Current through Register 1531, September 27, 2024
(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(1) Unless rescinded pursuant to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.
