105 CMR 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.