Senate Bill No. 492
(By Senators Tomblin, Mr. President, and Sprouse,
By Request of the Executive)
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[Introduced February 10, 1999;
referred to the Committee on Health and Human Resources.]
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A BILL to amend and reenact sections two, three, four, four-a,
five, six, seven, seven-a, eight, nine, ten, eleven,
thirteen and fifteen, article two-d, chapter sixteen of the
code of West Virginia, one thousand nine hundred thirty-one,
as amended, all relating to definitions; certificate of
need; new institutional health services definition;
exemptions from certificate of need; conversion of acute
beds to skilled nursing beds in rural areas; powers and
duties of health care authority relating to certificate of
need program, health planning, state health plan,
application fees, long term care beds, ICF/MR beds, life
care retirement centers, moratoriums for certain health
services, certificate of need standards and rural health
facilities; minimum criteria for certificate of need
reviews, long-range plans; procedures for certificate of need reviews; notification to the public; public hearings;
file closing; annual report; access for the public;
reconsideration; expedited review; review for nonhealth- related projects; filing with consumer advocate; rule-making
powers; final decision; required findings; emergency
certificate of need; appeal of final decision; certificate
of need is nontransferable; extensions and withdrawals of
certificates of need; injunctive relief; civil penalties;
and previously approved rules and regulations.
Be it enacted by the Legislature of West Virginia:
That sections two, three, four, four-a, five, six, seven,
seven-a, eight, nine, ten, eleven, thirteen and fifteen, 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.
Definitions of words and terms defined in articles five-f
and twenty-nine-b of this chapter are incorporated in this
section unless this section has different 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 that establishes rates for health care
facilities similar to those proposed; or
(9) Organizations representing health care providers.
(b) "Ambulatory health care facility" means a free-standing
facility that provides health care to noninstitutionalized and
nonhomebound persons on an outpatient basis. For purposes of
this definition, a free-standing facility is not located on the
campus of an existing health care facility. 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 this
exemption from review shall not be construed to include practices
where major medical equipment otherwise subject to review under
the provisions of this article is acquired, offered or developed:
Provided, however, That this exemption from review 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 free-standing
facility that provides surgical treatment to patients not
requiring hospitalization. For purposes of this definition, a
free-standing facility is not physically attached to a health
care facility. 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 this exemption from
review shall not be construed to include practices where major
medical equipment otherwise subject to review under the
provisions of this article is acquired, offered or developed:
Provided, however, That this exemption from review shall not be
construed to include 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 the 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 licensed to a
health care facility, or the number of adult and pediatric beds
permanently staffed and maintained for immediate use by
inpatients in patient rooms or wards in an unlicensed facility.
(f) "Campus" means the adjacent grounds and buildings, or
grounds and buildings not separated by more than a public
right-of-way, of a health care facility.
(g) "Capital expenditure" means:
(1) An expenditure made by or on behalf of a health care
facility, which:
(A)(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)(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; or
(2) The donation of equipment or facilities to a health care
facility, which if acquired directly by that facility would be
subject to review; or
(3) The transfer of equipment or facilities for less than
fair market value if the transfer of the equipment or facilities
at fair market value would be subject to review; or
(4) A series of expenditures, if the sum total exceeds the
expenditure minimum and if determined by the state agency to be
a single capital expenditure subject to review. In making this
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.
(h) "Expenditure minimum" means one million five hundred
thousand dollars. and includes Effective the first day of July,
two thousand, the expenditure minimum shall be one million seven
hundred fifty thousand dollars. Effective the first day of July,
two thousand one, the expenditure minimum shall be two million
dollars. The expenditure minimum shall include 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.
(i) "Health", used as a term, includes physical and mental
health.
(j) "Health care facility" means a publicly or privately
owned facility, agency or entity that offers or provides health
care services, whether a for-profit or nonprofit entity and
whether or not licensed, or required to be licensed, in whole or
in part, and includes, but is not limited to, 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; hospice agencies;
rehabilitation facilities; health maintenance organizations; and
community mental health and mental retardation facilities. 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 or consultation
and education for individuals with mental illness, mental
retardation or drug or alcohol addiction.
(k) "Health care provider" means a person, partnership,
corporation, facility, hospital 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, remedial or behavioral health care,
treatment or confinement.
(l) "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 U.S.C. §300e-9(d) required to have a certificate of
authority to operate in this state pursuant to section three,
article twenty-five-a, chapter thirty-three of this code; 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) of this
subdivision 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: (i) Directly through
physicians who are either employees or partners of the
organization; or (ii) through arrangements with individual
physicians or one or more groups of physicians organized on a
group practice or individual practice basis.
(m) "Health services" means clinically related preventive,
diagnostic, treatment or rehabilitative services, including
alcohol, drug abuse and mental health services.
(n) "Home health agency" means an organization primarily
engaged in providing professional nursing services either
directly or through contract arrangements and at least one of the
following services: Home health aide services, other therapeutic
services, physical therapy, speech therapy, occupational therapy,
nutritional services or medical social services to persons in
their place of residence on a part-time or intermittent basis.
(o) "Hospice agency" means a private or public agency or
organization licensed in West Virginia for the administration or
provision of hospice care services to terminally ill persons in
the persons' temporary or permanent residences by using an
interdisciplinary team, including, at a minimum, persons
qualified to perform nursing services; social work services; the
general practice of medicine or osteopathy; and pastoral or
spiritual counseling.
(p) "Hospital" means a facility licensed as such pursuant to
the provisions of article five-b of this chapter, and any acute
care facility operated by the state government, that primarily
provides inpatient diagnostic, treatment or rehabilitative
services to injured, disabled or sick persons under the
supervision of physicians and includes psychiatric and
tuberculosis hospitals.
(q) "Intermediate care facility" means an institution that
provides health-related services to individuals with mental or
physical conditions that require services above the level of room
and board, but do not require the degree of services provided in
a hospital or skilled-nursing facility.
(r) "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, which contains the information required by the state
agency in rules adopted pursuant to section eight of this
article.
(s) "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 costs in excess of seven hundred fifty one
million five hundred thousand dollars. This term Effective the
first day of July, two thousand, the threshold for the cost of
major medical equipment shall be one million seven hundred fifty
thousand dollars. This threshold shall be increased to two
million dollars effective the first day of July, two thousand
one. Major medical equipment 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 U.S.C. §1395x (10) and (11). In
determining whether medical equipment is major medical equipment,
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.
(t) "Medically underserved population" means the population
of an area designated by the state agency as having a shortage of
personal health services. The state agency may consider unusual
local conditions that are a barrier to accessibility or
availability of health services. The designation shall be in
rules 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
U.S.C. §254(b)(3).
(u) "New institutional health service" means any service as
described in section three of this article.
(v) "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 to provide specified health services.
(w) "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.
(x) "Physician" means a doctor of medicine or osteopathy
legally authorized to practice by the state.
(y) "Proposed new institutional health service" means any
service as described in section three of this article.
(z) "Psychiatric hospital" means an institution that
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.
(aa) "Rehabilitation facility" means an inpatient facility
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.
(bb) "Review agency" means an agency of the state,
designated by the governor as the agency for the review of state
agency decisions.
(cc) "Skilled nursing facility" means an institution, or a
distinct part of an institution, that primarily provides
inpatient skilled nursing care and related services, or
rehabilitation services, to injured, disabled or sick persons.
(dd) "State agency" means the health care cost review authority created, established and continued pursuant to article
twenty-nine-b of this chapter.
(ee) "State health plan" means the document approved by the
governor after preparation by the former statewide health
coordinating council, or that document as approved by the
governor after amendment by the former health care planning
council or the state agency.
(ff) "Substantial change to the bed capacity" of a health
care facility means any change, associated with a capital
expenditure, 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.
(gg) "Substantial change to the health services" of a health
care facility means: (1) The addition of a health service
offered by or on behalf of the health care facility, 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; (2) or the termination of a health service offered
by or on behalf of the facility: Provided, That "substantial change to the health services" does not include the providing of
ambulance service, wellness centers or programs, adult day care
or respite care by acute care facilities.
(hh) "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; new institutional health services
defined.
(a) 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.
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.
(b) For purposes of this article, a proposed "new
institutional health service" includes:
(1) The construction, development, acquisition or other
establishment of a new health care facility or health maintenance
organization;
(2) The partial or total closure of a health care facility
or health maintenance organization with which a capital
expenditure is associated;
(3) 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;
(A) 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;
(B) 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
(C) In the case of donated property, on the date on which
the gift is completed under state law;
(4) A substantial change to the bed capacity of a health
care facility with which a capital expenditure is associated;
(5) The addition of health services as specified by the
state agency 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. The state agency shall promulgate emergency rules
pursuant to the provisions of section fifteen, article three,
chapter twenty-nine-a of this code by the first day of July, one
thousand nine hundred ninety-nine, to specify the health services
which are subject to certificate of need review. The state
agency shall specify by rule those health services subject to
certificate of need as recommended by the certificate of need
study conducted pursuant to section nineteen-a, article
twenty-nine-b of this code.
(6) The addition of ventilator services for any nursing
facility bed by any health care facility or health maintenance
organization;
(7) 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;
(8) 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;
(9) The acquisition of major medical equipment;
(10) 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; or
(11) An expansion of the service area for hospice or home
health service, regardless of the time period in which the
expansion is contemplated or made.
§16-2D-4. Exemptions from certificate of need program.
(a) Except as provided in subsection (b), subdivision (9), section three of this article, nothing in this article or the
rules and regulations adopted pursuant to the provisions of this
article may be construed to authorize the licensure, supervision,
regulation or control in any manner of the following:
(1) 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 the acquisition, offering or development of
one or more health services, including ambulatory surgical
facilities or centers, lithotripsy, magnetic resonance imaging
and radiation therapy by one or more health professionals. The
state agency shall adopt rules pursuant to section eight of this
article which specify the health services acquired, offered or
developed by health professionals which are subject to
certificate of need review;
(2) Dispensaries and first-aid stations located within
business or industrial establishments maintained solely for the
use of employees: Provided, That such facility does not contain inpatient or resident beds for patients or employees who
generally remain in the facility for more than twenty-four hours;
(3) Establishments, such as motels, hotels and
boardinghouses, which provide medical, nursing personnel and
health related services;
(4) The remedial care or treatment of residents or patients
in any home or institution conducted only for those who rely
solely upon treatment by prayer or spiritual means in accordance
with the creed or tenets of any recognized church or religious
denomination;
(5) The creation of new primary care services located in
communities that are underserved with respect to primary care
services: Provided, That to qualify for this exemption, an
applicant must be a community-based nonprofit organization with
a community board that provides or will provide primary care
services to people without regard to ability to pay: Provided,
however, That the exemption from certificate of need review of
new primary care services provided by this subdivision shall not
include the acquisition, offering or development of major medical
equipment otherwise subject to review under the provisions of
this article or to include the acquisition, offering or
development of CT scanners, ambulatory surgical facilities,
lithotripsy, magnetic resonance imaging or radiation therapy. The office of community and rural health services shall define
which services constitute primary care services for purposes of
this subdivision, and shall, to prevent duplication of primary
care services, determine whether a community is underserved with
respect to certain primary care services within the meaning of
this subdivision. Any organization planning to qualify for an
exemption pursuant to this subdivision shall submit to the state
agency a letter of intent describing the proposed new services
and area of service; and
(6) The creation of birthing centers by nonprofit primary
care centers that have a community board and provide primary care
services to people in their community without regard to ability
to pay, or by nonprofit hospitals with less than one hundred
licensed acute care beds: Provided, That to qualify for this
exemption, an applicant must be located in an area that is
underserved with respect to low-risk obstetrical services:
Provided, however, That if a primary care center attempting to
qualify for this exemption is located in the same county as a
hospital that is also eligible for this exemption, or if a
hospital attempting to qualify for this exemption is located in
the same county as a primary care center that is also eligible
for this exemption, then at least one primary care center and at
least one hospital from said county shall be required to collaborate for the provision of services at a birthing center in
order to qualify for this exemption: Provided further, That for
purposes of this subsection, a "birthing center" is a short-stay
ambulatory health care facility designed for low-risk births
following normal uncomplicated pregnancy. Any primary care
center or hospital planning to qualify for an exemption pursuant
to this subdivision shall submit to the state agency a letter of
intent describing the proposed birthing center and area of
service.
(b) (1) A certificate of need is not required for the
offering of an inpatient institutional health service or the
acquisition of major medical equipment for the provision of an
inpatient institutional health service or the obligation of a
capital expenditure for the provisions of an inpatient
institutional health service, if with respect to such offering,
acquisition or obligation, the state agency has, upon application
under subdivision (2) of this subsection, granted an exemption
to:
(A) A health maintenance organization or a combination of
health maintenance organizations if: (i) The organization or
combination of organizations has, in the service area of the
organization or the service areas of the organizations in the
combination, an enrollment of at least fifty thousand individuals; (ii) the facility in which the service will be
provided is or will be geographically located so that the service
will be reasonably accessible to such enrolled individuals; and
(iii) at least seventy-five percent of the patients who can
reasonably be expected to receive the institutional health
service will be individuals enrolled with such organization or
organizations in the combination;
(B) A health care facility if: (i) The facility primarily
provides or will provide inpatient health services; (ii) the
facility is or will be controlled, directly or indirectly, by a
health maintenance organization or a combination of health
maintenance organizations which has, in the service area of the
organization or service areas of the organizations in the
combination, an enrollment of at least fifty thousand
individuals; (iii) the facility is or will be geographically
located so that the service will be reasonably accessible to such
enrolled individuals; and (iv) at least seventy-five percent of
the patients who can reasonably be expected to receive the
institutional health service will be individuals enrolled with
such organization or organizations in the combination; or
(C) A health care facility, or portion thereof, if: (i) The
facility is or will be leased by a health maintenance
organization or combination of health maintenance organizations which has, in the service area of the organization or the service
areas of the organizations in the combination, an enrollment of
at least fifty thousand individuals and on the date the
application is submitted under subdivision (2) of this
subsection, at least fifteen years remain in the term of the
lease; (ii) the facility is or will be geographically located so
that the service will be reasonably accessible to such enrolled
individuals; and (iii) at least seventy-five percent of the
patients who can reasonably be expected to receive the new
institutional health service will be individuals enrolled with
such organization.
(2) (A) A health maintenance organization, combination of
health maintenance organizations or other health care facility is
not exempt under subdivision (1) of this subsection from
obtaining a certificate of need unless:
(i) It has submitted, at such time and in such form and
manner as the state agency shall prescribe, an application for
such exemption to the state agency;
(ii) The application contains such information respecting
the organization, combination or facility and the proposed
offering, acquisition or obligation as the state agency may
require to determine if the organization or combination meets the
requirements of subdivision (1) of this subsection or the facility meets or will meet such requirements; and
(iii) The state agency approves such application.
(B) The state agency shall approve an application submitted
under paragraph (A) of this subdivision, if it determines that
the applicable requirements of subdivision (1) of this subsection
are met or will be met on the date the proposed activity for
which an exemption was requested will be undertaken.
(3) A health care facility, or any part thereof, or medical
equipment with respect to which an exemption was granted under
subdivision (1) of this subsection, may not be sold or leased and
a controlling interest in such facility or equipment or in a
lease of such facility or equipment may not be acquired and a
health care facility described in paragraph (C) of said
subdivision, which was granted an exemption under said
subdivision, may not be used by any person other than the lessee
described in paragraph (C) of said subdivision, unless:
(A) The state agency issues a certificate of need approving
the sale, lease, acquisition or use; or
(B) The state agency determines, upon application, that the
entity to which the facility or equipment is proposed to be sold
or leased, which intends to acquire the controlling interest in
or to use the facility is:
(i) A health maintenance organization or a combination of health maintenance organizations which meets the enrollment
requirements of subparagraph (i), paragraph (A), subdivision (1)
of this subsection, and with respect to such facility or
equipment, the entity meets the accessibility and patient
enrollment requirements of subparagraphs (ii) and (iii) of said
paragraph; or
(ii) A health care facility which meets the inpatient,
enrollment and accessibility requirements of subparagraphs (i),
(ii) and (iii), paragraph (B), subdivision (1) of this subsection
and with respect to its patients meets the enrollment
requirements of subparagraph (iv) of said paragraph (B).
(4) In the case of a health maintenance organization or an
ambulatory care facility or health care facility which ambulatory
or health care facility is controlled, directly or indirectly, by
a health maintenance organization or a combination of health
maintenance organizations, the certificate of need requirements
apply only to the offering of inpatient institutional health
services, the acquisition of major medical equipment, and the
obligation of capital expenditures for the offering of inpatient
institutional health services and then only to the extent that
such offering, acquisition or obligation is not exempt under
subdivision (1) of this subsection.
(5) The state agency shall establish the period within which approval or disapproval by the state agency of applications for
exemptions under subdivision (1) of this subsection shall be
made.
(c) (b) (1) A health care facility is not required to obtain
a certificate of need for the acquisition of major medical
equipment to be used solely for research, the addition of health
services to be offered solely for research, or the obligation of
a capital expenditure to be made solely for research if the
health care facility provides the notice required in subdivision
(2) of this subsection, and the state agency does not find,
within sixty days after it receives such notice, that the
acquisition, offering or obligation will, or will have the effect
to:
(A) Affect the charges of the facility for the provision of
medical or other patient care services other than the services
which are included in the research;
(B) Result in a substantial change to the bed capacity of
the facility; or
(C) Result in a substantial change to the health services of
the facility.
(2) Before a health care facility acquires major medical
equipment to be used solely for research, offers a health service
solely for research or obligates a capital expenditure solely for research, such health care facility shall notify in writing the
state agency of such facility's intent and the use to be made of
such medical equipment, health service or capital expenditure.
(3) If major medical equipment is acquired, a health service
is offered or a capital expenditure is obligated and a
certificate of need is not required for such acquisition,
offering or obligation as provided in subdivision (1) of this
subsection, such equipment or service or equipment or facilities
acquired through the obligation of such capital expenditure may
not be used in such a manner as to have the effect or to make a
change described in paragraphs (A), (B) and (C) of said
subdivision unless the state agency issues a certificate of need
approving such use.
(4) For purposes of this subsection, the term "solely for
research" includes patient care provided on an occasional and
irregular basis and not as part of a research program.
(d) (c) (1) The state agency may adopt regulations rules
pursuant to section eight of this article to specify the
circumstances under which a certificate of need may not be
required for the obligation of a capital expenditure to acquire,
either by purchase or under lease or comparable arrangement, an
existing health care facility: Provided, That a certificate of
need shall be required for the obligation of a capital expenditure to acquire, either by purchase or under lease or
comparable arrangement, an existing health care facility if:
(A) The notice required by subdivision (2) of this
subsection is not filed in accordance with that subdivision with
respect to such acquisition; or
(B) The state agency finds, within thirty days after the
date it receives a notice in accordance with subdivision (2) of
this subsection, with respect to such acquisition, that the
services or bed capacity of the facility will be changed by
reason of said acquisition.
(2) Before any person enters into a contractual arrangement
to acquire an existing health care facility, such person shall
notify the state agency of his or her intent to acquire the
facility and of the services to be offered in the facility and
its bed capacity. Such notice shall be made in writing and shall
be made at least thirty days before contractual arrangements are
entered into to acquire the facility with respect to which the
notice is given. The notice shall contain all information the
state agency requires. in accordance with subsections (e) and
(s), section seven of this article
(e) The state agency shall adopt regulations, pursuant to
section eight of this article, wherein criteria are established
to exempt from review the addition of certain health services, not associated with a capital expenditure, that are projected to
entail annual operating costs of less than the expenditure
minimum for annual operating costs. For purposes of this
subsection, "expenditure minimum for annual operating costs"
means three hundred thousand dollars for the first twelve months
following the effective date of this section and for each twelve- month period thereafter, the state agency may, by regulations
adopted pursuant to section eight of this article, adjust the
expenditure minimum for annual operating costs to reflect the
impact of inflation.
(f) (d) The state agency shall adopt rules within ninety
days of the effective date of the amendment of this section in
the year one thousand nine hundred ninety pursuant to section
eight of this article to specify the circumstances under which
and the procedures by which a certificate of need may not be
required for shared services between two or more acute care
facilities providing services made available through existing
technology that can reasonably be mobile. The state agency shall
specify the types of items in the regulations and under what
circumstances mobile MRI and mobile lithotripsy may be so
exempted from review. In no case, however, will mobile cardiac
catheterization be exempted from certificate of need review. In
addition, if the shared services mobile unit proves less cost effective than a fixed unit, the acute care facility will not be
exempted from certificate of need review.
On a yearly basis, the state agency shall review existing
technologies to determine if other shared services should be
included under this exemption.
(g) This subsection applies only to hospitals designated as
rural primary care hospitals by West Virginia office of rural
health policy in conformance with requirements of the health care
financing administration of the federal department of health and
human services under Section 1920 of Public Law 101-239, Section
6000(g) of the federal Omnibus Budget Reconciliation Act of 1989.
A hospital, designated as a rural primary care hospital, in
accordance with final rules issued by the health care financing
administration, shall undergo a reduction in its number of
licensed acute care beds as determined by the office of rural
health policy.
The office of rural health policy shall notify the health
care cost review authority of such designation including the
number of staffed and operated beds immediately prior to
designation and the number of acute care beds certified by the
health care financing administration.
A rural primary care hospital may reject this designation
any time within twenty-four calendar months, beginning from the date of designation by the office of rural health policy. If a
hospital chooses to reject this designation, it may do so upon
written notification to the office of rural health policy and the
health care cost review authority. If such designation is
rejected by a rural primary care hospital, license restoration,
not to exceed the number of acute care beds staffed and operated
by the hospital immediately prior to receiving designation as a
rural primary care hospital, shall be exempt from the certificate
of need program review.
Within twenty-five months from designating rural primary
care hospitals, the office of rural health policy shall notify
the health care cost review authority of the status of the
designated hospitals including the number of licensed beds.
The state agency shall promulgate rules within ninety days
of the effective date of this amendment in order to carry out the
purpose of this subsection.
§16-2D-4a. Conversion of hospital acute beds to skilled nursing
beds.
(a) Legislative findings and purpose. -- The Legislature
hereby finds and declares that a need exists for skilled nursing
health care beds in this state due to a shortage of existing
facilities with adequate bed capacity and lack of willingness to
provide such services; that patients in need of skilled nursing services have sometimes been retained in an inappropriate level
of care facility; that such practices have resulted in
malutilization of health care facilities and resources; that
there currently exists a surplus of acute care beds in hospitals,
particularly those in rural areas within this state; that the
surplus of acute care beds is, for the foreseeable future,
permanent in nature; that the same excess capacity of acute care
beds promotes economic inefficiencies in operation while failing
to meet community needs; that nursing homes are unable under
subsection (h), section five of this article, to add intermediate
or dually certified beds to skilled nursing beds at the present
time in numbers in excess of ten percent or not more than ten
beds, whichever is less; and that remedial action by the
Legislature is necessary to effectuate relief of these problems
to promote the health and welfare of the citizens of the state by
allowing, in certain instances, for the conversion of acute care
beds to skilled nursing beds by hospitals, but with no increase
in overall hospital bed capacity.
(b) Notwithstanding the provisions of subsection (h),
section five of this article, and, further, notwithstanding the
provisions of subsection (b), subdivision (4), section three of
this article, the state agency shall adopt rules pursuant to
section eight of this article, to exempt from review the conversion of acute care beds to skilled nursing care beds by a
licensed hospital by the state department of health if the
hospital meets the following conditions:
(1) It is located in a nonmetropolitan statistical area as
defined by the bureau of census of the federal government;
(2) It has experienced an average occupancy rate of less
than fifty percent for the twelve months preceding the date of
request for this exemption; and
(3) The nursing home service area within which the hospital
is located is under the bed ceiling as calculated by the thirty
beds per thousand population formula as set forth in the
long-term care chapter of the state health plan, except for the
purposes of this article existing nursing home beds shall be used
in the calculation.
(c) The state agency shall include in its rules requirements
that:
(1) In converting beds, the hospital must change one acute
care bed into one skilled nursing care bed;
(2) 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) (b), subdivision (4), 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) (ff), section two of this article;
(3) The hospital shall meet all applicable federal and state
licensing requirements for the provisions of skilled nursing
services including a requirement that all skilled care beds
created under this exemption shall be located in distinct-part,
long-term care units;
(4) No hospital is permitted to convert more than
twenty-five percent of its licensed bed capacity in any
twenty-four month period pursuant to this exemption; however, in
the event that subsection (h) (g), section five of this article,
is repealed and to the extent that other methods of converting
acute care beds are available under this article, the hospital
may request certificate of need approval of such conversions;
(5) The hospital shall undergo substantial compliance review
of a conversion under this exemption under such terms and at such
a time as set by the state agency in its rules.
(d) Nothing in this section negatively affects the rights of
inspection and certification which are elsewhere required by
federal law or regulations or by this code or duly adopted regulation of an authorized state entity.
§16-2D-5. Powers and duties of state agency.
(a) The state agency shall administer the certificate of
need program as provided by this article.
(b) The state agency is 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. The state agency shall review
the state health plan, including the certificate of need
standards and make any necessary amendments and modifications
within three years from the effective date of this section. The
state agency shall also review the cost effectiveness of the
certificate of need program. The state agency may form task
forces to assist it in addressing these issues. The task forces
shall be composed of representatives of consumers, business,
providers, payers and state agencies.
(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
the 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 the 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 shall
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. The
state agency shall establish a task force or utilize an existing
task force to study the need for additional nursing facility beds
in this state. The study shall include a review of the current
moratorium on the development of nursing facility beds; the exemption for the conversion of acute care beds to skilled
nursing facility beds; the development of a methodology to assess
the need for additional nursing facility beds; and, certification
of new beds by medicare and medicaid. The task force shall be
composed of representatives of consumers, business, providers,
payers and government agencies.
(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 (b), section three of this article, an
existing acute care hospital may apply to the health care
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 shall not bill for any
medicaid reimbursement for any converted beds. In converting beds, the hospital shall convert a minimum of one acute care bed
into one medicare certified only skilled nursing bed. The health
care authority may require a hospital to convert up to and
including three acute care beds for each medicare certified only
skilled nursing bed: Provided further, That a hospital
designated or provisionally designated by the state agency as a
rural primary care hospital may convert up to thirty beds to a
distinct-part nursing facility, including skilled nursing beds
and intermediate care beds, on a one-for-one basis if the rural
primary care hospital is located in a county without a certified
free-standing nursing facility and the hospital may bill for
medicaid reimbursement for the converted beds: And provided
further, That if the hospital rejects the designation as a rural
primary care hospital then the hospital may not bill for medicaid
reimbursement. The health care 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 (b), section three of this article for
which purposes 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 (ff), 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 shall demonstrate a need for the project.
(4) The hospital shall 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 shall 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 negatively affects the rights of inspection and
certification which are otherwise required by federal law or
regulations or by this code or duly adopted rules of an
authorized state entity.
(j) (1) 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 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 is not applicable to
projects submitted under this subsection. The health care
authority shall adopt rules to implement this subsection which
shall include a requirement that:
(A) The one hundred eighty beds are to be distributed on a
statewide basis;
(B) There be a minimum of twenty beds and a maximum of sixty
beds in each approved unit;
(C) The unit developed by the retirement life care center
meet all federal and state licensing certification and
operational requirements applicable to nursing homes;
(D) The retirement center demonstrate a need for the
project;
(E) The retirement center offer personal care, home health
services and other lower levels of care to its residents; and
(F) The retirement center demonstrate both short and long- term financial feasibility.
(2) Nothing in this subsection negatively affects the rights
of inspection and certification which are otherwise required by
federal law or regulations or by this code or duly adopted rules of an authorized state entity.
(k) The state agency may order a moratorium upon the
processing of an application or applications for the offering or
development of a new institutional health service, filed pursuant
to section three of this article when criteria and guidelines for
evaluating the need for the new institutional health service have
not yet been adopted or are obsolete. The state agency may also
order a moratorium on the offering or development of a health
service, notwithstanding the provisions of subdivision (5),
subsection (b), section three of this article, when it determines
that the proliferation of the service may cause an adverse impact
on the cost of health care or the health status of the public.
The A 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 for certificates of need shall be
processed pursuant to section six of this article.
(l) (1) 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,
it 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.
(2) 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 the proposed amendments or
modifications, the governor shall either approve or disapprove
all or part of the 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.
(m) The state agency may exempt from or expedite rate
review, certificate of need, and annual assessment requirements
and issue grants and loans to financially vulnerable health care facilities located in underserved areas that the state agency and
the office of community and rural health services determine are
collaborating with other providers in the service area to provide
cost effective health care services.
(n) Notwithstanding any provision contained in this article
or section and any rule issued by the state agency, including
compliance with certificate of need requirements, any rural
hospital with less than eighty licensed acute care beds as of the
first day of January, one thousand nine hundred ninety-eight, may
convert up to forty-four percent of existing licensed acute care
beds to skilled nursing beds for certification by both medicare
and medicaid for reimbursement purposes provided that the
following conditions are met:
(1) There is no overall increase in the bed capacity of the
hospital; one acute care bed is converted to one dually certified
medicare and medicaid skilled nursing bed.
(2) All converted acute care beds shall be permanently
deleted from the acute care bed complement of the hospital, which
may not thereafter add, by conversion or otherwise, acute care
beds to its bed complement without satisfying the requirements of
subdivision (4), subsection (b), section three of this article,
for which purposes the 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 as found in subsection (e), section two of this article.
(3) Prior to the conversion, the occupancy rate for licensed
acute care beds cannot exceed forty percent for twenty-four
consecutive months prior to the first month in which this section
is effective.
(4) The hospital shall meet all federal and state licensing
requirements for the provision of skilled nursing services.
Additionally, all skilled nursing beds created under this
exemption shall be located in distinct long-term care units in a
previously constructed part of the hospital that can be used for
that purpose.
(5) The hospital is located in a nonmetropolitan statistical
area as defined by the bureau of the census of the federal
government and is located in the same city in which a hospital
providing mental health inpatient services owned and operated by
the state of West Virginia ceased offering the inpatient services
not later than one thousand nine hundred ninety.
(6) Nothing in this section negatively affects the rights of
inspection and certification which are elsewhere required by
federal law or regulations.
§16-2D-6. Minimum criteria for certificate of need reviews.
(a) Except as provided in subsections subsection (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) (1) 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) (2) The relationship of services reviewed to the long-range development plan of the person providing or proposing the
services;
(4) (3) 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) (4) The availability of less costly or more effective
alternative methods of providing the services to be offered,
expanded, reduced, relocated or eliminated;
(6) (5) 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) (6) 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) (7) 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 and other applicable health
systems plan and annual implementation plan plans;
(9) (8) The appropriate and nondiscriminatory utilization of
existing and available health care providers;
(10) (9) The relationship, including the organizational
relationship, of the health services proposed to be provided to
ancillary or support services;
(11) (10) 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) (11) 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) (12) 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) (13) 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) (14) 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) (15) 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) (16) 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) (17) 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) (18) 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) (19) In the case of existing services or facilities,
the quality of care provided by the services or facilities in the
past;
(23) (20) 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) (21) The special circumstances of health care
facilities with respect to the need for conserving energy;
(25) (22) 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) (23) 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 rules 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 rules 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.
§16-2D-7. Procedures for certificate of need reviews.
(a) Prior to submission of an application for a certificate
of need, the state agency shall require the submission of
long-range plans by health care facilities with respect to the
development of proposals subject to review under this article.
The plans shall be in such form and contain such information as
the state agency shall require.
(b) An application for a certificate of need shall be
submitted to the state agency prior to the offering or
development of all new institutional services within this state.
Persons proposing new institutional health services shall submit
letters of intent not less than fifteen days prior to submitting
an application. The letters of intent shall be of such detail as
specified by the state agency.
(c) The state agency may adopt regulations rules pursuant to
section eight of this article for:
(1) Provision for applications to be submitted in accordance
with a timetable established by the state agency;
(2) Provision for such reviews to be undertaken in a timely
fashion; and
(3) Except for proposed new institutional health services
which meet the requirements for consideration under subsection
(g) (f), section nine of this article with regard to the
elimination or prevention of certain imminent safety hazards or
to comply with certain licensure or accreditation standards,
provision for all completed applications pertaining to similar
types of services, facilities or equipment to be considered in
relation to each other, at least three times a year.
(d) An application for a certificate of need shall specify
the time the applicant will require to make such service or
equipment available or to obligate such expenditure and a
timetable for making such service or equipment available or
obligating such expenditure.
(e) The application shall be in such form and contain such
information as the state agency shall establish by rule, or
regulation but requests for information shall be limited to only
that information which is necessary for the state agency to
perform the review.
(f) Within fifteen days of receipt of application, the state
agency shall determine if the application is complete. The state
agency may request additional information from the applicant.
(g) The state agency shall provide timely written notice to
the applicant and to all affected persons of the beginning of the
review, and to any person who has asked the state agency to place
the person's name on a mailing list maintained by the state
agency. Notification shall include the proposed schedule for
review, the period within which a public hearing during the
course of the review may be requested by affected persons, which
period may not be less than thirty days from the date of the
written notification of the beginning of the review required by
this section, and the manner in which notification will be
provided of the time and place of any public hearing so
requested. For the purposes of this subsection, the date of
notification is the date on which the notice is sent or the date
on which the notice appears in a newspaper of general
circulation, whichever is later.
(h) Written notification to members of the public and
third-party payers may be provided through newspapers of general
circulation in the applicable health service area and public
information channels; notification to all other affected persons
shall be by mail which may be as part of a newsletter.
(i) If, after a review has begun, the state agency requires
the person subject to the review to submit additional information
respecting the subject of the review, such person shall be provided at least fifteen days to submit the information and the
state agency shall, at the request of such person, extend the
review period by fifteen days. This extension applies to all
other applications which have been considered in relation to the
application for which additional information is required.
(j) The state agency shall adopt schedules for reviews which
provide that no review may, to the extent practicable, take
longer than ninety days from the date that notification, as
described under subsection (g) of this section, is sent to the
applicant to the date of the final decision of the state agency,
and in the case of expedited applications, may by regulations
rules adopted pursuant to section eight of this article provide
for a shortened review period.
(k) The state agency shall adopt criteria for determining
when it would not be practicable to complete a review within
ninety days.
(l) The state agency shall provide a public hearing in the
course of agency review if requested by any affected person and
the state agency may on its own initiate such a public hearing.
(1) The state agency shall, prior to such hearing, provide
notice of such hearing and shall conduct such hearing in
accordance with administrative hearing requirements in article
five, chapter twenty-nine-a of this code, and its procedure adopted pursuant to this section.
(2) In a hearing any person has the right to be represented
by counsel and to present oral or written arguments and evidence
relevant to the matter which is the subject of the hearing. Any
person affected by the matter which is the subject of the hearing
may conduct reasonable questioning of persons who make factual
allegations relevant to such matter.
(3) The state agency shall maintain a verbatim record of the
hearing.
(4) After the commencement of a hearing on the applicant's
application and before a decision is made with respect to it,
there may be no ex parte contacts between (a) the applicant for
the certificate of need, any person acting on behalf of the
applicant or holder of a certificate of need, or any person
opposed to the issuance of a certificate for the applicant and
(b) any person in the state agency who exercises any
responsibility respecting the application.
(5) The state agency may not impose fees for such a public
hearing.
(m) If a public hearing is not conducted during the review
of a new institutional health service, the state agency may, by
regulations rules adopted pursuant to section eight of this
article, provide for a file closing date during the review period after which date no other factual information or evidence may be
considered in the determination of the application for the
certificate of need. A detailed itemization of documents in the
state agency file on a proposed new institutional health service
shall, on request, be made available by the state agency at any
time before the file closing date.
(n) The extent of additional information received by the
state agency from the applicant for a certificate of need after
a review has begun on the applicant's proposed new institutional
health service, with respect to the impact on such new
institutional health service and additional information which is
received by the state agency from the applicant, may be cause for
the state agency to determine the application to be a new
proposal, subject to a new review cycle.
(o) The state agency shall in timely fashion notify, upon
request, providers of health services and other persons subject
to review under this article of the status of the state agency
review of new institutional health services subject to review,
findings made in the course of such review, and other appropriate
information respecting such review.
(p) The state agency shall prepare and publish, at least
annually, reports of reviews completed and being conducted, with
general statements about the status of each review still in progress and the findings and rationale for each completed review
since the publication of the last report.
(q) The state agency shall provide for access by the general
public to all applications reviewed by the state agency and to
all other pertinent written materials essential to agency review.
(r) (1) Any person may request in writing a public hearing
for purposes of reconsideration of a state agency decision. No
fees may be imposed by the state agency for the hearing. For
purposes of this section, a request for a public hearing for
purposes of reconsideration shall be deemed to have shown good
cause if, in a detailed statement, it:
(A) Presents significant, relevant information not
previously considered by the state agency, and demonstrates that
with reasonable diligence the information could not have been
presented before the state agency made its decision;
(B) Demonstrates that there have been significant changes in
factors or circumstances relied upon by the state agency in
reaching its decision;
(C) Demonstrates that the state agency has materially failed
to follow its adopted procedures in reaching its decision; or
(D) Provides such other bases for a public hearing as the
state agency determines constitutes good cause.
(2) To be effective, a request for such a hearing shall be received within thirty days after the date upon which all parties
received notice of the state agency decision, and the hearing
shall commence within thirty days of receipt of the request.
(3) Notification of such public hearing shall be sent, prior
to the date of the hearing, to the person requesting the hearing,
the person proposing the new institutional health service, and
shall be sent to others upon request.
(4) The state agency shall hold public reconsideration
hearings in accordance with the provisions for administrative
hearings contained in:
(A) Its adopted procedures;
(B) Ex parte contact provisions of subdivision (4),
subsection (l) of this section; and
(C) The administrative procedures for contested cases
contained in article five, chapter twenty-nine-a of this code.
(5) The state agency shall make written findings which state
the basis for its decision within forty-five days after the
conclusion of such hearing.
(6) A decision of the state agency following a
reconsideration hearing shall be considered a decision of the
state agency for purposes of sections nine and ten of this
article and for purposes of the notification of the status of
review, findings and annual report provisions of subsections (o) and (p) of this section.
(s) The state agency may adopt regulations rules pursuant to
section eight of this article for reviews and such regulations
rules may vary according to the purpose for which a particular
review is being conducted or the type of health services being
reviewed.
(t) Notwithstanding other provisions of this article, the
state agency shall adopt rules and regulations for determining
when there is an application which warrants expedited review. If
procedures adopted by the state agency to handle expedited
applications do not conform to the provisions of this article,
such procedures shall be approved by the federal secretary of
health and human services and shall be adopted as regulations
pursuant to section eight of this article.
(u) Notwithstanding other provisions of this article, the
state agency shall promulgate emergency rules pursuant to
the provisions of section fifteen, article three, chapter
twenty-nine-a of this code by the first day of July, one thousand
nine hundred ninety-nine, to establish a review process for
nonhealth related projects. The review process shall not exceed
forty-five days. The state agency shall specify in the rule
which projects are eligible for this review.
§16-2D-7a. Coordination and filing with consumer advocate.
Each health care facility or health care provider filing a
certificate of need application with the state agency pursuant to
section sections four and seven of this article shall notify the
director of the office of consumer advocacy established pursuant
to section sixteen, article two, chapter thirty-three of this
code of said application by submitting a copy of the same to the
office of the consumer advocate on or before the date of such
filing.
§16-2D-8. Agency to promulgate additional rules.
(a) The state agency is hereby empowered to promulgate
additional rules: and regulations
(1) To carry out the provisions of this article; and
(2) To assure hospitals' compliance with requests for
information concerning rates charged for each of the twenty-five
most frequently used hospital services in the State including the
average semiprivate and private room rates.
(b) All rules and regulations shall be promulgated pursuant
to chapter twenty-nine-a of this code and as described herein.
In addition, before adopting proposed rules and regulations the
state agency shall give interested persons an opportunity to
offer written comments on the rules, and regulations or any
revisions thereof, which it proposes to adopt. as follows:
(1) The state agency shall distribute copies of its proposed review rules and regulations, and proposed revisions thereof, to
statewide health agencies and organizations, the statewide health
coordinating council, and each health systems agency for a health
service area located in whole or in part within the State and any
agency which establishes rates for health care facilities in the
State;
(2) The state agency shall publish, in at least one
newspaper in each planning and development region in this State,
a notice stating that rules and regulations for review of
certificate of need applications or any revisions thereof, have
been proposed for adoption and are available at specified
addresses for inspection and copying by interested persons. In
addition, notice may be given through other public information
channels; and
(3) The state agency shall distribute copies of its adopted
review rules and regulations, and any revisions thereof, to the
agencies and organizations specified in this section and to the
secretary of health and human services, and shall provide such
copies to other persons upon request.
(c) Subsequent amendments and modifications to any rule
promulgated pursuant to this article may be implemented by
emergency rule.
§16-2D-9. Agency to render final decision; issue certificate of need; write findings; specify capital expenditure maximum.
(a) Only the state agency, or the appropriate administrative
or judicial review body, may issue, deny or withdraw certificates
of need, grant exemptions from certificate of need reviews, or
determine that certificate of need reviews are not required.
(b) Except as provided in subsection (f) of this section, A
certificate of need may only be issued if the proposed new
institutional health service is:
(1) Found to be needed; and
(2) Except in emergency circumstances that pose a threat to
public health, consistent with the state health plan. Provided,
That if a health care facility which is controlled, directly or
indirectly, by a health maintenance organization applies for a
certificate of need for a proposed new institutional health
service, the state agency may not disapprove the application
solely because such an institutional health service is not
discussed in the state health plan or annual implementation plan
(c) The state agency shall render a final decision on every
application for a certificate of need or application for
exemption in the form of an approval, a denial, or an approval
with conditions. Any decision of the state agency with respect
to a certificate of need, or exemption, shall be based solely on:
(1) The review of the state agency conducted in accordance
with procedures and criteria in this article and in regulations
rules
adopted pursuant to section eight of this article; and
(2) The record established in administrative proceedings
held with respect to the certificate of need or exemption.
(d) Approval with conditions does not give the state agency
authority to mandate new institutional health services not
proposed by the health care facility or health maintenance
organization. Issuance of a certificate of need or exemption may
not be made subject to any condition unless the condition
directly relates to criteria in this article or in rules and
regulations adopted pursuant to section eight of this article.
Conditions may be imposed upon the operations of the health care
facility or health maintenance organization for no longer than a
three-year period. Compliance with such conditions may be
enforced through the mechanisms detailed in section thirteen of
this article.
(e) (1) For each proposed new institutional health service
it approves, the state agency shall, in addition to the written
findings required in subsection (e), section six of this article,
make a written finding, which shall take into account the current
accessibility of the facility as a whole, on the extent to which
the new institutional health service will meet the criteria in subdivisions (4), (14) (3), (11) and (25) (22), subsection (a),
section six of this article, regarding the needs of medically
underserved population, except in the following cases:
(A) Where the proposed new institutional health service is
one described in subsection (g) of this section to eliminate or
prevent certain imminent safety hazards or to comply with certain
licensure or accreditation standards; or
(B) Where the new institutional health service is a proposed
capital expenditure not directly related to the provision of
health services or to beds or major medical equipment. or
(C) Where the new institutional health service is proposed
by or on behalf of a health care facility which is controlled,
directly or indirectly, by a health maintenance organization
(2) If the state agency disapproves a proposed new
institutional health service for failure to meet the needs of
medically underserved populations, it shall so state in a written
finding.
(f) (1) Notwithstanding review criteria in subdivision (12),
subsection (a), section six of this article, if a health care
facility which is controlled, directly or indirectly, by a health
maintenance organization applies for a certificate of need, such
application shall be approved by the state agency if the state
agency finds, in accordance with criteria prescribed by the state agency by regulations adopted pursuant to section eight of this
article, that:
(A) Approval of such application is required to meet the
needs of the members of the health maintenance organization and
of the new members which such organization can reasonably be
expected to enroll; and
(B) The health maintenance organization is unable to
provide, through services or facilities which can reasonably be
expected to be available to the organization, its institutional
health services in a reasonable and cost- effective manner which
is consistent with the basic method of operation of the
organization and which makes such services available on a long- term basis through physicians and other health professionals
associated with it.
(2) Except as provided in subdivision (1), subsection (b),
section four of this article, a health care facility, or any part
thereof, or medical equipment with respect to which a certificate
of need was issued under this subsection, may not be sold or
leased, and a controlling interest in such facility or equipment
or in a lease of such facility or equipment may not be acquired
unless the state agency issues a certificate of need approving
the sale, acquisition or lease.
(g) (f) (1) Notwithstanding review criteria in section six of this article, an application for a certificate of need shall
be approved, if the state agency finds that the facility or
service with respect to which such capital expenditure is
proposed to be made is needed and that the obligation of such
capital expenditure is consistent with the state health plan, for
a capital expenditure which is required:
(A) To eliminate or prevent imminent safety hazards as
defined by federal, state or local fire, building or life safety
codes or regulations;
(B) To comply with state licensure standards; or
(C) To comply with accreditation or certification standards,
compliance with which is required to receive reimbursements under
Title XVIII of the Social Security Act or payments under the
state plan for medical assistance approved under Title XIX of
such act.
(2) An application for a certificate of need approved under
this subsection shall be approved only to the extent that the
capital expenditure is required to eliminate or prevent the
hazards described in subparagraph (A), subdivision (1),
subsection (g) (f), or to comply with the standards described in
either subparagraph (B) or (C), subdivision (1), subsection (g)
(f) of this section.
(h) (1) (g) The state agency shall send its decision along with written findings to the person proposing the new
institutional health service or exemption and shall make it
available to others upon request.
(2) In the case of a new institutional health service
proposed by a health maintenance organization, the state agency
shall send the written findings to the appropriate regional
office of the federal department of health and human services at
the time they are sent to the applicant.
(3) In any decision where the state agency finds that a
proposed new institutional health service does not satisfy the
criteria in subdivisions (4), (14) and (25), subsection (a),
section six of this article, regarding the needs of medically
underserved population, it shall so notify in writing the
applicant and the appropriate regional office of the federal
department of health and human services.
(i) (h) In the case of a final decision to approve or
approve with conditions a proposal for a new institutional health
service, the state agency shall issue a certificate of need to
the person proposing the new institutional health service.
(j) (i) The state agency shall specify in the certificate
the maximum amount of capital expenditures which may be obligated
under such certificate. The state agency shall prescribe the
method used to determine capital expenditure maximums and shall adopt regulations rules
pursuant to section eight of this article
for the review of approved new institutional health services for
which the capital expenditure maximum is exceeded or is expected
to be exceeded.
(k) (j) If the state agency fails to make a decision within
the time period specified for the review, the applicant may,
within one year following the expiration of such period, bring an
action, at the election of the applicant, in either the circuit
court of Kanawha County, or with the judge thereof in vacation,
or in the circuit court of the county in which the applicant or
any one of the applicants resides or does business, or with the
judge thereof in vacation to require the state agency to approve
or disapprove the application. An application for a proposed new
institutional health service or exemption may not be approved or
denied by the circuit court solely because the state agency
failed to reach a decision.
§16-2D-10. Appeal of certificate of need decisions.
(a) A final decision of the state agency, including a state
agency decision issued after a reconsideration, if such
reconsideration was requested and granted under subsection (t)
(r), section seven of this article, and the record upon which it
was made, shall upon request of any affected persons or the
applicable health systems agency if the decision is inconsistent with a recommendation made by the applicable health systems
agency to the state agency with respect to the certificate of
need, be reviewed by an agency of the State (other than the state
agency) designated by the governor. To be effective, such
request shall be received within thirty days after the date upon
which all parties the affected person received notice of the
state agency decision, and the hearing shall commence within
thirty days of receipt of the request.
(b) To the extent not inconsistent with this section, for
the purpose of administrative reviews of state agency decisions,
the review agency shall conduct its proceedings in conformance
with the West Virginia rules of civil procedure for trial courts
of record and the local rules for use in the civil courts of
Kanawha county and shall review appeals in accordance with the
provisions governing the judicial review of contested
administrative cases in section four, article five, chapter
twenty-nine-a of this code, notwithstanding the exceptions of
section five, article five, chapter twenty-nine-a of this code.
(c) The decision of the reviewing agency shall be made in
writing within forty-five days after the conclusion of such
hearing.
(d) The written findings of the review agency shall be sent
to the person who requested the review, to the person proposing the new institutional health service to the health systems agency
requesting a review and to the state agency, and shall be made
available by the state agency to others upon request.
(e) The decision of the reviewing agency shall be considered
the final decision of the state agency; however, the reviewing
agency may remand the matter to the state agency for further
action or consideration.
(f) Upon the entry of a final decision by the reviewing
agency the designated health system agency, if the decision
respecting the certificate of need is inconsistent with a
recommendation made by that health systems agency to the state
agency with respect to the certificate of need, and any other
"person adversely affected by the review" have has standing in
and may within thirty days after the date upon which all parties
receive such person received notice of the decision of the review
agency take an appeal at the election of the petitioner, in
either the circuit court of Kanawha county, or in the circuit
court of the county in which the petitioner or any of the
petitioners resides or does business, from any decision of the
state agency granting, with or without conditions, denying or
withdrawing a certificate of need or exemption. The decision of
the review agency shall be reviewed by such circuit court in
accordance with the provisions for the judicial review of administrative decisions contained in section four, article five,
chapter twenty-nine-a of this code. For the purposes of this
subsection, "person adversely affected by the review" includes
the state agency and any person who meets the definition of
affected person in section two of this article. and any person
who participated in the proceeding before the state agency
§16-2D-11. Nontransference, time period compliance and
withdrawal of certificate of need.
(a)A certificate of need is nontransferable and shall be
valid for a maximum of one year from the date of issuance. A
transfer includes the sale, lease, transfer of stock or
partnership shares, or other comparable arrangement which has the
effect of transferring the control of the owner of the
certificate of need. Upon the expiration of the certificate or
during the certification period, the person proposing the new
institutional health service shall provide the state agency such
information on the development of the project as the state agency
may request. The state agency shall periodically monitor capital
expenditures obligated under certificates, determine whether
sufficient progress is being made in meeting the timetable
specified in the approved application for the certificate and
whether there has been compliance with the application and any
conditions of certification. The state agency shall take into account recommendations made by the health systems agency in
making its determination. The certificate of need may be
extended by the state agency for additional periods of time as
are reasonably necessary to expeditiously complete the project.
A certificate of need may no longer be in effect, and may no
longer be required, after written notice of substantial
compliance with the approved application and any conditions of
certification is issued to the applicant, after the activity is
undertaken for which the certificate of need was issued, and
after the state agency is provided written notice of such
undertaking. The person proposing a new institutional health
service may not be issued a license therefor until the state
agency has issued a written notice of substantial compliance with
the approved application and any conditions of certification, nor
may a new institutional health service be used until such person
has received such notice. A new institutional health service may
not be found to be in substantial compliance with the approved
application and any conditions of certification if there is a
substantial change, as defined in regulations rules adopted
pursuant to subsection (b), subdivision (10), section three of
this article, in the approved new institutional health service
for which change a certificate of need has not been issued.
(b) (1) The certificate of need may be withdrawn by the state agency for:
(A) Insufficient progress in meeting the timetable specified
in the approved application for the certificate and for not
making a good faith effort to meet it in developing the project;
or
(B) Noncompliance with any conditions of certification; or
(C) A substantial change, as defined in regulations rules
adopted pursuant to subdivision (10), subsection (i) (b), section
three of this article, in an approved new institutional health
service for which change a certificate of need has not been
issued; or
(D) Material misrepresentation by an applicant upon which
the state agency relied in making its decision; or
(E) Other reasons that may be established by the state
agency in regulations rules adopted pursuant to section eight of
this article.
(2) Any decision of the state agency to withdraw a
certificate of need shall be based solely on:
(A) The provisions of this article and on regulations rules
adopted in accordance with section eight of this article; and
(B) The record established in administrative proceedings
held with respect to the state agency's proposal to withdraw the
certificate.
(3) In the case of a proposed withdrawal of a certificate of
need:
(A) After commencement of a hearing on the state agency's
proposal to withdraw a certificate of need and before a decision
is made on withdrawal, there may be no ex parte contacts between
(i) the holder of the certificate of need, any person acting on
behalf of the holder, or any person in favor of the withdrawal
and (ii) any person in the state agency who exercises
responsibility respecting withdrawal of the certificate;
(B) The state agency shall follow the notification of review
provisions of subsections (g) and (h), the public hearing
provisions of subsection (n) (l), the notification of the status
of review and findings provisions of subsection (g) (o), the
annual report provisions of subsection (r) (p), and the
reconsideration provisions of subsection (t) (r), all of section
seven of this article, and the conditional decision provisions of
subsection (d), and the notification of decision and findings
provisions of subsection (h) (g) and the statement to the
applicable health systems agency provisions of subsection (k),
all of section nine of this article; and
(C) Appeals of withdrawals of certificates of need shall be
made pursuant to section ten of this article.
(4) A new institutional health service may not be acquired, offered, or developed within this state if a certificate of need
authorizing that new institutional health service has been
withdrawn by the state agency and the acquisition, offering, or
development of the new institutional health service is subject to
review under this article.
§16-2D-13. Injunctive relief; civil penalty.
(a) In addition to all other remedies, and aside from
various penalties provided by law, if any person acquires, offers
or develops any new institutional health service for which a
certificate of need is required under this article without first
having a certificate of need therefor as herein provided, or
violates any other provision of this article or any lawful rule
or regulation promulgated thereunder, affected persons, as
defined in section two of this article, and the state agency
shall request that the attorney general may maintain a civil
action in the circuit court of the county wherein such violation
has occurred, or wherein such person may be found, to enjoin,
restrain or prevent such violation. No injunction bond shall be
required to be filed in any such proceeding.
(b) The state agency may assess a civil penalty for
violation of this article. Upon the state agency determining
that there is probable cause to believe that any person is
knowingly offering, developing, or has acquired any new institutional health service subject to certificate of need
review without having first obtained a certificate of need
therefor or that any person is otherwise in violation of the
provisions of this article, or any lawful rule or regulation
promulgated thereunder, the state agency shall provide such
person with written notice which shall state the nature of the
alleged violation and the time and place at which such person
shall appear to show good cause why a civil penalty should not be
imposed, at which time and place such person shall be afforded
an opportunity to cross-examine the state agency's witnesses and
afforded an opportunity to present testimony and other evidence
in support of his position. The hearing shall be conducted in
accordance with the administrative hearing provisions of section
four, article five, chapter twenty-nine-a of this code. If,
after reviewing the record of such hearing, the state agency
director determines that such person is in violation of the
certificate of need law, the state agency shall assess a civil
penalty of not less than five hundred dollars nor more than
twenty-five thousand dollars. In determining the amount of the
penalty, the state agency shall consider the degree and extent of
harm caused by the violation and the cost of rectifying the
damage. Any person assessed shall be notified of the assessment
in writing, and the notice shall specify the reasons for the assessment. If the person assessed fails to pay the amount of
the assessment to the state agency within thirty days, the
attorney general state agency may institute a civil action in the
circuit court of the county wherein such violation has occurred,
or wherein such person may be found to recover the amount of the
assessment. In any such civil action, the scope of the court's
review of the state agency's action, which shall include a review
of the amount of the assessment, shall be as provided in section
four, article five, chapter twenty-nine-a of this code for the
judicial review of contested administrative cases.
§16-2D-15. Previously approved rules.
All rules and regulations previously promulgated to
implement this article shall continue in force following the
amendments to this article; except that, where such previous
rules and regulations differ from the requirements of the
amendments to this article, then such part of those rules and
regulations are hereby abrogated and shall have no further legal
effect. The state agency shall commence a review of such rules
and regulations and shall promulgate revised rules. and
regulations
_____________
(NOTE: The purpose of this bill is to amend the certificate
of need law to increase the thresholds for the expenditure
minimum and major medical equipment; to authorize the state agency to specify new services subject to certificate of need
review by rule; to eliminate the exemption from review for
certain HMO's; to require the state agency to review the state
health plan and the certificate of need standards within three
years and to review the cost effectiveness of the certificate of
need program; to require the state agency to study the need for
nursing facility beds in this state; to create the power to
declare a moratorium on the development of certain health
services; and, to create an expedited review process for
nonhealth related projects.
Strike-throughs indicate language that would be stricken
from the present law, and underscoring indicates new language
that would be added.)
_____________
HEALTH AND HUMAN RESOURCES COMMITTEE AMENDMENTS
On page ___, section two, by striking out all of
subdivision (h) and inserting in lieu thereof a new subdivision
(h), to read as follows:
(h) "Expenditure minimum" means
one two million dollars
and includes 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.;
On page ___, section two, by striking out all of
subdivision (s) and inserting in lieu thereof a new subdivision
(s), to read as follows:
(s) "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 costs in excess of
seven hundred fifty
thousand two million dollars. This 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 U.S.C.
§1395x.
(10) and (11). In determining whether medical equipment is major medical equipment, 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.;
On page ___, section two, line ___, after "§254" by
striking out "(b)(3)";
On page ___, section two, line ___, by striking out the
words "cost review";
On page ___, section three, line ___, by striking out the
word "code" and inserting in lieu thereof the word "chapter";
On page ___, section three, line ___, by striking out the
word "regulations" and inserting in lieu thereof the word
"rules";
On page ___, section four, line ___, by striking out the
words "and regulations";
And,
On page ___, section five, line ___, after the word "by"
by inserting the word "both".
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