West Virginia Code of State Rules
Agency 69 - Health And Human Resources
Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Series 69-11 - Medication-Assisted Treatment - Opioid Treatment Programs
Section 69-11-6 - Licensure; Fees and Costs
Universal Citation: 69 WV Code of State Rules 69-11-6
Current through Register Vol. XLI, No. 38, September 20, 2024
6.1. General Licensure Provisions.
6.1.a. No
person, partnership, association or corporation may operate an opioid treatment
program in the State of West Virginia without first obtaining a license
pursuant to W. Va. Code §
16-5Y-3
and this rule.
6.1.b. A license is
valid only for the location and persons named and described in the
application.
6.1.c. Each opioid
treatment program location shall be licensed separately, regardless of whether
the program is operated under the same business name or management as another
program.
6.1.d. Before
establishing, operating, maintaining or advertising an opioid treatment program
within the State of West Virginia, a program shall:
6.1.d.1. Hold current, valid certification
from the SAMHSA;
6.1.d.2. Be
registered and qualified by the United States Department of Health and Human
Services under the Controlled Substances Act,
21
U.S.C. §§
801, et
seq. (1970), as amended, to dispense medication-assisted treatment
medications in the treatment of substance use disorder;
6.1.d.3. Be approved by the state opioid
treatment authority for operation of an opioid treatment program in this
state;
6.1.d.4. Have been approved
for a certificate of need pursuant to W. Va. Code §
16-5Y-12
and §§
16-2D-1,
et seq.; and
6.1.d.5. Obtain from the Secretary a license
authorizing the operation of the opioid treatment program and
facility.
6.1.e. Each
licensed opioid treatment program shall designate a medical director. The
medical director shall practice at the program and be responsible for the
operation of the program in accordance with the requirements of this rule. An
opioid treatment program may have two co-medical directors.
6.1.f. A license is not transferable or
assignable.
6.1.g. If the ownership
of an opioid treatment program changes, the new owner shall notify the
Secretary within 10 days of the change in ownership and immediately apply for a
new license. The new owner's application for a license is valid for three
months from the date the application is received by the director.
6.1.h. The opioid treatment program shall
notify the Secretary in writing 30 days prior to a change in name or location
of the program and request an application form for a license
amendment.
6.1.i. If there is a
change in the medical director, the opioid treatment program must comply with
the provisions of subdivisions 6.1.e. and 8.4.f. of this rule.
6.1.j. If the opioid treatment program is not
in substantial compliance with this rule, but does not pose a significant risk
to the health, safety or rights of the patients, a license expiring in less
than one year may be issued.
6.1.k.
A licensure survey may be conducted periodically during the course of the
annual licensing term.
6.1.l. The
Secretary or his or her designee may enter the premises of any practice, office
or facility if the Secretary has reasonable belief that it is being operated or
maintained as an opioid treatment program without a license.
6.1.m. If the owner, medical director or
other person in charge of a licensed opioid treatment program or of any other
unlicensed practice, office or facility which the Secretary has reasonable
belief is being operated as an opioid treatment program refuses entry pursuant
to this rule, the Secretary shall petition the Circuit Court of Kanawha County
or the county in which the program is located for an inspection
warrant.
6.1.n. If the Secretary
finds on the basis of an inspection that any person, partnership, association
or corporation is operating as an opioid treatment program without a license,
the opioid treatment program shall apply for a license within 10 days of
receipt of notification by the Secretary.
6.1.o. An opioid treatment program that fails
to apply for a license is subject to the penalties established by section 38 of
this rule.
6.1.p. An opioid
treatment program shall surrender an expired, revoked or otherwise invalid
license to the Secretary upon written demand.
6.2. Licensure Application.
6.2.a. The program sponsor of an opioid
treatment program shall submit an application for an opioid treatment program
license to the Secretary not less than 30 days and not more than 60 days prior
to the anticipated initiation of services.
6.2.b. All applications for an initial,
provisional or renewed license shall include and provide the documentation
specified in W. Va. Code §
16-5Y-3
in addition to the following:
6.2.b.1.
Documentation of all current federal accreditations, certifications and
authorizations; and
6.2.b.2. A
description of the organizational structure of the opioid treatment program,
including identification of the governing body, advisory council and peer
review committee.
6.3. License Fees and Inspection Costs.
6.3.a. All applicants for an initial,
provisional or renewed license shall be accompanied by a non-refundable fee in
the amount required by this rule. The annual renewal fee is based upon the
average daily total census of the program. In addition to the set fee, the
annual renewal fee shall be adjusted on the first day of June of each year to
correspond with increases in the consumer price index. The amounts for initial,
provisional and renewal feeds are as follows:
6.3.a.1. Initial license fee -
$250;
6.3.a.2. Provisional license
fee - only for existing programs as of the effective date of this rule seeking
an initial license - $250;
6.3.a.3.
Renewal license fee - fewer than 500 patients - $521.12;
6.3.a.4. Renewal license fee - 500 to 1,000
patients - $1,042.24; and
6.3.a.5.
Renewal license fee - more than 1,000 patients - $1,563.36.
6.3.b. An opioid treatment program
shall pay for the cost of the initial inspection made by the Secretary prior to
issuance of a license. The cost of the initial inspection of an opioid
treatment program is $400, plus the actual costs of the initial inspections and
shall be billed by the Secretary.
6.4. Initial Inspection and Issuance of License.
6.4.a. Upon receipt of an application
for an initial license to operate as an opioid treatment program, the Secretary
or his or her designee shall make an inspection of the program and facility in
order to determine whether the program has satisfied all of the federal and
state requirements for licensure.
6.4.b. If the inspection reveals violations,
deficiencies or shortcomings on the part of the opioid treatment program or
facility, the Secretary shall advise the program of the deficiencies. The
program may submit one or more written plans of correction demonstrating
compliance with the corrections required. The Secretary may conduct follow-up
inspections if required.
6.4.c.
Following an application review, onsite inspection or inspections and approval
of subsequent plans of correction by the Department of Health and Human
Resources as may be needed, if there is substantial compliance with the
requirements of this rule and the cost of the inspection has been paid as
required by subdivision 6.3.b., the Secretary will issue a license in one of
three categories:
6.4.c.1. An initial license,
valid for 12 months from the date of issuance, shall be issued to programs
establishing a new service found to be in substantial compliance on initial
review with regard to policy, procedure, facility and recordkeeping
regulations;
6.4.c.2. A provisional
license shall be issued when an opioid treatment program seeks a renewal, or is
an existing program as of the effective date of this rule and is seeking an
initial license, and the opioid treatment program is not in substantial
compliance with this rule, but does not pose a significant risk to the rights,
health and safety of a consumer. It shall expire not more than six months from
the date of issuance, and may not be consecutively reissued; or
6.4.c.3. A renewal license shall be issued
when an opioid treatment program is in substantial compliance with this rule. A
renewal license shall expire not more than 12 months from the date of
issuance.
6.4.d. A
license is valid for the opioid treatment program named in the application and
is not transferable or assignable.
6.5. Denial of License.
6.5.a. The Secretary may deny an application
for an initial, provisional or renewal license if:
6.5.a.1. The Secretary determines that the
application is deficient in any respect;
6.5.a.2. The opioid treatment program will
not be or is not being operated in accordance with federal or state standards,
or federal or state standards, laws and rules;
6.5.a.3. The opioid treatment program will
not permit an inspection or survey to proceed or will not permit in a timely
manner access to records or information deemed relevant by the
Secretary;
6.5.a.4. The opioid
treatment program has made misrepresentations in obtaining accreditation,
certification or licensure;
6.5.a.5. The opioid treatment program has an
owner, employee or associate who has received an ineligible employment fitness
determination from the West Virginia Clearance for Access: Registry and
Employment Screening unit of the West Virginia Department of Health and Human
Resources and has not received a variance;
6.5.a.6. The opioid treatment program fails
to have a medical director practicing at the program location; or
6.5.a.7. The opioid treatment programs fails
to have an established process for maintaining current, accessible patient
records from admission through discharge.
6.5.b. If the Secretary determines not to
issue a license, the Secretary shall notify the applicant in writing of the
denial and the basis for the decision. Following the denial, the program must
follow closure procedures in subdivision 37.2.c. of this rule, including
notification to existing patients.
6.5.c. An opioid treatment program shall
surrender an expired, revoked or otherwise invalid license to the Secretary
upon written demand.
6.5.d. An
opioid treatment program may protest the denial of an initial, provisional or
renewal license pursuant to the administrative procedures in section 39 of this
rule.
6.6. Renewed or Amended Licenses.
6.6.a. The opioid treatment
program shall submit an application for a license to the Secretary not less
than 60 days prior to the expiration of the current license. After the
Secretary receives a complete renewal application with the required fee, the
existing license shall not expire until the new license has been issued or
denied.
6.6.b. The program shall
notify the Secretary 30 days prior to a change in the name, geographic location
or services of a program or a change in the substantial nature of the opioid
treatment program and simultaneously shall apply for a license
amendment.
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