Current through Register Vol. 54, No. 12, March 23, 2024
(a) The following criteria, and standards
applicable to each criterion, shall be used to review each application for a
certificate of need. A certificate of need shall be recommended, approved and
issued when the application substantially meets the following criteria provided
that each decision, except in circumstances which pose a threat to public
health, shall be consistent with the State Health Plan (SHP):
(1) Whether the relationship of the
application to the applicable Health Systems Plan (HSP) and annual
implementation plan has been considered.
(2) Whether the services are compatible with
the long-range development plan of the applicant.
(3) Whether there is a need by the population
served or to be served by the services or facility. Particular consideration
shall be given to whether the proposed new institutional health service meets
or contributes to the health related needs of members of medically underserved
groups.
(4) Whether there is any
appropriate, less costly or more effective alternative method of providing the
services available.
(5) Whether the
service or facility is economically feasible, considering anticipated volume of
care, the capability of the service or facility and the availability of
reasonable financing.
(6) Whether
the proposed service or facility is financially feasible both on an
intermediate and long term basis, and whether the impact on the cost of and
charges for providing services by the applicant is appropriate.
(7) Whether the proposed service or facility
is compatible with the existing health care system in the area. Consideration
shall be given to efficiency and appropriateness of the existing services and
facilities similar to those proposed.
(8) Whether the service or facility is
justified by community need and within the financial capabilities of the
institution both on an intermediate and long term basis and whether it will
have an inappropriate, adverse impact on the overall cost of providing health
services in the area.
(9) Whether
there are available resources, including health manpower, management personnel
and funds for capital and operating needs to the applicant for the provision of
the services proposed to be provided, and whether there is a greater need for
alternative uses for such resources for the provision of other health services.
The effect on the clinical needs of health professional training programs in
the medical service area, the extent to which health professional schools in
the medical service area will have access to the services for training purposes
and the extent to which the proposed service will be accessible to all the
residents of the area to be served by such services shall also be considered in
determining resources.
(10) Whether
the proposed service or facility will have available to it appropriate
ancillary and support services and an appropriate organizational relationship
to such services.
(11) Whether the
proposed services are consistent with the special needs and circumstances of
those entities which provide services or resources both within and without the
health service area in which the proposed services are to be located, including
medical and other health professional schools, multidisciplinary clinics and
specialty centers.
(12) Whether the
proposed services are not incompatible with any biomedical or behavioral
research projects designed for national need for which local conditions offer
special advantages.
(13)
Consideration of the need and availability in the community for services and
facilities for allopathic and osteopathic physicians and their patients; and
the religious orientation of the facility and the religious needs of the
community to be served. This paragraph is not intended to create duplicative
systems of care.
(14) Whether
competitive factors relating to the supply of the health services being
reviewed have been considered. Particular attention shall be given to the
existence and capacity of market conditions, current or potential, in advancing
the purposes of quality assurance, cost containment, and responsiveness to
consumer preference. Particular attention shall also be given to the existence
and capacity of utilization review programs and other public and private cost
control measures to give effect to consumer preferences and to establish
appropriate incentives for capital allocations.
(15) Whether consideration has been given to
improvements or innovations in the financing and delivery of health services
which would foster competition and serve to promote quality assurance, cost
effectiveness, and responsiveness to consumer preferences.
(16) Whether, in the case of existing
services for facilities, the quality of care provided by services or facilities
in the past have been considered.
(17) Whether the special circumstances of
applications with respect to the need for conserving energy have been
considered.
(d) If the application
is for a proposed service or facility which includes a construction project, a
certificate of need shall be recommended, approved, and issued when the
provisions of subsection (a) are satisfied and the following occur:
(1) The costs and methods of the proposed
construction including the costs and methods of providing energy are
appropriate.
(2) The impact of the
costs of providing health services by the applicant resulting from the
construction is found to be appropriate and the impact on the costs and charges
to the public of providing health services by other persons is found to be not
inappropriate.
(e)
Whenever new institutional health services for inpatients are proposed, a
finding will be made in writing by the Department:
(1) That the capital and operating costs,
efficiency and appropriateness of the proposed new service and its potential
impact on patient charges has been considered.
(2) That less costly alternatives which are
more efficient and more appropriate to the inpatient service are not available
and the development of the alternatives has been studied and found not
practicable.
(3) That existing
inpatient facilities providing inpatient services similar to those proposed are
being used in an appropriate and efficient manner.
(4) That in the case of new construction,
alternatives to new construction such as modernization or sharing arrangements
have been considered and have been implemented to the maximum extent
practicable.
(5) That patients will
experience serious problems in terms of cost, availability, accessibility or
such other problems as may be identified in the applicable HSP or SHP in
obtaining inpatient care of the type proposed if the proposed new services is
not approved.
(f) With
respect to any application regarding the offering, developing, constructing, or
otherwise establishing of a health maintenance organization, all of the
criteria applicable in subsection (a) shall apply unless the proposed entity is
found to meet the requirements for exemption contained in
42 U.S.C.A. §
300m-6(a)(5) and
(b)(1) and regulations adopted
thereto.
(g) Notwithstanding
subsections (a), (d) and (e), the following types of applications for
certificates of need shall be approved unless the Department finds that the
project in question is not needed or that it is not consistent with the SHP.
Applications described in the following paragraphs will be approved only to the
extent necessary to remedy the deficiencies they address:
(1) Application for a project which is
necessary to eliminate or prevent imminent safety hazards as defined by the
Life Safety Code or other appropriate codes or regulations.
(2) Application for a project which is
necessary to comply with State licensure standards.
(3) Application for a project which is
necessary to comply with accreditation standards, compliance with which is
required to receive reimbursement or payments under Title XVIII or XIX of the
Social Security Act (42
U.S.C.A. §§
300v-300y-11).
The provisions of this §
401.4 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)).
This section cited in 28 Pa. Code §
401.5 (relating to Certificate of
Need); and 28 Pa. Code §
401.7 (relating to simultaneous
and comparative review).
