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| THE GENERAL ASSEMBLY OF PENNSYLVANIA |
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| HOUSE BILL |
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| INTRODUCED BY MUNDY, PASHINSKI, SANTARSIERO, BISHOP, BRENNAN, BUXTON, CALTAGIRONE, CARROLL, D. COSTA, DeLUCA, FRANKEL, FREEMAN, GEORGE, HORNAMAN, JOSEPHS, KORTZ, MATZIE, MURPHY, M. O'BRIEN, READSHAW AND K. SMITH, JANUARY 25, 2011 |
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| REFERRED TO COMMITTEE ON AGING AND OLDER ADULT SERVICES, JANUARY 25, 2011 |
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| AN ACT |
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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 definitions, powers and duties of |
11 | Department of Health and State health services plan; |
12 | reenacting provisions relating to regulations; reenacting and |
13 | amending provisions relating to certificates of need and |
14 | issuance of license; prohibiting certain referrals and claims |
15 | of payment; and repealing sunset provisions. |
16 | The General Assembly of the Commonwealth of Pennsylvania |
17 | hereby enacts as follows: |
18 | Section 1. Section 103 of the act of July 19, 1979 (P.L.130, |
19 | No.48), known as the Health Care Facilities Act, amended |
20 | December 18, 1992 (P.L.1602, No.179) and October 16, 1998 (P.L. |
21 | 777, No.95), is reenacted and amended to read: |
22 | Section 103. Definitions. |
23 | The following words and phrases when used in this act shall |
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1 | have, unless the context clearly indicates otherwise, the |
2 | meanings given to them in this section: |
3 | "Act." The comprehensive Health Care Facilities Act. |
4 | "Board." The Health Policy Board established under section |
5 | 401.1. |
6 | "Certificate of need." A notice of approval issued by the |
7 | [department] Department of Health under the provisions of this |
8 | act, including those notices of approval issued as an amendment |
9 | to an existing certificate of need. |
10 | "Certification of need (CON) review board." The CON review |
11 | board, which consists of technical experts in the fields of |
12 | medicine, health facility administration, health economics, |
13 | health care cost inflation and the like, including experts from |
14 | within the Commonwealth agencies, together with consumers of |
15 | health care, all of whom are appointed by the Secretary of |
16 | Health. |
17 | "Clinically related health service." Certain diagnostic, |
18 | treatment or rehabilitative services as determined in section |
19 | 701. |
20 | ["Community-based health services planning committee." A |
21 | committee established in accordance with procedures approved by |
22 | the Department of Health which includes representatives of local |
23 | or regional groups of consumers, business, labor, health care |
24 | providers, payors or other affected interests.] |
25 | "Conflict of interest." [For the purpose of section 501, |
26 | the] The interest of any person, whether financial, by |
27 | association with, or as a contributor of money or time to, any |
28 | nonprofit corporation or other corporation, partnership, |
29 | association, or other organization, and whenever a person is a |
30 | director, officer or employee of such organization, but shall |
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1 | not exist whenever the organization in which such person is |
2 | interested is being considered as part of a class or group for |
3 | whom regulations are being considered, if the material facts as |
4 | to the relationship or interest are disclosed or are known to |
5 | the board. |
6 | "Consumer." A natural person who is not involved in the |
7 | provision of health services or health insurance. For the |
8 | purpose of this act, any person who holds a fiduciary position |
9 | in any health care facility, health maintenance organization or |
10 | third party payor shall not be considered a consumer. |
11 | "Council." The Health Care Cost Containment Council. |
12 | "Department." The Department of Health of the Commonwealth. |
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] A |
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, diagnostic imaging |
23 | centers, MRI facilities, long-term care nursing facilities, |
24 | cancer treatment centers using radiation therapy on an |
25 | ambulatory basis and inpatient drug and alcohol treatment |
26 | facilities, both profit and nonprofit and including those |
27 | operated by an agency or State or local government. The term |
28 | shall also include a hospice. The term shall not include an |
29 | office used primarily for the private or group practice by |
30 | health care practitioners where no reviewable clinically related |
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1 | health service is offered, a facility providing treatment solely |
2 | on the basis of prayer or spiritual means in accordance with the |
3 | tenets of any church or religious denomination or a facility |
4 | conducted by a religious organization for the purpose of |
5 | providing health care services exclusively to clergy or other |
6 | persons in a religious profession who are members of the |
7 | religious denominations conducting the facility. |
8 | "Health care practitioner." An individual who is authorized |
9 | to practice some component of the healing arts by a license, |
10 | permit, certificate or registration issued by a Commonwealth |
11 | licensing agency or board. |
12 | "Health care provider" or "provider." An individual, a trust |
13 | or estate, a partnership, a corporation (including associations, |
14 | joint stock companies and insurance companies), the |
15 | Commonwealth, or a political subdivision or instrumentality |
16 | (including a municipal corporation or authority) thereof, that |
17 | operates a health care facility. |
18 | "Health planning area." A geographic area within the |
19 | Commonwealth designated by the Department of Health for purposes |
20 | of health planning. |
21 | "Hearing board." The State Health Facility Hearing Board |
22 | created in the Office of General Counsel under the provisions of |
23 | this act. |
24 | "Interested person" or "person expressing an interest." [For |
25 | the purposes of Chapter 7, a] A member of the public who is to |
26 | be served by the proposed new health service in the area to be |
27 | served by the applicant, a health care facility or health |
28 | maintenance organization or any health care provider providing |
29 | similar services in the area to be served by the applicant or |
30 | who has received a certificate of need to provide services in |
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1 | the area to be served by the applicant or who has formally filed |
2 | with the [department] Department of Health a letter of intent to |
3 | provide similar services in the area in which the proposed |
4 | service is to be offered or developed and any third party payor |
5 | of health services provided in that area who provides written |
6 | notice to the [department] Department of Health that the person |
7 | is interested in a specific certificate of need application |
8 | before the [department] Department of Health. |
9 | "Local review committee." A committee established in |
10 | accordance with procedures approved by the Department of Health |
11 | that includes representatives of local or regional groups of |
12 | consumers, business, labor, health care providers, payors or |
13 | other affected interests. |
14 | "Offer." Make provision for providing in a regular manner |
15 | and on an organized basis clinically related health services. |
16 | "Patient." A natural person receiving health care in or from |
17 | a health care provider. |
18 | "Person." A natural person, corporation (including |
19 | associations, joint stock companies and insurance companies), |
20 | partnership, trust, estate, association, the Commonwealth, and |
21 | any local governmental unit, authority and agency thereof. |
22 | "Policy board." The Health Policy Board created in the |
23 | Department of Health under the provisions of this act. |
24 | "Public meeting." A meeting open to the public where any |
25 | person has an opportunity to comment on a certificate of need |
26 | application or proposed State health [services] improvement plan |
27 | amendment. |
28 | "Secretary." The Secretary of [the Department of] Health of |
29 | the Commonwealth of Pennsylvania. |
30 | ["State health services plan." A document developed by the |
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1 | Department of Health, after consultation with the policy board |
2 | and approved by the Governor, that is consistent with section |
3 | 401.3, that meets the current and projected needs of the |
4 | Commonwealth's citizens. The State health services plan shall |
5 | contain, in part, the standards and criteria against which |
6 | certificate of need applications are reviewed and upon which |
7 | decisions are based.] |
8 | "Third party payor." A person who makes payments on behalf |
9 | of patients under compulsion of law or contract who does not |
10 | supply care or services as a health care provider or who is |
11 | engaged in issuing any policy or contract of individual or group |
12 | health insurance or hospital or medical service benefits. The |
13 | term shall not include the Federal, State, or any local |
14 | government unit, authority, or agency thereof or a health |
15 | maintenance organization. |
16 | Section 2. Sections 201 and 401.3 of the act, amended or |
17 | added December 18, 1992 (P.L.1602, No.179), are reenacted and |
18 | amended to read: |
19 | Section 201. Powers and duties of the department. |
20 | The Department of Health shall have the power and its duties |
21 | shall be: |
22 | (1) To exercise exclusive jurisdiction over health care |
23 | providers in accordance with the provisions of this act. |
24 | (2) To issue determinations of reviewability or |
25 | nonreviewability of certificate of need proposals. |
26 | (2.1) To develop qualitative and quantitative standards |
27 | and criteria for the review and approval of certificate of |
28 | need applications. |
29 | (3) To issue certificates of need and amended |
30 | certificates of need in accordance with the provisions of |
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1 | this act. |
2 | (4) To withdraw expired certificates of need. |
3 | (5) To require, pursuant to regulation, submission of |
4 | periodic reports by providers of health services and other |
5 | persons subject to review respecting the development of |
6 | proposals subject to review. |
7 | [(6) Upon consultation with the policy board, to |
8 | research, prepare and, after approval by the Governor, |
9 | publish, no later than 18 months after the effective date of |
10 | this act and annually thereafter, a revised State health |
11 | services plan for the Commonwealth as defined under this act. |
12 | Until the State health services plan as defined in section |
13 | 401.3 is adopted, the department shall apply the State health |
14 | plan in existence on the effective date of this act, along |
15 | with any subsequent updates to that plan.] |
16 | (6.1) To develop a certificate of need exceptions |
17 | process that permits exceptions to be granted to the |
18 | standards and criteria in order to reflect local experience |
19 | or ensure access or to respond to circumstances that pose a |
20 | threat to public health and safety. The exceptions process |
21 | shall begin only after the department issues a denial of a |
22 | certificate of need application. Exceptions must be publicly |
23 | disclosed. This provision creates no right or entitlement to |
24 | an exception. |
25 | (7) To collect and disseminate such other information as |
26 | may be appropriate to determine the appropriate level of |
27 | facilities and services for the effective implementation of |
28 | certification of need under this act. Where such information |
29 | is collected by any other agency of State government, |
30 | duplication shall be avoided by coordination of data |
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1 | collection activities[.], if the coordination does not |
2 | otherwise unduly burden those State agencies. |
3 | [(8) To furnish such staff support and expertise to the |
4 | policy board as may be needed to perform its |
5 | responsibilities.] |
6 | (9) To receive, log and review all applications for |
7 | certificates of need or amendments thereof and approve or |
8 | disapprove the same. |
9 | (10) To minimize the administrative burden on health |
10 | care providers by eliminating unnecessary duplication of |
11 | financial and operational reports and to the extent possible |
12 | and without undue burden coordinating reviews and inspections |
13 | performed by Federal, State, local and private agencies. |
14 | (11) To adopt and promulgate regulations necessary to |
15 | carry out the purposes and provisions of this act relating to |
16 | certificate of need. |
17 | (12) To enforce the rules and regulations promulgated by |
18 | the department as provided in this act. |
19 | (13) To provide technical assistance to individuals and |
20 | public and private entities in filling out the necessary |
21 | forms for the development of projects and programs. |
22 | (14) To establish and publish in the Pennsylvania |
23 | Bulletin a fee schedule for certificate of need applications |
24 | and letters of intent in accordance with section 902.1. |
25 | (15) To coordinate any data collection activities |
26 | necessary for administration of this act so as not to |
27 | duplicate unnecessarily the data collection activities of |
28 | other Federal and State agencies. |
29 | (16) To modify the list of reviewable clinically related |
30 | health services established under section 701. |
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1 | (17) To establish and publish in the Pennsylvania |
2 | Bulletin a detailed schedule of the review process for each |
3 | certificate of need application submitted to the department. |
4 | Section 401.3. State health [services] improvement plan. |
5 | The State health [services] improvement plan shall consist of |
6 | at a minimum: |
7 | (1) An identification of the clinically related health |
8 | services necessary to serve the health needs of the |
9 | population of this Commonwealth, including those medically |
10 | underserved areas in rural and inner-city locations. |
11 | (2) An analysis of the availability, accessibility and |
12 | affordability of the clinically related health services |
13 | necessary to meet the health needs of the population of this |
14 | Commonwealth. |
15 | [(3) Qualitative and quantitative standards and criteria |
16 | for the review of certificate of need applications by the |
17 | department under this act. |
18 | (4) An exceptions process which permits exceptions to be |
19 | granted to the standards and criteria in order to reflect |
20 | local experience or ensure access or to respond to |
21 | circumstances which pose a threat to public health and |
22 | safety.] |
23 | Section 3. Section 602 of the act is reenacted to read: |
24 | Section 602. Regulations. |
25 | The department is hereby authorized and empowered pursuant to |
26 | the provisions of this act to adopt rules and regulations |
27 | establishing procedures required by this act for administration |
28 | of certificate of need. |
29 | Section 4. Sections 603, 701 and 702 of the act, amended |
30 | December 18, 1992 (P.L.1602, No.179), are reenacted and amended |
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1 | to read: |
2 | Section 603. Enforcement of orders relating to certificate of |
3 | need. |
4 | (a) (1) No certificate of need shall be granted to any |
5 | person for a health care facility or reviewable clinically |
6 | related health service unless such facility or clinically |
7 | related health service is found by the department and CON |
8 | review board to be needed. |
9 | (2) No person shall offer or develop a health care |
10 | facility or reviewable clinically related health service |
11 | without obtaining a certificate of need as required by this |
12 | act. |
13 | (3) No binding arrangement or commitment for financing |
14 | the offering or development of a health care facility or |
15 | reviewable clinically related health service shall be made by |
16 | any person unless a certificate of need for such clinically |
17 | related health service or facility has been granted in |
18 | accordance with this act. |
19 | (b) Orders for which the time of appeal has expired shall be |
20 | enforced by the department and the CON review board in summary |
21 | proceedings or, when necessary, with the aid of the court. |
22 | (c) No [collateral attack on any order, including] questions |
23 | relating to jurisdiction shall be permitted in the enforcement |
24 | proceeding, but such relief may be sought when such relief has |
25 | not been barred by the failure to take a timely appeal. |
26 | (d) Any person operating a reviewable clinically related |
27 | health service or health care facility within this Commonwealth |
28 | for which no certificate of need has been obtained, after |
29 | service of a cease and desist order of the department, [or after |
30 | expiration of the time for appeal of any final order on appeal, |
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1 | upon conviction thereof,] shall be [sentenced to pay] subject to |
2 | a fine of not less than [$100] $1,000 or more than [$1,000] |
3 | $10,000 and costs of [prosecution] enforcement. Each day of |
4 | operating a clinically related health service or health care |
5 | facility after issuance of a cease and desist order shall |
6 | constitute a separate offense. |
7 | (e) Any person who violates this act by failing to obtain a |
8 | certificate of need, by deviating from the provisions of the |
9 | certificate, by beginning construction, by providing services, |
10 | or by acquiring equipment after the expiration of a certificate |
11 | of need shall be subject to a penalty of not less than [$100] |
12 | $1,000 per day and not more than [$1,000] $10,000 per day. Each |
13 | day of each such violation shall be considered a separate |
14 | offense. |
15 | (f) The department may seek injunctive relief to prevent |
16 | continuing violations of this act. In seeking such relief, the |
17 | department need not prove damages or irreparable harm. |
18 | (g) No license to operate a health care facility or |
19 | reviewable clinically related health service by any person in |
20 | this Commonwealth shall be granted and any license issued shall |
21 | be void and of no effect as to any facility, organization, |
22 | service or part thereof for which a certificate of need is |
23 | required by this act and not granted. |
24 | Section 701. Certificate of need required; clinically related |
25 | health services subject to review. |
26 | (a) Any person, including, but not limited to, a health care |
27 | facility, health maintenance organization or health care |
28 | provider who offers, develops, constructs, renovates, expands or |
29 | otherwise establishes or undertakes to establish within the |
30 | State a clinically related health service that is included in |
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1 | the department's list of reviewable services developed under |
2 | subsections (d) and (e) or a health care facility as defined in |
3 | section 103 must obtain a certificate of need from the |
4 | department and CON review board if one or more of the following |
5 | factors applies: |
6 | (1) [The proposal requires a capital expenditure in |
7 | excess of $2,000,000 under] Under generally accepted |
8 | accounting principles, consistently applied[.], the proposal |
9 | requires a capital expenditure in excess of: |
10 | (i) for a new high-cost technology or high-cost |
11 | replacement technology in any health care facility, |
12 | $500,000; |
13 | (ii) for equipment or other facility improvements in |
14 | an ambulatory surgical facility, or in an office where |
15 | reviewable clinically related health care services are |
16 | offered, whether a free-standing facility or office |
17 | within a hospital, $1,000,000; or |
18 | (iii) for any other hospital-based improvement, |
19 | $2,000,000. |
20 | (2) The proposal involves the establishment of a health |
21 | care facility or a reviewable clinically related health |
22 | service. |
23 | (3) The proposal increases the number of licensed beds |
24 | by more than ten beds or 10%, whichever is less, every two |
25 | years. |
26 | (i) If the additional beds are acute care beds and |
27 | are not beds in a distinct-part psychiatric, |
28 | rehabilitation or long-term care unit, all licensed beds |
29 | of the acute-care facility shall be counted in |
30 | determining whether the increased number of beds exceeds |
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1 | 10%. |
2 | (ii) If the additional beds are beds in a distinct- |
3 | part psychiatric, rehabilitation or long-term care unit |
4 | of an acute care facility, only the beds within that unit |
5 | shall be counted in determining whether the increased |
6 | number of beds exceeds 10%. |
7 | (iii) If the additional beds are in a freestanding |
8 | psychiatric, rehabilitation or long-term care facility, |
9 | all licensed beds of the freestanding facility shall be |
10 | counted in determining whether the increased number of |
11 | beds exceeds 10%. |
12 | (4) The proposal substantially expands an existing |
13 | clinically related health service as determined by the |
14 | department [in the State health services plan]. |
15 | (b) For the purposes of this act, an expenditure for the |
16 | purpose of acquiring an existing health care facility [or |
17 | replacement of equipment where there is no change in service] |
18 | shall not be considered to be a capital expenditure subject to |
19 | review. Expenditures for nonclinical activities or services, |
20 | such as parking garages, computer systems or refinancing of |
21 | debt, and research projects involving premarket approval of new |
22 | equipment shall not be subject to review. |
23 | (c) The capital expenditure threshold identified in |
24 | subsection (a)(1) may be modified periodically by the department |
25 | to reflect any increase in the construction cost or other |
26 | factors influencing health care-related capital expenditures. |
27 | The department shall publish a modification of the expenditure |
28 | threshold through the regulatory review process. |
29 | (d) A list of reviewable clinically related health services |
30 | shall be published by the department and the CON review board |
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1 | within 30 days of the effective date of this act and may be |
2 | modified by regulation on an annual basis. Exclusive of new |
3 | high-cost technology, the initial list published by the |
4 | department and the CON review board as required under this |
5 | subsection shall be no more extensive than those services |
6 | reviewable on the effective date of this act. Criteria for |
7 | inclusion of reviewable services shall include, but not be |
8 | limited to: |
9 | (1) the quality of the service to be offered is likely |
10 | to be compromised through insufficient volumes or |
11 | utilization; |
12 | (2) the service is dependent upon the availability of |
13 | scarce natural resources such as human organs; |
14 | (3) the operating costs associated with the service are |
15 | reimbursed by major third party payors on a cost |
16 | reimbursement basis; or |
17 | (4) the service involves the use of new technology. |
18 | (e) Any changes to the list required under subsection (d) |
19 | and proposed by regulation shall be developed by the department |
20 | [after consultation with the policy board.] and the CON review |
21 | board. |
22 | (f) A facility providing treatment solely on the basis of |
23 | prayer or spiritual means in accordance with the tenets of any |
24 | church or religious denomination or a facility conducted by a |
25 | religious organization for the purpose of providing health care |
26 | services exclusively to clergy or other persons in a religious |
27 | profession who are members of the religious denomination |
28 | conducting the facility shall not be considered to constitute a |
29 | health service subject to review under this act. |
30 | (g) As used in this section, "new high-cost technology" |
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1 | means new technological equipment with an aggregate purchase |
2 | cost of greater than $500,000. The department and the CON review |
3 | board shall consult with national medical and surgical |
4 | speciality organizations recognized by the American Board of |
5 | Medical Specialities (ABMS) and other nationally recognized |
6 | scientific resources in the determination of what constitutes |
7 | new technological equipment. |
8 | Section 702. Certificates of need; notice of intent; |
9 | application; issuance. |
10 | (a) Projects requiring a certificate of need shall, at the |
11 | earliest possible time in their planning, but not later than |
12 | April 1 of the calendar year prior to the year of the proposed |
13 | project start date, be submitted to the department and the CON |
14 | review board in a letter of intent in such detail advising of |
15 | the scope and nature of the project as required by regulations. |
16 | Within 30 days after receipt of the letter of intent, the |
17 | department and the CON review board shall inform the applicant |
18 | providing the letter of intent whether the proposed project is |
19 | subject to a certificate of need review or if additional |
20 | information is required to make that determination. If the |
21 | department [determines] and the CON review board determine that |
22 | the project is subject to a certificate of need review, the |
23 | project shall be subject to the remaining provisions of this |
24 | act. |
25 | (b) A person desiring to obtain or amend a certificate of |
26 | need shall apply in writing to the department, supplying such |
27 | information as is required by the department and the CON review |
28 | board, including, but not limited to, a cost impact analysis as |
29 | further defined by the department in regulations implementing |
30 | this act, and certifying that all data, information and |
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1 | statements are factual to the best of their knowledge, |
2 | information and belief. The department and the CON review board |
3 | shall have 60 days after receipt of the application within which |
4 | to assess the application and in which to request specific |
5 | further information. If further information is requested, the |
6 | department and the CON review board shall complete its |
7 | preliminary assessment of the application within 45 days of |
8 | receipt of the same. No information shall be required that is |
9 | not specified in the rules and regulations promulgated by the |
10 | department. |
11 | (c) Timely notice of the beginning of review of the |
12 | application by the department shall be published after |
13 | preliminary assessment of the application is completed by the |
14 | department and the CON review board. The "date of notification" |
15 | of the beginning of review shall be the date such notice is |
16 | sent, or the date such notice is published in the Pennsylvania |
17 | Bulletin or in a newspaper of general circulation, whichever is |
18 | latest. |
19 | (d) The department and the CON review board shall approve or |
20 | disapprove the application within 90 days from the date of |
21 | notification of the beginning of the review unless the period |
22 | for review is extended by the applicant in writing. |
23 | (e) (1) Certificates of need shall be granted or refused by |
24 | the department. They shall not be conditioned upon the |
25 | applicant changing other aspects of its facilities or |
26 | services or requiring the applicant to meet other specified |
27 | requirements, and no such condition shall be imposed by the |
28 | department in granting or refusing approval of certificates |
29 | of need. |
30 | (2) A certificate of need shall state the maximum amount |
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1 | of expenditures which may be obligated under it and |
2 | applicants proceeding with an approved project may not exceed |
3 | this level of expenditure except as allowed under the |
4 | conditions and procedures established by the department |
5 | through regulation. |
6 | (f) (1) The department and the CON review board shall make |
7 | written findings which state the basis for any final decision |
8 | made by the department. Such findings shall be served upon |
9 | the applicant and provided to all persons expressing an |
10 | interest in the proceedings and shall be made available to |
11 | others upon written request. |
12 | (2) All decisions of the department and the CON review |
13 | board shall be based solely on the record. No ex parte |
14 | contact regarding the application between any employee of the |
15 | department or the CON review board who exercises |
16 | responsibilities respecting the application and the |
17 | applicant, any person acting on behalf of the applicant or |
18 | any person opposed to the issuance of the certificate of need |
19 | shall occur after the commencement of a hearing on the |
20 | application and before a decision is made by the department. |
21 | (g) Modification of the application at any stage of the |
22 | proceeding shall not extend the time limits provided by this act |
23 | unless the department and the CON review board expressly [finds] |
24 | find that the modification represents a substantial change in |
25 | the character of the application. |
26 | (h) The responsibility of performing certificate of need |
27 | review may not be delegated by the department and the CON review |
28 | board. The department and the CON review board shall consider |
29 | recommendations of [one or more community-based health services |
30 | planning committees] the local review committees whose |
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1 | localities are affected by specific applications in reviewing |
2 | the applications. |
3 | (i) The department and the CON review board may provide that |
4 | categories of projects shall receive simultaneous and |
5 | comparative review. |
6 | (j) Once the department and the CON review board have |
7 | finished the initial review of an application and determined |
8 | that the application shall be reviewed by a local review |
9 | committee, the department and the CON review board shall notify |
10 | the council in writing that a community review is pending and |
11 | request analyses to assist the review process. The council shall |
12 | offer its analyses to the department and the CON review board |
13 | prior to the completion of the review process. The department |
14 | and the CON review board shall share these analyses with the |
15 | local review committee. If the council determines that it does |
16 | not have the requisite data and information to provide analyses |
17 | to the department and the CON review board, the council shall |
18 | notify the department in writing. The department and the CON |
19 | review board shall notify the local review committee about the |
20 | council's determination. In carrying out its responsibilities, |
21 | the council shall have all the powers and duties of the council |
22 | enumerated by the act of July 8, 1986 (P.L.408, No.89), known as |
23 | the "Health Care Cost Containment Act." |
24 | Section 5. Section 703 of the act, amended July 12, 1980 |
25 | (P.L.655, No.136), is reenacted and amended to read: |
26 | Section 703. Notice and hearings before [health systems |
27 | agencies] the department and CON review board. |
28 | (a) Notice of completed applications for certificates of |
29 | need or amendment thereto and of the beginning of review shall |
30 | be published by the [health systems agency] department in the |
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1 | appropriate news media and by the department in the Pennsylvania |
2 | Bulletin in accordance with 45 Pa.C.S. [Chap. 7B] Ch. 7 Subch. B |
3 | (relating to publication of documents), and the [health systems |
4 | agency] department shall notify all affected persons with notice |
5 | of the schedule for review, the date by which a public hearing |
6 | must be demanded, and of the manner notice will be given of a |
7 | hearing, if one is to be held. Notice to affected persons (other |
8 | than members of the public who are to be served by the proposed |
9 | new institutional health service) shall be by mail (which may be |
10 | part of a newsletter). Members of the public may be notified |
11 | through newspapers of general circulation. Directly affected |
12 | persons may file objections within 15 days of such publication |
13 | with the [local health systems agency] department setting forth |
14 | specifically the reasons such objections were filed. Persons |
15 | filing the objections shall be parties to the proceeding, unless |
16 | and until such objections are withdrawn. |
17 | (b) Affected persons may request a public hearing or the |
18 | [health systems agency] department may require a public hearing |
19 | during the course of such review. Fourteen days written notice |
20 | of the hearing shall be given to affected persons in the same |
21 | manner as a notice of a completed application is provided in |
22 | subsection (a). In the hearing, any person shall have the right |
23 | to be represented by counsel and to present oral or written |
24 | arguments and relevant evidence. Any person directly affected |
25 | may conduct reasonable questioning of persons who make relevant |
26 | factual allegations. A record of the hearing shall be |
27 | maintained. |
28 | Section 6. Sections 704 and 705 of the act, amended December |
29 | 18, 1992 (P.L.1602, No.179), are reenacted to read: |
30 | Section 704. Notice of public meetings. |
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1 | (a) Notification of the beginning of review of a certificate |
2 | of need application shall be published by the department in the |
3 | appropriate news media and in the Pennsylvania Bulletin in |
4 | accordance with 45 Pa.C.S. Ch. 7 Subch. B (relating to |
5 | publication of documents). The notice shall identify the |
6 | schedule for review, the date by which a public meeting must be |
7 | requested and the manner in which notice will be given of a |
8 | meeting, if one is held. |
9 | (b) Interested persons may request a public meeting within |
10 | 15 days of publication, and the department shall hold such a |
11 | meeting or the department may require a public meeting during |
12 | the course of such review. The department shall publish written |
13 | notice of the meeting in the appropriate news media and the |
14 | Pennsylvania Bulletin at least 14 days prior to the public |
15 | meeting date. In the meeting, the applicant and any interested |
16 | person providing prior notice to the department shall have the |
17 | right to present oral or written comments and relevant evidence |
18 | on the application in the manner prescribed by the department. |
19 | The department shall prepare a transcript of the oral testimony |
20 | presented at the meeting. Meetings shall be held in accordance |
21 | with the guidelines and procedures established by the department |
22 | and published in the Pennsylvania Code as a statement of policy. |
23 | The department may require the applicant to provide copies of |
24 | the application to any interested person making a request for |
25 | such application, at the expense of the interested person. |
26 | (c) The applicant may, for good cause shown, request in |
27 | writing a public hearing for the purpose of reconsideration of a |
28 | decision of the department within ten days of service of the |
29 | decision of the department. The department shall treat the |
30 | request in accordance with the provisions of 1 Pa. Code § 35.241 |
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1 | (relating to application for rehearing or reconsideration). The |
2 | department shall set forth the cause for the hearing and the |
3 | issues to be considered at such hearing. If such hearing is |
4 | granted, it shall be held no sooner than six days and no later |
5 | than 30 days after the notice to grant such a hearing and shall |
6 | be limited to the issues submitted for reconsideration. A |
7 | transcript shall be made of the hearing and a copy of the |
8 | transcript shall be provided at cost to the applicant. The |
9 | department shall affirm or reverse its decision and submit the |
10 | same to the person requesting the hearing within 30 days of the |
11 | conclusion of such hearing. Any change in the decision shall be |
12 | supported by the reasons for the change. |
13 | (d) Where hearings under subsection (b) are held on more |
14 | than two days, consecutive days of hearings and intervening |
15 | weekends and holidays shall be excluded in calculating the time |
16 | permitted for the department to conduct its review, and, if |
17 | briefs are to be filed, ten days subsequent to the adjournment |
18 | of the hearing shall also be excluded. |
19 | Section 705. Good cause. |
20 | Good cause shall be deemed to have been shown if: |
21 | (1) there is significant, relevant information not |
22 | previously considered; |
23 | (2) there is significant change in factors or |
24 | circumstances relied on in making the decision; |
25 | (3) there has been material failure to comply with the |
26 | procedural requirements of this act; or |
27 | (4) good cause is otherwise found to exist. |
28 | Section 7. Sections 706, 707 and 708.1 of the act, amended |
29 | or added December 18, 1992 (P.L.1602, No.179), are reenacted and |
30 | amended to read: |
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1 | Section 706. Information during review. |
2 | During the course of review the department and the CON review |
3 | board shall upon request of any person set forth the status, any |
4 | findings made in the proceeding and other appropriate |
5 | information requested. The department and the CON review board |
6 | may require such request in writing. |
7 | Section 707. Criteria for review of applications for |
8 | certificates of need or amendments. |
9 | (a) An application for certificate of need shall be |
10 | considered for approval when the department [determines] and the |
11 | CON review board determine that the application substantially |
12 | meets the requirements listed below: |
13 | (1) There is need by the population served or to be |
14 | served by the proposed service or facility. |
15 | (2) The proposed service or facility will provide care |
16 | consistent with quality standards established by the [State |
17 | health services plan] department. |
18 | (3) The proposed service or facility will meet the |
19 | standards identified [in the State health services plan] by |
20 | the department for access to care by medically underserved |
21 | groups, including individuals eligible for medical assistance |
22 | and persons without health insurance. |
23 | (4) The applicant has submitted a data-based cost |
24 | analysis that includes an analysis demonstrating that: |
25 | (i) There is not a more appropriate, less costly or |
26 | more effective alternative method of providing the |
27 | proposed services. |
28 | (ii) The service or facility is financially and |
29 | economically feasible, considering anticipated volume of |
30 | care and the availability of reasonable financing based |
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1 | on information from the applicant and other sources |
2 | during the review process. |
3 | (iii) The proposed service or facility will not have |
4 | an inappropriate, adverse impact on the overall level of |
5 | health care expenditures in the area. |
6 | (iv) The proposed service or facility does not |
7 | adversely impact the maintenance and development of rural |
8 | and inner-city health services generally and, in |
9 | particular, those services provided by health care |
10 | providers that are based in rural and inner-city |
11 | locations and have an established history of providing |
12 | services to medically underserved populations. |
13 | [(b) The department shall issue a certificate of need if the |
14 | project substantially meets the criteria of subsection (a)(1), |
15 | (2) and (3) and the project is consistent with the State health |
16 | services plan unless the department can demonstrate: |
17 | (1) There is a more appropriate, less costly or more |
18 | effective alternative method of providing the proposed |
19 | services. |
20 | (2) The service or facility is not financially and |
21 | economically feasible, considering anticipated volume of care |
22 | and the availability of reasonable financing based on |
23 | information received from the applicant and other sources |
24 | during the review process. |
25 | (3) The proposed service or facility will have an |
26 | inappropriate, adverse impact on the overall level of health |
27 | care expenditures in the area. |
28 | (4) The proposed service or facility adversely impacts |
29 | the maintenance and development of rural and inner-city |
30 | health services generally and, in particular, those services |
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1 | provided by health care providers which are based in rural |
2 | and inner-city locations and which have an established |
3 | history of providing services to medically underserved |
4 | populations.] |
5 | (c) Notwithstanding the provisions of [subsections (a) and |
6 | (b)] subsection (a), applications for projects described in |
7 | subsection (d) shall be approved unless the department [finds] |
8 | and the CON review board find that the facility or service with |
9 | respect to such expenditure as proposed is not needed [or that |
10 | the project is not consistent with the State health services |
11 | plan]. An application made under this subsection shall be |
12 | approved only to the extent that the department [determines] and |
13 | the CON review board determine it is required to overcome the |
14 | conditions described in subsection (d). |
15 | (d) Subject to the provisions of subsection (c), |
16 | [subsections (a) and (b)] subsection (a) shall not apply to |
17 | capital expenditures required to: |
18 | (1) eliminate or prevent imminent safety hazards as a |
19 | result of violations of safety codes or regulations; |
20 | (2) comply with State licensure standards; or |
21 | (3) comply with accreditation standards, compliance with |
22 | which is required to receive reimbursement or payments under |
23 | Title XVIII or XIX of the Federal Social Security Act. |
24 | Section 708.1. Monitoring certificate of need; expiration of a |
25 | certificate of need. |
26 | A certificate of need or an amendment to it shall expire two |
27 | years from the date issued unless substantially implemented, as |
28 | defined by regulation. The department and the CON review board |
29 | may grant extensions for a specified time upon request of the |
30 | applicant and upon a showing that the applicant has or is making |
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1 | a good faith effort to substantially implement the project. An |
2 | expired certificate of need shall be invalid, and no person may |
3 | proceed to undertake any activity pursuant to it for which a |
4 | certificate of need or amendment is required. The applicant |
5 | shall report to the department, on forms prescribed by the |
6 | department, the status of the project until such time as the |
7 | project is licensed or operational, if no license is required. |
8 | Section 8. Section 709 of the act, amended December 18, 1992 |
9 | (P.L.1602, No.179), is reenacted to read: |
10 | Section 709. Emergencies. |
11 | Notwithstanding any other provision of this act, in the event |
12 | of an emergency the department may suspend the foregoing |
13 | application process and permit such steps to be taken as may be |
14 | required to meet the emergency including the replacement of |
15 | equipment or facilities. |
16 | Section 9. Section 710 of the act is reenacted to read: |
17 | Section 710. Notice of termination of services. |
18 | For informational purposes only, at least 30 days prior to |
19 | termination or substantial reduction of a service or a permanent |
20 | decrease in the bed complement, the provider shall notify the |
21 | [health systems agency and the] department of its intended |
22 | action. |
23 | Section 10. Section 711 of the act, amended December 18, |
24 | 1992 (P.L.1602, No.179), is reenacted and amended to read: |
25 | Section 711. Review of activities. |
26 | (a) The department and the CON review board shall prepare |
27 | and publish not less frequently than annually reports of reviews |
28 | conducted under this act, including a statement on the status of |
29 | each such review and of reviews completed by it and statements |
30 | of the decisions made in the course of such reviews since the |
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1 | last report. The department and the CON review board shall also |
2 | make available to the general public for examination at |
3 | reasonable times of the business day all applications reviewed |
4 | by it. Such reports and applications shall be considered public |
5 | records. |
6 | (b) The department's and the CON review board's report which |
7 | shall be submitted to the members of the Health and Welfare |
8 | Committees of the Senate and House of Representatives shall |
9 | contain the following information: |
10 | (1) The volume of applications submitted, by project |
11 | type, their dollar value, and the numbers and costs |
12 | associated with those approved and those not approved. |
13 | (2) The assessment of the extent of competition in |
14 | specific service sectors that guided decisions. |
15 | (3) A detailed description of projects involving |
16 | nontraditional or innovative service delivery methods or |
17 | organizational arrangements and the decisions made on each of |
18 | these projects. |
19 | (4) The average time for review, by level of review. |
20 | (5) The fees collected for reviews and the cost of the |
21 | program. |
22 | Section 11. Section 712 of the act, added July 12, 1980 |
23 | (P.L.655, No.136) and repealed in part December 20, 1982 (P.L. |
24 | 1409, No.326), is reenacted and amended to read: |
25 | Section 712. Actions against violations of law and rules and |
26 | regulations[; bonds]. |
27 | (a) Whenever any person, regardless of whether such person |
28 | is a licensee, has willfully violated any of the provisions of |
29 | this act or the rules and regulations adopted thereunder, the |
30 | department may maintain any action in the name of the |
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1 | Commonwealth for an injunction or other process restraining or |
2 | prohibiting such person from engaging in such activity. |
3 | Section 12. Section 808 of the act, amended December 18, |
4 | 1992 (P.L.1602, No.179) and July 7, 2006 (P.L.334, No.69), is |
5 | reenacted and amended to read: |
6 | Section 808. Issuance of license. |
7 | (a) Standards.--The department shall issue a license to a |
8 | health care provider when it is satisfied that the following |
9 | standards have been met: |
10 | (1) that the health care provider is a responsible |
11 | person; |
12 | (2) that the place to be used as a health care facility |
13 | is adequately constructed, equipped, maintained and operated |
14 | to safely and efficiently render the services offered; |
15 | (3) that the health care facility provides safe and |
16 | efficient services which are adequate for the care, treatment |
17 | and comfort of the patients or residents of such facility; |
18 | (4) that there is substantial compliance with the rules |
19 | and regulations adopted by the department pursuant to this |
20 | act; and |
21 | (5) that a certificate of need has been issued if one is |
22 | necessary. |
23 | (b) Separate and limited licenses.--Separate licenses shall |
24 | not be required for different services within a single health |
25 | care facility except that home health care, home care, hospice |
26 | or long-term nursing care will require separate licenses. A |
27 | limited license, excluding from its terms a particular service |
28 | or portion of a health care facility, may be issued under the |
29 | provisions of this act. |
30 | (c) Addition of services.--When the certificate of need for |
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1 | a facility is amended as to services which can be offered, the |
2 | department shall issue an appropriate license for those services |
3 | upon demonstration of compliance with licensure requirements. |
4 | (d) Monitoring.-- |
5 | (1) One year after the certificate of need has been |
6 | issued, the department shall monitor quality of the facility |
7 | or service by requesting from the council relevant data, |
8 | which may include mortality rates and the number of |
9 | procedures performed. |
10 | (2) If the department finds that the facility or service |
11 | is not meeting the standards set forth in subsection (a), the |
12 | department shall take disciplinary action pursuant to this |
13 | act and existing regulations. |
14 | Section 13. The act is amended by adding a section to read: |
15 | Section 808.1. Prohibition of referrals and claims of payment. |
16 | (a) Referrals.--A provider may not: |
17 | (1) Refer a person for treatment and services if the |
18 | provider has a financial interest with the person or in the |
19 | entity that receives the referral. |
20 | (2) Enter into an arrangement or scheme, including, but |
21 | not limited to, a cross-referral arrangement, that the |
22 | provider knows or should know has a principal purpose of |
23 | assuring referrals by the provider to a particular entity |
24 | that, if the provider directly made referrals to the entity, |
25 | would be in violation of this act. |
26 | (b) Claim for payment.--No claim for payment may be |
27 | presented by an entity to any individual, third-party payor or |
28 | other entity for a service furnished pursuant to conduct |
29 | prohibited under subsection (a). |
30 | (c) Refund.--If an entity collects any amount that was |
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1 | billed in violation of this section, the entity shall refund |
2 | that amount on a timely basis to the payor or individual. |
3 | Section 14. Section 901 of the act, amended July 12, 1980 |
4 | (P.L.655, No.136), is reenacted and amended to read: |
5 | Section 901. Existing facilities and institutions. |
6 | (a) (1) No certificate of need shall be required for any |
7 | buildings, real property and equipment owned, leased or being |
8 | operated, or under contract for construction, purchase, or |
9 | lease and for all services being rendered by licensed or |
10 | approved providers [on April 1, 1980.] prior to the effective |
11 | date of this paragraph. |
12 | (2) Nor shall a certificate of need be required for any |
13 | new institutional health services for which an approval has |
14 | been granted under section 1122 of the Social Security Act or |
15 | for which an application is found pursuant to such section to |
16 | be in conformity with the standards, criteria or plans to |
17 | which such section refers, or as to which the Federal |
18 | Secretary of Health and Human Services makes a finding that |
19 | reimbursement shall be granted.[: Provided, however, That |
20 | such approval is in force on August 1, 1980 or such |
21 | application shall have been filed prior to August 1, 1980 or |
22 | the acceptance of applications for reviews under this act, |
23 | whichever shall last occur.] |
24 | (b) Existing facilities and institutions shall be required |
25 | to obtain a certificate of need for projects outlined in section |
26 | 701. |
27 | Section 15. Section 902.1 of the act, added December 18, |
28 | 1992 (P.L.1602, No.179), is reenacted and amended to read: |
29 | Section 902.1. Fees for review of certificate of need |
30 | applications. |
|
1 | (a) The department shall charge a fee of [$150] $500 for |
2 | each letter of intent filed. The letter of intent fee shall be |
3 | deducted from the total application fee required under |
4 | subsection (b) if an application is submitted on the project |
5 | proposed in the letter of intent. |
6 | (b) For each application the department shall charge a fee, |
7 | payable on submission of an application. The fee shall not be |
8 | less than $500 plus up to [$3] $10 per $1,000 of proposed |
9 | capital expenditure and shall not be more than [$20,000] |
10 | $50,000. |
11 | (c) The department shall publish a fee schedule in the |
12 | Pennsylvania Bulletin which shall explain the procedure for |
13 | filing fees. |
14 | (d) All fees payable under this section are due upon the |
15 | date of filing a letter of intent or application. If a person |
16 | fails to file the appropriate fee, all time frames required of |
17 | the department under this act, with respect to review of a |
18 | letter of intent or application, are suspended until the |
19 | applicable fee is paid in full. |
20 | (e) Each local review committee may apply for up to $10,000 |
21 | in funding from the department for administrative functions |
22 | associated with reviewing certificate of need proposals. This |
23 | funding is to be allocated from the Patient Safety Authority |
24 | appropriation. |
25 | Section 16. Section 904.1 of the act, added December 18, |
26 | 1992 (P.L.1602, No.179), is repealed: |
27 | [Section 904.1. Sunset. |
28 | The authority, obligations and duties arising under Chapter 7 |
29 | and all other provisions of this act pertaining to certificates |
30 | of need shall terminate four years after the effective date of |
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1 | this section. Twelve months prior to this expiration, the |
2 | Legislative Budget and Finance Committee shall commence a review |
3 | of the impact of the certificate of need program on quality, |
4 | access and cost of health care services, including the costs of |
5 | appeals, reviewable under this act.] |
6 | Section 17. This act shall take effect immediately. |
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