Current through Register Vol. 54, No. 12, March 23, 2024
(a)
Statewide goals.
(1) Sufficient ambulatory surgery capacity
shall be available and accessible in this Commonwealth to meet local community
needs.
(2) Ambulatory surgery shall
be promoted throughout this Commonwealth whenever it represents a cost
effective alternative to inpatient surgery.
(3) Until 50% of total surgical procedures in
an HSA region-or whatever alternative percentage is consistent with local
health systems plans adopted by the Health Systems Agency and approved by the
Statewide Health Coordinating Council are performed on an ambulatory basis, as
indicated hereafter, no application for CDN approval of an ambulatory surgical
facility or service shall be considered by the Department as in appropriately
increasing total community health care costs, provided the project represents
the least costly and most effective method of providing services and meets the
guidelines set forth in this section.
(b)
Definitions. The
following words and terms, when used in this section, have the following
meanings, unless the context clearly indicates otherwise:
(1)
Ambulatory surgical
facility-A facility not located upon the premises of a hospital which
provides outpatient surgical treatment. The term does not include individual or
group practice offices or private physicians or dentists, unless the offices
have a distinct part used solely for outpatient surgical treatment on a regular
and organized basis. See §
401.2 (relating to definitions).
(2) Ambulatory surgical service-The provision of outpatient
surgical treatment in a health care facility. (3) Independent
ambulatory surgical facility-An ambulatory surgical facility whose
majority or controlling interest is not owned or controlled by a hospital,
group of hospitals or by corporations owning or controlling hospitals. A
hospital or a corporation owning or controlling a hospital desiring to
establish an ambulatory surgical facility well outside its current service area
shall be considered an independent ambulatory surgical facility for review
purposes in the new service area. (4) Outpatient surgical
treatment-Surgical treatment to patients who do not require
hospitalization, but who require constant medical supervision following the
surgical procedure performed. See § 401.2.
(c)
Community need-general.
(1) The need for an increase in ambulatory
surgical services exists if less than 50% of total surgical procedures in an
HSA region or whatever alternative percentage is consistent with local health
systems plans are performed on an ambulatory basis. The volume of surgical
procedures performed in a physician's office-that is, not a health care
facility-shall be excluded.
(2)
Additional capacity for ambulatory surgery is needed if each HSA and the
Department determine that existing providers of surgery in subregional markets
are not making a good faith effort to perform 50% of total surgeries, or
whatever alternative percentage is consistent with local health systems plans,
on an ambulatory basis.
(3) Once
the 50% ambulatory surgical target is met, no additional ambulatory surgery
proposals will be considered needed except those which:
(i) Are generated by a facility at full
capacity and with a need to expand in order to meet demand.
(ii) Seek to serve underserved
populations.
(iii) Are necessary to
provide new technology/procedures.
(4) The review of individual ambulatory
surgical projects will be based upon a comparative analysis. Comparative
analysis of competing proposals will be based upon the criteria for review of
CON applications as set forth in the act and this title.
(5) In the interest of fair competition,
equal consideration will be given to the following:
(i) Hospitals with no current excess
capacity, that is, current operating rooms are utilized for both inpatient and
outpatient surgery more than 80% of the time based upon 8 hours per day, 5 days
per week.
(ii) Hospitals with
excess capacity, but willing to reduce capacity by closing at least one
existing operating room for every new ambulatory surgical operating room
approved. The closure shall be considered a part of the CON application, and an
increase in operating rooms after the implementation of the project shall be
considered a change in the scope of the project, and is, therefore subject to
CON review.
(iii) Independent
freestanding ambulatory surgical facilities.
(6) Hospitals with current excess operating
room capacity unwilling to commit to a reduction in inpatient operating rooms
will be reviewed on their own merits, but will be given lesser priority than
those proposals listed in this section.
(7) Optional preferences-the Department will
give additional priority to applications meeting one or more of subparagraphs
(i)-(iv). Subparagraphs (i) and (ii) will be used to establish priorities among
hospital sponsored or related projects only. The terms shall be considered a
part of the CON application and a change shall be considered reviewable.
(i) A proposal which reduces current
inpatient operating room capacity by a greater amount than the number of new
surgical operating rooms requested.
(ii) A proposal which, in addition to
reducing operating rooms, reduces setup and staffed inpatient acute care
beds.
(iii) A proposal in which an
applicant is willing to guarantee its charges by procedure for at least a
2-year period following initial operation of the approved project. In order to
qualify for this preference, the applicant shall include within its
application, evidence of binding contractual relationships with major
third-party payors guaranteeing charges for the required 2-year
period.
(iv) A proposal in which
the applicant agrees not to change ownership any sooner than 2 years after the
project becomes operational. The ability and expertise of an owner is a
critical factor in the issuance of a CON for the development of an ambulatory
surgical facility. Thus, all applicants given preference under this
subparagraph should be advised that changes in ownership would be considered a
substantial change and therefore may be subject to CON review.
(d)
Economic and
financial feasibility.
(1) Proposals
to increase ambulatory surgical capacity shall be financially feasible,
considering the anticipated volume of care, the reasonableness of service
changes and the availability of appropriate financing.
(2) Careful consideration should be given to
each project's allocation of costs between a parent corporation and a proposed
ambulatory surgical facility to ensure that there is no hidden or unfair
subsidization by the parent corporation to make the project appear less costly
than it may actually be.
(e)
Quality of care. Each
ambulatory surgery project shall meet the licensure requirements of this
title.
(f)
Access to
care. Each ambulatory surgery project shall demonstrate in its
application a commitment to serve a fair share of medically underserved
patients in its community.
(g)
Project review. Projects for ambulatory surgical services and
facilities shall be reviewed on a batching basis. The effective date for
implementation of batching will be the date on which the Department publishes a
notice of proposed rulemaking in the Pennsylvania Bulletin on
batching.
(h)
Research and
data. The Department and the HSAs will collect current information on
ambulatory surgical utilization and costs. The Department will require each
applicant to report on a timely basis to the Department and the HSAs
information on utilization and charges that the Department determines necessary
to assure the provisions of this section are implemented.