CHAPTER 402
S.P. 536 - L.D. 1541
Emergency preamble. Whereas, acts of the Legislature do not become effective until 90 days after adjournment unless enacted as emergencies; and
Whereas, the 121st Legislature in the Second Special Session enacted legislation requiring pharmaceutical manufacturers to report certain pricing information to the Department of Health and Human Services; and
Whereas, certain provisions of those reporting requirements require clarification or are duplicative of data otherwise available to the department; and
Whereas, clarification of those provisions is necessary in order to amend the law as close as possible in time to the first reporting date; and
Whereas, the reportable information constitutes trade secrets, and the existing confidentiality protection afforded to the reported information is not adequate; and
Whereas, in the judgment of the Legislature, these facts create an emergency within the meaning of the Constitution of Maine and require the following legislation as immediately necessary for the preservation of the public peace, health and safety; now, therefore,
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 22 MRSA §2698-B, sub-§1, as enacted by PL 2003, c. 667, §1 and affected by §2, is amended to read:
1. Quarterly report. A manufacturer of prescription drugs dispensed in this State under a health program directed or administered by the State shall, on a quarterly basis, report by National Drug Code the following pharmaceutical pricing criteria to the commissioner for each of its drugs:
A. The average wholesale price;
B. The wholesale acquisition cost;
C. The average manufacturer price as defined in 42 United States Code, Section 1396r-8(k); and
D. The best price as defined in Section 1927 of the Social Security Act, 42 United States Code, Section 1396r-8(c)(1)(C) as in effect on January 1, 2005.
The pricing information required under this subsection is for drugs defined under the Medicaid drug rebate program.
Sec. 2. 22 MRSA §2698-B, sub-§2, as enacted by PL 2003, c. 667, §1 and affected by §2, is repealed.
Sec. 3. 22 MRSA §2698-B, sub-§§3, 4 and 5, as enacted by PL 2003, c. 667, §1 and affected by §2, are amended to read:
3. Description of methodology. When reporting the average wholesale price, wholesale acquisition cost, average manufacturer price and best price, a manufacturer of prescription drugs dispensed in this State shall also include a detailed description of the methodologies by which the prices were calculated summary of its methodology. The department may accept the standards of the national drug rebate agreement entered into by the federal Department of Health and Human Services and Section 1927 of the Social Security Act, 42 United States Code, Section 1396r-8(c)(1)(C) for reporting pricing methodology or may adopt its own standards by rule.
4. Certification. When a manufacturer of prescription drugs dispensed in this State reports the average wholesale price, wholesale acquisition cost, average manufacturer price or best price, the president or chief executive officer or chief officer of the manufacturer or an employee of the manufacturer in a position that reports directly to the chief executive officer or chief financial officer who has been delegated authority to sign shall certify to the department, on a form provided by the commissioner, that the reported prices are accurate as of the date they are submitted.
5. Confidentiality. Except as provided in this subsection, all information provided to the commissioner by a manufacturer of prescription drugs under this section is confidential and may not be disclosed by any person or by the department to any person without the consent of the manufacturer. Disclosure may be made by the department to an entity providing services to the department under this section and such a disclosure does not change the confidential status of the information. The information may be used by the entity only for the work that is authorized or approved by the department. Disclosure may be ordered by a court for good cause shown or made in a court filing under seal unless or until otherwise ordered by a court. Nothing in this subsection limits the Attorney General's use of civil investigative demand authority under the Maine Unfair Trade Practices Act to investigate violations of this section.
Sec. 4. 22 MRSA §2698-B, sub-§8 is enacted to read:
8. Rulemaking. The department may adopt rules to implement this section. Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A.
Emergency clause. In view of the emergency cited in the preamble, this Act takes effect when approved.
Effective June 17, 2005.
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