Current through Register Vol. 54, No. 12, March 23, 2024
(a) No person shall offer, develop, construct
or otherwise establish or undertake to establish within the State a new
institutional health service without first obtaining a certificate of need from
the Department.
(b) A new
institutional health service shall mean the following:
(1) The construction, development or other
establishment of a health care facility or health maintenance
organization.
(2) An expenditure by
or on behalf of a health care facility or Health Maintenance Organization (HMO)
in excess of the minimum capital expenditure threshold established by Federal
law or regulation which, under generally accepted accounting principles,
consistently applied is a capital expenditure. For the purpose of this
subsection, any expenditure which is not properly chargeable under generally
accepted accounting principles as an expense of operation and maintenance shall
be deemed a capital expenditure. An acquisition of a building, property, or
equipment by or on behalf of a health care facility or a HMO under lease or
comparable arrangement, or through donation, which would have required review
if the acquisition had been by purchase, shall be deemed a capital expenditure
subject to review.
(3) An
expenditure by or on behalf of a health care facility or a health maintenance
organization in excess of the minimum capital expenditure threshold established
by Federal law or regulation made in preparation for the offering or
development of a new institutional health service and any binding arrangement
or commitment by either of them for financing the offering or development of
the new institutional health service.
(4) Expenditures for the acquisition of an
existing health care facility or health maintenance organization shall not be
subject to review if notice has been provided to the Department under
subsection (c), and the Department finds within 30 days of receipt of the
notice that the services or bed capacity of the facility to be acquired will
not be changed in being acquired within 1 year from the date of the change of
ownership. This does not prohibit facilities from increasing, redistributing,
or relocating beds by 10 beds or 10%, whichever is less, of the bed capacity as
allowed by paragraph (6).
(5) The
acquisition of major medical equipment not owned by or located in a health care
facility if the equipment will be used to provide service for inpatients of a
health care facility, or if notice has not been provided to the Department
under subsection (c).
(6) The
obligation of any capital expenditure by or on behalf of a health care facility
which results in the addition of a health service not provided in or through
the facility in the previous 12 months or which increases the total number of
beds, or redistributes beds among various categories other than levels of care
in a nursing home, or relocates such beds from one physical facility or site to
another, by more than 10 beds or 10% of total bed capacity, whichever is less,
over a 2-year period. For purposes of this paragraph, categories of beds in a
hospital are those categories of beds established and defined in the
instructions and definitions of the Department's Annual Hospital Questionnaire.
Although dialysis stations are not defined as beds in the annual hospital
questionnaire, facilities with dialysis stations may increase the number of
stations in accordance with this subsection, except that the 10 beds or 10%
rule will apply to the number of dialysis stations only. The total bed capacity
of the hospital if the dialysis unit is located in a hospital, is separate and
distinct from dialysis stations. The 2-year periods shall begin on the date of
licensure. Increases not added during a 2-year period cannot be accumulated and
carried over to another period, nor will a change in ownership allow increases
of more than 10 beds or 10% of total capacity in a 2-year period.
(7) The addition of a health service which is
offered in or through a health care facility having an annual operating expense
in excess of the minimum operating expense threshold established by Federal law
or regulation and which was not offered on a regular basis in or through the
health care facility within the 12-month period prior to the time such services
would be offered. A health service shall be considered to be offered by or
through a health care facility or a health maintenance organization if the
service is offered or made available on a regular basis to inpatients or
outpatients of a health care facility.
(c) Before any person enters into a
contractual arrangement to acquire major medical equipment which will not be
owned by or located in health care facility or before any person acquires an
existing health care facility, the person shall notify the Department of his
intent to acquire such equipment or existing health care facility.
(1) The notice shall be in writing and shall
be made at least 30 days before contractual arrangements are entered into to
acquire the major medical equipment or the existing health care
facility.
(2) In the case of the
intended acquisition of major medical equipment, the notice shall contain
information regarding the use that will be made of the equipment. In the case
of the intended acquisition of an existing health care facility, the notice
shall contain information with regard to the services to be offered in the
facility and its bed capacity.
(3)
Within 30 days after the receipt of the notice, the Department will inform the
person providing the notice whether or not the proposed acquisition of either
the major medical equipment or the existing health care facility is a new
institutional health service. If the Department determines that the acquisition
will be a new institutional health service, the acquisition shall be subject to
this chapter.
(4) A decision of the
Department that an acquisition requires a certificate of need may be appealed
to the Hearing Board.
The provisions of this §
401.3 issued under section 2102(a)
and (g) of The Administrative Code of 1929 (71 P. S. §
532(a) and (g)); and section
201(14) of the Health Care Facilities Act (35 P. S. §
448.201(14)).