An Act To Amend the Prescription Privacy Law
Maine Legislature, Session 123, LD 0004
Committee Amendment CA_A_H584 (House)
Amends: 22 MRSA §1711-E, 22 MRSA §8704, 22 MRSA §8713

COMMITTEE AMENDMENT ,jJ "to H.P. 5, L.D. 4, Bill, "An Act To Amend the 
Prescription Privacy Law" 
Amend the bill by striking out everything after the enacting clause and before the 
summary and inserting the following: 
'Sec. 1. 22 MRSA §1711-E, as enacted by PL 2005, c. 589, §1, is amended to 
read: 
§1711-E. Confidentiality of prescription drug information 
1. Definitions. As used in this section, unless the context otherwise indicates, the 
following terms have the following meanings. 
A. "Carrier" has the same meaning as in Title 24-A, section 4301-A, subsection 3. 
A-I. 
"Administrator" has the same meaning as in Title 24-A, section 1901, 
subsection 1. 
A-2. "Detailing" means one-to-one contact with a prescriber or employees or agents 
of a prescriber for the purpose of increasing or reinforcing the prescribing of a certain 
drug by the prescriber. 
B. 
"Electronic transmission intermediary" means an entity that provides the 
infrastructure that connects the computer systems or other electronic devices used by 
and between health care practitioners, prescribers, pharmacies, health care facilities 
and~ pharmacy benefit managers te~ carriers and administrators and agents and 
contractors of those oarriers aHa ageRts persons and entities in order to facilitate the 
secure transmission of an individual's prescription drug order, refill, authorization 
request, claim, payment or other prescription drug information. 
C. "Health care facility" has the same meanings as in section 17l1-C, subsection 1, 
paragraph D. 
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D. "Health care practitioner" has the same meanings as in section l711-C, subsection 
], paragraph F. 
E. 
"Health plan" means a health plan providing prescription drug coverage as 
authorized under the federal Medicare Prescription Drug, Improvement and 
Modernization Act of 2003, Public Law 108-173. 
F. 
"Individual" means a natural person who is the subject of prescription drug 
information. 
F-l. "Marketing" means any of the following activities undertaken or materials or 
products made available to prescribers or to their employees or agents related to the 
transfer of prescription drugs from the producer or seller to the consumer or buyer: 
(1) Advertising, publicizing, promoting or selling a prescription drug; 
(2) Activities undertaken for the purpose of influencing the market share of a 
prescription drug or the prescribing patterns of a prescriber, a detailing visit or a 
personal appearance; 
(3) 
Activities undertaken to evaluate or improve the effectiveness of a 
professional detailing sales force; or 
(4) A brochure, media advertisement or announcement, poster or free sample of 
a prescription drug. 
"Marketing" does not include pharmacy reimbursement, formulary compliance, 
pharmacy file transfers in response to a patient request or as a result of the sale or 
purchase of a pharmacy, patient care management, utilization review by a health care 
provider or agent of a health care provider or the patient's health plan or an agent of 
the patient's health plan, and health care research. 
F-2. "Pharmacy" means a mail order prescription pharmacy as defined in Title 32, 
section 13702, subsection 13 or a drug outlet as defined in Title 32, section 13702, 
subsection 10. 
G. 
"Pharmacy benefits manager" has the same meaning as in section 2699, 
subsection 1, paragraph F. 
G-l. "Prescriber" means a person who is licensed, registered or otherwise authorized 
in the appropriate jurisdiction to prescribe and administer drugs in the course of 
professional practice. 
H. "Prescription drug information" means information concerning prescription drugs 
as defined in Title 32, section 13702, subsection 24 and includes prescription drug 
orders as defined in Title 32, section 13702, subsection 25. 
I. 
"Prescription drug information intermediary" means a person or entity that 
communicates, facilitates or participates in the exchange of prescription drug 
information regarding an individual or a prescriber. "Prescription drug information 
intermediary" includes, but is not limited to, a pharmacy benefits manager, a health 
plan, an administrator and an electronic transmission intermediary and any person or 
entity employed by or contracted to provide services to that entity. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A " 
t. H.P. s. L.D. 4 
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I-A. Fiodi0l:s. The Legislature finds that enactment of this section will assist the 
State to achieve the following compelling state interests: to improve the public health, to 
limit annual increases in the cost of health care and to protect the privacy of patients and 
prescribers in the health care system of this State. 
A. 
The State has a duty to assist public and private payors and health care 
practitioners and consumers to maintain an effective and efficient health care system 
that is based on sound medical and scientific knowledge and the professional 
judgment of health care practitioners and that is trusted by the general pUblic. 
B. Patients and prescribers have requested that the Legislature provide a mechanism 
for protecting the confidentiality of identifying prescription drug information from 
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use for marketing purposes. Joining them are payors of all types and the general 
public demanding from the health care system efficiency, effectiveness and increased 
access for all persons. 
C. Across the nation data companies purchase for marketing purposes computerized 
prescription drug records from pharmacies and insurers that identify prescribers. 
These records are sold to prescription drug manufacturers that use personally 
identifying prescriber information to attempt to influence prescribers to prescribe 
higher priced drugs, thus increasing the market share and profitability of the 
manufacturers and driving up the cost of health care. 
D. Restricting the use of prescriber identifying information wiJl act to decrease drug 
detailing that targets the prescriber, thus increasing decisions to prescribe lower 
priced drugs and decisions made on the basis of medical and scientific knowledge 
and driving down the cost of health care. 
E. With redirected drug detailing programs, manufacturers of prescription drugs will 
be able to increase their investments in new and more effective prescription drugs and 
savings will accrue to payors that can be used for increased access to health care and 
for other necessary public and private purposes. 
F. The provisions of this section are narrowly and carefully tailored to address the 
findings listed in this subsection, to achieve the State's purposes listed in subsection 
1-8 and to advance the State's compelling interests. 
I-B. Purposes. It is the intent of the Legislature in enacting this section to achieve 
the following compelling state interests: to improve public health, to limit annual 
increases in the cost of health care and to protect the privacy of patients and prescribers in 
the health care system of this State. 
A. 
The establishment of a system to protect patient confidentiality is critical to 
patient trust in the integrity of the health care system of this State. It will protect 
prescribers' expectations of privacy, freeing them from pressure to prescribe based on 
comparisons among them and their peers and aiding them in making health care 
decisions based on the best interests of the patient and on medical and scientific 
evidence about prescription drugs and health care treatments. It will decrease the 
influence of drug representatives. This will build patient and prescriber confidence in 
the health care system. 
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to H.P. 5. LJ) •• 
B. 
Restrictions on the use of personally identifying information for marketing 
purposes will protect personal privacy rights, end the use of prescriber comparisons 
for purposes related to manufacturer profitability and decrease unnecessary marketing 
costs. 
C. The provisions of this section are narrowly and carefully tailored to address the 
findings listed in subsection I-A, to achieve the State's purposes listed in this 
subsection and in conjunction with the following efforts to advance the State's 
compelling interests: 
(1) Prior authorization and drug utilization review in the MaineCare program 
under section 3174-M; 
(2) Reporting of a broad array of prescription drug marketing costs under section 
2698-A and subsequent reporting by the department to the Legislature and the 
Attorney General; 
(3) Prescription drug price disclosure under section 2698-B; 
(4) Generic and therapeutically equivalent substitution of prescription drugs 
under Title 32, section 13781; and 
(5) 
Protection of patient prescription drug information held by health care 
practitioners under section 1711-C. 
2. 
Confidentiality of prescription drug information that identifies the 
individual. A carrier or prescription drug information intermediary may not license, use, 
sell, transfer or exchange for value, for any marketing purpose, prescription drug 
information that identifies directly or indirectly the individual eKeept if expfessly 
peffHitted I:lRdef seetioR 1711 C, Title 24, Title 24 A Of the fedefal Health mSl:lfftR6e 
Portability aDd Aeeol:lRtallility A-6t of 1996, Pl:lblie Law lQ4 191, as aiHes:ded. 
2-A. 
Confidentiality of prescription drug information that identifies the 
prescriber. 
Beginning January 1, 2008, a carrier, pharmacy or prescription drug 
information intermediary may not license, use, sell, transfer or exchange for value, for 
any marketing purpose, prescription drug information that identifies a prescriber who has 
filed for confidentiality protection in accordance with subsection 4. 
3. Enforcement. A violation of this seetioR subsection 2 or 2-A is a violation of the 
Maine Unfair Trade Practices Act. 
4. Confidentiality protection procedures. The procedures in this subsection apply 
to the protection of prescription drug information that identifies a prescriber. 
A. Beginning October -l, 2007, a board of licensure of a prescriber shall provide as 
part of the application process for licensure and relicensure confidentiality protection 
information and procedures as set forth in this paragraph. 
(1) The application materials must state that prescription drug information that 
identifies the prescriber is used for marketing purposes by carriers, pharmacies 
and prescription drug information intermediaries and that. with regard to that use 
of information, the confidentiality of the prescriber may be protected under this 
section in one of 3 ways: 
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COMMl'ITEE AMENDMENT ,A " 
to H.P. 5, L.D. 4 
(a) If the licensing procedure is done by regular mail. by signing and 
submitting to the Maine Health Data Organization the accompanying 
confidentiality protection form and addressed envelope: 
(b) If the licensing procedure includes a check-off box on the application 
form or electronically, by completing the check-off box and submitting the 
form to the licensing board: or 
ec) If the licensing procedure is done over the Internet and the licensing 
board has provided an electronic link over the Internet from the application 
materials, by use of the electronic link to the Maine Health Data Organization 
website. 
(2) The licensing board shall submit to the Maine Health Data Organization on a 
monthly basis a list of all prescribers who have filed with the licensing board for 
confidentiality protection. 
(3) The confidentiality protection information must inform the prescriber that 
filing for confidentiality protection is effective until it is revoked by the 
prescriber. 
B. 
The boards of licensure may adopt rules to implement paragraph A. 
Rules 
adopted pursuant to this paragraph are routine technical rules as defined by Title 5, 
chapter 375, subchapter 2-A. 
C. The department shall assess an annual fee payable by October I st each year 
beginning in 2007 on manufacturers of prescription drugs whose drugs are dispensed 
to members of the MaineCare program under chapter 855 and enrollees in the elderly 
low-cost drug program under section 254-D. Fees collected under this paragraph 
must be deposited in a separate account and do not lapse at the end of the fiscal year. 
Eighty percent of the assessments must be used to cover the costs of the Maine 
Health Data Organization pursuant to paragraph A and section 8713 and 20% of the 
assessments must be used to cover the costs of the boards of licensure pursuant to 
paragraph A. 
S. Rules. The department, after consultation with the Governor's Office of Health 
Policy and Finance, shall adopt rules to implement this section. Rules adopted pursuant 
to this subsection are routine technical rules as defined by Title 5, chapter 375, subchapter 
2-A. 
Sec.2. 22 MRSA §8704, sub-§4, as amended by PL 1999, c. 127, Pt. B, §8, is 
further amended to read: 
4. Rulemaking. The board shall adopt rules necessary for the proper administration 
and enforcement of the requirements of this chapter and to carry out the duties of the 
organization under section I71I-E, subsection 4 and section 8713. All rules must be 
adopted in accordance with Title 5, chapter 375 and unless otherwise provided are routine 
technical rules as defined in Title 5, chapter 375, subchapter -II-t\ 2-A. 
Sec. 3. 22 MRSA §8704, sub-§7, as amended by PL 2005, c. 565, §5, is further 
amended to read: 
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COMMITTEE AMENDMENT "A "to H.P. 5, L.D. 4 
7. Annual report. The board shall prepare and submit an annual report on the 
operation of the organization and the Maine Health Data Processing Center as authorized 
in Title 10, section 681, including any activity contracted for by the organization or 
contracted services provided by the center, with resulting net earnings, to the Governor 
and the joint standing committee of the Legislature having jurisdiction over health and 
human services matters no later than February 1st of each year. The report must include 
an annual accounting of all revenue received and expenditures incurred in the previous 
year and all revenue and expenditures planned for the next year. The report must include 
a list of persons or entities that requested data from the organization in the preceding year 
with a brief summary of the stated purpose of the request. 
As part of its annual report, the organization shall report on filings for confidentiality 
protection under section 1711-E, subsection 4, the disclosure of the names of prescribers 
who filed for confidentiality protection, funding through the assessment under section 
1711-E, subsection 4, paragraph C and recommendations for legislation to improve 
operation of section 1711-E, subsection 4. 
Sec. 4. 22 MRSA §8713 is enacted to read: 
§8713. Confidentiality protection for certain health care practitioners 
The organization shall establish procedures to accept filings for confidentiality 
protection from health care practitioners who file with the organization under section 
1711-E, subsection 4 and licensing boards that submit lists of names of practitioners who 
file for confidentiality protection. The procedures must provide for disclosure, upon 
request, of the names of practitioners who filed for confidentiality protection. The costs 
of the organization for performing the functions under this section must be met by 
funding provided under section 1711-E, subsection 4, paragraph C. 
Sec. 5. Transfer to the Maine Health Data Organization. Notwithstanding 
any other provision of law, the State Controller after consultation with the Commissioner 
of Health and Human Services and the Director of the Maine Health Data Organization 
shall transfer funds as determined and available under section 1 of this Act in each of 
fiscal years 2007-08 and 2008-09 from the Bureau of Medical Services, Other Special 
Revenue Funds account in the Department of Health and Human Services to the Maine 
Health Data Organization, Other Special Revenue Funds account for costs incurred as a 
result of this Act. 
Sec. 6. Transfer to Department of Professional and Financial Regulation. 
Notwithstanding any other provision of law, the State Controller after consultation with 
the Commissioner of Health and Human Services and the Commissioner of Professional 
and Financial Regulation shall transfer funds as determined and available under section I 
of this Act in each of fiscal years 2007-08 and 2008-09 from the Bureau of Medical 
Services, Other Special Revenue Funds account in the Department of Health and Human 
Services to the Administrative Services - Professional and Financial Regulation, Other 
Special Revenue Funds account in the Department of Professional and Financial 
Regulation for costs incurred under this Act. 
Sec. 7. Appropriations and allocations. The following appropriations and 
allocations are made. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A " 
to H.P. 5, L.D. 4 
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HEALTH AND HUMAN SERVICES, DEPARTMENT OF (FORMERLY DHS) 
Bureau of Medical Services 0129 
Initiative: Provides a base allocation for the costs of the prescription drug privacy 
program. 
OTHER SPECIAL REVENUE FUNDS 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
SUMMARY 
2007-08 
$500 
$500 
2008-09 
$500 
$500 
II 
This amendment replaces the bill and is the majority report of the committee. The 
amendment provides an opt-out mechanism by which prescribers of prescription drugs 
may protect from marketing uses prescription drug information that identifies the 
prescriber. The amendment: 
1. Adds a definition of "marketing"; 
2. Adds to the definition of "prescription drug information intermediary" persons or 
entities employed by or under contract to a prescription drug information intermediary; 
3. Provides a statement of findings: 
A. That the Legislature finds that enactment of this legislation will: improve the 
public health, limit annual increases in the cost of health care and protect the privacy 
of patients and prescribers in Maine's health care system; 
B. That the State has a duty to assist in the maintenance of an effective and efficient 
health care system; 
C. 
That patients and prescribers have requested that the Legislature provide a 
mechanism for protecting confidentiality; 
D. That data companies sell prescriber and patient information to drug manufacturers 
who use it to influence prescribers to prescribe higher priced drugs, thereby 
increasing the cost of health care; 
E. That restricting the use of prescriber-identifying information will decrease drug 
detailing and increase the use of lower priced drugs, thus decreasing the cost of health 
care; 
F. That the reSUlting savings may be used for increased investment in drugs and 
increased access to health care; and 
G. That the legislation is a narrowly and carefully tailored approach to achieving 
compelling state interests and other purposes; 
4. Provides a statement of purposes the Legislature intends to achieve, including 
improving the public health, limiting annual increases in the cost of health care and 
COMMITTEE AMENDMENT 
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to H.P. " L.D. 4 
protecting the privacy of patients and prescribers in Maine's health care system. Other 
purposes include protection of personal privacy rights, ending the use of prescriber 
comparisons and decreasing marketing costs. 
In part as a reaction to a Journal of the American Medical Association article, "The 
Accuracy of Drug Information from Pharmaceutical Sales Representatives," vol. 273, no. 
16, pp. 1296-98 (1995), which concluded that 11% of the in-person statements made to 
physicians by pharmaceutical sales representatives contradicted information that was 
readily available to them, the amendment also provides a mechanism to be used in 
conjunction with academic detailing that is being considered by the Legislature this year 
and details the efforts of the Legislature in prior years to address problems with cost and 
access to health care and confidentiality of health information. 
It also provides a statement that the provisions of the amendment are narrowly and 
carefully tailored to address the findings listed in the amendment to achieve the State's 
purposes listed in the amendment and in conjunction with the following efforts to 
advance the State's compelling interests: 
A. Prior authorization and drug utilization review in the MaineCare program under 
the Maine Revised Statutes, Title 22, section 3 1 74-M; 
B. Reporting of a broad array of prescription drug marketing costs under Title 22, 
section 2698-A and subsequent reporting by the Department of Health and Human 
Services to the Legislature and the Attorney General; 
C. Prescription drug price disclosure under Title 22, section 2698-B; 
D. Generic and therapeutically equivalent substitution of prescription drugs under 
Title 32, section 13781; and 
E. 
Protection of patient prescription drug information held by health care 
practitioners under Title 22, section 1711-C; 
5. 
Separates the confidentiality provisions applicable to the patient and the 
prescriber; 
6. Beginning January 1, 2008, states that a carrier, pharmacy or prescription drug 
information intermediary may not license, use, sell, transfer or exchange for value for 
marketing purposes prescriber-identifying prescription drug information of a prescriber 
who has filed for confidentiality protection; 
7. Establishes a mechanism for confidentiality protection through an opt-out 
procedure similar to the federal Do Not Call List utilizing the licensing and relicensing 
process for prescribers. 
The procedures include information for the prescriber and 
methods for filing with the Maine Health Data Organization to protect confidentiality of 
prescriber-identifying information; 
8. Grants rule-making authority to the licensing boards and the Maine Health Data 
Organization, provides them funding through an assessment on manufacturers of 
prescription drugs dispensed through the MaineCare program and elderly low-cost drug 
program and requires a report on confidentiality protection activity within the Maine 
Health Data Organization under the law as part of the organization's annual report to the 
Legislature; 
COMMITTEE AMENDMENT 
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COMMITrEE AMENDMENT "A " 
to H.P. 5, L.D. 4 
9. Provides authority to the Department of Health and Human Services to transfer 
funding to the Maine Health Data Organization and the Department of Professional and 
Financial Regulation to fund their costs for the mechanism to protect the confidentiality 
of prescriber-identifying prescription drug information; and 
10. Adds an appropriations and allocations section. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
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Approved: 06113/07 ;r!?/ar::.. 
LD4 
LR 22(02) 
An Act To Amend the Prescription Privacy Law 
Fiscal Note for Bill as Amended by Committee Amendment ,A " 
Committee: Health and Human Services 
Fiscal Note Required: Yes 
Fiscal Note 
Current biennium revenue increase - Other Special Revenue Funds 
Current biennium cost increase - Other Special Revenue Funds 
Minor cost increase - General Fund 
Minor revenue increase - General Fund 
2007-08 
2008-09 
Projections 
2009-10 
Projecti 
2010-11 
Appropriations/Allocations 
Other Special Revenue Funds 
Correctional and Judicial Impact Statements 
Establishes new civil violations. 
$500 
$500 
The collection of additional fines may also increase General Fund revenue by minor amounts. 
Fiscal Detail and Notes 
$500 
$500 
Provides a base allocation for the Bureau of Medical Services in the Department of Health and Human Services for 
the costs of implementing the provisions of this bill to be funded utilizing existing budget resources including 
available balances of fees and assessments on manufacturers of prescription drugs. 
Assumes additional costs to the Maine Health Data Organization to implement the provisions of this bill will be 
funded through the transfer of funds from an assessment on manufacturers of prescription drugs. 
Assumes additional costs to the Department of Professional and Financial Regulation to implement the provisions of 
this bill will be funded through the transfer of funds from an assessment on manufacturers of prescription drugs. 
LR0022(02) - Fiscal Note - Page I of I