PRINTER'S NO. 3780
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 19780H2782B3780 - 2 -
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 19780H2782B3780 - 3 -
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 19780H2782B3780 - 4 -
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 19780H2782B3780 - 6 -
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 19780H2782B3780 - 7 -
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. 19780H2782B3780 - 8 -
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 19780H2782B3780 - 9 -
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 19780H2782B3780 - 14 -
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. I15L32DGS/19780H2782B3780 - 29 -