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:
Sec. 2. 22 MRSA §8702, sub-§12 is enacted to read:
Sec. 3. 22 MRSA §8703, sub-§1, as amended by PL 2003, c. 469, Pt. C, §22, is further amended to read:
Sec. 4. 22 MRSA §8704, sub-§1, ¶A, 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, financial, quality and , 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
(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:
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
|OTHER SPECIAL REVENUE FUNDS TOTAL
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.
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 financial 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 fine 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.
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