Section 401.2. Definitions

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.

(ii) Acquisition of equipment. The equipment must either be purchased; the lease agreement must be entered into by the proponent; or if acquired by a comparable arrangement, the health care facility or health maintenance organization must have possession of the equipment.

(iii) Addition of a new service. A written statement must be submitted to the Department verifying that the service is in operation.

(iv) Donated property. In the case of donated property, the date on which title to the donated property is transferred in accordance with applicable State statute.

Third-party payor—A person who makes payments on behalf of patients under compulsion of law or contract who does not supply care or services as a health care provider or who is engaged in issuing any policy or contract of individual or group health insurance or hospital or medical service benefits, but shall not include the Federal, State, or any local government unit, authority or agency thereof or a health maintenance organization.

The provisions of this § 401.2 amended April 13, 1984, effective April 14, 1984, 14 Pa.B. 1294. Immediately preceding text appears at serial pages (55635) to (55637), and (52906) to (52910).

Notation

Authority

The provisions of this § 401.2 issued 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)).

Cross References

This section cited in 28 Pa. Code § 401.5 (relating to Certificate of Need); 28 Pa. Code § 401.6 (relating to certificate of need—statement of policy); and 55 Pa. Code § 1187.113a (relating to nursing facility replacement beds—statement of policy).