PRINTER'S NO. 4176
No. 2760 Session of 2004
INTRODUCED BY BAKER, STERN, BOYD, CREIGHTON, DAILEY, HESS, KELLER, MANDERINO, MUNDY, PISTELLA, SATHER, T. STEVENSON, TANGRETTI, E. Z. TAYLOR, J. TAYLOR, THOMAS, TIGUE, WALKO, YOUNGBLOOD AND DeLUCA, JUNE 28, 2004
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, JUNE 28, 2004
AN ACT 1 Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An 2 act relating to health care; prescribing the powers and 3 duties of the Department of Health; establishing and 4 providing the powers and duties of the State Health 5 Coordinating Council, health systems agencies and Health Care 6 Policy Board in the Department of Health, and State Health 7 Facility Hearing Board in the Department of Justice; 8 providing for certification of need of health care providers 9 and prescribing penalties," reenacting and amending 10 provisions relating to certificates of need. 11 The General Assembly of the Commonwealth of Pennsylvania 12 hereby enacts as follows: 13 Section 1. The title of the act of July 19, 1979 (P.L.130, 14 No.48), known as the Health Care Facilities Act, is reenacted 15 and amended to read: 16 AN ACT 17 Relating to health care; prescribing the powers and duties of 18 the Department of Health; establishing and providing the 19 powers and duties of the [State Health Coordinating Council, 20 health systems agencies and] Health [Care] Policy Board in
1 the Department of Health[, and State Health Facility Hearing
2 Board in the Department of Justice]; and providing for
3 certification of need of health care providers and
4 prescribing penalties.
5 Section 2. Section 103 of the act, amended December 18, 1992
6 (P.L.1602, No.179) and October 16, 1998 (P.L.777, No.95), is
7 reenacted and amended to read:
8 Section 103. Definitions.
9 The following words and phrases when used in this act shall
10 have, unless the context clearly indicates otherwise, the
11 meanings given to them in this section:
12 "Act." The comprehensive Health Care Facilities Act.
13 "Board." The Health Policy Board established under section
14 401.1.
15 "Certificate of need." A notice of approval issued by the
16 department under the provisions of this act, including those
17 notices of approval issued as an amendment to an existing
18 certificate of need.
19 "Clinically related health service." Certain diagnostic,
20 treatment or rehabilitative services as determined in section
21 701.
22 "Community-based health services planning committee." A
23 committee established in accordance with procedures approved by
24 the Department of Health which includes representatives of local
25 or regional groups of consumers, business, labor, health care
26 providers, payors or other affected interests.
27 "Conflict of interest." For the purpose of section 501, the
28 interest of any person, whether financial, by association with,
29 or as a contributor of money or time to, any nonprofit
30 corporation or other corporation, partnership, association, or
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1 other organization, and whenever a person is a director, officer 2 or employee of such organization, but shall not exist whenever 3 the organization in which such person is interested is being 4 considered as part of a class or group for whom regulations are 5 being considered, if the material facts as to the relationship 6 or interest are disclosed or are known to the board. 7 "Consumer." A natural person who is not involved in the 8 provision of health services or health insurance. For the 9 purpose of this act, any person who holds a fiduciary position 10 in any health care facility, health maintenance organization or 11 third party payor shall not be considered a consumer. 12 "Department." The Department of Health. 13 "Develop." When used in connection with health services or 14 facilities, means to undertake those activities which on their 15 completion will result in the offer of a new health service or 16 the incurring of a financial obligation in relation to the 17 offering of such a service. 18 "Health care facility." For purposes of Chapter 7, any 19 health care facility providing clinically related health 20 services, including, but not limited to, a general or special 21 hospital, including psychiatric hospitals, rehabilitation 22 hospitals, ambulatory surgical facilities, long-term care 23 nursing facilities, cancer treatment centers using radiation 24 therapy on an ambulatory basis and inpatient drug and alcohol 25 treatment facilities, both profit and nonprofit and including 26 those operated by an agency or State or local government. The 27 term shall also include a hospice. The term shall also include 28 an office where reviewable clinically related health services 29 are offered. The term shall not include an office used primarily 30 for the private or group practice by health care practitioners 20040H2760B4176 - 3 -
1 where no reviewable clinically related health service is 2 offered, a facility providing treatment solely on the basis of 3 prayer or spiritual means in accordance with the tenets of any 4 church or religious denomination or a facility conducted by a 5 religious organization for the purpose of providing health care 6 services exclusively to clergy or other persons in a religious 7 profession who are members of the religious denominations 8 conducting the facility. 9 "Health care practitioner." An individual who is authorized 10 to practice some component of the healing arts by a license, 11 permit, certificate or registration issued by a Commonwealth 12 licensing agency or board. 13 "Health care provider" or "provider." An individual, a trust 14 or estate, a partnership, a corporation (including associations, 15 joint stock companies and insurance companies), the 16 Commonwealth, or a political subdivision or instrumentality 17 (including a municipal corporation or authority) thereof, that 18 operates a health care facility. 19 "Health planning area." A geographic area within the 20 Commonwealth designated by the Department of Health for purposes 21 of health planning. 22 ["Hearing board." The State Health Facility Hearing Board 23 created in the Office of General Counsel under the provisions of 24 this act.] 25 "Interested person" or "person expressing an interest." For 26 the purposes of Chapter 7, a member of the public who is to be 27 served by the proposed new health service in the area to be 28 served by the applicant, a health care facility or health 29 maintenance organization or any health care provider providing 30 similar services in the area to be served by the applicant or 20040H2760B4176 - 4 -
1 who has received a certificate of need to provide services in 2 the area to be served by the applicant or who has formally filed 3 with the department a letter of intent to provide similar 4 services in the area in which the proposed service is to be 5 offered or developed and any third party payor of health 6 services provided in that area who provides written notice to 7 the department that the person is interested in a specific 8 certificate of need application before the department. 9 "Offer." Make provision for providing in a regular manner 10 and on an organized basis clinically related health services. 11 "Patient." A natural person receiving health care in or from 12 a health care provider. 13 "Person." A natural person, corporation (including 14 associations, joint stock companies and insurance companies), 15 partnership, trust, estate, association, the Commonwealth, and 16 any local governmental unit, authority and agency thereof. 17 "Policy board." The Health Policy Board created in the 18 Department of Health under the provisions of this act. 19 "Public meeting." A meeting open to the public where any 20 person has an opportunity to comment on a certificate of need 21 application or proposed State health services plan amendment. 22 "Secretary." The Secretary of the Department of Health of 23 the Commonwealth of Pennsylvania. 24 "State health services plan." A document developed by the 25 Department of Health, after consultation with the policy board 26 and approved by the Governor, that is consistent with section 27 401.3, that meets the current and projected needs of the 28 Commonwealth's citizens. The State health services plan shall 29 contain, in part, the standards and criteria against which 30 certificate of need applications are reviewed and upon which 20040H2760B4176 - 5 -
1 decisions are based. 2 "Third party payor." A person who makes payments on behalf 3 of patients under compulsion of law or contract who does not 4 supply care or services as a health care provider or who is 5 engaged in issuing any policy or contract of individual or group 6 health insurance or hospital or medical service benefits. The 7 term shall not include the Federal, State, or any local 8 government unit, authority, or agency thereof or a health 9 maintenance organization. 10 Section 3. Section 201 of the act, amended December 18, 1992 11 (P.L.1602, No.179), is reenacted and amended to read: 12 Section 201. Powers and duties of the department. 13 The Department of Health shall have the power and its duties 14 shall be: 15 (1) To exercise exclusive jurisdiction over health care 16 providers in accordance with the provisions of this act. 17 (2) To issue determinations of reviewability or 18 nonreviewability of certificate of need proposals. 19 (3) To issue certificates of need and amended 20 certificates of need in accordance with the provisions of 21 this act. 22 (4) To withdraw expired certificates of need. 23 (5) To require, pursuant to regulation, submission of 24 periodic reports by providers of health services and other 25 persons subject to review respecting the development of 26 proposals subject to review. 27 [(6) Upon consultation with the policy board, to 28 research, prepare and, after approval by the Governor, 29 publish, no later than 18 months after the effective date of 30 this act and annually thereafter, a revised State health 20040H2760B4176 - 6 -
1 services plan for the Commonwealth as defined under this act. 2 Until the State health services plan as defined in section 3 401.3 is adopted, the department shall apply the State health 4 plan in existence on the effective date of this act, along 5 with any subsequent updates to that plan.] 6 (6.1) Upon consultation with the policy board, to 7 research, prepare and, after approval by the Governor, 8 publish, no later than six months after the effective date of 9 this paragraph and annually thereafter, a State health 10 services plan for the Commonwealth as defined under this act. 11 (7) To collect and disseminate such other information as 12 may be appropriate to determine the appropriate level of 13 facilities and services for the effective implementation of 14 certification of need under this act. Where such information 15 is collected by any other agency of State government, 16 duplication shall be avoided by coordination of data 17 collection activities. 18 (8) To furnish such staff support and expertise to the 19 policy board as may be needed to perform its 20 responsibilities. 21 (9) To receive, log and review all applications for 22 certificates of need or amendments thereof and approve or 23 disapprove the same. 24 (10) To minimize the administrative burden on health 25 care providers by eliminating unnecessary duplication of 26 financial and operational reports and to the extent possible 27 coordinating reviews and inspections performed by Federal, 28 State, local and private agencies. 29 (11) To adopt and promulgate regulations necessary to 30 carry out the purposes and provisions of this act relating to 20040H2760B4176 - 7 -
1 certificate of need. 2 (12) To enforce the rules and regulations promulgated by 3 the department as provided in this act. 4 (13) To provide technical assistance to individuals and 5 public and private entities in filling out the necessary 6 forms for the development of projects and programs. 7 (14) To establish and publish in the Pennsylvania 8 Bulletin a fee schedule for certificate of need applications 9 and letters of intent in accordance with section 902.1. 10 (15) To coordinate any data collection activities 11 necessary for administration of this act so as not to 12 duplicate unnecessarily the data collection activities of 13 other Federal and State agencies. 14 (16) To modify the list of reviewable clinically related 15 health services established under section 701. 16 Section 4. Section 401.3 of the act, added December 18, 1992 17 (P.L.1602, No.179), is reenacted to read: 18 Section 401.3. State health services plan. 19 The State health services plan shall consist of at a minimum: 20 (1) An identification of the clinically related health 21 services necessary to serve the health needs of the 22 population of this Commonwealth, including those medically 23 underserved areas in rural and inner-city locations. 24 (2) An analysis of the availability, accessibility and 25 affordability of the clinically related health services 26 necessary to meet the health needs of the population of this 27 Commonwealth. 28 (3) Qualitative and quantitative standards and criteria 29 for the review of certificate of need applications by the 30 department under this act. 20040H2760B4176 - 8 -
1 (4) An exceptions process which permits exceptions to be 2 granted to the standards and criteria in order to reflect 3 local experience or ensure access or to respond to 4 circumstances which pose a threat to public health and 5 safety. 6 Section 5. Section 602 of the act is reenacted to read: 7 Section 602. Regulations. 8 The department is hereby authorized and empowered pursuant to 9 the provisions of this act to adopt rules and regulations 10 establishing procedures required by this act for administration 11 of certificate of need. 12 Section 6. Sections 603, 701 and 702 of the act, amended 13 December 18, 1992 ( P.L.1602, No.179), are reenacted and amended 14 to read: 15 Section 603. Enforcement of orders relating to certificate of 16 need. 17 (a) (1) [No] After December 31, 2004, no certificate of 18 need shall be granted to any person for a health care 19 facility or reviewable clinically related health service 20 unless such facility or clinically related health service is 21 found by the department to be needed. 22 (2) [No] After December 31, 2004, no person shall offer 23 or develop a health care facility or reviewable clinically 24 related health service without obtaining a certificate of 25 need as required by this act. 26 (3) [No] After December 31, 2004, no binding arrangement 27 or commitment for financing the offering or development of a 28 health care facility or reviewable clinically related health 29 service shall be made by any person unless a certificate of 30 need for such clinically related health service or facility 20040H2760B4176 - 9 -
1 has been granted in accordance with this act. 2 (b) Orders for which the time of appeal has expired shall be 3 enforced by the department in summary proceedings or, when 4 necessary, with the aid of the court. 5 (c) No collateral attack on any order, including questions 6 relating to jurisdiction shall be permitted in the enforcement 7 proceeding, but such relief may be sought when such relief has 8 not been barred by the failure to take a timely appeal. 9 (d) [Any] After December 31, 2004, any person operating a 10 reviewable clinically related health service or health care 11 facility within this Commonwealth for which no certificate of 12 need has been obtained, after service of a cease and desist 13 order of the department, or after expiration of the time for 14 appeal of any final order on appeal, upon conviction thereof, 15 shall be sentenced to pay a fine of not less than [$100] $1,000 16 or more than [$1,000] $10,000 and costs of prosecution. Each day 17 of operating a clinically related health service or health care 18 facility after issuance of a cease and desist order shall 19 constitute a separate offense. 20 (e) [Any] After December 31, 2004, any person who violates 21 this act by failing to obtain a certificate of need, by 22 deviating from the provisions of the certificate, by beginning 23 construction, by providing services, or by acquiring equipment 24 after the expiration of a certificate of need shall be subject 25 to a penalty of not less than [$100] $1,000 per day and not more 26 than [$1,000] $10,000 per day. Each day of each such violation 27 shall be considered a separate offense. 28 (f) The department may seek injunctive relief to prevent 29 continuing violations of this act. In seeking such relief, the 30 department need not prove irreparable harm. 20040H2760B4176 - 10 -
1 (g) [No] After December 31, 2004, no license to operate a 2 health care facility or reviewable clinically related health 3 service by any person in this Commonwealth shall be granted and 4 any license issued after December 31, 2004, shall be void and of 5 no effect as to any facility, organization, service or part 6 thereof for which a certificate of need is required by this act 7 and not granted. Nor shall a certificate of need be required for 8 any new institutional health service provided by a health care 9 facility that serves a medically underserved area and is located 10 in a nonmetropolitan area and in a county of the sixth, seventh 11 or eighth class. 12 Section 701. Certificate of need required; clinically related 13 health services subject to review. 14 (a) [Any] After December 31, 2004, any person, including, 15 but not limited to, a health care facility, health maintenance 16 organization or health care provider who offers, develops, 17 constructs, renovates, expands or otherwise establishes or 18 undertakes to establish within the State a clinically related 19 health service that is included in the department's list of 20 reviewable services developed under subsections (d) and (e) or a 21 health care facility as defined in section 103 must obtain a 22 certificate of need from the department if one or more of the 23 following factors applies: 24 (1) The proposal requires a capital expenditure in 25 excess of [$2,000,000] $3,000,000 under generally accepted 26 accounting principles, consistently applied. 27 (2) The proposal involves the establishment of a health 28 care facility or a reviewable clinically related health 29 service. 30 [(3) The proposal increases the number of licensed beds 20040H2760B4176 - 11 -
1 by more than ten beds or 10%, whichever is less, every two 2 years. 3 (i) If the additional beds are acute care beds and 4 are not beds in a distinct-part psychiatric, 5 rehabilitation or long-term care unit, all licensed beds 6 of the acute-care facility shall be counted in 7 determining whether the increased number of beds exceeds 8 10%. 9 (ii) If the additional beds are beds in a distinct- 10 part psychiatric, rehabilitation or long-term care unit 11 of an acute care facility, only the beds within that unit 12 shall be counted in determining whether the increased 13 number of beds exceeds 10%. 14 (iii) If the additional beds are in a freestanding 15 psychiatric, rehabilitation or long-term care facility, 16 all licensed beds of the freestanding facility shall be 17 counted in determining whether the increased number of 18 beds exceeds 10%.] 19 (4) The proposal substantially expands an existing 20 clinically related health service as determined by the 21 department in the State health services plan. 22 (b) For the purposes of this act, an expenditure for the 23 purpose of acquiring an existing health care facility or 24 replacement of equipment where there is no change in service 25 shall not be considered to be a capital expenditure subject to 26 review. Expenditures for nonclinical activities or services, 27 such as parking garages, computer systems or refinancing of 28 debt, and research projects involving premarket approval of new 29 equipment shall not be subject to review. 30 (c) The capital expenditure threshold identified in 20040H2760B4176 - 12 -
1 subsection (a)(1) may be modified periodically by the department 2 to reflect any increase in the construction cost or other 3 factors influencing health care-related capital expenditures. 4 The department shall publish a modification of the expenditure 5 threshold through the regulatory review process. 6 (d) A list of reviewable clinically related health services 7 shall be published by the department within 30 days of [the 8 effective date of this act] December 31, 2004, and may be 9 modified by regulation on an annual basis. [Exclusive of new 10 high-cost technology, the initial list published by the 11 department as required under this subsection shall be no more 12 extensive than those services reviewable on the effective date 13 of this act.] Criteria for inclusion of reviewable services 14 shall include, but not be limited to: 15 (1) the quality of the service to be offered is likely 16 to be compromised through insufficient volumes or 17 utilization; 18 (2) the service is dependent upon the availability of 19 scarce natural resources such as human organs; or 20 [(3) the operating costs associated with the service are 21 reimbursed by major third party payors on a cost 22 reimbursement basis; or] 23 (4) the service involves the use of new technology. 24 (e) Any changes to the list required under subsection (d) 25 and proposed by regulation shall be developed by the department 26 after consultation with the policy board. 27 (f) A facility providing treatment solely on the basis of 28 prayer or spiritual means in accordance with the tenets of any 29 church or religious denomination or a facility conducted by a 30 religious organization for the purpose of providing health care 20040H2760B4176 - 13 -
1 services exclusively to clergy or other persons in a religious
2 profession who are members of the religious denomination
3 conducting the facility shall not be considered to constitute a
4 health service subject to review under this act.
5 [(g) As used in this section, "new high-cost technology"
6 means new technological equipment with an aggregate purchase
7 cost of greater than $500,000. The department shall consult with
8 national medical and surgical speciality organizations
9 recognized by the American Board of Medical Specialities (ABMS)
10 and other nationally recognized scientific resources in the
11 determination of what constitutes new technological equipment.]
12 Section 702. Certificates of need; notice of intent;
13 application; issuance.
14 (a) [Projects] After December 31, 2004, projects requiring a
15 certificate of need shall, at the earliest possible time in
16 their planning, be submitted to the department in a letter of
17 intent in such detail advising of the scope and nature of the
18 project as required by regulations. Within 30 days after receipt
19 of the letter of intent, the department shall inform the
20 applicant providing the letter of intent whether the proposed
21 project is subject to a certificate of need review or if
22 additional information is required to make that determination.
23 If the department determines that the project is subject to a
24 certificate of need review, the project shall be subject to the
25 remaining provisions of this act.
26 (b) A person desiring to obtain or amend a certificate of
27 need shall apply in writing to the department, supplying such
28 information as is required by the department and certifying that
29 all data, information and statements are factual to the best of
30 their knowledge, information and belief. The department shall
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1 have 60 days after receipt of the application within which to 2 assess the application and in which to request specific further 3 information. If further information is requested, the department 4 shall complete its preliminary assessment of the application 5 within 45 days of receipt of the same. No information shall be 6 required that is not specified in the rules and regulations 7 promulgated by the department. 8 (c) Timely notice of the beginning of review of the 9 application by the department shall be published after 10 preliminary assessment of the application is completed by the 11 department. The "date of notification" of the beginning of 12 review shall be the date such notice is sent, or the date such 13 notice is published in the Pennsylvania Bulletin or in a 14 newspaper of general circulation, whichever is latest. 15 (d) The department shall approve or disapprove the 16 application within [90] 120 days from the date of notification 17 of the beginning of the review [unless the period for review is 18 extended by the applicant in writing]. Unless a disapproval is 19 issued by the department within the period provided in this 20 section, an application made under section 702 shall be deemed 21 approved. 22 (e) (1) Certificates of need shall be granted or refused. 23 They shall not be conditioned upon the applicant changing 24 other aspects of its facilities or services or requiring the 25 applicant to meet other specified requirements, and no such 26 condition shall be imposed by the department in granting or 27 refusing approval of certificates of need. 28 (2) A certificate of need shall state the maximum amount 29 of expenditures which may be obligated under it and 30 applicants proceeding with an approved project may not exceed 20040H2760B4176 - 15 -
1 this level of expenditure except as allowed under the 2 conditions and procedures established by the department 3 through regulation. 4 (f) (1) The department shall make written findings which 5 state the basis for any final decision made by the 6 department. Such findings shall be served upon the applicant 7 and provided to all persons expressing an interest in the 8 proceedings and shall be made available to others upon 9 written request. 10 (2) All decisions of the department shall be based 11 solely on the record. No ex parte contact regarding the 12 application between any employee of the department who 13 exercises responsibilities respecting the application and the 14 applicant, any person acting on behalf of the applicant or 15 any person opposed to the issuance of the certificate of need 16 shall occur after the commencement of a hearing on the 17 application and before a decision is made by the department. 18 (g) Modification of the application at any stage of the 19 proceeding shall not extend the time limits provided by this act 20 unless the department expressly finds that the modification 21 represents a substantial change in the character of the 22 application. 23 (h) The responsibility of performing certificate of need 24 review may not be delegated by the department. The department 25 shall consider recommendations of one or more community-based 26 health services planning committees whose localities are 27 affected by specific applications. 28 (i) The department may provide that categories of projects 29 shall receive simultaneous and comparative review. 30 Section 7. Section 703 of the act, amended July 12, 1980 20040H2760B4176 - 16 -
1 (P.L.655, No.136), is amended to read: 2 [Section 703. Notice and hearings before health systems 3 agencies. 4 (a) Notice of completed applications for certificates of 5 need or amendment thereto and of the beginning of review shall 6 be published by the health systems agency in the appropriate 7 news media and by the department in the Pennsylvania Bulletin in 8 accordance with 45 Pa.C.S. Chap. 7B (relating to publication of 9 documents), and the health systems agency shall notify all 10 affected persons with notice of the schedule for review, the 11 date by which a public hearing must be demanded, and of the 12 manner notice will be given of a hearing, if one is to be held. 13 Notice to affected persons (other than members of the public who 14 are to be served by the proposed new institutional health 15 service) shall be by mail (which may be part of a newsletter). 16 Members of the public may be notified through newspapers of 17 general circulation. Directly affected persons may file 18 objections within 15 days of such publication with the local 19 health systems agency setting forth specifically the reasons 20 such objections were filed. Persons filing the objections shall 21 be parties to the proceeding, unless and until such objections 22 are withdrawn. 23 (b) Affected persons may request a public hearing or the 24 health systems agency may require a public hearing during the 25 course of such review. Fourteen days written notice of the 26 hearing shall be given to affected persons in the same manner as 27 a notice of a completed application is provided in subsection 28 (a). In the hearing, any person shall have the right to be 29 represented by counsel and to present oral or written arguments 30 and relevant evidence. Any person directly affected may conduct 20040H2760B4176 - 17 -
1 reasonable questioning of persons who make relevant factual 2 allegations. A record of the hearing shall be maintained.] 3 Section 8. Sections 704, 705, 706, 707, 708.1 and 709 of the 4 act, amended or added December 18, 1992 (P.L.1602, No.179), are 5 reenacted to read: 6 Section 704. Notice of public meetings. 7 (a) Notification of the beginning of review of a certificate 8 of need application shall be published by the department in the 9 appropriate news media and in the Pennsylvania Bulletin in 10 accordance with 45 Pa.C.S. Ch. 7 Subch. B (relating to 11 publication of documents). The notice shall identify the 12 schedule for review, the date by which a public meeting must be 13 requested and the manner in which notice will be given of a 14 meeting, if one is held. 15 (b) Interested persons may request a public meeting within 16 15 days of publication, and the department shall hold such a 17 meeting or the department may require a public meeting during 18 the course of such review. The department shall publish written 19 notice of the meeting in the appropriate news media and the 20 Pennsylvania Bulletin at least 14 days prior to the public 21 meeting date. In the meeting, the applicant and any interested 22 person providing prior notice to the department shall have the 23 right to present oral or written comments and relevant evidence 24 on the application in the manner prescribed by the department. 25 The department shall prepare a transcript of the oral testimony 26 presented at the meeting. Meetings shall be held in accordance 27 with the guidelines and procedures established by the department 28 and published in the Pennsylvania Code as a statement of policy. 29 The department may require the applicant to provide copies of 30 the application to any interested person making a request for 20040H2760B4176 - 18 -
1 such application, at the expense of the interested person. 2 (c) The applicant may, for good cause shown, request in 3 writing a public hearing for the purpose of reconsideration of a 4 decision of the department within ten days of service of the 5 decision of the department. The department shall treat the 6 request in accordance with the provisions of 1 Pa. Code § 35.241 7 (relating to application for rehearing or reconsideration). The 8 department shall set forth the cause for the hearing and the 9 issues to be considered at such hearing. If such hearing is 10 granted, it shall be held no sooner than six days and no later 11 than 30 days after the notice to grant such a hearing and shall 12 be limited to the issues submitted for reconsideration. A 13 transcript shall be made of the hearing and a copy of the 14 transcript shall be provided at cost to the applicant. The 15 department shall affirm or reverse its decision and submit the 16 same to the person requesting the hearing within 30 days of the 17 conclusion of such hearing. Any change in the decision shall be 18 supported by the reasons for the change. 19 (d) Where hearings under subsection (b) are held on more 20 than two days, consecutive days of hearings and intervening 21 weekends and holidays shall be excluded in calculating the time 22 permitted for the department to conduct its review, and, if 23 briefs are to be filed, ten days subsequent to the adjournment 24 of the hearing shall also be excluded. 25 Section 705. Good cause. 26 Good cause shall be deemed to have been shown if: 27 (1) there is significant, relevant information not 28 previously considered; 29 (2) there is significant change in factors or 30 circumstances relied on in making the decision; 20040H2760B4176 - 19 -
1 (3) there has been material failure to comply with the
2 procedural requirements of this act; or
3 (4) good cause is otherwise found to exist.
4 Section 706. Information during review.
5 During the course of review the department shall upon request
6 of any person set forth the status, any findings made in the
7 proceeding and other appropriate information requested. The
8 department may require such request in writing.
9 Section 707. Criteria for review of applications for
10 certificates of need or amendments.
11 (a) An application for certificate of need shall be
12 considered for approval when the department determines that the
13 application substantially meets the requirements listed below:
14 (1) There is need by the population served or to be
15 served by the proposed service or facility.
16 [(2) The proposed service or facility will provide care
17 consistent with quality standards established by the State
18 health services plan.]
19 (3) The proposed service or facility will meet the
20 standards identified in the State health services plan for
21 access to care by medically underserved groups, including
22 individuals eligible for medical assistance and persons
23 without health insurance.
24 (b) The department shall issue a certificate of need if the
25 project substantially meets the criteria of subsection (a)(1)[,]
26 and (2) [and (3)] and the project is consistent with the State
27 health services plan unless the department can demonstrate:
28 (1) There is a more appropriate, less costly or more
29 effective alternative method of providing the proposed
30 services.
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1 (2) The service or facility is not financially and 2 economically feasible, considering anticipated volume of care 3 and the availability of reasonable financing based on 4 information received from the applicant and other sources 5 during the review process. 6 (3) The proposed service or facility will have an 7 inappropriate, adverse impact on the overall level of health 8 care expenditures in the area. 9 (4) The proposed service or facility adversely impacts 10 the maintenance and development of rural and inner-city 11 health services generally and, in particular, those services 12 provided by health care providers which are based in rural 13 and inner-city locations and which have an established 14 history of providing services to medically underserved 15 populations. 16 (c) Notwithstanding the provisions of subsections (a) and 17 (b), applications for projects described in subsection (d) shall 18 be approved unless the department finds that the facility or 19 service with respect to such expenditure as proposed is not 20 needed or that the project is not consistent with the State 21 health services plan. An application made under this subsection 22 shall be approved only to the extent that the department 23 determines it is required to overcome the conditions described 24 in subsection (d). 25 (d) Subject to the provisions of subsection (c), subsections 26 (a) and (b) shall not apply to capital expenditures required to: 27 (1) eliminate or prevent imminent safety hazards as a 28 result of violations of safety codes or regulations; 29 (2) comply with State licensure standards; or 30 (3) comply with accreditation standards, compliance with 20040H2760B4176 - 21 -
1 which is required to receive reimbursement or payments under 2 Title XVIII or XIX of the Federal Social Security Act. 3 Section 708.1. Monitoring certificate of need; expiration of a 4 certificate of need. 5 A certificate of need or an amendment to it shall expire two 6 years from the date issued unless substantially implemented, as 7 defined by regulation. The department may grant extensions for a 8 specified time upon request of the applicant and upon a showing 9 that the applicant has or is making a good faith effort to 10 substantially implement the project. An expired certificate of 11 need shall be invalid, and no person may proceed to undertake 12 any activity pursuant to it for which a certificate of need or 13 amendment is required. The applicant shall report to the 14 department, on forms prescribed by the department, the status of 15 the project until such time as the project is licensed or 16 operational, if no license is required. 17 Section 709. Emergencies. 18 Notwithstanding any other provision of this act, in the event 19 of an emergency the department may suspend the foregoing 20 application process and permit such steps to be taken as may be 21 required to meet the emergency including the replacement of 22 equipment or facilities. 23 Section 9. Section 711 of the act, amended December 18, 1992 24 (P.L.1602, No.179), is reenacted to read: 25 Section 711. Review of activities. 26 (a) The department shall prepare and publish not less 27 frequently than annually reports of reviews conducted under this 28 act, including a statement on the status of each such review and 29 of reviews completed by it and statements of the decisions made 30 in the course of such reviews since the last report. The 20040H2760B4176 - 22 -
1 department shall also make available to the general public for 2 examination at reasonable times of the business day all 3 applications reviewed by it. Such reports and applications shall 4 be considered public records. 5 (b) The department's report which shall be submitted to the 6 members of the Health and Welfare Committees of the Senate and 7 House of Representatives shall contain the following 8 information: 9 (1) The volume of applications submitted, by project 10 type, their dollar value, and the numbers and costs 11 associated with those approved and those not approved. 12 (2) The assessment of the extent of competition in 13 specific service sectors that guided decisions. 14 (3) A detailed description of projects involving 15 nontraditional or innovative service delivery methods or 16 organizational arrangements and the decisions made on each of 17 these projects. 18 (4) The average time for review, by level of review. 19 (5) The fees collected for reviews and the cost of the 20 program. 21 Section 10. Section 712 of the act, added July 12, 1980 22 (P.L.655, No.136), is reenacted and amended to read: 23 Section 712. Actions against violations of law and rules and 24 regulations[; bonds]. 25 [(a)] Whenever any person, regardless of whether such person 26 is a licensee, has willfully violated any of the provisions of 27 this act or the rules and regulations adopted thereunder, the 28 department may maintain any action in the name of the 29 Commonwealth for an injunction or other process restraining or 30 prohibiting such person from engaging in such activity. 20040H2760B4176 - 23 -
1 Section 11. Section 808 of the act, amended December 18,
2 1992 (P.L.1602, No.179) and October 16, 1998 (P.L.777, No.95),
3 is reenacted and amended to read:
4 Section 808. Issuance of license.
5 (a) Standards.--The department shall issue a license to a
6 health care provider when it is satisfied that the following
7 standards have been met:
8 (1) that the health care provider is a responsible
9 person;
10 (2) that the place to be used as a health care facility
11 is adequately constructed, equipped, maintained and operated
12 to safely and efficiently render the services offered;
13 (3) that the health care facility provides safe and
14 efficient services which are adequate for the care, treatment
15 and comfort of the patients or residents of such facility;
16 (4) that there is substantial compliance with the rules
17 and regulations adopted by the department pursuant to this
18 act; and
19 (5) that after December 31, 2004, a certificate of need
20 has been issued if one is necessary.
21 (b) Separate and limited licenses.--Separate licenses shall
22 not be required for different services within a single health
23 care facility except that home health care, hospice or long-term
24 nursing care will require separate licenses. A limited license,
25 excluding from its terms a particular service or portion of a
26 health care facility, may be issued under the provisions of this
27 act.
28 (c) Addition of services.--When the certificate of need for
29 a facility is amended as to services which can be offered, the
30 department shall issue an appropriate license for those services
20040H2760B4176 - 24 -
1 upon demonstration of compliance with licensure requirements.
2 Section 12. Section 901 amended July 12, 1980 (P.L.655,
3 No.136), is reenacted and amended to read:
4 Section 901. Existing facilities and institutions.
5 No certificate of need shall be required for any buildings,
6 real property and equipment owned, leased or being operated, or
7 under contract for construction, purchase, or lease and for all
8 services being rendered by licensed or approved providers on
9 [April 1, 1980] December 31, 2004. [Nor shall a certificate of
10 need be required for any new institutional health services for
11 which an approval has been granted under section 1122 of the
12 Social Security Act or for which an application is found
13 pursuant to such section to be in conformity with the standards,
14 criteria or plans to which such section refers, or as to which
15 the Federal Secretary of Health and Human Services makes a
16 finding that reimbursement shall be granted: Provided, however,
17 That such approval is in force on August 1, 1980 or such
18 application shall have been filed prior to August 1, 1980 or the
19 acceptance of applications for reviews under this act, whichever
20 shall last occur.]
21 Section 13. Sections 902.1 and 904.1 of the act, added
22 December 18, 1992 (P.L.1602, No.179), are reenacted and amended
23 to read:
24 Section 902.1. Fees for review of certificate of need
25 applications.
26 (a) The department shall charge a fee of [$150] $500 for
27 each letter of intent filed. The letter of intent fee shall be
28 deducted from the total application fee required under
29 subsection (b) if an application is submitted on the project
30 proposed in the letter of intent.
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1 (b) For each application the department shall charge a fee, 2 payable on submission of an application. The fee shall not be 3 less than $500 plus up to [$3] $10 per $1,000 of proposed 4 capital expenditure and shall not be more than $20,000. 5 (c) The department shall publish a fee schedule in the 6 Pennsylvania Bulletin which shall explain the procedure for 7 filing fees. 8 (d) All fees payable under this section are due upon the 9 date of filing a letter of intent or application. If a person 10 fails to file the appropriate fee, all time frames required of 11 the department under this act, with respect to review of a 12 letter of intent or application, are suspended until the 13 applicable fee is paid in full. 14 Section 904.1. Sunset. 15 The authority, obligations and duties arising under Chapter 7 16 and all other provisions of this act pertaining to certificates 17 of need shall terminate [four years after the effective date of 18 this section] December 31, 2014. [Twelve months prior to this 19 expiration] On December 31, 2013, the Legislative Budget and 20 Finance Committee shall commence a review of the impact of the 21 certificate of need program on quality, access and cost of 22 health care services, including the costs of appeals, reviewable 23 under this act. 24 Section 14. This act shall take effect immediately. F16L35DMS/20040H2760B4176 - 26 -