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PRINTER'S NO. 1416
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1204
Session of
2019
INTRODUCED BY DeLUCA, FRANKEL, HILL-EVANS, CALTAGIRONE, FREEMAN,
KINSEY AND KORTZ, APRIL 15, 2019
REFERRED TO COMMITTEE ON HEALTH, APRIL 15, 2019
AN ACT
Amending the act of July 19, 1979 (P.L.130, No.48), entitled "An
act relating to health care; prescribing the powers and
duties of the Department of Health; establishing and
providing the powers and duties of the State Health
Coordinating Council, health systems agencies and Health Care
Policy Board in the Department of Health, and State Health
Facility Hearing Board in the Department of Justice;
providing for certification of need of health care providers
and prescribing penalties," in preliminary provisions,
reenacting and amending provisions relating to definitions;
in powers and duties of the department, reenacting and
amending provisions relating to powers and duties of the
department; in Statewide Health Coordinating Council and
health systems agencies, reenacting and amending provisions
relating to State health services plan; in administration of
the act, reenacting provisions relating to regulations and
reenacting and amending provisions relating to enforcement of
orders relating to certificate of need; in certificate of
need, reenacting and amending provisions relating to
certificate of need required and clinically related health
services subject to review, to certificates of need and
notice of intent and application and issuance and to notice
and hearings before health systems agencies, reenacting
provisions relating to notice of public meetings and to good
cause, reenacting and amending provisions relating to
information during review, to criteria for review of
applications for certificates of need or amendments and to
monitoring certificate of need, expiration of a certificate
of need and reenacting provisions relating to emergencies and
reenacting and amending provisions relating to notice of
termination of services, to review of activities and to
actions against violations of law and rules and regulations
and bonds; in licensing of health care facilities, reenacting
and amending provisions relating to issuance of license; in
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general provisions and repeals and effective date, reenacting
and amending provisions relating to existing facilities and
institutions and to fees for review of certificate of need
applications and repealing provisions relating to sunset.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Sections 103, 201 and 401.3 of the act of July
19, 1979 (P.L.130, No.48), known as the Health Care Facilities
Act, are reenacted and amended to read:
Section 103. Definitions.
The following words and phrases when used in this act shall
have, unless the context clearly indicates otherwise, the
meanings given to them in this section:
"Act." The comprehensive Health Care Facilities Act.
"Board." The Health Policy Board established under section
401.1.
"Certificate of need." A notice of approval issued by the
[department] Department of Health under the provisions of this
act, including those notices of approval issued as an amendment
to an existing certificate of need.
"Certification of need (CON) review board." The CON review
board, which consists of technical experts in the fields of
medicine, health facility administration, health economics,
health care cost inflation and the like, including experts from
within the Commonwealth agencies, together with consumers of
health care, all of whom are appointed by the Secretary of
Health.
"Clinically related health service." Certain diagnostic,
treatment or rehabilitative services as determined in section
701.
["Community-based health services planning committee." A
committee established in accordance with procedures approved by
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the Department of Health which includes representatives of local
or regional groups of consumers, business, labor, health care
providers, payors or other affected interests.]
"Conflict of interest." [For the purpose of section 501,
the] The interest of any person, whether financial, by
association with, or as a contributor of money or time to, any
nonprofit corporation or other corporation, partnership,
association, or other organization, and whenever a person is a
director, officer or employee of such organization, but shall
not exist whenever the organization in which such person is
interested is being considered as part of a class or group for
whom regulations are being considered, if the material facts as
to the relationship or interest are disclosed or are known to
the board.
"Consumer." A natural person who is not involved in the
provision of health services or health insurance. For the
purpose of this act, any person who holds a fiduciary position
in any health care facility, health maintenance organization or
third party payor shall not be considered a consumer.
" Council. " The Health Care Cost Containment Council.
"Department." The Department of Health of the Commonwealth.
"Develop." When used in connection with health services or
facilities, means to undertake those activities which on their
completion will result in the offer of a new health service or
the incurring of a financial obligation in relation to the
offering of such a service.
"Health care facility." [For purposes of Chapter 7, any] A
health care facility providing clinically related health
services, including, but not limited to, a general or special
hospital, including psychiatric hospitals, rehabilitation
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hospitals, ambulatory surgical facilities, diagnostic imaging
centers, MRI facilities, long-term care nursing facilities,
cancer treatment centers using radiation therapy on an
ambulatory basis and inpatient drug and alcohol treatment
facilities, both profit and nonprofit and including those
operated by an agency or State or local government. The term
shall also include a hospice. The term shall not include an
office used primarily for the private or group practice by
health care practitioners where no reviewable clinically related
health service is offered, a facility providing treatment solely
on the basis of prayer or spiritual means in accordance with the
tenets of any church or religious denomination or a facility
conducted by a religious organization for the purpose of
providing health care services exclusively to clergy or other
persons in a religious profession who are members of the
religious denominations conducting the facility.
"Health care practitioner." An individual who is authorized
to practice some component of the healing arts by a license,
permit, certificate or registration issued by a Commonwealth
licensing agency or board.
"Health care provider" or "provider." An individual, a trust
or estate, a partnership, a corporation (including associations,
joint stock companies and insurance companies), the
Commonwealth, or a political subdivision or instrumentality
(including a municipal corporation or authority) thereof, that
operates a health care facility.
"Health planning area." A geographic area within the
Commonwealth designated by the Department of Health for purposes
of health planning.
"Hearing board." The State Health Facility Hearing Board
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created in the Office of General Counsel under the provisions of
this act.
"Interested person" or "person expressing an interest." [For
the purposes of Chapter 7, a] A member of the public who is to
be served by the proposed new health service in the area to be
served by the applicant, a health care facility or health
maintenance organization or any health care provider providing
similar services in the area to be served by the applicant or
who has received a certificate of need to provide services in
the area to be served by the applicant or who has formally filed
with the [department] Department of Health a letter of intent to
provide similar services in the area in which the proposed
service is to be offered or developed and any third party payor
of health services provided in that area who provides written
notice to the [department] Department of Health that the person
is interested in a specific certificate of need application
before the [department] Department of Health.
" Local review committee. " A committee established in
accordance with procedures approved by the Department of Health
that includes representatives of local or regional groups of
consumers, business, labor, health care providers, payors or
other affected interests.
"Offer." Make provision for providing in a regular manner
and on an organized basis clinically related health services.
"Patient." A natural person receiving health care in or from
a health care provider.
"Person." A natural person, corporation (including
associations, joint stock companies and insurance companies),
partnership, trust, estate, association, the Commonwealth, and
any local governmental unit, authority and agency thereof.
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"Policy board." The Health Policy Board created in the
Department of Health under the provisions of this act.
"Public meeting." A meeting open to the public where any
person has an opportunity to comment on a certificate of need
application or proposed State health [services] improvement plan
amendment.
"Secretary." The Secretary of [the Department of] Health of
the Commonwealth of Pennsylvania.
["State health services plan." A document developed by the
Department of Health, after consultation with the policy board
and approved by the Governor, that is consistent with section
401.3, that meets the current and projected needs of the
Commonwealth's citizens. The State health services plan shall
contain, in part, the standards and criteria against which
certificate of need applications are reviewed and upon which
decisions are based.]
"Third party payor." A person who makes payments on behalf
of patients under compulsion of law or contract who does not
supply care or services as a health care provider or who is
engaged in issuing any policy or contract of individual or group
health insurance or hospital or medical service benefits. The
term shall not include the Federal, State, or any local
government unit, authority, or agency thereof or a health
maintenance organization.
Section 201. Powers and duties of the department.
The Department of Health shall have the power and its duties
shall be:
(1) To exercise exclusive jurisdiction over health care
providers in accordance with the provisions of this act.
(2) To issue determinations of reviewability or
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nonreviewability of certificate of need proposals.
(2.1) To develop qualitative and quantitative standards
and criteria for the review and approval of certificate of
need applications.
(3) To issue certificates of need and amended
certificates of need in accordance with the provisions of
this act.
(4) To withdraw expired certificates of need.
(5) To require, pursuant to regulation, submission of
periodic reports by providers of health services and other
persons subject to review respecting the development of
proposals subject to review.
[(6) Upon consultation with the policy board, to
research, prepare and, after approval by the Governor,
publish, no later than 18 months after the effective date of
this act and annually thereafter, a revised State health
services plan for the Commonwealth as defined under this act.
Until the State health services plan as defined in section
401.3 is adopted, the department shall apply the State health
plan in existence on the effective date of this act, along
with any subsequent updates to that plan.]
(6.1) To develop a certificate of need exceptions
process that permits exceptions to be granted to the
standards and criteria in order to reflect local experience
or ensure access or to respond to circumstances that pose a
threat to public health and safety. The exceptions process
shall begin only after the department issues a denial of a
certificate of need application. Exceptions must be publicly
disclosed. This provision creates no right or entitlement to
an exception.
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(7) To collect and disseminate such other information as
may be appropriate to determine the appropriate level of
facilities and services for the effective implementation of
certification of need under this act. Where such information
is collected by any other agency of State government,
duplication shall be avoided by coordination of data
collection activities[.], if the coordination does not
otherwise unduly burden those State agencies.
[(8) To furnish such staff support and expertise to the
policy board as may be needed to perform its
responsibilities.]
(9) To receive, log and review all applications for
certificates of need or amendments thereof and approve or
disapprove the same.
(10) To minimize the administrative burden on health
care providers by eliminating unnecessary duplication of
financial and operational reports and to the extent possible
and without undue burden coordinating reviews and inspections
performed by Federal, State, local and private agencies.
(11) To adopt and promulgate regulations necessary to
carry out the purposes and provisions of this act relating to
certificate of need.
(12) To enforce the rules and regulations promulgated by
the department as provided in this act.
(13) To provide technical assistance to individuals and
public and private entities in filling out the necessary
forms for the development of projects and programs.
(14) To establish and publish in the Pennsylvania
Bulletin a fee schedule for certificate of need applications
and letters of intent in accordance with section 902.1.
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(15) To coordinate any data collection activities
necessary for administration of this act so as not to
duplicate unnecessarily the data collection activities of
other Federal and State agencies.
(16) To modify the list of reviewable clinically related
health services established under section 701.
(17) To establish and publish in the Pennsylvania
Bulletin a detailed schedule of the review process for each
certificate of need application submitted to the department.
Section 401.3. State health [services] improvement plan.
The State health [services] improvement plan shall consist of
at a minimum:
(1) An identification of the clinically related health
services necessary to serve the health needs of the
population of this Commonwealth, including those medically
underserved areas in rural and inner-city locations.
(2) An analysis of the availability, accessibility and
affordability of the clinically related health services
necessary to meet the health needs of the population of this
Commonwealth.
[(3) Qualitative and quantitative standards and criteria
for the review of certificate of need applications by the
department under this act.
(4) An exceptions process which permits exceptions to be
granted to the standards and criteria in order to reflect
local experience or ensure access or to respond to
circumstances which pose a threat to public health and
safety.]
Section 2. Section 602 of the act is reenacted to read:
Section 602. Regulations.
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The department is hereby authorized and empowered pursuant to
the provisions of this act to adopt rules and regulations
establishing procedures required by this act for administration
of certificate of need.
Section 3. Sections 603, 701, 702 and 703 of the act are
reenacted and amended to read:
Section 603. Enforcement of orders relating to certificate of
need.
(a) (1) No certificate of need shall be granted to any
person for a health care facility or reviewable clinically
related health service unless such facility or clinically
related health service is found by the department and CON
review board to be needed.
(2) No person shall offer or develop a health care
facility or reviewable clinically related health service
without obtaining a certificate of need as required by this
act.
(3) No binding arrangement or commitment for financing
the offering or development of a health care facility or
reviewable clinically related health service shall be made by
any person unless a certificate of need for such clinically
related health service or facility has been granted in
accordance with this act.
(b) Orders for which the time of appeal has expired shall be
enforced by the department and the CON review board in summary
proceedings or, when necessary, with the aid of the court.
(c) No [collateral attack on any order, including] questions
relating to jurisdiction shall be permitted in the enforcement
proceeding, but such relief may be sought when such relief has
not been barred by the failure to take a timely appeal.
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(d) Any person operating a reviewable clinically related
health service or health care facility within this Commonwealth
for which no certificate of need has been obtained, after
service of a cease and desist order of the department, [or after
expiration of the time for appeal of any final order on appeal,
upon conviction thereof,] shall be [sentenced to pay] subject to
a fine of not less than [$100] $1,000 or more than [$1,000]
$10,000 and costs of [prosecution] enforcement. Each day of
operating a clinically related health service or health care
facility after issuance of a cease and desist order shall
constitute a separate offense.
(e) Any person who violates this act by failing to obtain a
certificate of need, by deviating from the provisions of the
certificate, by beginning construction, by providing services,
or by acquiring equipment after the expiration of a certificate
of need shall be subject to a penalty of not less than [$100]
$1,000 per day and not more than [$1,000] $10,000 per day. Each
day of each such violation shall be considered a separate
offense.
(f) The department may seek injunctive relief to prevent
continuing violations of this act. In seeking such relief, the
department need not prove damages or irreparable harm.
(g) No license to operate a health care facility or
reviewable clinically related health service by any person in
this Commonwealth shall be granted and any license issued shall
be void and of no effect as to any facility, organization,
service or part thereof for which a certificate of need is
required by this act and not granted.
Section 701. Certificate of need required; clinically related
health services subject to review.
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(a) Any person, including, but not limited to, a health care
facility, health maintenance organization or health care
provider who offers, develops, constructs, renovates, expands or
otherwise establishes or undertakes to establish within the
State a clinically related health service that is included in
the department's list of reviewable services developed under
subsections (d) and (e) or a health care facility as defined in
section 103 must obtain a certificate of need from the
department and CON review board if one or more of the following
factors applies:
(1) [The proposal requires a capital expenditure in
excess of $2,000,000 under] Under generally accepted
accounting principles, consistently applied[.], the proposal
requires a capital expenditure in excess of:
(i) for a new high-cost technology or high-cost
replacement technology in any health care facility,
$500,000;
(ii) for equipment or other facility improvements in
an ambulatory surgical facility, or in an office where
reviewable clinically related health care services are
offered, whether a free-standing facility or office
within a hospital, $1,000,000; or
(iii) for any other hospital-based improvement,
$2,000,000.
(2) The proposal involves the establishment of a health
care facility or a reviewable clinically related health
service.
(3) The proposal increases the number of licensed beds
by more than ten beds or 10%, whichever is less, every two
years.
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(i) If the additional beds are acute care beds and
are not beds in a distinct-part psychiatric,
rehabilitation or long-term care unit, all licensed beds
of the acute-care facility shall be counted in
determining whether the increased number of beds exceeds
10%.
(ii) If the additional beds are beds in a distinct-
part psychiatric, rehabilitation or long-term care unit
of an acute care facility, only the beds within that unit
shall be counted in determining whether the increased
number of beds exceeds 10%.
(iii) If the additional beds are in a freestanding
psychiatric, rehabilitation or long-term care facility,
all licensed beds of the freestanding facility shall be
counted in determining whether the increased number of
beds exceeds 10%.
(4) The proposal substantially expands an existing
clinically related health service as determined by the
department [in the State health services plan].
(b) For the purposes of this act, an expenditure for the
purpose of acquiring an existing health care facility [or
replacement of equipment where there is no change in service
shall not], including the replacement of equipment which is part
of the acquisition even if there is no change in service, shall
be considered to be a capital expenditure subject to review.
Expenditures for nonclinical activities or services, such as
parking garages, computer systems or refinancing of debt, and
research projects involving premarket approval of new equipment
shall not be subject to review.
(c) The capital expenditure threshold identified in
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subsection (a)(1) may be modified periodically by the department
to reflect any increase in the construction cost or other
factors influencing health care-related capital expenditures.
The department shall publish a modification of the expenditure
threshold through the regulatory review process.
(d) A list of reviewable clinically related health services
shall be published by the department and the CON review board
within 30 days of the effective date of this act and may be
modified by regulation on an annual basis. Exclusive of new
high-cost technology, the initial list published by the
department and the CON review board as required under this
subsection shall be no more extensive than those services
reviewable on the effective date of this act. Criteria for
inclusion of reviewable services shall include, but not be
limited to:
(1) the quality of the service to be offered is likely
to be compromised through insufficient volumes or
utilization;
(2) the service is dependent upon the availability of
scarce natural resources such as human organs;
(3) the operating costs associated with the service are
reimbursed by major third party payors on a cost
reimbursement basis; or
(4) the service involves the use of new technology.
(e) Any changes to the list required under subsection (d)
and proposed by regulation shall be developed by the department
[after consultation with the policy board.] and the CON review
board.
(f) A facility providing treatment solely on the basis of
prayer or spiritual means in accordance with the tenets of any
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church or religious denomination or a facility conducted by a
religious organization for the purpose of providing health care
services exclusively to clergy or other persons in a religious
profession who are members of the religious denomination
conducting the facility shall not be considered to constitute a
health service subject to review under this act.
(g) As used in this section, "new high-cost technology"
means new technological equipment with an aggregate purchase
cost of greater than $500,000. The department and the CON review
board shall consult with national medical and surgical
speciality organizations recognized by the American Board of
Medical Specialities (ABMS) and other nationally recognized
scientific resources in the determination of what constitutes
new technological equipment.
Section 702. Certificates of need; notice of intent;
application; issuance.
(a) Projects requiring a certificate of need shall, at the
earliest possible time in their planning, but not later than
April 1 of the calendar year prior to the year of the proposed
project start date, be submitted to the department and the CON
review board in a letter of intent in such detail advising of
the scope and nature of the project as required by regulations.
Within 30 days after receipt of the letter of intent, the
department and the CON review board shall inform the applicant
providing the letter of intent whether the proposed project is
subject to a certificate of need review or if additional
information is required to make that determination. If the
department [determines] and the CON review board determine that
the project is subject to a certificate of need review, the
project shall be subject to the remaining provisions of this
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act.
(b) A person desiring to obtain or amend a certificate of
need shall apply in writing to the department, supplying such
information as is required by the department and the CON review
board, including, but not limited to, a cost impact analysis as
further defined by the department in regulations implementing
this act, and certifying that all data, information and
statements are factual to the best of their knowledge,
information and belief. The department and the CON review board
shall have 60 days after receipt of the application within which
to assess the application and in which to request specific
further information. If further information is requested, the
department and the CON review board shall complete its
preliminary assessment of the application within 45 days of
receipt of the same. No information shall be required that is
not specified in the rules and regulations promulgated by the
department.
(c) Timely notice of the beginning of review of the
application by the department shall be published after
preliminary assessment of the application is completed by the
department and the CON review board. The "date of notification"
of the beginning of review shall be the date such notice is
sent, or the date such notice is published in the Pennsylvania
Bulletin or in a newspaper of general circulation, whichever is
latest.
(d) The department and the CON review board shall approve or
disapprove the application within 90 days from the date of
notification of the beginning of the review unless the period
for review is extended by the applicant in writing.
(e) (1) Certificates of need shall be granted or refused by
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the department. They shall not be conditioned upon the
applicant changing other aspects of its facilities or
services or requiring the applicant to meet other specified
requirements, and no such condition shall be imposed by the
department in granting or refusing approval of certificates
of need.
(2) A certificate of need shall state the maximum amount
of expenditures which may be obligated under it and
applicants proceeding with an approved project may not exceed
this level of expenditure except as allowed under the
conditions and procedures established by the department
through regulation.
(f) (1) The department and the CON review board shall make
written findings which state the basis for any final decision
made by the department. Such findings shall be served upon
the applicant and provided to all persons expressing an
interest in the proceedings and shall be made available to
others upon written request.
(2) All decisions of the department and the CON review
board shall be based solely on the record. No ex parte
contact regarding the application between any employee of the
department or the CON review board who exercises
responsibilities respecting the application and the
applicant, any person acting on behalf of the applicant or
any person opposed to the issuance of the certificate of need
shall occur after the commencement of a hearing on the
application and before a decision is made by the department.
(g) Modification of the application at any stage of the
proceeding shall not extend the time limits provided by this act
unless the department and the CON review board expressly [finds]
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find that the modification represents a substantial change in
the character of the application.
(h) The responsibility of performing certificate of need
review may not be delegated by the department and the CON review
board. The department and the CON review board shall consider
recommendations of [one or more community-based health services
planning committees] the local review committees whose
localities are affected by specific applications in reviewing
the applications.
(i) The department and the CON review board may provide that
categories of projects shall receive simultaneous and
comparative review.
(j) Once the department and the CON review board have
finished the initial review of an application and determined
that the application shall be reviewed by a local review
committee, the department and the CON review board shall notify
the council in writing that a community review is pending and
request analyses to assist the review process. The council shall
offer its analyses to the department and the CON review board
prior to the completion of the review process. The department
and the CON review board shall share these analyses with the
local review committee. If the council determines that it does
not have the requisite data and information to provide analyses
to the department and the CON review board, the council shall
notify the department in writing. The department and the CON
review board shall notify the local review committee about the
council's determination. In carrying out its responsibilities,
the council shall have all the powers and duties of the council
enumerated by the act of July 8, 1986 (P.L.408, No.89) , known as
the "Health Care Cost Containment Act."
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Section 703. Notice and hearings before [health systems
agencies] the department and CON review board.
(a) Notice of completed applications for certificates of
need or amendment thereto and of the beginning of review shall
be published by the [health systems agency] department in the
appropriate news media and by the department in the Pennsylvania
Bulletin in accordance with 45 Pa.C.S. [Chap. 7B] Ch. 7 Subch. B
(relating to publication of documents), and the [health systems
agency] department shall notify all affected persons with notice
of the schedule for review, the date by which a public hearing
must be demanded, and of the manner notice will be given of a
hearing, if one is to be held. Notice to affected persons (other
than members of the public who are to be served by the proposed
new institutional health service) shall be by mail (which may be
part of a newsletter). Members of the public may be notified
through newspapers of general circulation. Directly affected
persons may file objections within 15 days of such publication
with the [local health systems agency] department setting forth
specifically the reasons such objections were filed. Persons
filing the objections shall be parties to the proceeding, unless
and until such objections are withdrawn.
(b) Affected persons may request a public hearing or the
[health systems agency] department may require a public hearing
during the course of such review. Fourteen days written notice
of the hearing shall be given to affected persons in the same
manner as a notice of a completed application is provided in
subsection (a). In the hearing, any person shall have the right
to be represented by counsel and to present oral or written
arguments and relevant evidence. Any person directly affected
may conduct reasonable questioning of persons who make relevant
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factual allegations. A record of the hearing shall be
maintained.
Section 4. Sections 704 and 705 of the act are reenacted to
read:
Section 704. Notice of public meetings.
(a) Notification of the beginning of review of a certificate
of need application shall be published by the department in the
appropriate news media and in the Pennsylvania Bulletin in
accordance with 45 Pa.C.S. Ch. 7 Subch. B (relating to
publication of documents). The notice shall identify the
schedule for review, the date by which a public meeting must be
requested and the manner in which notice will be given of a
meeting, if one is held.
(b) Interested persons may request a public meeting within
15 days of publication, and the department shall hold such a
meeting or the department may require a public meeting during
the course of such review. The department shall publish written
notice of the meeting in the appropriate news media and the
Pennsylvania Bulletin at least 14 days prior to the public
meeting date. In the meeting, the applicant and any interested
person providing prior notice to the department shall have the
right to present oral or written comments and relevant evidence
on the application in the manner prescribed by the department.
The department shall prepare a transcript of the oral testimony
presented at the meeting. Meetings shall be held in accordance
with the guidelines and procedures established by the department
and published in the Pennsylvania Code as a statement of policy.
The department may require the applicant to provide copies of
the application to any interested person making a request for
such application, at the expense of the interested person.
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(c) The applicant may, for good cause shown, request in
writing a public hearing for the purpose of reconsideration of a
decision of the department within ten days of service of the
decision of the department. The department shall treat the
request in accordance with the provisions of 1 Pa. Code ยง 35.241
(relating to application for rehearing or reconsideration). The
department shall set forth the cause for the hearing and the
issues to be considered at such hearing. If such hearing is
granted, it shall be held no sooner than six days and no later
than 30 days after the notice to grant such a hearing and shall
be limited to the issues submitted for reconsideration. A
transcript shall be made of the hearing and a copy of the
transcript shall be provided at cost to the applicant. The
department shall affirm or reverse its decision and submit the
same to the person requesting the hearing within 30 days of the
conclusion of such hearing. Any change in the decision shall be
supported by the reasons for the change.
(d) Where hearings under subsection (b) are held on more
than two days, consecutive days of hearings and intervening
weekends and holidays shall be excluded in calculating the time
permitted for the department to conduct its review, and, if
briefs are to be filed, ten days subsequent to the adjournment
of the hearing shall also be excluded.
Section 705. Good cause.
Good cause shall be deemed to have been shown if:
(1) there is significant, relevant information not
previously considered;
(2) there is significant change in factors or
circumstances relied on in making the decision;
(3) there has been material failure to comply with the
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procedural requirements of this act; or
(4) good cause is otherwise found to exist.
Section 5. Sections 706, 707 and 708.1 of the act are
reenacted and amended to read:
Section 706. Information during review.
During the course of review the department and the CON review
board shall upon request of any person set forth the status, any
findings made in the proceeding and other appropriate
information requested. The department and the CON review board
may require such request in writing.
Section 707. Criteria for review of applications for
certificates of need or amendments.
(a) An application for certificate of need shall be
considered for approval when the department [determines] and the
CON review board determine that the application substantially
meets the requirements listed below:
(1) There is need by the population served or to be
served by the proposed service or facility.
(2) The proposed service or facility will provide care
consistent with quality standards established by the [State
health services plan] department.
(3) The proposed service or facility will meet the
standards identified [in the State health services plan] by
the department for access to care by medically underserved
groups, including individuals eligible for medical assistance
and persons without health insurance.
(4) The applicant has submitted a data-based cost
analysis that includes an analysis demonstrating that:
(i) There is not a more appropriate, less costly or
more effective alternative method of providing the
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proposed services.
(ii) The service or facility is financially and
economically feasible, considering anticipated volume of
care and the availability of reasonable financing based
on information from the applicant and other sources
during the review process.
(iii) The proposed service or facility will not have
an inappropriate, adverse impact on the overall level of
health care expenditures in the area.
(iv) The proposed service or facility does not
adversely impact the maintenance and development of rural
and inner-city health services generally and, in
particular, those services provided by health care
providers that are based in rural and inner-city
locations and have an established history of providing
services to medically underserved populations.
[(b) The department shall issue a certificate of need if the
project substantially meets the criteria of subsection (a)(1),
(2) and (3) and the project is consistent with the State health
services plan unless the department can demonstrate:
(1) There is a more appropriate, less costly or more
effective alternative method of providing the proposed
services.
(2) The service or facility is not financially and
economically feasible, considering anticipated volume of care
and the availability of reasonable financing based on
information received from the applicant and other sources
during the review process.
(3) The proposed service or facility will have an
inappropriate, adverse impact on the overall level of health
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care expenditures in the area.
(4) The proposed service or facility adversely impacts
the maintenance and development of rural and inner-city
health services generally and, in particular, those services
provided by health care providers which are based in rural
and inner-city locations and which have an established
history of providing services to medically underserved
populations.]
(c) Notwithstanding the provisions of [subsections (a) and
(b)] subsection (a), applications for projects described in
subsection (d) shall be approved unless the department [finds]
and the CON review board find that the facility or service with
respect to such expenditure as proposed is not needed [or that
the project is not consistent with the State health services
plan]. An application made under this subsection shall be
approved only to the extent that the department [determines] and
the CON review board determine it is required to overcome the
conditions described in subsection (d).
(d) Subject to the provisions of subsection (c),
[subsections (a) and (b)] subsection (a) shall not apply to
capital expenditures required to:
(1) eliminate or prevent imminent safety hazards as a
result of violations of safety codes or regulations;
(2) comply with State licensure standards; or
(3) comply with accreditation standards, compliance with
which is required to receive reimbursement or payments under
Title XVIII or XIX of the Federal Social Security Act.
Section 708.1. Monitoring certificate of need; expiration of a
certificate of need.
A certificate of need or an amendment to it shall expire two
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years from the date issued unless substantially implemented, as
defined by regulation. The department and the CON review board
may grant extensions for a specified time upon request of the
applicant and upon a showing that the applicant has or is making
a good faith effort to substantially implement the project. An
expired certificate of need shall be invalid, and no person may
proceed to undertake any activity pursuant to it for which a
certificate of need or amendment is required. The applicant
shall report to the department, on forms prescribed by the
department, the status of the project until such time as the
project is licensed or operational, if no license is required.
Section 6. Section 709 of the act is reenacted to read:
Section 709. Emergencies.
Notwithstanding any other provision of this act, in the event
of an emergency the department may suspend the foregoing
application process and permit such steps to be taken as may be
required to meet the emergency including the replacement of
equipment or facilities.
Section 7. Sections 710, 711, 712, 808, 901 and 902.1 of the
act are reenacted and amended to read:
Section 710. Notice of termination of services.
For informational purposes only, at least 30 days prior to
termination or substantial reduction of a service or a permanent
decrease in the bed complement, the provider shall notify the
[health systems agency and the] department of its intended
action.
Section 711. Review of activities.
(a) The department and the CON review board shall prepare
and publish not less frequently than annually reports of reviews
conducted under this act, including a statement on the status of
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each such review and of reviews completed by it and statements
of the decisions made in the course of such reviews since the
last report. The department and the CON review board shall also
make available to the general public for examination at
reasonable times of the business day all applications reviewed
by it. Such reports and applications shall be considered public
records.
(b) The department's and the CON review board's report which
shall be submitted to the members of the Health and Welfare
Committees of the Senate and House of Representatives shall
contain the following information:
(1) The volume of applications submitted, by project
type, their dollar value, and the numbers and costs
associated with those approved and those not approved.
(2) The assessment of the extent of competition in
specific service sectors that guided decisions.
(3) A detailed description of projects involving
nontraditional or innovative service delivery methods or
organizational arrangements and the decisions made on each of
these projects.
(4) The average time for review, by level of review.
(5) The fees collected for reviews and the cost of the
program.
Section 712. Actions against violations of law and rules and
regulations[; bonds].
(a) Whenever any person, regardless of whether such person
is a licensee, has willfully violated any of the provisions of
this act or the rules and regulations adopted thereunder, the
department may maintain any action in the name of the
Commonwealth for an injunction or other process restraining or
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prohibiting such person from engaging in such activity.
Section 808. Issuance of license.
(a) Standards.--The department shall issue a license to a
health care provider when it is satisfied that the following
standards have been met:
(1) that the health care provider is a responsible
person;
(2) that the place to be used as a health care facility
is adequately constructed, equipped, maintained and operated
to safely and efficiently render the services offered;
(3) that the health care facility provides safe and
efficient services which are adequate for the care, treatment
and comfort of the patients or residents of such facility;
(4) that there is substantial compliance with the rules
and regulations adopted by the department pursuant to this
act;
(5) that a certificate of need has been issued if one is
necessary; and
(6) that, in the case of abortion facilities, such
facility is in compliance with the requirements of 18 Pa.C.S.
Ch. 32 (relating to abortion) and such regulations
promulgated thereunder.
(b) Separate and limited licenses.--Separate licenses shall
not be required for different services within a single health
care facility except that home health care, home care, hospice
or long-term nursing care will require separate licenses. A
limited license, excluding from its terms a particular service
or portion of a health care facility, may be issued under the
provisions of this act.
(c) Addition of services.--When the certificate of need for
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a facility is amended as to services which can be offered, the
department shall issue an appropriate license for those services
upon demonstration of compliance with licensure requirements.
(d) Monitoring.--
(1) One year after the certificate of need has been
issued, the department shall monitor quality of the facility
or service by requesting from the council relevant data,
which may include mortality rates and the number of
procedures performed.
(2) If the department finds that the facility or service
is not meeting the standards set forth in subsection (a), the
department shall take disciplinary action pursuant to this
act and existing regulations.
Section 901. Existing facilities and institutions.
(a) (1) No certificate of need shall be required for any
buildings, real property and equipment owned, leased or being
operated, or under contract for construction, purchase, or
lease and for all services being rendered by licensed or
approved providers [on April 1, 1980.] prior to the effective
date of this paragraph.
(2) Nor shall a certificate of need be required for any
new institutional health services for which an approval has
been granted under section 1122 of the Social Security Act or
for which an application is found pursuant to such section to
be in conformity with the standards, criteria or plans to
which such section refers, or as to which the Federal
Secretary of Health and Human Services makes a finding that
reimbursement shall be granted.[: Provided, however, That
such approval is in force on August 1, 1980 or such
application shall have been filed prior to August 1, 1980 or
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the acceptance of applications for reviews under this act,
whichever shall last occur.]
(b) E xisting facilities and institutions shall be required
to obtain a certificate of need for projects outlined in section
701.
Section 902.1. Fees for review of certificate of need
applications.
(a) The department shall charge a fee of [$150] $500 for
each letter of intent filed. The letter of intent fee shall be
deducted from the total application fee required under
subsection (b) if an application is submitted on the project
proposed in the letter of intent.
(b) For each application the department shall charge a fee,
payable on submission of an application. The fee shall not be
less than $500 plus up to [$3] $10 per $1,000 of proposed
capital expenditure and shall not be more than [$20,000]
$50,000.
(c) The department shall publish a fee schedule in the
Pennsylvania Bulletin which shall explain the procedure for
filing fees.
(d) All fees payable under this section are due upon the
date of filing a letter of intent or application. If a person
fails to file the appropriate fee, all time frames required of
the department under this act, with respect to review of a
letter of intent or application, are suspended until the
applicable fee is paid in full.
(e) Each local review committee may apply for up to $10,000
in funding from the department for administrative functions
associated with reviewing certificate of need proposals. This
funding is to be allocated from the Patient Safety Authority
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appropriation.
Section 8. Section 904.1 of the act is repealed:
[Section 904.1. Sunset.
The authority, obligations and duties arising under Chapter 7
and all other provisions of this act pertaining to certificates
of need shall terminate four years after the effective date of
this section. Twelve months prior to this expiration, the
Legislative Budget and Finance Committee shall commence a review
of the impact of the certificate of need program on quality,
access and cost of health care services, including the costs of
appeals, reviewable under this act.]
Section 9. This act shall take effect in 90 days.
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