Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part IV - Health Facilities › Subpart D - Health Planning › Chapter 401 - CERTIFICATE OF NEED PROGRAM › Section 401.2 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
The following words or terms, when used in this chapter,
					 have the following meanings, unless the context clearly indicates
					 otherwise:
Act
-The Health Care Facilities Act
					 (35
					 P. S. §§
											448.101-448.904).
Administrative review
-An expedited review
					 conducted solely by the Department.
Affected person
-A person whose proposal
					 is being reviewed for purposes of certificate of need, the health systems
					 agency for the health service area in which the proposed new institutional
					 health service is to be offered or developed, health systems agencies serving
					 contiguous health service areas, health care facilities and health maintenance
					 organizations located in the health service area which provide institutional
					 health services, and those members of the public who are to be served by the
					 proposed new institutional health services and those agencies, if any, which
					 establish rates for health care facilities and health maintenance organizations
					 located in the health systems area in which the proposed new institutional
					 health service is to be offered or developed.
Ambulatory surgical facility
-A facility
					 not located upon the premises of a hospital which provides outpatient surgery
					 to patients who do not require overnight hospitalization but who do require
					 medical supervision following the procedure. An ambulatory surgical facility
					 does not include individual or group practice offices of private physicians or
					 dentists, unless such offices have a distinct part used solely for outpatient
					 surgical treatment on a regular and organized basis.
Annual implementation plan
-The latest
					 annual statement of objectives of the health systems agency to achieve the
					 goals of the health systems plan, including the priorities established among
					 the objectives.
Association with
-Acting as a director,
					 officer or employe of an organization at the present time or within the last 12
					 months.
Bed capacity
-The total number of licensed
					 or approved beds which are set up and staffed and licensed or approved beds
					 which are out of service. Out of service beds include the following:
(i) Beds which are set up but not staffed due
				  to seasonal fluctuations in demand or construction or renovation of the
				  facility.
(ii) Beds which are not
				  being utilized because of the conversion of a multibed room to a single bed
				  room.
Business days
-Days when the Department is
					 open and staffed for regular business.
Certificate of Need
-A certificate issued
					 by the Department under this chapter, including those issued as an amendment to
					 an existing Certificate of Need.
Council
-The Statewide Health Coordinating
					 Council established under the National Health Planning and Resources
					 Development Act of 1974 (42
					 U.S.C.A. §§
											300k-300n-6).
Department
-The Department of Health of
					 the Commonwealth.
Develop
-When used in connection with
					 health services or facilities, means to undertake those activities which on
					 their completion will result in the offering of a new health service or the
					 incurring of a financial obligation in relation to the offering of such a
					 service.
Health care facility
-General or special
					 hospitals, including tuberculosis and psychiatric hospitals, rehabilitation
					 facilities, skilled nursing facilities, intermediate care facilities, kidney
					 disease treatment centers including free-standing dialysis units and ambulatory
					 surgical facilities. The term includes both profit and nonprofit facilities
					 including those operated by an agency of State or local government. Health care
					 facilities does not include the following:
(i) An office used exclusively for a private
				  or group practice by physicians or dentists does not constitute a health care
				  facility unless the office is located within a health care facility or the
				  services of the practice are offered by or through a health care
				  facility.
(ii) A program which
				  renders treatment or care for drug or alcohol abuse or dependence does not
				  constitute a health care facility unless the office is located within a health
				  care facility or the service is offered in, by or through a health care
				  facility.
(iii) A facility
				  providing treatment solely on the basis of prayer or spiritual means in
				  accordance with the tenets of a religious denomination or church does not
				  constitute a health facility.
(iv)
				  A facility providing health care services exclusively to persons in a religious
				  profession who are members of the religious denomination or church which
				  operate the facility does not constitute a health care facility.
(v) A freestanding home health care agency.
Health maintenance organization (HMO)
-An
					 organization defined as a health maintenance organization by
					 42 U.S.C.A. §
											300n(8) or by the Health
					 Maintenance Organization Act (40 P. S. §§
											1551-1567).
Health service area
-The area served by a
					 health systems agency designated under the National Health Planning and
					 Resources Development Act of 1974 (42 U.S.C.A. §§
											300k-300n-6).
Health services
-Clinically related, that
					 is, diagnostic, treatment or rehabilitative services, including alcohol, drug
					 abuse and mental health services.
Health Systems Agency (HSA)
-An entity
					 which has been conditionally or fully designated under the National Health
					 Planning and Resources Development Act of 1974 (42 U.S.C.A. §§
											300k-300n-6).
Health Systems Plan (HSP)
-The latest HSA
					 Board approved statement of health service area goals and strategies for
					 achieving the goals.
Hearing Board
-The State Health Facility
					 Hearing Board created in the Office of General Counsel under the provisions of
					 the act.
HHS
-The United States Department of
					 Health and Human Services.
Home health care
-The provision of nursing
					 and other therapeutic services to disabled, injured or sick persons in their
					 place of residence and other health related services provided to protect and
					 maintain persons in their own home.
Hospital
-An institution licensed or
					 approved by the Department as a hospital.
Intermediate care facility
-A facility or
					 part of a facility in which professionally supervised nursing care and related
					 medical or other health services are provided for a period exceeding 24 hours
					 for two or more individuals who do not require the degree of care and treatment
					 which a hospital or skilled nursing facility is designed to provide, but who
					 because of age, illness, disease, injury, convalescence or mental or physical
					 infirmity, need medical or other health services. Intermediate care facilities
					 exclusively for mentally retarded persons are considered intermediate care
					 facilities for the purpose of the act.
Kidney disease treatment facility
-A
					 facility, including a free-standing dialysis unit, providing treatment to
					 persons with end-stage renal or other kidney disease. For purposes of the act,
					 dialysis stations will be treated as licensed/approved beds.
Major medical equipment
-edical equipment
					 which is used for the provision of medical and other health services and which
					 costs in excess of the minimum expenditure threshold for major medical
					 equipment established by Federal statute or regulations except major medical
					 equipment acquired by or on behalf of a clinical laboratory to provide clinical
					 laboratory services if the clinical laboratory is independent of a physician's
					 office and a hospital and it has been determined under the Medicare program to
					 meet the applicable requirements of the Social Security Act (42 U.S.C.A. §§
											300v-300y-11). In determining
					 whether medical equipment has a value in excess of the threshold, the value of
					 studies, surveys, designs, plans, working drawings, specifications and other
					 activities essential to the acquisition of the equipment shall be
					 included.
National Health Planning and Resources Development
					 Act of 1974
- 42
					 U.S.C.A. §§
											300k-300n-6.
Nonsubstantive review
-A review which is
					 less comprehensive than a full review but maintains all statutory procedures
					 including third party rights, and an HSA recommendation. Projects may receive a
					 nonsubstantive review as determined by the Department after consultation with
					 the HSA. Projects eligible for a nonsubstantive review should not involve a
					 capital expenditure greater than $2 million and include, but are not limited
					 to, the following:
(i) Change of 10
				  beds or 10% of capacity or less, whichever is less, if the change conforms to
				  the Health Systems Plan. This subparagraph applies to bed changes to approved
				  projects and to cases in which facilities have already exercised the 10 bed/10%
				  option during a 2-year period.
(ii)
				  Replacement of equipment not involving a substantial change in functional
				  capacity or capability.
(iii)
				  Projects identified as needed in the Health Systems Plan or State Health
				  Plan.
(iv) Renovations necessary to
				  meet code requirements which do not expand the capacity of the
				  facility.
(v) Repairs or
				  reconstruction in cases of emergencies.
(vi) Addition of a new health service if the
				  annual operating expense is less than $500,000.
(vii) Nonclinical projects, such as parking,
				  energy, medical office buildings, and telephone.
(viii) Refinancing.
Due to the relatively insignificant consequences of some of
					 the changes that would require a nonsubstantive review, an administrative
					 review can be substituted if the HSA and the Department agree that only an
					 administrative review is necessary. The Department will render its decision on
					 the project within 30 business days of receipt of the required
					 information.
Offer
-ake provision for providing in a
					 regular manner and on an organized basis specified health services.
Organization
-A nonprofit corporation or
					 other corporation, partnership, association or other organization.
Person
-A natural person, corporation
					 including associations, joint stock companies and insurance companies,
					 partnerships, trusts, estates, associations, the Commonwealth, and any local
					 governmental unit, authority and agency thereof. The term includes all entities
					 owning or operating a health care facility or health maintenance
					 organization.
Persons directly affected
-A person whose
					 proposal for certificate of need is being reviewed, members of the public who
					 are to be served by the proposed new institutional health services, health care
					 facilities and health maintenance organizations located in the health service
					 area in which the service is proposed to be offered or developed which provide
					 services similar to the proposed services under review, and health care
					 facilities and health maintenance organizations which prior to receipt by the
					 agency of the proposal being reviewed have formally indicated an intention to
					 provide such similar service in the future and those agencies, if any, which
					 establish rates for health care facilities and health maintenance organizations
					 located in the health systems area in which the proposed new institutional
					 health service is to be offered or developed.
Policy board
-The Health Care Policy Board
					 created in the Department under the act.
Predevelopment costs
-Expenditures for
					 preparation of architectural designs, working drawings, plans and
					 specifications, and any other preparation directed toward planning, developing,
					 or offering a new institutional health service.
Project
-A proposal by a person to offer,
					 develop, construct, or otherwise establish or undertake to establish a new
					 institutional health service as defined in §
										401.3 (relating to new
					 institutional health services).
Public Health Service Act
-
					 42 U.S.C.A. §§
											201-300z-10.
Public hearing
-A meeting open to the
					 public where any person has an opportunity to present testimony held without
					 imposition of fee.
Rehabilitation facilities
-An inpatient
					 facility which is operated for the primary purpose of assisting in the
					 rehabilitation of disabled persons through an integrated program of medical and
					 other services which are provided under competent professional supervision.
					 These facilities are comprehensive physical rehabilitation facilities. They do
					 not include freestanding treatment facilities for drugs or alcohol or
					 both.
Retroactive review
-A review which is
					 conducted after a person has undertaken a reviewable activity without a
					 certificate of need. The reviews are procedurally identical to a regular review
					 specified in this chapter. Such persons are subject to penalties as specified
					 in the act.
Secretary
-The Secretary of the
					 Department.
Skilled nursing facility
-A facility or
					 part of a facility in which professionally supervised nursing care and related
					 medical or other health services are provided for a period exceeding 24 hours
					 for two or more individuals who are not in need of hospitalization and who are
					 not relatives of the nursing home administrator, but who because of age,
					 illness, disease, injury, convalescence, or physical or mental infirmity, need
					 such care.
State Health Plan (SHP)
-A statement of
					 goals for the State health care system based on the Health Systems Plans for
					 the State and approved by the Statewide Health Coordinating Council and the
					 Governor prepared triennially, reviewed annually and revised as necessary. It
					 describes the institutional health services needed to provide for the
					 well-being of persons receiving care within the State, the number and type of
					 resources, including facilities, personnel, major medical equipment, and other
					 resources, including financial resources, required to meet the goals of the
					 plan, states the extent to which existing health care facilities are in need of
					 modernization, conversion to other uses, or closure and the extent to which new
					 health care facilities need to be constructed or acquired.
Statewide Health Coordinating Council
-The
					 Council established in compliance with Title XV of the Public Health Service
					 Act.
Substantial implementation of a
					 project
-The completion of the following requirements relative to but
					 not limited to the following types of projects. All of the requirements listed
					 in this paragraph must be completed within 1 year after issuance of the
					 certificate or within 18 months after issuance of the certificate if an
					 extension has been granted.
(i)
New construction or renovation projects.
New construction or
				  renovation projects shall conform to all of the following:
(A) The title or long-term lease to the
				  appropriate site has been acquired.
(B) The appropriate State agency has approved
				  the complete set of schematic drawings for the project.
(C) A financial commitment has been obtained
				  for at least 60% of the total approved capital expenditure. The commitment may
				  be any combination of funds, such as the applicant's own funds, grants, gifts,
				  or an enforceable offer and acceptance from a financial institution to provide
				  adequate capital financing for the project.
(D) An enforceable construction contract has
				  been entered into causing the commencement of construction no later than 24
				  months after issuance of a certificate. Failure to commence construction within
				  this time period shall be considered an abandonment of the project, and the
				  certificate issued shall be withdrawn. Erection of the foundation shall
				  constitute commencement of construction.