22 §2698-B. Actual price disclosure and certification
Title 22: HEALTH AND WELFARE
Subtitle 2: HEALTH
Part 5: FOODS AND DRUGS
Chapter 603: PRESCRIPTION DRUG ACCESS HEADING: PL 1999, C. 786, PT. A, §3 (NEW)
Subchapter 3: PROFITEERING IN PRESCRIPTION DRUGS HEADING: PL 1999, C. 786, PT. A, §3 (NEW)
§2698-B. Actual price disclosure and certification
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. [2005, c. 402, §1 (RP).]
B. [2005, c. 402, §1 (RP).]
C. The average manufacturer price as defined in 42 United States Code, Section 1396r-8(k); and [2003, c. 667, §1 (NEW); 2003, c. 667, §2 (AFF).]
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. [2005, c. 402, §1 (AMD).]
The pricing information required under this subsection is for drugs defined under the Medicaid drug rebate program.
[ 2005, c. 402, §1 (AMD) .]
2. Calculation.
[ 2005, c. 402, §2 (RP) .]
3. Description of methodology. When reporting the average manufacturer price and best price, a manufacturer of prescription drugs dispensed in this State shall also include a 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.
[ 2005, c. 402, §3 (AMD) .]
4. Certification. When a manufacturer of prescription drugs dispensed in this State reports the average manufacturer price or best price, the 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.
[ 2005, c. 402, §3 (AMD) .]
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.
[ 2005, c. 402, §3 (AMD) .]
6. Violation. A violation of this section is a violation of Title 5, section 207 and must be enforced by the Attorney General pursuant to Title 5, section 209.
[ 2003, c. 667, §1 (NEW); 2003, c. 667, §2 (AFF) .]
7. Funding restriction. The department's costs for implementing this section must be met through the use of money that the Attorney General has acquired as a result of consumer protection litigation involving pharmaceutical pricing or practices. General Fund funding may not be used for the purposes of this section.
[ 2003, c. 667, §1 (NEW); 2003, c. 667, §2 (AFF) .]
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.
[ 2005, c. 402, §4 (NEW) .]
SECTION HISTORY
2003, c. 667, §1 (NEW). 2003, c. 667, §2 (AFF). 2005, c. 402, §§1-4 (AMD).