PRINTER'S NO. 3780

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 2782 Session of 1978


        INTRODUCED BY IRVIS, SEPTEMBER 19, 1978

        REFERRED TO COMMITTEE ON HEALTH AND WELFARE, SEPTEMBER 19, 1978

                                     AN ACT

     1  Relating to health care, prescribing the powers and duties of
     2     the Department of Health, establishing and providing the
     3     powers and duties of the Statewide Health Coordinating
     4     Council and Policy Board; providing for certification of need
     5     of health care providers and uniform financial reporting;
     6     prescribing penalties; and making an appropriation.

     7                         TABLE OF CONTENTS
     8  Chapter 1.  Preliminary Provisions
     9     Section  101.  Short title.
    10     Section  102.  Purposes.
    11     Section  103.  Definitions.
    12  Chapter 2.  Powers and Duties of the Department
    13     Section  201.  Powers and duties of the department.
    14  Chapter 3.  Organization and Powers and Duties of the
    15              Health Care Policy Board.
    16     Section  301.  Health Care Policy Board.
    17     Section  302.  Health Care Policy Board; powers and duties.
    18     Section  303.  Policy board compensation, expenses.
    19  Chapter 4.  Statewide Health Coordinating Council and Health
    20              Systems Agencies


     1     Section  401.  Statewide Health Coordinating Council.
     2     Section  402.  Statewide Health Coordinating Council; powers.
     3     Section  403.  Health systems agencies.
     4     Section  404.  Health systems agencies; powers.
     5  Chapter 5.  Administration of the Act
     6     Section  501.  Promulgation of rules and regulations.
     7     Section  502.  Enforcement of orders.
     8  Chapter 6.  Certificate of Need
     9     Section  601.  Certificate of need requisite for licensure.
    10     Section  602.  Certificate of need, when required.
    11     Section  603.  Certificates of need; notice of intent
    12                    application; issuance.
    13     Section  604.  Notice and hearings before health systems
    14                    agencies.
    15     Section  605.  Appeal of department's decision.
    16     Section  606.  Criteria for review of applications for
    17                    certificate of need or amendments.
    18     Section  607.  Expiration of certificate of need.
    19     Section  608.  Emergencies.
    20     Section  609.  Appeals and procedure on appeal.
    21     Section  610.  Review of activities.
    22     Section  611.  Immunity from legal liability.
    23     Section  612.  Penalties.
    24     Section  613.  Decertification of specialized hospital
    25                    services.
    26  Chapter 7.  Uniform Reporting
    27     Section  701.  Uniform financial reporting.
    28     Section  702.  Modifications in the reporting system.
    29     Section  703.  Regulation.
    30  Chapter 8.  Proceedings Against Health Facility Violators
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     1     Section 801.  Actions against violations of law and rules
     2                   and regulations.
     3     Section 802.  Bonds.
     4  Chapter 9.  General Provisions; Appropriation; Repeals;
     5              Effective Date
     6     Section 901.  Licenses and certificates for existing
     7                   facilities.
     8     Section 902.  Administration of act.
     9     Section 903.  Appropriation.
    10     Section 904.  Severability.
    11     Section 905.  Repeals.
    12     Section 906.  Effective date.
    13     The General Assembly of the Commonwealth of Pennsylvania
    14  hereby enacts as follows:
    15                             CHAPTER 1
    16                       PRELIMINARY PROVISIONS
    17  Section 101.  Short title.
    18     This act shall be known and may be cited as the "Health Care
    19  Planning and Resources Development Act."
    20  Section 102.  Purposes.
    21     The General Assembly finds that the health and welfare of
    22  Pennsylvania citizens will be enhanced by the orderly and
    23  economical distribution of health care resources. Such
    24  distribution of resources will be furthered by governmental
    25  involvement to facilitate the development and organization of a
    26  coordinated and comprehensive system of health care. The goal of
    27  such a system is to enhance the public health and welfare by
    28  assuring that needed health care is available to everyone; that
    29  the health care delivery system is responsive and adequate to
    30  the needs of all citizens; that health care services are
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     1  provided at a fair and reasonable cost and services and
     2  facilities are efficiently and effectively used; that health
     3  care services and facilities continue to meet high quality
     4  standards; that health care expenditures be allocated in the
     5  most effective way to improve the health status of citizens;
     6  and, that all citizens receive humane, courteous, and dignified
     7  treatment. In developing such a coordinated and comprehensive
     8  health care system, it is the policy of the Commonwealth to
     9  foster responsible private operation and ownership of health
    10  care facilities, to encourage innovation and continuous
    11  development of improved methods of health care and to aid
    12  efficient and effective planning using local health system
    13  agencies. It is the intent of the General Assembly that the
    14  Department of Health foster a sound, efficient, and dynamic
    15  health care system which provides for quality health care to all
    16  individuals at appropriate health service facilities throughout
    17  the Commonwealth.
    18  Section 103.  Definitions.
    19     The following words and phrases when used in this act shall
    20  have, unless the context clearly indicates otherwise, the
    21  meanings given to them in this section:
    22     "Act."  The Health Care Planning and Resources Development
    23  Act.
    24     "Annual implementation plan."  The latest health systems
    25  agency's annual statement of objectives to achieve the goals of
    26  the health systems plan, including the priorities established
    27  among the objectives.
    28     "Certificate of need."  A certificate issued by the
    29  department under the provisions of this act, including those
    30  issued for amendments or supplements thereto and increases in
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     1  services.
     2     "Consumer."  A natural person who uses or potentially will
     3  use the services of a provider of health care, excluding,
     4  however, the following: a health care provider, or third party
     5  payor, or a practitioner of the healing arts. It shall also
     6  exclude persons one-tenth or more of whose gross income is from
     7  provision of health services research or instruction in health
     8  care or from entities producing or supplying drugs or other
     9  articles for use in health care or health care research or
    10  instruction, or the parent, spouse, child, brother, or sister
    11  residing in the same household with any of the above excluded
    12  persons.
    13     "Council."  The Statewide Health Coordinating Council
    14  established pursuant to Federal Public Law 93-641.
    15     "Department."  The Department of Health.
    16     "Develop."  When used in connection with health services or
    17  facilities, means to undertake those activities which on their
    18  completion will result in the offer of a new health service or
    19  the incurring of a financial obligation in relation to the
    20  offering of such a service.
    21     "Health care facility."  Any establishment, whether
    22  governmental or nongovernmental, providing bed facilities for
    23  two or more persons not related to the provider and/or health
    24  services with physician or nursing services on an inpatient
    25  basis, including hospitals, psychiatric hospitals, tuberculosis
    26  hospitals, skilled nursing facilities, kidney disease treatment
    27  centers, including freestanding hemodialysis units, intermediate
    28  care facilities, ambulatory surgical facilities, home health
    29  agencies and freestanding primary care centers, but it shall not
    30  include institutions for the education of the blind or the deaf,
    19780H2782B3780                  - 5 -

     1  or which provides treatment of residents or patients solely on
     2  the basis of prayer or spiritual means in accordance with the
     3  creed or tenets of any church or religious denomination; nor a
     4  facility which is conducted by a religious organization for the
     5  purpose of providing health care services exclusively to
     6  clergymen or other persons in a religious profession who are
     7  members of the religious denomination conducting the facility.
     8     "Health care project."  As used in this act shall not include
     9  expenditures of less than $150,000 made in the preparation of
    10  architectural designs, working drawings, plans and
    11  specifications site acquisition and preliminary plans, studies
    12  and surveys prior to review or expenditures in preparation of an
    13  application.
    14     "Health care provider."  A person who operates a health care
    15  facility or health maintenance organization.
    16     "Health service area."  The area served by a health systems
    17  agency as designated in accordance with Section 1511 of Federal
    18  Public Law 93-641.
    19     "Health services."  Clinically related (i.e. diagnostic,
    20  treatment or rehabilitative) services, and includes alcohol,
    21  drug abuse and mental health services.
    22     "Health systems agency" or "HSA."  An entity which has been
    23  conditionally or fully designated pursuant to Section 1515 of
    24  Federal Public Law 93-641.
    25     "Patient."  A natural person receiving health care in or from
    26  a licensed health care provider.
    27     "Person."  A natural person, corporation, partnership,
    28  association, the Commonwealth, and any local governmental unit,
    29  authority, and agency thereof.
    30     "Policy board."  The Health Care Policy Board created in the
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     1  Department of Health under the provisions of this act.
     2     "Public hearing."  A meeting open to the public where there
     3  is an opportunity for any person to present testimony.
     4     "Secretary."  The Secretary of the Department of Health of
     5  the Commonwealth of Pennsylvania.
     6     "Services."  Health care services provided at or by a health
     7  care facility.
     8     "State health plan."  The statement of goals for the State
     9  health care system based on the various HSA plans as annually
    10  approved by the SHCC.
    11     "State medical facilities plan."  The statement of needs and
    12  priorities consistent with the State health plan prepared
    13  annually to serve as a guide for allocation of Federal and State
    14  funds in support of capital expenditures of health care
    15  facilities and for consideration in issuing certificates of
    16  need.
    17     "Statewide Health Coordinating Council" or "SHCC."  The
    18  council established in compliance with Federal Public Law 93-
    19  641.
    20     "Third party payor."  A person who makes payments on behalf
    21  of patients under compulsion of law or contract who does not
    22  supply care or services as a health care provider, but shall not
    23  include the Federal, State, or any local government unit,
    24  authority, or agency thereof.
    25                             CHAPTER 2
    26                POWERS AND DUTIES OF THE DEPARTMENT
    27  Section 201.  Powers and duties of the department.
    28     The Department of Health shall have the power and its duties
    29  shall be:
    30         (1)  To issue certificates of need and amended or
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     1     supplemental certificates of need in accordance with the
     2     provisions of this act.
     3         (2)  With respect to health care facilities to
     4     investigate, and report to the Auditor General, upon every
     5     application to the Auditor General made by any institution,
     6     corporation, or unincorporated association, desiring to give
     7     a mortgage under the provisions of the act of April 29, 1915
     8     (P.L.201, No.112), entitled "An act making mortgages, given
     9     by benevolent, charitable, philanthropic, educational and
    10     eleemosynary institutions, corporations, or unincorporated
    11     associations, for permanent improvements and refunding
    12     purposes, prior liens to the liens of the Commonwealth for
    13     the appropriation of moneys; providing a method for the
    14     giving of such mortgages, and fixing the duties of the
    15     Auditor General and Board of Public Charities in connection
    16     therewith."
    17         (3)  To exercise jurisdiction over health care providers
    18     and health care facilities in accordance with the provisions
    19     of this act.
    20         (4)  To act as a single State agency through its staff,
    21     and the policy board, to administer and enforce duties and
    22     responsibilities conferred upon the State under Federal
    23     Public Law 93-641.
    24         (5)  To compile, maintain and publish a Statewide
    25     inventory of health care facilities and their types of
    26     services.
    27         (6)  To require submission of periodic reports by
    28     providers of health services and other persons subject to
    29     review respecting the development of proposals subject to
    30     review.
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     1         (7)  To require pursuant to regulations that providers
     2     make statistical and other reports to the department of such
     3     information as may be necessary to carry out the purpose and
     4     provisions of the act.
     5         (8)  To research and, after adoption by the SHCC, publish
     6     annually a State health plan for the Commonwealth.
     7         (9)  To furnish such staff support and expertise to the
     8     policy board as may be needed by them to perform their
     9     responsibilities.
    10         (10)  To receive and docket all notices of intention.
    11         (11)  To receive and review all applications for
    12     certificates of need or their amendments or supplements
    13     thereto and decide such applications.
    14         (12)  To prepare a State medical facilities plan for
    15     approval by the SHCC.
    16                             CHAPTER 3
    17             ORGANIZATION AND POWERS AND DUTIES OF THE
    18                      HEALTH CARE POLICY BOARD
    19  Section 301.  Health Care Policy Board.
    20     There is hereby created a Health Care Policy Board which
    21  shall consist of the Secretary of Health and eight other
    22  members, appointed by the Governor and confirmed by a majority
    23  vote of the Senate. Of the members first appointed, two shall be
    24  appointed for a term of one year, two for a term of two years,
    25  two for a term of three years, and two for a term of four years.
    26  Thereafter, appointments shall be made for four-year terms. A
    27  vacancy occurring during a term shall be filled for the
    28  unexpired term in the same manner his predecessor was appointed.
    29  The Secretary of Health or his designee shall serve ex officio,
    30  and act as chairman. Members of the policy board shall be four
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     1  consumers, (including at least one representative of organized
     2  labor and one representative of business) one hospital provider,
     3  one skilled nursing or intermediate care provider, one physician
     4  and one third party payor. Five members shall constitute a
     5  quorum. No member shall participate in any action or decision
     6  concerning any matter in which the member has a substantial
     7  economic interest.
     8  Section 302.  Health Care Policy Board; powers and duties.
     9     The Health Care Policy Board shall have the powers and duties
    10  to:
    11         (1)  Study and review all the requirements of this act
    12     and all State and Federal laws pertinent thereto.
    13         (2)  Review and approve or disapprove proposed
    14     regulations of the department pursuant to this act, relating
    15     to certificate of need.
    16         (3)  Review and approve or disapprove proposed
    17     regulations of the department pursuant to this act relating
    18     to uniform reporting, taking into consideration the
    19     principles of accounting established by the American
    20     Institute of Certified Public Accountants, the chart of
    21     accounts established by the American Hospital Association,
    22     and any other appropriate standards utilized by health care
    23     providers.
    24         (4)  To consider recommendations of the council relating
    25     to certification of need and to report periodically on its
    26     activities to the department and the council.
    27  Section 303.  Policy board compensation; expenses.
    28     Each member of the policy board shall be paid travel and
    29  other necessary expenses, and compensation at the rate of $100
    30  per day for attending meetings of the board.
    19780H2782B3780                 - 10 -

     1                             CHAPTER 4
     2               STATEWIDE HEALTH COORDINATING COUNCIL
     3                    AND HEALTH SYSTEMS AGENCIES
     4  Section 401.  Statewide Health Coordinating Council.
     5     The Statewide Health Coordinating Council as established or
     6  designated under Federal Law shall perform such functions as are
     7  provided in agreements with the Secretary of Health, Education
     8  and Welfare.
     9  Section 402.  Statewide Health Coordinating Council; powers.
    10     The Statewide Health Coordinating Council shall consult with
    11  the department and the policy board and make recommendations as
    12  to the carrying out of their functions in acting as the single
    13  State agency under the certificate of need provisions of this
    14  act.
    15  Section 403.  Health systems agencies.
    16     The health systems agencies as established and designated by
    17  the Secretary of Health, Education and Welfare, shall perform
    18  such functions as are provided in agreements with the Secretary
    19  of Health, Education and Welfare and such other functions as are
    20  not inconsistent therewith.
    21  Section 404.  Health systems agencies; powers.
    22     The health systems agencies shall have in addition to its
    23  functions as provided under Federal Public Law 93-641 the
    24  following powers and duties: to receive and review for their
    25  respective geographic areas all applications for certificates of
    26  need or terminations and all notices of reductions or increases
    27  in services, and, after due deliberation, prepare
    28  recommendations or objections for submission to the department.
    29                             CHAPTER 5
    30                     ADMINISTRATION OF THE ACT
    19780H2782B3780                 - 11 -

     1  Section 501.  Promulgation of rules and regulations.
     2     All rules and regulations under this act relating to uniform
     3  reporting and certificate of need shall be approved by the
     4  policy board and promulgated by the department, pursuant to the
     5  provisions of the act of July 31, 1968 (P.L.769, No.240), known
     6  as the "Commonwealth Documents Law" and shall provide fair
     7  access and due process to all interested parties in proceedings
     8  held to carry out the provisions of this act. In addition, the
     9  policy board shall publish (other than as a legal notice or
    10  classified advertisement) in at least two newspapers in general
    11  circulation in the Commonwealth, notice of the proposed
    12  regulations and where they may be examined by interested
    13  persons. It shall also send the proposed regulations to
    14  Statewide health agencies and organizations, and to each health
    15  systems agency.
    16  Section 502.  Enforcement of orders.
    17     (a)  Orders from which the time for appeal has expired may be
    18  enforced by the department in summary proceedings or, when
    19  necessary, with the aid of the Commonwealth Court.
    20     (b)  No collateral attack on any order including
    21  jurisdictional issues shall be sought in the enforcement
    22  proceeding but shall be sought in the Commonwealth Court when
    23  such relief has not been barred by the failure to take an
    24  appeal.
    25                             CHAPTER 6
    26                        CERTIFICATE OF NEED
    27  Section 601.  Certificate of need requisite for licensure.
    28     No license or renewal thereof to maintain or operate a health
    29  care facility shall be issued unless the applicant has a valid
    30  certificate of need issued by the department authorizing the use
    19780H2782B3780                 - 12 -

     1  of the facility and the rendering of the services offered at the
     2  facility for which the license is to be issued.
     3  Section 602.  Certificate of need, when required.
     4     (a)  No person shall develop, operate, lease, or construct a
     5  health care facility or health maintenance organization as
     6  defined by Federal law without first obtaining a certificate of
     7  need from the department authorizing such development,
     8  operation, lease, or construction. No person operating an
     9  existing health care facility or health maintenance organization
    10  under a certificate of need shall make expenditures toward any
    11  health care project including the fair market value of any
    12  leased or donated property in which he will:
    13         (1)  lease, erect, construct, alter, modernize, or
    14     improve any building;
    15         (2)  acquire any real property except land acquisition by
    16     gift, devise, or option; or
    17         (3)  lease or acquire equipment;
    18  which will involve a total capital health care project cost in
    19  excess of $150,000, nor shall any person offer or engage in any
    20  new health care service not offered on a regular basis in the
    21  prior 12 months or increase the bed complement (except for a
    22  temporary emergency increase), nor shall any person redistribute
    23  beds among various categories or relocate beds from one physical
    24  facility or site to another by more than ten beds or 10% of its
    25  total licensed bed capacity, whichever is less, over a two year
    26  period unless such person has first been authorized to do so by
    27  the department through the issuance of a new or amended
    28  certificate of need. No person shall enter into a fixed
    29  arrangement or commitment for the financing of a health care
    30  project covered under this chapter with a total capital cost in
    19780H2782B3780                 - 13 -

     1  excess of $150,000 without a certificate of need. Should a
     2  higher dollar limitation for review requirements of health care
     3  projects be permitted by Federal law, such higher amount shall
     4  apply throughout this act each time a dollar limit appears. No
     5  person shall purchase, lease, acquire or operate any major
     6  medical equipment costing over $150,000, regardless of location
     7  or ownership, without a certificate of need.
     8     (b)  A substantial decrease of a health care service requires
     9  only notice to the health systems agency and the department
    10  within 30 days after the decrease.
    11  Section 603.  Certificates of need; notice of intent
    12                application; issuance.
    13     (a)  Projects for facilities, services or equipment requiring
    14  a certificate of need shall, at the earliest possible time in
    15  their planning, be submitted to the health systems agency and
    16  the department in a letter of intent in such detail as possible
    17  advising of the scope and nature of the project.
    18     (b)  A person desiring to obtain or amend a certificate of
    19  need shall apply to the local health systems agency, if any, and
    20  to the department simultaneously supplying to them such
    21  information as is required by the health systems agency provided
    22  such requirements are not in conflict with any department
    23  regulations. The health systems agency and the department shall
    24  have 30 days after receipt of the application within which to
    25  determine whether the application is complete and in which to
    26  request specific further information. If further information is
    27  requested, the agency requiring the same shall determine whether
    28  the application is complete within 15 business days of receipt
    29  of the same.
    30     (c)  Review of the application by the health systems agency
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     1  shall begin with the giving of notice of a completed application
     2  and shall be completed within 60 days thereof unless the
     3  applicant agrees in writing to a specified extention of time for
     4  such review by the health systems agency. If the health systems
     5  agency recommendations or objections are not so completed, the
     6  application shall be deemed favorable recommended by the health
     7  systems agency.
     8     (d)  The department shall consider the timely filed
     9  recommendations or objections of the health systems agency in
    10  reviewing the application and shall take action on the
    11  application within 30 days from receipt of the health systems
    12  agency report or upon the expiration of the time for filing the
    13  same by granting, granting in part and refusing in part, or
    14  refusing the requested certificate of need. Conditions may be
    15  incorporated when an application is approved in whole or in
    16  part.
    17     (e)  No review may take longer than 90 days, as provided in
    18  subsections (c) and (d), to the extent practicable. A period
    19  longer than 90 days may be employed for certain proposals if
    20  they meet criteria adopted in advance by the department for
    21  determining when it would not be practicable to complete a
    22  review within 90 days.
    23     (f)  Where the decision of the department is inconsistent
    24  with the goals of the health systems plan, if any, or the
    25  recommendations or objections of the health systems agency, the
    26  department shall provide a detailed statement of the reasons for
    27  the inconsistency and forward the statement along with the
    28  decision to the parties and the health systems agency.
    29  Section 604.  Notice and hearings before health systems
    30                agencies.
    19780H2782B3780                 - 15 -

     1     (a)  Notice of filing applications for certificate of need or
     2  amendments thereto shall be published by the health systems
     3  agency in the appropriate news media and in the Pennsylvania
     4  Bulletin in accordance with the act of July 31, 1968 (P.L.769,
     5  No.240), known as the "Commonwealth Documents Law," and the
     6  health systems agency shall notify all affected persons with
     7  notice of the schedule for review, the date by which a public
     8  hearing must be demanded, and of the manner notice will be given
     9  of a hearing, if one is to be held. Such notice shall be sent by
    10  mail to the applicant, contiguous health systems agency's, and
    11  health care facilities and health maintenance organizations
    12  located within the health service agency; and any person
    13  directly affected including another health systems agency if the
    14  service will affect its area or a consumer, provider, or third
    15  party payor may file objections within 20 days of such
    16  publication with the local health systems agency setting forth
    17  specifically the reasons therefor. Persons filing objections
    18  shall be parties to the proceeding unless or until such
    19  objections are withdrawn.
    20     (b)  When a public hearing is requested by the applicant, by
    21  a member of the public to be served by the proposed project, by
    22  a health care facility or health maintenance organization
    23  located in the health service area where the service is to be
    24  offered which provides services similar to those proposed or by
    25  a health care facility or health maintenance organization which,
    26  prior to receipt by the agency of the proposal being reviewed,
    27  formally indicated intention to provide similar services, the
    28  health systems agency shall, and when requested by other persons
    29  filing objections may, hold a public hearing. Written notice of
    30  the hearing shall be given to the applicant and any objecting
    19780H2782B3780                 - 16 -

     1  party. In addition, notice shall be published (other than by
     2  legal notice of classified advertisement) in a newspaper of
     3  general circulation in the area and in the Pennsylvania Bulletin
     4  before the hearing. The applicant and any interested person
     5  shall be afforded the opportunity to submit testimony at the
     6  hearing.
     7     (c)  The recommendations or objections of the health systems
     8  agency shall be served on the parties, and the department.
     9     (d)  The period from the giving of notice to the parties of a
    10  hearing until the adjournment of a hearing shall not be included
    11  in calculating the time permitted for the health systems agency
    12  to conduct its review.
    13     (e)  Modification of the application shall not extend the
    14  time limits herein provided unless the health systems agency
    15  expressly finds that the modification represents a substantial
    16  change in the character of the application.
    17  Section 605.  Appeal of department's decision.
    18     (a)  A decision by the department on an application for a
    19  certificate of need may be appealed by the applicant and, where
    20  the department's decision is inconsistent with the
    21  recommendation of the appropriate health systems agency, by that
    22  health systems agency.
    23     (b)  A request for an appeal hearing must be directed in
    24  writing to the secretary within 30 days of the department's
    25  decision.
    26     (c)  The appeal hearing shall be started within 45 days of
    27  the department's receipt of such request or later, at the option
    28  of the person requesting the appeal; shall be held before an
    29  impartial hearing officer appointed by the Attorney General from
    30  a list of qualified persons; and shall be conducted in
    19780H2782B3780                 - 17 -

     1  accordance with the "Administrative Agency Law," Title 2 Pa.
     2  C.S. § 103 et. seq.
     3     (d)  The appeal hearing shall be limited in scope to:
     4         (1)  whether the findings and decision of the department
     5     are supported by substantial evidence;
     6         (2)  whether there was any prejudicial procedural error
     7     in the review of the application;
     8         (3)  whether there was any violation of the
     9     constitutional or statutory rights of the applicant.
    10     (e)  The decision of the hearing officer shall be issued in
    11  writing within 45 days after the conclusion of the appeal
    12  review. The decision of the hearing officer shall be considered
    13  the final decision of the department, but the hearing officer
    14  may remand the matter to the department or health systems agency
    15  for further action or consideration. The written findings of the
    16  hearing officer shall be sent to the applicant, the appropriate
    17  health systems agency and the department.
    18  Section 606.  Criteria for review of applications for
    19                certificate of need or amendments.
    20     (a)  The department shall adopt and utilize as appropriate,
    21  specific criteria for conducting reviews covered by this act.
    22  The criteria shall include at least the following general
    23  considerations:
    24         (1)  The health services being reviewed are consistent
    25     with or compatible to the applicable health services plan and
    26     annual implementation plan, State health plan, and State
    27     medical facilities plan.
    28         (2)  The services are compatible to the long-range
    29     development plan (if any) of the applicant.
    30         (3)  There is a need by the population served or to be
    19780H2782B3780                 - 18 -

     1     served by the services.
     2         (4)  There are no less costly, and more effective
     3     alternative methods of providing the services available.
     4         (5)  The service or facility is economically feasible,
     5     considering anticipated volume of care, the capability of the
     6     service area to meet reasonable charges for the service or
     7     facility, and the availability of financing.
     8         (6)  The service or facility is justified by community
     9     need and within the financial capabilities of the institution
    10     both on an intermediate and long-term basis and is compatible
    11     with the existing system in the health service area, and will
    12     not have an inappropriate, adverse impact on the overall cost
    13     of providing health services in the area.
    14         (7)  There are available resources (including health
    15     manpower, management personnel, and funds for capital and
    16     operating needs) to the applicant for the provision of the
    17     services proposed to be provided, and there is no greater
    18     need for alternative uses for such resources for the
    19     provision of other health services.
    20         (8)  The proposed service or facility will have available
    21     to it appropriate ancillary and support services.
    22         (9)  The proposed services are consistent with the
    23     special needs and circumstances of those entities which
    24     provide services or resources both within and without the
    25     health service area in which the proposed services are to be
    26     located, including medical and other health professional
    27     schools, multidisciplinary clinics, and specialty centers.
    28         (10)  The proposed services are not incompatible with any
    29     health maintenance organization existing in the area.
    30         (11)  The proposed services are not incompatible with any
    19780H2782B3780                 - 19 -

     1     biomedical or behavioral research projects designed for
     2     National need for which local conditions offer special
     3     advantages.
     4  Criteria adopted for reviews in accordance with this subsection
     5  may vary according to the purpose for which a particular review
     6  is being conducted or the type of health service being reviewed.
     7     (b)  If the application is for a proposed service or facility
     8  which includes a construction project:
     9         (1)  the costs and methods of proposed construction
    10     including the costs and methods of energy provision are
    11     appropriate; and
    12         (2)  the proposed construction will not have an
    13     inappropriate adverse impact on the cost of providing health
    14     services by the applicant.
    15     (c)  Whenever new institutional health services for
    16  inpatients are proposed, a finding shall be made in writing by
    17  the reviewing authority:
    18         (1)  that less costly alternatives which are more
    19     efficient, or more appropriate to such inpatient service are
    20     not available and the development of such alternatives has
    21     been studied and found not practicable;
    22         (2)  that existing inpatient facilities providing
    23     inpatient services similar to those proposed are being used
    24     in an appropriate and efficient manner;
    25         (3)  that in the case of new construction, alternatives
    26     to new construction such as modernization or sharing
    27     arrangements have been considered and have been implemented
    28     to the maximum extent practicable;
    29         (4)  that patients will experience serious problems in
    30     obtaining inpatient care of the type proposed in the absence
    19780H2782B3780                 - 20 -

     1     of the proposed new service; and
     2         (5)  that in the case of a proposal for the addition of
     3     beds for the provision of skilled nursing or intermediate
     4     care services, the addition will be consistent with the plans
     5     of the agency, if any, that is responsible for the provision
     6     and financing of long-term care (including home health)
     7     services.
     8  No certificate of need shall be issued for inpatient services
     9  when any findings of this subsection cannot be made. Additional
    10  findings under subsection (b) or (c) may be provided by
    11  regulation as required prior to the issuance of a certificate of
    12  need.
    13     (d)  The department by regulation shall adopt criteria for
    14  review of health maintenance organizations based upon
    15  subsections (a), (b) and (c) and the standards and procedures
    16  established under Federal law pursuant to Title XIII of the
    17  Public Health Service Act.
    18  Section 607.  Expiration of certificate of need.
    19     A certificate of need shall remain in effect, providing the
    20  facilities and services authorized are in use. In the absence of
    21  substantial implementation of a proposal for which a certificate
    22  of need was issued, the certificate shall expire one year after
    23  issuance, unless the department extends the time of expiration
    24  for a definite period, not to exceed six months. In case of
    25  projects which are approved to be carried out in phases, the
    26  certificate of need shall remain in effect after the first phase
    27  is substantially implemented unless the project is abandoned.
    28  Annual reports of progress shall be made to the department from
    29  the time a certificate of need is granted until the facility or
    30  service is in use.
    19780H2782B3780                 - 21 -

     1  Section 608.  Emergencies.
     2     Notwithstanding any other provisions of this act, in the
     3  event of an emergency the department may suspend the foregoing
     4  application process and permit such steps to be taken as may be
     5  required to meet the emergency including the replacement of
     6  equipment or facilities.
     7  Section 609.  Appeals and procedure on appeal.
     8     The action of the department, upon an application for a
     9  certificate of need, amendment or supplement thereof, may be
    10  appealed by any party or health systems agency who is involved
    11  in that proceeding to the Commonwealth Court as provided by law.
    12  If a hearing was held on the application, the issues on appeal
    13  shall be limited to issues raised at such hearings. In other
    14  cases, the appellant shall file a statement of the reasons for
    15  the appeal which shall be served upon the department and the
    16  local health systems agency, and all parties to the proceeding
    17  at the time of taking the appeal. An answer may be filed by any
    18  party served within 20 days of service upon them of such
    19  statement. Issues on the appeal in such cases shall be limited
    20  to those raised in the statement or any answer filed.
    21  Section 610.  Review of activities.
    22     The department and each health systems agency shall prepare
    23  and publish not less frequently than annually reports of reviews
    24  conducted under this act, including a statement on the status of
    25  each such review and of reviews completed by them, including
    26  statements of the finding and decisions made in the course of
    27  such reviews since the last report. The department and each
    28  health systems agency shall also make available to the general
    29  public for examination at reasonable times of the business day
    30  all applications reviewed by them and all written materials on
    19780H2782B3780                 - 22 -

     1  file at the agency pertinent to such review.
     2  Section 611.  Immunity from legal liability.
     3     Any person, whether an employee or not, who as a member of
     4  any board, governing body, or committee, or other part of any
     5  agency established or designated under this act who performs
     6  duties or activities in good faith on behalf of that agency and
     7  without malice shall be immune from any liability for payment of
     8  any form of damages.
     9  Section 612.  Penalties.
    10     Any person violating this act by a failure to obtain a
    11  certificate of need or deviating from the provisions of the
    12  certificate or beginning construction or providing services or
    13  acquiring equipment after the expiration of the certificate of
    14  need shall be subject to a penalty of not less than $100 per day
    15  and not more than $1,000 per day, and each day after notice to
    16  them of the existence of such violation shall be considered a
    17  separate offense. When appropriate, the department may obtain
    18  injunctive relief to prevent violations of the act.
    19  Section 613.  Decertification of specialized hospital services.
    20     (a)  Definitions for the purposes of this section:
    21         (1)  "Specialized services."  Are the specialized
    22     facilities, equipment and staff necessary:
    23             (i)  To perform heart catheterization studies or
    24         cardiac surgery.
    25             (ii)  To perform radiation therapy treatment of
    26         cancer and other diseases.
    27             (iii)  For hemodialysis treatment of acute or chronic
    28         renal insufficiency.
    29             (iv)  To perform kidney transplants.
    30             (v)  For the intensive care and management of high-
    19780H2782B3780                 - 23 -

     1         risk maternal, high-risk fetal patients or high-risk
     2         neonatal patients.
     3             (vi)  To perform computed tomography.
     4             (vii)  Such other specialized services as may be
     5         prescribed through regulation.
     6         (2)  "Specialized service certificate."  Means a written
     7     authorization by the department for a hospital to provide
     8     specialized services.
     9     (b)  The department through the certificate of need process
    10  shall be responsible for certifying the need for individual
    11  specialized services. After certification, the responsibility
    12  for monitoring compliance with standards and rules promulgated
    13  under this section shall be the responsibility of the department
    14  through its process for facility licensing and inspection.
    15     (c)  The department shall promulgate all regulations
    16  necessary to implement this section and to ensure that the
    17  specialized services offered are needed, reasonably accessible,
    18  and provided in a manner which is consistent with quality of
    19  care standards.
    20     (d)  (1)  The department, after due notice, may decertify a
    21     specialized service if the service is clearly and
    22     demonstrably not needed by the community being served or the
    23     resources of the hospital are incapable of maintaining the
    24     service.
    25         (2)  The department shall issue a notice of intent to
    26     decertify a service at least 90 days prior to initiating
    27     formal action. Such notice shall be in writing and shall
    28     specify with particularity the basis on which the department
    29     reached its preliminary position. No final determination may
    30     be made by the department unless a hearing has been held
    19780H2782B3780                 - 24 -

     1     under the "Administrative Agency Law", Title 2 Pa.C.S. § 103
     2     et seq. and written findings and conclusions have been
     3     prepared by the hearing officer at the hearing or the hearing
     4     has been waived by the hospital.
     5         (3)  The appropriate health systems agency shall be
     6     notified of the department's preliminary findings and shall
     7     be given a minimum of 60 days to review and comment on the
     8     proposed decertification.
     9         (4)  If the department determines a service is
    10     temporarily not in full compliance with applicable standards
    11     and rules promulgated under this section, but the service is
    12     needed, the department shall issue a warning to the
    13     certificate holder and work with the hospital to establish a
    14     plan of correction with a reasonable timetable. Failure to
    15     comply with such a timetable is grounds for decertification.
    16         (5)  The certification review process specified in this
    17     section shall, after the initial review, be conducted for
    18     each service not more frequently than every three years or
    19     less frequently than every five years. The initial review
    20     must be completed within 24 months from the date regulations
    21     are published.
    22         (6)  The hospital shall be given a reasonable period of
    23     time, not to exceed one year, to phase out a specialized
    24     service.
    25     (e)  A hospital may appeal a decision by the department in
    26  the manner provided for appeals from a certificate of need
    27  decision, except that the department shall bear the burden of
    28  proving that a decertification is in accordance with the
    29  provisions of this section and the regulations promulgated under
    30  this section.
    19780H2782B3780                 - 25 -

     1     (f)  No hospital may establish, lease or operate a
     2  specialized service without a certificate. Any hospital which
     3  violates this section shall be fined not less than $100 nor more
     4  than $1,000. Each day of violation constitutes a separate
     5  offense.
     6     (g)  The department shall make inspections and require
     7  reports as are reasonably necessary under this section, but not
     8  more often than annually, to assure compliance with the
     9  regulations promulgated under this section. To the maximum
    10  extent possible, these inspections shall be coordinated with
    11  other regulatory and accrediting bodies, both governmental and
    12  private.
    13     (h)  The department shall negotiate with nonprofit hospital
    14  plans, the single State agency for medical assistance and other
    15  third party payors for modification of reimbursement agreements
    16  with hospitals to include as reimbursable operational costs,
    17  unamortized costs, outstanding debts, phase-out costs and equity
    18  associated with services which are decertified under this
    19  section.
    20                             CHAPTER 7
    21                         UNIFORM REPORTING
    22  Section 701.  Uniform financial reporting.
    23     (a)  Insofar as may be necessary to obtain consistent data in
    24  financial reporting the department shall by regulation, after
    25  consultation and public hearings, prescribe a uniform system of
    26  financial reporting of revenues and expenses for health care
    27  providers, including common definitions and specifying the
    28  information to be reported and the manner of its reporting. The
    29  regulations shall not prohibit health care providers from
    30  maintaining data in such form as they may deem proper so long as
    19780H2782B3780                 - 26 -

     1  appropriate consistent data can be extracted therefrom. The
     2  system shall include:
     3         (1)  a balance sheet detailing assets and liabilities and
     4     changes in the balance sheet from the previous year;
     5         (2)  a statement of revenue and expenses for the fiscal
     6     year; and
     7         (3)  such other reports as the department may determine
     8     to be necessary to fairly and accurately present a health
     9     care provider's revenue and expenses as of the fiscal year.
    10     (b)  Every health care provider shall file with the
    11  department the required financial reports on forms provided by
    12  the department annually.
    13     (c)  Reports shall be filed within 120 days of the end of the
    14  fiscal year unless the time for filing is extended by the
    15  department, and the department may adopt regulations which
    16  assess reasonable late filing fees for failure to file as
    17  required.
    18  Section 702.  Modifications in the reporting system.
    19     The department may allow and provide for modifications in the
    20  reporting system in order to reflect differences between the
    21  various categories, sizes, or types of health care providers.
    22  Section 703.  Regulation.
    23     The department is hereby authorized and empowered to adopt
    24  rules and regulations establishing procedures for uniform
    25  reporting to be used in accordance with the provisions of this
    26  act.
    27                             CHAPTER 8
    28                PROCEEDINGS AGAINST HEALTH FACILITY
    29                             VIOLATORS
    30  Section 801.  Actions against violations of law and rules and
    19780H2782B3780                 - 27 -

     1                regulations.
     2     Whenever any person, regardless of whether such person is a
     3  licensee, has violated any of the provisions of this act or the
     4  rules and regulations adopted thereunder, the department may
     5  maintain an action in the name of the Commonwealth for an
     6  injunction or other process restraining or prohibiting such
     7  person from engaging in such activity.
     8  Section 802.  Bonds.
     9     No bonds shall be required of the department in any legal
    10  action.
    11                             CHAPTER 9
    12            GENERAL PROVISIONS; APPROPRIATION: REPEALS:
    13                           EFFECTIVE DATE
    14  Section 901.  Licenses and certificates for existing
    15                facilities.
    16     All health care providers licensed, approved, or certified on
    17  the effective date of this act to establish, maintain, or
    18  operate a health care facility or who are operating such
    19  facility which has been licensed, approved, or certified shall
    20  be issued forthwith a certificate of need and specialized
    21  service certificates, as appropriate, by the department for all
    22  buildings, real property, and equipment owned, leased, or being
    23  operated or under contract for construction, purchase, or lease,
    24  and for all services being rendered by the licensed, approved,
    25  or certified provider upon the effective date of this act.
    26  Section 902.  Administration of act.
    27     (a)  In carrying out the provisions of this act and other
    28  statutes of this Commonwealth relating to health care
    29  facilities, the department and other agencies and officials of
    30  State and local governments shall make every reasonable effort
    19780H2782B3780                 - 28 -

     1  to prevent duplication of inspections and examinations.
     2     (b)  The department shall not administer this act in a way
     3  that will stifle innovation or experimentation in health care
     4  and health care facilities or that will discourage contributions
     5  of private funds and services to health care facilities.
     6  Section 903.  Appropriation.
     7     The sum of $1,500,000, or as much thereof as may be
     8  necessary, is hereby appropriated to the Department of Health
     9  for the purpose of the administration and enforcement of this
    10  act.
    11  Section 904.  Severability.
    12     If any provision or clause of this act or application thereof
    13  to any person or circumstances is held invalid, such invalidity
    14  shall not affect other provisions or applications of the act
    15  which can be given effect without the invalid provision or
    16  application, and to this end, the provisions of this act are
    17  declared to be severable.
    18  Section 905.  Repeals.
    19     All acts or parts thereof are hereby repealed insofar as may
    20  be inconsistent with the provisions of this act.
    21  Section 906.  Effective date.
    22     This act shall take effect in six months.






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