N.J. Admin. Code § 13:45K-1.4

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:45K-1.4 - Manufacturer reporting

(a) A manufacturer shall notify the Division of price increases pursuant to N.J.S.A. 45:14-82.3.a within 10 days. Within 20 days of the price increase, the manufacturer shall report data required at N.J.S.A. 45:14-82.3.c and any other data requested by the Division to make clear the major components of prescription drug pricing along the supply chain and the impacts on insurance premiums and consumer cost sharing pursuant to the Data Collection Manual.

(b) A manufacturer shall notify the Division of the introduction of a new drug or biosimilar pursuant to N.J.S.A. 45:14-82.3.b within 10 days. Within 20 days of the market introduction, the manufacturer shall report data required at N.J.S.A. 45:14-82.3.d and any other data requested by the Division to make clear the major components of prescription drug pricing along the supply chain and the impacts on insurance premiums and consumer cost sharing pursuant to the Data Collection Manual.

(c) If a manufacturer required to report data to the Division pursuant to N.J.S.A. 45:14-82.3.c or d does not have access to State-specific data and has no way of obtaining it, the manufacturer shall:

1. Certify and provide proof satisfactory to the Division that it does not have access to State-specific data and has no way of obtaining it; and

2. Report national data to the Division within 20 days of a price increase or introduction of a new drug or biosimilar that requires notification to the Division pursuant to N.J.S.A. 45:14-82.3.a or b.

(d) A manufacturer shall certify the reporting pursuant to this section as accurate and complete under penalty of perjury, including reporting on its behalf by subsidiaries, employees, contractors, or any third parties.

N.J. Admin. Code § 13:45K-1.4

Adopted by 56 N.J.R. 2246(a), effective 10/15/2024