Section 12.09 - Determination of Unreasonable or Excessive Pricing(1) At least 30 days prior to any determination by the Commission that the Referred Manufacturer's pricing of the Drug is unreasonable or excessive, the Commission, through the Executive Director: (a) shall provide notice to the Referred Manufacturer that Commission has determined pursuant to 958 CMR 12.08 that Referred Manufacturer's pricing of the Drug is potentially unreasonable or excessive in relation to the value of the Drug as identified by the Commission and that the Commission intends to continue its review;(b) shall provide to the Referred Manufacturer a copy of information, analyses or reports reviewed or used in identifying the proposed value of the Drug, and, to the extent that the Commission engages with a third-party to provide cost-effectiveness analysis or research related to the proposed value of the Drug, such information shall include:1. a description of the methodologies and models used in such analysis;2. any assumptions and potential limitations of research findings in the context of the results; and3. any outcomes for affected subpopulations that utilize the Drug, if applicable;(c) shall request that the Referred Manufacturer provide further information about the pricing of the Drug, including a justification for its pricing of the Drug, and any response to the information, analyses or reports provided pursuant to 958 CMR 12.09(l)(b);(d) shall request information from other interested stakeholders, which may include, but not be limited to, patients, providers, provider organizations, clinical experts, and payers; and(e) may conduct a public hearing pursuant to 958 CMR 12.09.(2) The Referred Manufacturer must file such requested information, accompanied by the signed Attestation Form, within 30 days of receipt of the request described in 958 CMR 12.09(l)(c) or such other timeframe as may be agreed upon, in writing, between the Referred Manufacturer and the Commission, through the Executive Director.(3) Not later than 60 days after receiving completed information from the Referred Manufacturer under 958 CMR 12.09(2), the Commission, by a vote of the Board, shall issue a determination on whether the Referred Manufacturer's pricing of a Drug is unreasonable or excessive in relation to the Commission's proposed value of the Drug and shall notify the Referred Manufacturer.(4) Following a determination that the Referred Manufacturer's pricing of a Drug is unreasonable or excessive pursuant to 958 CMR 12.09(3), the Commission shall post a notice on its website stating the name of the Referred Manufacturer and the Drug reviewed, the Commission's proposed value for the Drug and that the Referred Manufacturer's pricing of a Drug is unreasonable or excessive in relation to the Commission's proposed value of the Drug.Adopted by Mass Register Issue 1412, eff. 3/6/2020.