ENROLLED
COMMITTEE SUBSTITUTE
FOR
H. B. 2476
(By Delegates Kiss and Petersen)
[Passed March 10, 1995; in effect from passage.]
AN ACT to amend and reenact sections two, three, five and six,
article two-d, chapter sixteen of the code of West Virginia,
one thousand nine hundred thirty-one, as amended, relating
generally to certificate of need procedures; providing the
definition of terms; requiring certificate of need for new
providers of personal care services; setting forth minimum
review criteria for certificate of need; authorizing the
health care cost review authority to amend or modify
certificate of need standards; setting forth the
requirements for amending the standards; and authorizing the
health care cost review authority to declare a limited
moratorium for purposes of amending obsolete or nonexistent
standards.
Be it enacted by the Legislature of West Virginia:
That sections two, three, five and six, article two-d,
chapter sixteen of the code of West Virginia, one thousand nine
hundred thirty-one, as amended, be amended and reenacted, all to
read as follows:
ARTICLE 2D. CERTIFICATE OF NEED.
§16-2D-2. Definitions.
As used in this article, unless otherwise indicated by the
context:
(a) "Affected person" means:
(1) The applicant;
(2) An agency or organization representing consumers;
(3) Any individual residing within the geographic area
served or to be served by the applicant;
(4) Any individual who regularly uses the health care
facilities within that geographic area;
(5) The health care facilities which provide services
similar to the services of the facility under review and which
will be significantly affected by the proposed project;
(6) The health care facilities which, prior to receipt by
the state agency of the proposal being reviewed, have formally
indicated an intention to provide similar services in the future;
(7) Third-party payors who reimburse health care facilities
similar to those proposed for services;
(8) Any agency which establishes rates for health care
facilities similar to those proposed; or
(9) Organizations representing health care providers.
(b) "Ambulatory health care facility" means a facility which
is free-standing and not physically attached to a health care
facility and which provides health care to noninstitutionalized
and nonhomebound persons on an outpatient basis. This definition
does not include the private office practice of any one or more health professionals licensed to practice in this state pursuant
to the provisions of chapter thirty of this code: Provided, That
such exemption from review of private office practice shall not
be construed to include such practices where major medical
equipment otherwise subject to review under the provisions of
this article is acquired, offered or developed: Provided,
however, That such exemption from review of private office
practice shall not be construed to include certain health
services otherwise subject to review under the provisions of
subdivision (1), subsection (a), section four of this article.
(c) "Ambulatory surgical facility" means a facility which is
free-standing and not physically attached to a health care
facility and which provides surgical treatment to patients not
requiring hospitalization. This definition does not include the
private office practice of any one or more health professionals
licensed to practice surgery in this state pursuant to the
provisions of chapter thirty of this code: Provided, That such
exemption from review of private office practice shall not be
construed to include such practices where major medical equipment
otherwise subject to review under the provisions of this article
is acquired, offered or developed: Provided, however, That such
exemption from review of private office practice shall not be
construed to include certain health services otherwise subject to
review under the provisions of subdivision (1), subsection (a),
section four of this article.
(d) "Applicant" means: (1) The governing body or the person
proposing a new institutional health service who is, or will be, the health care facility licensee wherein the new institutional
health service is proposed to be located, and (2) in the case of
a proposed new institutional health service not to be located in
a licensed health care facility, the governing body or the person
proposing to provide such new institutional health service.
Incorporators or promoters who will not constitute the governing
body or persons responsible for the new institutional health
service may not be an applicant.
(e) "Bed capacity" means the number of beds for which a
license is issued to a health care facility, or, if a facility is
unlicensed, the number of adult and pediatric beds permanently
staffed and maintained for immediate use by inpatients in patient
rooms or wards.
(f) "Capital expenditure" means an expenditure:
(1) Made by or on behalf of a health care facility; and
(2) (A) Which (i) under generally accepted accounting
principles is not properly chargeable as an expense of operation
and maintenance, or (ii) is made to obtain either by lease or
comparable arrangement any facility or part thereof or any
equipment for a facility or part; and (B) which (i) exceeds the
expenditure minimum, or (ii) is a substantial change to the bed
capacity of the facility with respect to which the expenditure is
made, or (iii) is a substantial change to the services of such
facility. For purposes of subparagraph (i), paragraph (B),
subdivision (2) of this definition, the cost of any studies,
surveys, designs, plans, working drawings, specifications, and
other activities, including staff effort and consulting and other services, essential to the acquisition, improvement, expansion,
or replacement of any plant or equipment with respect to which an
expenditure described in paragraph (B), subdivision (2) of this
definition is made shall be included in determining if such
expenditure exceeds the expenditure minimum. Donations of
equipment or facilities to a health care facility which if
acquired directly by such facility would be subject to review
shall be considered capital expenditures, and a transfer of
equipment or facilities for less than fair market value shall be
considered a capital expenditure for purposes of such
subdivisions if a transfer of the equipment or facilities at fair
market value would be subject to review. A series of
expenditures, each less than the expenditure minimum, which when
taken together are in excess of the expenditure minimum, may be
determined by the state agency to be a single capital expenditure
subject to review. In making its determination, the state agency
shall consider: Whether the expenditures are for components of
a system which is required to accomplish a single purpose;
whether the expenditures are to be made over a two-year period
and are directed towards the accomplishment of a single goal
within the health care facility's long-range plan; or whether the
expenditures are to be made within a two-year period within a
single department such that they will constitute a significant
modernization of the department.
(g) "Expenditure minimum" means seven hundred fifty thousand
dollars per fiscal year.
(h) "Health," used as a term, includes physical and mental health.
(i) "Health care facility" is defined as including
hospitals, skilled nursing facilities, kidney disease treatment
centers, including free-standing hemodialysis units, intermediate
care facilities, ambulatory health care facilities, ambulatory
surgical facilities, home health agencies, rehabilitation
facilities and health maintenance organizations; community mental
health and mental retardation facilities, whether under public or
private ownership, or as a profit or nonprofit organization and
whether or not licensed or required to be licensed in whole or in
part by the state. For purposes of this definition, "community
mental health and mental retardation facility" means a private
facility which provides such comprehensive services and
continuity of care as emergency, outpatient, partial
hospitalization, inpatient and consultation and education for
individuals with mental illness, mental retardation or drug or
alcohol addiction.
(j) "Health care provider" means a person, partnership,
corporation, facility or institution licensed or certified or
authorized by law to provide professional health care service in
this state to an individual during that individual's medical
care, treatment or confinement.
(k) "Health maintenance organization" means a public or
private organization, organized under the laws of this state,
which:
(1) Is a qualified health maintenance organization under
Section 1310(d) of the Public Health Service Act, as amended, Title 42 United States Code Section 300e-9(d); or
(2) (A) Provides or otherwise makes available to enrolled
participants health care services, including substantially the
following basic health care services: Usual physician services,
hospitalization, laboratory, X ray, emergency and preventive
services and out-of-area coverage; and
(B) Is compensated except for copayments for the provision
of the basic health care services listed in paragraph (A),
subdivision (2), subsection (k) of this definition to enrolled
participants on a predetermined periodic rate basis without
regard to the date the health care services are provided and
which is fixed without regard to the frequency, extent or kind of
health service actually provided; and
(C) Provides physicians' services primarily (i) directly
through physicians who are either employees or partners of such
organization, or (ii) through arrangements with individual
physicians or one or more groups of physicians organized on a
group practice or individual practice basis.
(l) "Health services" means clinically related preventive,
diagnostic, treatment or rehabilitative services, including
alcohol, drug abuse and mental health services.
(m) "Home health agency" is an organization primarily
engaged in providing directly or through contract arrangements,
professional nursing services, home health aide services, and
other therapeutic and related services, including, but not
limited to, physical, speech and occupational therapy and
nutritional and medical social services to persons in their place of residence on a part-time or intermittent basis.
(n) "Hospital" means an institution which is primarily
engaged in providing to inpatients, by or under the supervision
of physicians, diagnostic and therapeutic services for medical
diagnosis, treatment, and care of injured, disabled or sick
persons, or rehabilitation services for the rehabilitation of
injured, disabled or sick persons. This term also includes
psychiatric and tuberculosis hospitals.
(o) "Intermediate care facility" means an institution which
provides, on a regular basis, health-related care and services to
individuals who do not require the degree of care and treatment
which a hospital or skilled nursing facility is designed to
provide, but who, because of their mental or physical condition,
require health-related care and services above the level of room
and board.
(p) "Long-range plan" means a document formally adopted by
the legally constituted governing body of an existing health care
facility or by a person proposing a new institutional health
service. Each long-range plan shall consist of the information
required by the state agency in regulations adopted pursuant to
section eight of this article.
(q) "Major medical equipment" means a single unit of medical
equipment or a single system of components with related functions
which is used for the provision of medical and other health
services and which costs in excess of three hundred thousand
dollars, except that such term does not include medical equipment
acquired by or on behalf of a clinical laboratory to provide clinical laboratory services if the clinical laboratory is
independent of a physician's office and a hospital and it has
been determined under Title XVIII of the Social Security Act to
meet the requirements of paragraphs ten and eleven of Section
1861(s) of such act, Title 42 United States Code Sections 1395x
(10) and (11). In determining whether medical equipment costs
more than three hundred thousand dollars, the cost of studies,
surveys, designs, plans, working drawings, specifications, and
other activities essential to the acquisition of such equipment
shall be included. If the equipment is acquired for less than
fair market value, the term "cost" includes the fair market
value.
(r) "Medically underserved population" means the population
of an urban or rural area designated by the state agency as an
area with a shortage of personal health services or a population
having a shortage of such services, after taking into account
unusual local conditions which are a barrier to accessibility or
availability of such services. Such designation shall be in
regulations adopted by the state agency pursuant to section eight
of this article, and the population so designated may include the
state's medically underserved population designated by the
Federal Secretary of Health and Human Services under Section
330(b)(3) of the Public Health Service Act, as amended, Title 42
United States Code Section 254(b)(3).
(s) "New institutional health service" means such service as
described in section three of this article.
(t) "Offer", when used in connection with health services, means that the health care facility or health maintenance
organization holds itself out as capable of providing, or as
having the means for the provision of, specified health services.
(u) "Person" means an individual, trust, estate,
partnership, committee, corporation, association and other
organizations such as joint-stock companies and insurance
companies, a state or a political subdivision or instrumentality
thereof or any legal entity recognized by the state.
(v) "Personal care services" means medically oriented
activities or tasks ordered by a physician and which is
implemented according to a nursing plan of care which has been
completed by, and which is supervised by, a registered nurse and
billed to the state. These services include those activities
which are intended to enable persons to meet their physical needs
and to be treated by a physician in their place of residence.
The term shall include, but not be limited to, services related
to personal hygiene, dressing, feeding, nutrition, environmental
support functions and health related tasks.
(w) "Physician" means a doctor of medicine or osteopathy
legally authorized to practice by the state.
(x) "Proposed new institutional health service" means such
service as described in section three of this article.
(y) "Psychiatric hospital" means an institution which
primarily provides to inpatients, by or under the supervision of
a physician, specialized services for the diagnosis, treatment
and rehabilitation of mentally ill and emotionally disturbed
persons.
(z) "Rehabilitation facility" means an inpatient facility
which is operated for the primary purpose of assisting in the
rehabilitation of disabled persons through an integrated program
of medical and other services which are provided under competent
professional supervision.
(aa) "Review agency" means an agency of the state,
designated by the governor as the agency for the review of state
agency decisions.
(bb) "Skilled nursing facility" means an institution or a
distinct part of an institution which is primarily engaged in
providing to inpatients skilled nursing care and related services
for patients who require medical or nursing care, or
rehabilitation services for the rehabilitation of injured,
disabled or sick persons.
(cc) "State agency" means the health care cost review
authority created, established, and continued pursuant to article
twenty-nine-b of this chapter.
(dd) "State health plan" means the document approved by the
governor after preparation by the former health care planning
commission, or that document as approved by the governor after
amendment by the health care planning council or its successor
agency.
(ee) "Substantial change to the bed capacity" of a health
care facility means any change, with which a capital expenditure
is associated, that increases or decreases the bed capacity, or
relocates beds from one physical facility or site to another, but
does not include a change by which a health care facility reassigns existing beds as swing beds between acute care and
long-term care categories: Provided, That a decrease in bed
capacity in response to federal rural health initiatives shall be
excluded from this definition.
(ff) "Substantial change to the health services" of a health
care facility means the addition of a health service which is
offered by or on behalf of the health care facility and which was
not offered by or on behalf of the facility within the twelve-
month period before the month in which the service is first
offered, or the termination of a health service which was offered
by or on behalf of the facility, but does not include the
providing of hospice care, ambulance service, wellness centers or
programs, adult day care, or respite care by acute care
facilities.
(gg) "To develop", when used in connection with health
services, means to undertake those activities which upon their
completion will result in the offer of a new institutional health
service or the incurring of a financial obligation, in relation
to the offering of such a service.
§16-2D-3. Certificate of need.
Except as provided in section four of this article, any new
institutional health service may not be acquired, offered or
developed within this state except upon application for and
receipt of a certificate of need as provided by this article.
Any new provider of personal care service offered by any person,
facility, corporation or entity, other than an agency of the
state, may not be offered or developed in this state, if the service is to be funded in whole, or in part, by state or federal
medicaid funds, except upon application for and receipt of a
certificate of need as provided in section six of this article:
Provided, That a certificate of need shall not be required for a
person providing specialized foster care personal care services
to one individual and those services are delivered in the
provider's home. Whenever a new institutional health service for
which a certificate of need is required by this article is
proposed for a health care facility for which, pursuant to
section four of this article, no certificate of need is or was
required, a certificate of need shall be issued before the new
institutional health service is offered or developed. No person
may knowingly charge or bill for any health services associated
with any new institutional health service that is knowingly
acquired, offered or developed in violation of this article, and
any bill made in violation of this section is legally
unenforceable. For purposes of this article, a proposed "new
institutional health service" includes:
(a) The construction, development, acquisition or other
establishment of a new health care facility or health maintenance
organization;
(b) The partial or total closure of a health care facility
or health maintenance organization with which a capital
expenditure is associated;
(c) Any obligation for a capital expenditure incurred by or
on behalf of a health care facility, except as exempted in
section four of this article, or health maintenance organization in excess of the expenditure minimum or any obligation for a
capital expenditure incurred by any person to acquire a health
care facility. An obligation for a capital expenditure is
considered to be incurred by or on behalf of a health care
facility:
(1) When a contract, enforceable under state law, is entered
into by or on behalf of the health care facility for the
construction, acquisition, lease or financing of a capital asset;
(2) When the governing board of the health care facility
takes formal action to commit its own funds for a construction
project undertaken by the health care facility as its own
contractor; or
(3) In the case of donated property, on the date on which
the gift is completed under state law;
(d) A substantial change to the bed capacity of a health
care facility with which a capital expenditure is associated;
(e) (1) The addition of health services which are offered by
or on behalf of a health care facility or health maintenance
organization and which were not offered on a regular basis by or
on behalf of the health care facility or health maintenance
organization within the twelve-month period prior to the time the
services would be offered; and
(2) The addition of ventilator services for any nursing
facility bed by any health care facility or health maintenance
organization;
(f) The deletion of one or more health services, previously
offered on a regular basis by or on behalf of a health care facility or health maintenance organization which is associated
with a capital expenditure;
(g) A substantial change to the bed capacity or health
services offered by or on behalf of a health care facility,
whether or not the change is associated with a proposed capital
expenditure, if the change is associated with a previous capital
expenditure for which a certificate of need was issued and if the
change will occur within two years after the date the activity
which was associated with the previously approved capital
expenditure was undertaken;
(h) The acquisition of major medical equipment;
(i) A substantial change in an approved new institutional
health service for which a certificate of need is in effect. For
purposes of this subsection, "substantial change" shall be
defined by the state agency in regulations adopted pursuant to
section eight of this article.
§16-2D-5. Powers and duties of state agency.
(a) The state agency is hereby empowered to administer the
certificate of need program as provided by this article.
(b) The state agency shall be responsible for coordinating
and developing the health planning research efforts of the state
and for amending and modifying the state health plan which
includes the certificate of need standards.
(c) The state agency may seek advice and assistance of other
persons, organizations and other state agencies in the
performance of the state agency's responsibilities under this
article.
(d) For health services for which competition appropriately
allocates supply consistent with the state health plan, the state
agency shall, in the performance of its functions under this
article, give priority, where appropriate to advance the purposes
of quality assurance, cost effectiveness and access, to actions
which would strengthen the effect of competition on the supply of
such services.
(e) For health services for which competition does not or
will not appropriately allocate supply consistent with the state
health plan, the state agency shall, in the exercise of its
functions under this article, take actions, where appropriate to
advance the purposes of quality assurance, cost effectiveness and
access and the other purposes of this article, to allocate the
supply of such services.
(f) Notwithstanding the provisions of section seven of this
article, the state agency may charge a fee for the filing of any
application, the filing of any notice in lieu of an application,
the filing of any exemption determination request or the filing
of any request for a declaratory ruling. The fees charged may
vary according to the type of matter involved, the type of health
service or facility involved or the amount of capital expenditure
involved. The state agency shall implement this subsection by
filing procedural rules pursuant to chapter twenty-nine-a of this
code. The fees charged shall be deposited into a special fund
known as the certificate of need program fund to be expended for
the purposes of this article.
(g) No hospital, nursing home or other health care facility shall add any intermediate care or skilled nursing beds to its
current licensed bed complement. This prohibition also applies
to the conversion of acute care or other types of beds to
intermediate care or skilled nursing beds: Provided, That
hospitals eligible under the provisions of section four-a and
subsection (i), section five of this article may convert acute
care beds to skilled nursing beds in accordance with the
provisions of these sections, upon approval by the state agency.
Furthermore, no certificate of need shall be granted for the
construction or addition of any intermediate care or skilled
nursing beds except in the case of facilities designed to replace
existing beds in unsafe existing facilities. A health care
facility in receipt of a certificate of need for the construction
or addition of intermediate care or skilled nursing beds which
was approved prior to the effective date of this section must
incur an obligation for a capital expenditure within twelve
months of the date of issuance of the certificate of need. No
extensions shall be granted beyond the twelve-month period:
Provided, however, That a maximum of sixty beds may be approved,
as a demonstration project, by the state agency for a unit to
provide nursing services to patients with alzheimer's disease if:
(1) The unit is located in an existing facility which was
formerly owned and operated by the state of West Virginia and is
presently owned by a county of the state of West Virginia; (2)
the facility has provided health care services, including
personal care services, within one year prior to the effective
date of this section; (3) the facility demonstrates that awarding the certificate of need and operating the facility will be cost
effective for the state; and (4) that any applicable lease,
lease-purchase or contract for operating the facility was awarded
through a process of competitive bidding consistent with state
purchasing practices and procedures: Provided further, That an
application for said demonstration project shall be filed with
the state agency on or before the twenty-first day of October,
one thousand nine hundred ninety-three.
(h) No additional intermediate care facility for the
mentally retarded (ICF/MR) beds shall be granted a certificate of
need, except that prohibition does not apply to ICF/MR beds
approved under the Kanawha County circuit court order of the
third day of August, one thousand nine hundred eighty-nine, civil
action number MISC-81-585 issued in the case of E. H. v. Matin,
168 W.V. 248, 284 S.E.2d 232 (1981).
(i) Notwithstanding the provisions of subsection (g),
section five of this article and, further notwithstanding the
provisions of subsection (d), section three of this article, an
existing acute care hospital may apply to the health care cost
review authority for a certificate of need to convert acute care
beds to skilled nursing beds: Provided, That the proposed
skilled nursing beds are medicare certified only: Provided,
however, That any hospital which converts acute care beds to
medicare certified only skilled nursing beds is prohibited from
billing for any medicaid reimbursement for any beds so converted.
In converting beds, the hospital must convert a minimum of one
acute care bed into one medicare certified only skilled nursing bed. The health care cost review authority may require a
hospital to convert up to and including three acute care beds for
each medicare certified only skilled nursing bed. The health
care cost review authority shall adopt rules to implement this
subsection which require that:
(1) All acute care beds converted shall be permanently
deleted from the hospital's acute care bed complement and the
hospital may not thereafter add, by conversion or otherwise,
acute care beds to its bed complement without satisfying the
requirements of subsection (d), section three of this article for
which purposes such an addition, whether by conversion or
otherwise, shall be considered a substantial change to the bed
capacity of the hospital notwithstanding the definition of that
term found in subsection (ee), section two of this article.
(2) The hospital shall meet all federal and state licensing
certification and operational requirements applicable to nursing
homes including a requirement that all skilled care beds created
under this subsection shall be located in distinct-part, long-
term care units.
(3) The hospital must demonstrate a need for the project.
(4) The hospital must use existing space for the medicare
certified only skilled nursing beds. Under no circumstances
shall the hospital construct, lease or acquire additional space
for purposes of this section.
(5) The hospital must notify the acute care patient, prior
to discharge, of facilities with skilled nursing beds which are
located in or near the patient's county of residence.
Nothing in this subsection shall negatively affect the
rights of inspection and certification which are otherwise
required by federal law or regulations or by this code of duly
adopted regulations of an authorized state entity.
(j) Notwithstanding the provisions of subsection (g) of this
section, a retirement life care center with no skilled nursing
beds may apply to the health care cost review authority for a
certificate of need for up to sixty skilled nursing beds provided
the proposed skilled beds are medicare certified only. On a
statewide basis, a maximum of one hundred eighty skilled beds
which are medicare certified only may be developed pursuant to
this subsection. The state health plan shall not be applicable
to projects submitted under this subsection. The health care
cost review authority shall adopt rules to implement this
subsection which shall include:
(1) A requirement that the one hundred eighty beds are to be
distributed on a statewide basis;
(2) There shall be a minimum of twenty beds and a maximum of
sixty beds in each approved unit;
(3) The unit developed by the retirement life care center
shall meet all federal and state licensing certification and
operational requirements applicable to nursing homes;
(4) The retirement center must demonstrate a need for the
project;
(5) The retirement center must offer personal care, home
health services and other lower levels of care to its residents;
and
(6) The retirement center must demonstrate both short and
long-term financial feasibility.
Nothing in this subsection shall negatively affect the
rights of inspection and certification which are otherwise
required by federal law or regulations or by this code of duly
adopted regulations of an authorized state entity.
(k) The provisions of this article are severable and if any
provision, section or part thereby shall be held invalid,
unconstitutional or inapplicable to any person or circumstance,
such invalidity, unconstitutionality or inapplicability shall not
affect or impair any other remaining provisions contained herein.
(l) The state agency is hereby empowered to order a
moratorium upon the processing of an application or applications
for the development of a new institutional health service filed
pursuant to section three of this article, when criteria and
guidelines for evaluating the need for such new institutional
health service have not yet been adopted or are obsolete. Such
moratorium shall be declared by a written order which shall
detail the circumstances requiring the moratorium. Upon the
adoption of criteria for evaluating the need for the new
institutional health service affected by the moratorium, or one
hundred eighty days from the declaration of a moratorium,
whichever is less, the moratorium shall be declared to be over
and affected applications shall be processed pursuant to section
six of this article.
(m) The state agency shall coordinate the collection of
information needed to allow the state agency to develop recommended modifications to certificate of need standards as
required in this article. When the state agency proposes
amendments or modifications to the certificate of need standards,
they shall file with the secretary of state, for publication in
the state register, a notice of proposed action, including the
text of all proposed amendments and modifications, and a date,
time and place for receipt of general public comment. To comply
with the public comment requirement of this section, the state
agency may hold a public hearing or schedule a public comment
period for the receipt of written statements or documents.
All proposed amendments and modifications to the certificate
of need standards, with a record of the public hearing or written
statements and documents received pursuant to a public comment
period, shall be presented to the governor. Within thirty days
of receiving said proposed amendments or modifications, the
governor shall either approve or disapprove all or part of said
amendments and modifications, and, for any portion of amendments
or modifications not approved, shall specify the reason or
reasons for nonapproval. Any portions of the amendments or
modifications not approved by the governor may be revised and
resubmitted.
§16-2D-6. Minimum criteria for certificate of need reviews.
(a) Except as provided in subsections (f) and (g), section
nine of this article, in making its determination as to whether
a certificate of need shall be issued, the state agency shall, at
a minimum, consider all of the following criteria that are
applicable: Provided, That in the case of a health maintenance organization or an ambulatory care facility or health care
facility controlled, directly or indirectly, by a health
maintenance organization or combination of health maintenance
organizations, the criteria considered shall be only those set
forth in subdivision (12) of this subsection: Provided, however,
That the criteria set forth in subsection (f) of this section
applies to all hospitals, nursing homes and health care
facilities when ventilator services are to be provided for any
nursing facility bed:
(1) The recommendation of the designated health systems
agency for the health service area in which the proposed new
institutional health service is to be located;
(2) The relationship of the health services being reviewed
to the state health plan and to the applicable health systems
plan and annual implementation plan adopted by the designated
health systems agency for the health service area in which the
proposed new institutional health service is to be located;
(3) The relationship of services reviewed to the long-range
development plan of the person providing or proposing the
services;
(4) The need that the population served or to be served by
the services has for the services proposed to be offered or
expanded, and the extent to which all residents of the area, and
in particular low income persons, racial and ethnic minorities,
women, handicapped persons, other medically underserved
population, and the elderly, are likely to have access to those
services;
(5) The availability of less costly or more effective
alternative methods of providing the services to be offered,
expanded, reduced, relocated or eliminated;
(6) The immediate and long-term financial feasibility of the
proposal as well as the probable impact of the proposal on the
costs of and charges for providing health services by the person
proposing the new institutional health service;
(7) The relationship of the services proposed to the
existing health care system of the area in which the services are
proposed to be provided;
(8) In the case of health services proposed to be provided,
the availability of resources, including health care providers,
management personnel, and funds for capital and operating needs,
for the provision of the services proposed to be provided and the
need for alternative uses of these resources as identified by the
state health plan, applicable health systems plan and annual
implementation plan;
(9) The appropriate and nondiscriminatory utilization of
existing and available health care providers;
(10) The relationship, including the organizational
relationship, of the health services proposed to be provided to
ancillary or support services;
(11) Special needs and circumstances of those entities which
provide a substantial portion of their services or resources, or
both, to individuals not residing in the health service areas in
which the entities are located or in adjacent health service
areas. The entities may include medical and other health professional schools, multidisciplinary clinics and specialty
centers;
(12) To the extent not precluded by subdivision (1),
subsection (f), section nine of this article, the special needs
and circumstances of health maintenance organizations. These
needs and circumstances are limited to:
(A) The needs of enrolled members and reasonably anticipated
new members of the health maintenance organization for the health
services proposed to be provided by the organization; and
(B) The availability of the new health services from
nonhealth maintenance organization providers or other health
maintenance organizations in a reasonable and cost-effective
manner which is consistent with the basic method of operation of
the health maintenance organization. In assessing the
availability of these health services from these providers, the
agency shall consider only whether the services from these
providers:
(i) Would be available under a contract of at least five
years' duration;
(ii) Would be available and conveniently accessible through
physicians and other health professionals associated with the
health maintenance organization;
(iii) Would cost no more than if the services were provided
by the health maintenance organization; and
(iv) Would be available in a manner which is
administratively feasible to the health maintenance organization;
(13) The special needs and circumstances of biomedical and behavioral research projects which are designed to meet a
national need and for which local conditions offer special
advantages;
(14) In the case of a reduction or elimination of a service,
including the relocation of a facility or a service, the need
that the population presently served has for the service, the
extent to which that need will be met adequately by the proposed
relocation or by alternative arrangements, and the effect of the
reduction, elimination or relocation of the service on the
ability of low income persons, racial and ethnic minorities,
women, handicapped persons, other medically underserved
population, and the elderly, to obtain needed health care;
(15) In the case of a construction project: (A) The cost
and methods of the proposed construction, including the costs and
methods of energy provision and (B) the probable impact of the
construction project reviewed on the costs of providing health
services by the person proposing the construction project and on
the costs and charges to the public of providing health services
by other persons;
(16) In the case of health services proposed to be provided,
the effect of the means proposed for the delivery of proposed
health services on the clinical needs of health professional
training programs in the area in which the services are to be
provided;
(17) In the case of health services proposed to be provided,
if the services are to be available in a limited number of
facilities, the extent to which the schools in the area for health professions will have access to the services for training
purposes;
(18) In the case of health services proposed to be provided,
the extent to which the proposed services will be accessible to
all the residents of the area to be served by the services;
(19) In accordance with section five of this article, the
factors influencing the effect of competition on the supply of
the health services being reviewed;
(20) Improvements or innovations in the financing and
delivery of health services which foster competition, in
accordance with section five of this article, and serve to
promote quality assurance and cost effectiveness;
(21) In the case of health services or facilities proposed
to be provided, the efficiency and appropriateness of the use of
existing services and facilities similar to those proposed;
(22) In the case of existing services or facilities, the
quality of care provided by the services or facilities in the
past;
(23) In the case where an application is made by an
osteopathic or allopathic facility for a certificate of need to
construct, expand, or modernize a health care facility, acquire
major medical equipment, or add services, the need for that
construction, expansion, modernization, acquisition of equipment,
or addition of services shall be considered on the basis of the
need for and the availability in the community of services and
facilities for osteopathic and allopathic physicians and their
patients. The state agency shall consider the application in terms of its impact on existing and proposed institutional
training programs for doctors of osteopathy and medicine at the
student, internship, and residency training levels;
(24) The special circumstances of health care facilities
with respect to the need for conserving energy;
(25) The contribution of the proposed service in meeting the
health related needs of members of medically underserved
populations which have traditionally experienced difficulties in
obtaining equal access to health services, particularly those
needs identified in the state health plan, applicable health
systems plan and annual implementation plan, as deserving of
priority. For the purpose of determining the extent to which the
proposed service will be accessible, the state agency shall
consider:
(A) The extent to which medically underserved populations
currently use the applicant's services in comparison to the
percentage of the population in the applicant's service area
which is medically underserved, and the extent to which medically
underserved populations are expected to use the proposed services
if approved;
(B) The performance of the applicant in meeting its
obligation, if any, under any applicable federal regulations
requiring provision of uncompensated care, community service, or
access by minorities and handicapped persons to programs
receiving federal financial assistance, including the existence
of any civil rights access complaints against the applicant;
(C) The extent to which medicare, medicaid and medically indigent patients are served by the applicant; and
(D) The extent to which the applicant offers a range of
means by which a person will have access to its services,
including, but not limited to, outpatient services, admission by
a house staff and admission by personal physician;
(26) The existence of a mechanism for soliciting consumer
input into the health care facility's decision making process.
(b) The state agency may include additional criteria which
it prescribes by regulations adopted pursuant to section eight of
this article.
(c) Criteria for reviews may vary according to the purpose
for which a particular review is being conducted or the types of
health services being reviewed.
(d) An application for a certificate of need may not be made
subject to any criterion not contained in this article or not
contained in regulations adopted pursuant to section eight of
this article.
(e) In the case of any proposed new institutional health
service, the state agency may not grant a certificate of need
under its certificate of need program unless, after consideration
of the appropriateness of the use of existing facilities
providing services similar to those being proposed, the state
agency makes, in addition to findings required in section nine of
this article, each of the following findings in writing: (1)
That superior alternatives to the services in terms of cost,
efficiency and appropriateness do not exist and the development
of alternatives is not practicable; (2) that existing facilities providing services similar to those proposed are being used in an
appropriate and efficient manner; (3) that in the case of new
construction, alternatives to new construction, such as
modernization or sharing arrangements, have been considered and
have been implemented to the maximum extent practicable; (4) that
patients will experience serious problems in obtaining care of
the type proposed in the absence of the proposed new service; and
(5) that in the case of a proposal for the addition of beds for
the provision of skilled nursing or intermediate care services,
the addition will be consistent with the plans of other agencies
of the state responsible for the provision and financing of long-
term care facilities or services including home health services.
(f) In the case where an application is made by a hospital,
nursing home or other health care facility to provide ventilator
services which have not previously been provided for a nursing
facility bed, the state agency shall consider the application in
terms of the need for the service and whether the cost exceeds
the level of current medicaid services. No facility may, by
providing ventilator services, provide a higher level of service
for a nursing facility bed without demonstrating that the change
in level of service by provision of the additional ventilator
services will result in no additional fiscal burden to the state.
(g) In the case where application is made by any person or
entity to provide personal care services which are to be billed
for medicaid reimbursement, the state agency shall consider the
application in terms of the need for the service and whether the
cost exceeds the level of the cost of current medicaid services. No person or entity may provide personal care services to be
billed for medicaid reimbursement without demonstrating that the
provision of the personal care service will result in no
additional fiscal burden to the state: Provided, That a
certificate of need shall not be required for a person providing
specialized foster care personal care services to one individual
and those services are delivered in the provider's home. The
state agency will also consider the total fiscal liability to the
state for all applications which have been submitted.