Current through Register 1527, August 2, 2024
Section 100.360 - Other Conditions(A) In addition to all applicable Standard Conditions attached to a Notice of Determination of Need, the Department may prescribe any Other Conditions that are reasonably related to the scope of the project and that are consistent with the objectives of 105 CMR 100.000.(B) A Notice of Determination of Need issued to a Holder resulting from an Application that includes DoN Required Service or DoN Required Equipment pursuant to 105 CMR 100.715(B)(1) shall be subject to the following Other Conditions: (1) In no event shall the Holder refer or influence any referral of patients to DoN-required Services or DoN-required Equipment, unless the Holder is a Registered Individual Practitioner as defined in 105 CMR 700.001: Definitions providing said services or utilizing said equipment. Public advertisement shall not be deemed a referral or influence of referrals.(2) Any Person with an ownership interest in DoN-required Services or DoN-required Equipment, whether direct or indirect, shall disclose said interest to any patients utilizing said services or equipment in a conspicuous manner.(3) The Holder shall submit annually to the Department information and data in connection with utilization and volume rates of DoN-required Services or DoN-required Equipment in a form and manner as specified by the Commissioner.(C) A Notice of Determination of Need issued to a Holder resulting from an Application that includes Ambulatory Surgery pursuant to 105 CMR 100.715(B)(2) shall certify that the Freestanding Ambulatory Surgery Center will be certified pursuant to 42 CFR Part 416 and will remain in substantial compliance therein.(D) A Notice of Determination of Need issued to a Holder resulting from an Application required pursuant to 105 CMR 100.735 shall include the following Other Conditions: (1) Unless rescinded pursuant to 105 CMR 100.360(D)(3), any Notice of Determination of Need for a Transfer of Ownership pursuant to 105 CMR 100.735, which is issued to a Holder and that is subject to a Cost and Market Impact Review pursuant to M.G.L. c. 6D, § 13 and 958 CMR 7.00: Notices of Material Change and Cost and Market Impact Reviews shall not go into effect until 30 days following HPC's completed Cost and Market Impact Review. Unless extended for Good Cause Related to Project Implementation, or as a result of an approved amendment to a previously issued Notice of Determination of Need, the Notice of Determination of Need shall constitute a valid authorization for a period of not more than three years following the approval of the Department, unless otherwise expressly noted as an Other Condition, and shall only be for the purposes of the approved project. No Notice of Determination of Need shall remain in authorization unless the Holder complies with all prescribed terms and Conditions as set forth by the Department.(2) The Department shall receive within 30 days of issuance of the written notification made pursuant to 105 CMR 100.625(A) a written acknowledgment of receipt of such written notification by the Holder, documented in the form of an attestation, signed by the Holder's chief executive officer and board chair, and returned to the Department and all Parties of Record.(3) Notwithstanding 105 CMR 100.360(D)(1), as part of a completed Cost and Market Impact Review, the HPC may provide a written recommendation to the Commissioner that the Notice of Determination of Need should not go into effect on the basis of findings contained within the completed and publicly released Cost and Market Impact Review. Upon receipt, the Commissioner shall determine if the Cost and Market Impact Review contains information sufficient for the Commissioner to conclude that the Holder would fail to meet one or more of the specified Factors. Should the Commissioner determine that the Holder would fail to meet one or more of the specified Factors, he or she shall refer the matter to the Department. The Department may rescind or amend an approved Notice of Determination of Need based upon information in the Cost and Market Impact Review as it relates to compliance with the Determination of Need Factors. If a Notice of Determination of Need is rescinded by the Department and a new Application is filed, such Application must satisfy 105 CMR 100.210 and shall account for the concerns expressed by the Department within their findings.(E)(1) A Notice of Determination of Need for Substantial Capital Expenditure or Substantial Change in Service issued to a Holder resulting from an Application proposed on behalf of a Long-term Care Facility made pursuant to 105 CMR 100.715 that is not deemed a Conservation Project by the Department shall contribute an amount equal to 3% of the total Capital Expenditure of the approved project in accordance with the Department Guideline.(2) A Notice of Determination of Need issued to a Holder resulting from an Application for a Conservation Project proposed on behalf of a Health Care Facility other than a Long-term Care Facility made pursuant to 105 CMR 100.715 shall contribute an amount equal to 2.5% of the total Capital Expenditure of the approved project in accordance with the Department Guideline.(3) A Notice of Determination of Need for Substantial Capital Expenditure or Substantial Change in Service issued to a Holder resulting from an Application for a Conservation Project proposed on behalf of a Long-term Care Facility made pursuant to 105 CMR 100.715 shall contribute an amount equal to 1% of the total Capital Expenditure of the approved project in accordance with the Department Guideline.(F) If it is determined by the Department that the Holder of a Notice of Determination of Need for Transfer of Ownership pursuant to 105 CMR 100.735, has failed to sufficiently demonstrate compliance with the terms and Conditions of the issued Notice of Determination of Need, the Holder shall fund projects which address one or more of the Health Priorities set out in Department Guideline, as approved by the Department, which in total, shall equal up to 5% of the Total Value of the approved project. In making such determination, the Department shall provide written notification to the Holder at least 30 days prior to requiring such funding, and shall provide the Holder the opportunity to appear before the Department. The Department shall consider factors external to the Holder that may impact the Holder's ability to demonstrate compliance.Adopted by Mass Register Issue S1331, eff. 1/27/2017.Amended by Mass Register Issue 1381, eff. 12/28/2018.