Section 100.726 - Exemptions for Certain Substantial Capital Expenditures and Substantial Changes in Service(A) No Notice of Determination of Need shall be required for any Substantial Capital Expenditure or any Substantial Change in Service that is solely related to the conduct of basic biomedical research or applied medical research. However, Entities making a Substantial Capital Expenditure or Substantial Changes in Service pursuant to 105 CMR 100.715 shall notify the Department, in the form and manner as specified by the Commissioner, at least 60 days prior to undertaking such an expenditure or change in service. Such Provider Organizations shall be required to report information concerning said research project(s) to the Department, in the form, manner, and frequency as reasonably requested by the Commissioner.(B) Notice of Determination of Need shall be required for any Substantial Capital Expenditure or any Substantial Change in Service that is solely related to the conduct of basic biomedical research or applied medical research if it results in any of the following: (1) Any increase in the number of clinical beds or outpatient capacity of a Health Care Facility;(2) Any increase in the gross patient service revenue of a Health Care Facility;(3) Determination by the Commissioner that the Health Care Facility notification pursuant to 105 CMR 100.715 does not constitute an expenditure or change in service that is solely related to the conduct of basic biomedical research or applied medical research; or,(4) Failure by a Health Care Facility to comply with the notification requirement outlined within 105 CMR 100.726(A).(C) No Notice of Determination of Need shall be required for any Substantial Capital Expenditure or any Substantial Change in Service at a Federally Qualified Community Health Center.Adopted by Mass Register Issue 1381, eff. 12/28/2018.