COMMITTEE SUBSTITUTE
FOR
Senate Bill No. 321
(By Senators Prezioso, Foster, Jenkins, Stollings, Kessler, D.
Facemire, Deem, Bowman and Plymale)
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[Originating in the Committee on Health and Human Resources;
reported March 13, 2009.]
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A BILL to amend and reenact §16-2D-2, §16-2D-3, §16-2D-4, §16-2D-5
and §16-2D-7 of the Code of West Virginia, 1931, as amended,
all relating generally to the certificate of need process;
eliminating certain services of certificate of need review;
defining terms; raising the expenditure minimum amount for a
capital expenditure and major medical equipment threshold;
eliminating archaic language; providing for legislative rule-
making authority; setting forth standards for when certain
ambulatory health care facilities are not subject to
certificate of review; providing that electronic health
records are not subject to certificate of review; providing
that nonhealth-related projects are subject to certificate of
review; and modifying the fee structure for certificate of
review by setting forth a capitated amount for certificate of
need fees.
Be it enacted by the Legislature of West Virginia:
That §16-2D-2, §16-2D-3, §16-2D-4, §16-2D-5 and §16-2D-7 of
the Code of West Virginia, 1931, 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
any facility engaged solely in the provision of lithotripsy
services or 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;
(2) The donation of equipment or facilities to a health care
facility, which if acquired directly by that facility would be
subject to review;
(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
two million dollars $2,700,000
for the calendar year 2009. The state agency shall adjust the
expenditure minimum annually and publish an update of the amount on
or before December 31 of each year. The expenditure minimum
adjustment shall be based on the DRI inflation index published in
the Global Insight DRI/WEFA Health Care Cost Review, or its
successor or appropriate replacement index. This amount shall
include 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.
(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 which:
(1) Is 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;
(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
two million dollars $2,700,000 in
the calendar year 2009. The state agency shall adjust the dollar
amount specified in this subsection annually and publish an update
of the amount on or before December 31 of each year. The
adjustment of the dollar amount shall be based on the DRI inflation
index published in the Global Insight DRI/WEFA Health Care Cost
Review or its successor or appropriate replacement index. 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, Section 1861(s) of such act, Title 42 U. S. C. §1395x. 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.
(u) "New institutional health service" means any service as
described in section three of this article.
(v) "Nonhealth-related project" means a capital expenditure
for the benefit of patients, visitors, staff or employees of a
health care facility and not directly related to preventive, diagnostic, treatment or rehabilitative services offered by the
health care facility. This includes, but is not limited to,
chapels, gift shops, news stands, computer and information
technology systems, educational, conference and meeting facilities,
but excluding medical school facilities, student housing, dining
areas, administration and volunteer offices, modernization of
structural components, boiler repair or replacement, vehicle
maintenance and storage facilities, parking facilities, mechanical
systems for heating, ventilation systems, air conditioning systems
and loading docks.
(v) (w) "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) (x) "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) (y) "Physician" means a doctor of medicine or osteopathy
legally authorized to practice by the state.
(y) (z) "Proposed new institutional health service" means any
service as described in section three of this article.
(z) (aa) "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) (bb) "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) (cc) "Review agency" means an agency of the state,
designated by the Governor as the agency for the review of state
agency decisions.
(cc) (dd) "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) (ee) "State agency" means the Health Care Authority
created, established and continued pursuant to article
twenty-nine-b of this chapter.
(ee) (ff) "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) (gg) "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 is excluded from this
definition.
(gg) (hh) "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; or
(2) 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) (ii) "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 A person may
not 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:
Provided, That lithotripsy
services are not subject to certificate of need review. 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
review. as
recommended by the certificate of need study conducted pursuant to
section nineteen-a, article twenty-nine-b of this chapter;
(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 rules 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.
(c) Notwithstanding any other provisions of this article to
the contrary, the construction, development, acquisition or other
establishment of an institutional health service outside of this
state and within a county contiguous to the border of this state by or on behalf of a person that would otherwise be subject to review
under the provisions of this section is not subject to certificate
of need review. A hospital subject to review of the West Virginia
Health Care Authority that constructs, develops or acquires any
health care service or facility outside of West Virginia may not
use the financial condition or performance of the newly
constructed, developed, acquired or established health care service
or facility as a basis or justification for obtaining a rate
adjustment pursuant to article twenty-nine-b of this chapter.
§16-2D-4. Exemptions from certificate of need program.
(a) Except as provided in subdivision (9), subsection (b),
section three of this article, nothing in this article or the rules
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 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 shall 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 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 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.
(c) (1) The state agency may adopt 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 is 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 said 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.
(d) The state agency shall adopt rules 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 rules 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.
(e) The state agency shall promulgate rules for legislative
approval in accordance with the provisions of article three,
chapter twenty-nine-a of this code to specify the circumstances
under which, and the procedures by which, a certificate of need may
not be required for the construction, development, acquisition or
other establishment by a hospital of an ambulatory health care
facility. Certificate of need may not be required if:
(1) The ambulatory health care facility is located in the same
county as the hospital;
(2) Employs five or less physicians licensed to practice in
this state pursuant to either article three or article fourteen,
chapter thirty of this code;
(3) The total capital expenditure does not exceed the
expenditure minimum set forth in subsection two of this section;
and
(4) The construction, development, acquisition or other
establishment of an ambulatory health care facility is not opposed
by an affected person after substantive public notice pursuant to
the provisions of article three, chapter fifty-nine of this code
has been given by the Health Care Authority.
(f) The Health Care Authority shall provide at least thirty
days' notice to the public of the intent of a health care facility to construct, acquire or develop an ambulatory health care
facility. The Health Care Authority shall cause a Class II legal
advertisement to be published in a qualified newspaper of general
circulation where the construction, acquisition or development of
the ambulatory health care facility is or will be geographically
located. The thirty-day notice shall commence with the first date
of publication. Additionally, if the county in which the
ambulatory health care facility is or will be geographically
located contains a daily newspaper, a legal advertisement shall
also be placed at least once in the daily newspaper. Any public
notice shall include the name of the hospital seeking to develop,
acquire or construct an ambulatory health care facility, the kind
of practice to be developed, acquired or constructed, the
geographic location of the ambulatory health care facility and the
address where protests may be submitted or filed.
(g) The state agency shall promulgate emergency rules pursuant
to the provision of chapter twenty-nine-a of this code by July 1,
2009, to establish an exemption process for such projects.
(h) The acquisition, development or establishment of a
certified interoperable electronic health record or electronic
medical record system is not subject to certificate of need review.
(I) A health care facility is not required to obtain a
certificate of need for any nonhealth-related project that does not
exceed:
(1) Five million dollars for a hospital with less than one
hundred licensed acute care beds;
(2) Ten million dollars for a hospital with one hundred or
more licensed acute care beds; or
(3) Five million dollars for any other project.
(j) A certificate of need is not required for a psychiatric
hospital operated by state government for the purpose of
constructing forensic beds.
(k) Any behavioral health care service selected by the
Department of Health and Human Resources in response to its request
for application for services intended to return children currently
placed in out-of-state facilities to the state or to prevent
placement of children in out-of-state facilities is not subject to
a certificate of need.
§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. 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. Provided, That any fee charged pursuant to this subsection
may not exceed a dollar amount to be established by procedural
rule. The state agency shall evaluate and amend any procedural
rule promulgated prior to the amendments to this subsection made
during the 2009 regular session of the Legislature. 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 A hospital, nursing home or other health care facility
shall may not 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 of this
article and subsection (I) of this section 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
a certificate of need
shall may not 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 Extensions
shall may not 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 both by
Medicare and Medicaid. The task force shall be composed of
representatives of consumers, business, providers, payers and
government agencies.
(h)
No An additional intermediate care facility for the
mentally retarded (ICF/MR) beds
shall may not 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 August 3, 1989, 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) of this
section 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 freestanding
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
meets all federal and state licensing certification and operational
requirements applicable to nursing homes;
(D) The retirement center demonstrates a need for the project;
(E) The retirement center offers personal care, home health
services and other lower levels of care to its residents; and
(F) The retirement center demonstrates 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 offering
or development of a new institutional health service 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. 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
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 applications for
certificates of need are 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) When amending and modifying the certificate of need
standards, the state agency shall identify relevant criteria
contained in section six of this article or rules adopted pursuant
to section eight of this article and apply those relevant criteria
to the proposed new institutional health service in a manner that
promotes the public policy goals and legislative findings contained in section one of this article. In doing so, the state agency may
consult with or rely upon learned treatises in health planning,
recommendations and practices of other health planning agencies and
organizations, recommendations from consumers, recommendations from
health care providers, recommendations from third-party payors,
materials reflecting the standard of care, the state agency's own
developed expertise in health planning, data accumulated by the
state agency or other local, state or federal agency or
organization and any other source deemed relevant to the
certificate of need standards proposed for amendment or
modification.
(3) 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.
(4) The certificate of need standards adopted pursuant to this
section which are applicable to the provisions of this article are
not subject to article three, chapter twenty-nine-a of this code.
The state agency shall follow the provisions set forth in this
subsection for giving notice to the public of its actions, holding hearings or receiving comments on the certificate of need
standards. The certificate of need standards in effect on November
29, 2005, and all prior versions promulgated and adopted in
accordance with the provisions of this section are and have been in
full force and effect from each of their respective dates of
approval by the Governor.
(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.
§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
requires.
(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 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 (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 establishes by rule, 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 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 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 considered 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 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 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 rules pursuant to section eight
of this article for reviews and such 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 for determining when there is an
application which warrants expedited review.
(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.
_________
(NOTE: The purpose of this bill is to modify the certificate
of need process in West Virginia. The bill raises the capital
expenditure threshold and major medical equipment threshold from $2,000,000 to $2,700,000, eliminates lithotripsy from certificate
of review, amends the fee structure of the Health Care Authority
for certificate of need reviews. It provides that in specified
instances nonhealth-related projects are not subject to certificate
of need review. The bill provides that in specified instances
certain ambulatory health care facilities are not subject to
certificate of review and eliminates from certificate of review
acquisition of any health care facility outside of West Virginia by
a West Virginia health care facility.
Strike-throughs indicate language that would be stricken from
the present law, and underscoring indicates new language that would
be added.)
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