 
provided by rules adopted by the board. 
C. 
The operations of the organization must be supported from J. ~ sources as 
provided in this paragraph: 
(1) Fees collected pursuant to paragraphs A and B; 
(2) Annual assessments of not less than $100 assessed against the following 
entities licensed under Titles 24 and 24-A: nonprofit hospital and medical service 
organizations, health insurance carriers and health maintenance organizations on 
the basis of the total annual health care premium; and 3rd-party administrators, 
carriers that provide only administrative services for a plan sponsor and 
pharmacy benefits managers that process and pay claims on the basis of claims 
processed or paid for each plan sponsor. The assessments are to be determined 
on an annual basis by the board. Health care policies issued for specified disease, 
accident, injury, hospital indemnity, disability, long-term care or other limited 
benefit health insurance policies are not subject to assessment under this 
subparagraph. For purposes of this subparagraph, policies issued for dental 
services are not considered to be limited benefit health insurance policies. The 
total dollar amount of assessments under this subparagraph must equal the 
assessments under subparagraph (3); a£d 
(3) Annual assessments of not less than $100 assessed by the organization 
against providers. The assessments are to be determined on an annual basis by 
the board. The total dollar amount of assessments under this subparagraph must 
equal the assessments under subparagraph (2h and 
( 4) Annual assessments of $500 assessed by the organization against prescription 
drug manufacturers, wholesale drug distributors and pharmacy benefits 
managers. 
The aggregate level of annual assessments under subparagraphs (2) fmd~ (3) and (4) 
must be an amount sufficient to meet the organization's expenditures authorized in 
the state budget established under Title 5, chapter 149. The a:nn1:1al assessment may 
B:et 6*eeed $1,346,904 iB. fiscal year 2002 03. lR subseE]_l:lent fiscal years, the aHfll:lal 
assessment may increase above $1,346,904 by an amol:lllt not to exceed 5% per fiscal 
yeai:. The board may waive assessments otherwise due under subparagraphs (2) fmd~ 
(3) and (4) when a waiver is determined to be in the interests of the organization and 
the parties to be assessed. 
Sec. 8. 22 MRSA c. 1683, sub-c. 3 is enacted to read: 
SUBCHAPTER 3 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" /\ "to S.P. 350, L.D. 1162 ( "..) - 2 c.;-i) 
PRESCRIPTION DRUG PRICING FOR PURCHASERS 
§8731. Definitions 
As used in this subchapter, unless the context otherwise indicates, the following 
terms have the following meanings. 
1. Brand-name drug. "Brand-name drug" means a prescription drug marketed 
under a proprietary name or registered trademark name, including a biological product. 
2. Generic drug. "Generic drug" means a prescription drug, whether identified by 
its chemical, proprietary or nonproprietary name, that is not a brand-name drug and is 
therapeutically equivalent to a brand-name drug in dosage, safety, strength, method of 
consumption, quality, performance and intended use. "Generic drug" includes a 
biosimilar product. 
3. Manufacturer. "Manufacturer" means a manufacturer of prescription drugs that 
are distributed in the State. 
4. Pricing component data. "Pricing component data" means data unique to each 
manufacturer, wholesale drug distributor or pharmacy benefits manager subject to this 
subchapter that evidences the cost to each manufacturer, wholesale drug distributor or 
pharmacy benefits manager to make a prescription drug available to consumers and the 
payments received by each manufacturer, wholesale drug distributor or pharmacy 
benefits manager to make a prescription drug available to consumers, taking into account 
any price concessions, and that is measured uniformly among the entities, as determined 
by rules adopted by the organization pursuant to section 8737. 
5. 
Pricing unit. 
"Pricing unit" means the smallest dispensable amount of a 
prescription drug that could be dispensed. 
6. Wholesale acquisition cost. "Wholesale acquisition cost" means a manufacturer's 
listed price for sale to a wholesale drug distributor or other entity that purchases a 
prescription drug directly from the manufacturer. not including any price concessions. 
§8732. Drug price notifications and disclosures 
1. Notifications by manufacturers. No later than January 30, 2020 and annually 
thereafter, a manufacturer shall notify the organization when the manufacturer has during 
the prior calendar year: 
A. Increased the wholesale acquisition cost of a brand-name drug by more than 20% 
per pricing unit: 
B. Increased the wholesale acquisition cost of a generic drug that costs at least $10 
per pricing unit by more than 20% per pricing unit; or 
C. 
Introduced a new drug for distribution in this State when the wholesale 
acquisition cost is greater than the amount that would cause the drug to be considered 
a specialty drug under the Medicare Part D program. For the purposes of this 
subsection, "Medicare Part D" has the same meaning as in section 254-D, subsection 
1, paragraph F. 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" ft" to S.P. 350, L.D. 1162 ( ~-L SL) 
2. Disclosures by manufacturers, wholesale drug distributors and pharmacy 
benefits managers. Within 60 days of a request from the organization relating to a 
specific prescription drug, a manufacturer, wholesale drug distributor or pharmacy 
benefits manager shall notify the organization of pricing component data per pricing unit 
of a drug. 
§8733. Confidentiality 
Information provided to the organization as required by this subchapter by a 
manufacturer, wholesale drug distributor or pharmacy benefits manager is confidential 
and not a public record under Title 1, chapter 13, except that the organization may share 
information: 
1. 
Bureau of Insurance. 
With the Department of Professional and Financial 
Regulation, Bureau of Insurance, to the extent necessary for the bureau to enforce the 
provisions of Title 24-A, as long as any information shared is kept confidential; and 
2. Aggregate. In the aggregate, as long as it is not released in a manner that allows 
the identification of an individual drug or manufacturer, wholesale drug distributor or 
pharmacy benefits manager. 
§8734. Registration requirements 
Beginning January 1, 2020, a manufacturer and wholesale drug distributor subject to 
this subchapter shall register annually with the organization in a manner prescribed by the 
organization. 
§8735. Compliance 
1. 
Certification of accuracy. 
A manufacturer, wholesale drug distributor or 
pharmacy benefits manager that submits a notification or report to the organization 
pursuant to this subchapter shall submit with the notification or report a signed written 
certification of the notification's or report's accuracy. 
2. Civil penalty. A manufacturer, wholesale drug distributor or pharmacy benefits 
manager that violates this subchapter commits a civil violation for which a fine of 
$30,000 may be adjudged for each day of the violation. 
3. 
Audit. 
The organization may audit the data submitted by a manufacturer, 
wholesale drug distributor or pharmacy benefits manager pursuant to this subchapter. The 
manufacturer, wholesale drug distributor or pharmacy benefits manager shall pay for the 
costs of the audit. 
4. Corrective action plan. The organization may require a manufacturer, wholesale 
drug distributor or pharmacy benefits manager subject to this subchapter to develop a 
corrective action plan to correct any deficiencies the organization finds with the 
manufacturer's, wholesale drug distributor's or pharmacy benefits manager's compliance 
with this subchapter. 
§8736. Public report 
Beginning November 1, 2020 and annually thereafter, the organization shall produce 
and post on its publicly accessible website an annual report, including information 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT "f1--" to S.P. 350, L.D. 1162 ( S-Z :>----Z,J 
developed from the notifications and disclosures received pursuant to this subchapter on 
trends in the cost of prescription drugs, analysis of manufacturer prices and price 
increases, the major components of prescription drug pricing along the supply chain and 
the impacts on insurance premiums and cost sharing and any other information the 
organization determines is relevant to providing greater consumer awareness of the 
factors contributing to the cost of prescription drugs in the State. The report may not 
disclose information attributable to any particular manufacturer, wholesale drug 
distributor or pharmacy benefits manager subject to this subchapter and may not make 
public any information that is confidential pursuant to section 8733. The organization 
shall submit the report required by this section to the joint standing committee of the 
Legislature having jurisdiction over health data reporting and prescription drug matters 
and the committee may report out legislation to the first regular or second regular session 
of the Legislature, depending on the year in which the report is submitted. 
§8737. Rulemaking 
The organization may adopt rules to implement this subchapter. Rules adopted 
pursuant to this section are major substantive rules as defined in Title 5, chapter 375, 
subchapter 2-A. 
Sec. 9. Maine Revised Statutes headnote amended; revision clause. In the 
Maine Revised Statutes, Title 22, chapter 1683, before section 8701, the headnote 
"subchapter 1, general provisions" is enacted and the Revisor of Statutes shall implement 
this revision when updating, publishing or republishing the statutes. 
Sec. 10. Initial rulemaking. Notwithstanding the Maine Revised Statutes, Title 
22, section 8737, the Maine Health Data Organization may adopt emergency rules that 
are otherwise in accordance with section 8737 to implement the provisions of Title 22, 
chapter 1683, subchapter 3 and may adopt routine technical rules to implement that 
subchapter before April 1, 2020.' 
SUMMARY 
This amendment replaces the bill. The amendment does the following. 
The amendment requires prescription drug manufacturers to report annually to the 
Maine Health Data Organization no later than January 30, 2020 and annually thereafter, 
on prescription drug prices when the manufacturer has during the prior calendar year 
increased the wholesale acquisition cost of a brand-name drug by more than 20% per 
pricing unit, increased the wholesale acquisition cost of a generic drug that costs at least 
$10 per pricing unit by more than 20% per pricing unit or introduced a new drug for 
distribution in this State when the wholesale acquisition cost is greater than the amount 
that would cause the drug to be considered a specialty drug under the Medicare Part D 
program. 
The amendment also requires prescription drug manufacturers, wholesale drug 
distributors and pharmacy benefits managers to provide pricing component data per 
pricing unit of a drug within 60 days of a request by the Maine Health Data Organization. 
The amendment defines "pricing component data" as data unique to each manufacturer, 
wholesale drug distributor or pharmacy benefits manager that evidences the cost to make 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" /J-" to S.P. 350, L.D. 1162 ( S- L S'L) 
a prescription drug available to consumers and the payments received by each 
manufacturer, wholesale drug distributor or pharmacy benefits manager to make a 
prescription drug available to consumers, taking into account any price concessions, and 
that is measured uniformly among the entities, as determined by rules adopted by the 
organization. 
The amendment provides that reported information is confidential, except that 
information may be shared in the aggregate and with the Department of Professional and 
Financial Regulation, Bureau of Insurance for enforcement purposes. 
Beginning November 1, 2020 and annually thereafter, the amendment requires the 
Maine Health Data Organization to produce and post on its publicly accessible website an 
annual report, including information developed from the notifications and disclosures 
received from prescription drug manufacturers, wholesale drug distributors and pharmacy 
benefits managers on trends in the cost of prescription drugs, an analysis of manufacturer 
prices and price increases, the major components of prescription drug pricing along the 
supply chain and the impacts on insurance premiums and cost sharing and other 
information the organization determines is relevant to providing greater consumer 
awareness of the factors contributing to the cost of prescription drugs in the State. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 05/25/19 :::Wac:. 
LD 1162 
LR 786(02) 
An Act To Further Expand Drug Price Transparency 
Fiscal Note for Bill as Amended by Committee Amendment 'f.l-'' { s--2...St--"') 
Committee: Health Coverage, Insurance and Financial Services 
Fiscal Note Required: Yes 
Fiscal Note 
Minor cost increase - General Fund 
Minor revenue increase - General Fund 
Minor revenue increase - Other Special Revenue Funds 
Correctional and Judicial Impact Statements 
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 fine revenue will increase General Fund and dedicated revenue by minor amounts. 
Fiscal Detail and Notes 
The bill requires prescription drug manufacturers to report to the Maine Health Data Organization (MHDO) on 
prescription drug information under certain situations or when requested by MHDO and requires MHDO to annually 
produce and post a report of this information on its website. Any costs to MHDO to carry out these provisions are 
expected to be minor and can be absorbed within budgeted resources. The bill also authorizes MHDO to collect an 
annual assessment on drug manufacturers of $500. Additional revenues collected from these assessments are expected 
to increase Other Special Revenue Fund revenues by minor amounts. 
LR0786(02) - Fiscal Note - Page 1 of 1