Amendments to a Notice of Determination of Need

(A) Following issuance of a Notice of Determination of Need by the Department, no changes may be made to the project without the issuance of a new Notice of Determination of Need with the exception of an Immaterial Change or approval of a request for a Significant Change. A Significant Change must be within the scope of the Notice of Determination of Need as previously approved and the proposed change must be reasonable. The Holder, prior to implementing any Significant Change, shall submit to the Department a request for approval of the Significant Change that contains a narrative description of the previously approved project and of the proposed Significant Change and associated costs both to the Holder, as well as to the Holder’s Patient Panel. The request shall additionally contain the rationale for such change. Department Staff may request additional information from the Holder. The Holder shall ensure that copies of all submitted information are simultaneously provided to all Parties of Record to the previously approved Notice of Determination of Need. No action shall be taken until such amendment request has been published consistent with 105 CMR 100.405(A) for at least 30 days. A public hearing may be requested by the Department or Parties of Record within 14 days of said information being properly posted. Following such period: (1) For an amendment to a Notice of Determination of Need previously issued by the Commissioner pursuant to 105 CMR 100.630, the Commissioner shall make a determination, consistent with 105 CMR 100.615 or 105 CMR 100.620, within 60 days, or may refer said proposed Significant Change to the Department for further consideration and Final Action; or (2) For an amendment to a Notice of Determination of Need previously issued by the Department, the Department shall make a determination, pursuant to 105 CMR 100.615, 100.620, or 100.640, within 60 days. Final Action by the Department shall conform to the provisions of 105 CMR 100.625. Such Final Actions may include additional terms and Conditions to be attached to the Notice of Determination of Need. All information submitted in relation to the request for Significant Change shall be public, consistent with 105 CMR 100.405(A). (B) Decisions made by the Commissioner pursuant to 105 CMR 100.635(A)(1), (2), and (3) may be reviewed by the Department pursuant to a written request sent to the Department by the Holder, a Party of Record, or a Government Agency within 14 days of the Commissioner's decision, together with a written statement of objection. The Department shall notify the requester of, and at least seven days prior to, the date of the Department's meeting at which the Commissioner's decision will be reviewed. (C) Unless specified by the Department in an Other Condition, the approval of an amendment to a previously issued Notice of Determination of Need shall not result in the extension of the period of authorization.