Chapter 460
H.P. 5 - L.D. 4
An Act To Amend the Prescription Privacy Law
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 22 MRSA §1711-E, as enacted by PL 2005, c. 589, §1, is amended to read:
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-1. "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 to , carriers and administrators and agents and contractors of those carriers and agents 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 1711-C, subsection 1, paragraph D.
D. "Health care practitioner" has the same meanings as in section 1711-C, subsection 1, 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-1.
"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-1. "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.
1-A. Findings.
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 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 will 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-B and to advance the State's compelling interests.
1-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.
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 1-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 except if expressly permitted under section 1711-C, Title 24, Title 24-A or the federal Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended.
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 section 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 1, 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:
(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
(c) 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 1st 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. Eighty percent of the fees collected under this paragraph must be deposited in a separate account that does not lapse at the end of the fiscal year and must be used to cover the costs of the Maine Health Data Organization pursuant to paragraph A and section 8713. Twenty percent of the assessments must be retained by the department.
5. 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 1711-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-A 2-A.
Sec. 3. 22 MRSA §8704, sub-§7, as amended by PL 2005, c. 565, §5, is further amended to read:
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:
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. Appropriations and allocations. The following appropriations and allocations are made.
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 |
2007-08 |
2008-09 |
|
All Other
|
$500 |
$500 |
|
 |
|
| OTHER SPECIAL REVENUE FUNDS TOTAL |
$500 |
$500 |
Effective September 20, 2007