Source: http://www.legis.state.wv.us/wvcode/code.cfm?chap=16&art=5H&section=10
Timestamp: 2016-09-26 10:59:12
Document Index: 663622954

Matched Legal Cases: ['§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16', '§16']

5H - CHRONIC PAIN CLINIC LICENSING 16 - 5 H- 1 16 - 5 H- 2 16 - 5 H- 2 16 - 5 H- 3 16 - 5 H- 4 16 - 5 H- 5 16 - 5 H- 5 16 - 5 H- 6 16 - 5 H- 7 16 - 5 H- 7 16 - 5 H- 8 16 - 5 H- 9 16 - 5 H- 10 5I - HOSPICE LICENSURE ACT
WVC 16 - 5 H- 1 §16-5H-1. Purpose and short title.
This article shall be known as the Chronic Pain Clinic
Licensing Act. The purpose of this act is to establish licensing
requirements for facilities that treat patients for chronic pain
management in order to ensure that patients may be lawfully treated
for chronic pain by physicians in facilities that comply with
oversight requirements developed by the Department of Health and
§16-5H-2. Definitions. (a) “Chronic pain” means pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months. For purposes of this article, “chronic pain” does not include pain directly associated with a terminal condition. (b) “Director” means the Director of the Office of Health Facility Licensure and Certification within the Office of the Inspector General. (c) “Owner” means any person, partnership, association or corporation listed as the owner of a pain management clinic on the licensing forms required by this article. (d) “Pain management clinic” means all privately owned pain management clinics, facilities or offices not otherwise exempted from this article and which meets both of the following criteria: (1) Where in any month more than fifty percent of patients of the clinic are prescribed or dispensed opioids or other controlled substances specified in rules promulgated pursuant to this article for chronic pain resulting from conditions that are not terminal; and (2) The facility meets any other identifying criteria established by the secretary by rule. (e) “Physician” means an individual authorized to practice medicine or surgery or osteopathic medicine or surgery in this state. (f) “Prescriber” means an individual who is authorized by law to prescribe drugs or drug therapy related devices in the course of the individual's professional practice, including only a medical or osteopathic physician authorized to practice medicine or surgery; a physician assistant or osteopathic physician assistant who holds a certificate to prescribe drugs; or an advanced nurse practitioner who holds a certificate to prescribe. (g) “Secretary” means the Secretary of the West Virginia Department of Health and Human Resources. The secretary may define in rules any term or phrase used in this article which is not expressly defined. WVC 16 - 5 H- 2 §16-5H-2. Definitions.
(a) "Chronic pain" means pain that has persisted after
reasonable medical efforts have been made to relieve the pain or
cure its cause and that has continued, either continuously or
episodically, for longer than three continuous months. For
purposes of this article, "chronic pain" does not include pain
associated with a terminal condition or with a progressive disease
that, in the normal course of progression, may reasonably be
expected to result in a terminal condition.
(b) "Director" means the Director of the Office of Health
Facility Licensure and Certification within the Office of the
(c) "Owner" means any person, partnership, association or
corporation listed as the owner of a pain management clinic on the
licensing forms required by this article.
(d) "Pain management clinic" means all privately owned pain
management clinics, facilities or offices not otherwise exempted
from this article and which meets both of the following criteria:
(1) Where in any month more than fifty percent of patients of
the prescribers or dispensers are prescribed or dispensed opioids
or other controlled substances specified in rules promulgated
pursuant to this article for chronic pain resulting from non-
malignant conditions;
(2) The facility meets any other identifying criteria
established by the secretary by rule.
(e) "Physician" means an individual authorized to practice
medicine or surgery or osteopathic medicine or surgery in this state.
(f) "Prescriber" means an individual who is authorized by law
to prescribe drugs or drug therapy related devices in the course of
the individual's professional practice, including only a medical or
osteopathic physician authorized to practice medicine or surgery;
a physician assistant or osteopathic physician assistant who holds
a certificate to prescribe drugs; or an advanced nurse practitioner
who holds a certificate to prescribe.
(g) "Secretary" means the Secretary of the West Virginia
Department of Health and Human Resources. The secretary may define
in rules any term or phrase used in this article which is not
expressly defined.
WVC 16 - 5 H- 3 §16-5H-3. Pain management clinics to obtain license; application;
fees and inspections.
(a) No person, partnership, association or corporation may
operate a pain management clinic without first obtaining a license
from the secretary in accordance with the provisions of this
article and the rules lawfully promulgated pursuant to this
(b) Any person, partnership, association or corporation
desiring a license to operate a pain management clinic in this
state shall file with the Office of Health Facility Licensure and
Certification an application in such form as the secretary shall
prescribe and furnish accompanied by a fee to be determined by the
(c) The Director of the Office of Health Facility Licensure
and Certification or his or her designee shall inspect each
facility prior to issuing a license and review all documentation
submitted with the application. The secretary shall issue a
license if the facility is in compliance with the provisions of
this article and with the rules lawfully promulgated pursuant to
(d) A license shall expire one year from the date of issuance. Sixty days prior to the expiration date, an application for renewal
shall be submitted on forms furnished by the secretary. A license
shall be renewed if the secretary determines that the applicant is
in compliance with this article and with all rules promulgated
pursuant to this article. A license issued to one facility
pursuant to this article is not transferable or assignable. A change of ownership of a licensed pain management clinic requires
submission of a new application.
(e) The secretary or his or her designee shall inspect on a
periodic basis all pain management clinics that are subject to this
article and all rules adopted pursuant to this article to ensure
WVC 16 - 5 H- 4 §16-5H-4. Operational requirements.
(a) Any person, partnership, association or corporation that
desires to operate a pain management clinic in this state must
submit to the director documentation that the facility meets all of
(1) The clinic shall be licensed in this state with the
secretary, the Secretary of State, the State Tax Department and all
other applicable business or license entities.
(2) The application shall list all owners of the clinic. At
least one owner shall be a physician actively licensed to practice
medicine, surgery or osteopathic medicine or surgery in this state. The clinic shall notify the secretary of any change in ownership
within ten days of the change and must submit a new application
within the time frame prescribed by the secretary.
(3) Each pain management clinic shall designate a physician
owner who shall practice at the clinic and who will be responsible
for the operation of the clinic. Within ten days after termination
of a designated physician, the clinic shall notify the director of
the identity of another designated physician for that clinic. Failing to have a licensed designated physician practicing at the
location of the clinic may be the basis for a suspension or
revocation of the clinic license. The designated physician shall:
(A) Have a full, active and unencumbered license to practice
medicine, surgery or osteopathic medicine or surgery in this state:
(i) Complete a pain medicine fellowship that is accredited by
the Accreditation Council for Graduate Medical Education or such other similar program as may be approved by the secretary; or
(ii) Hold current board certification by the American Board of
Pain Medicine or current board certification by the American Board
of Anesthesiology or such other board certification as may be
(C) Practice at the licensed clinic location for which the
physician has assumed responsibility;
(D) Be responsible for complying with all requirements related
to the licensing and operation of the clinic;
(E) Supervise, control and direct the activities of each
individual working or operating at the facility, including any
employee, volunteer or individual under contract, who provides
treatment of chronic pain at the clinic or is associated with the
provision of that treatment. The supervision, control and
direction shall be provided in accordance with rules promulgated by
(4) All persons employed by the facility shall comply with the
requirements for the operation of a pain management clinic
established by this article or by any rule adopted pursuant to this
(5) No person may own or be employed by or associated with a
pain management clinic who has previously been convicted of, or
pleaded guilty to, any felony in this state or another state or
territory of the United States. All owners, employees, volunteers
or associates of the clinic shall undergo a criminal records check
prior to operation of the clinic or engaging in any work, paid or
otherwise. The application for license shall include copies of the background check for each anticipated owner, physician, employee,
volunteer or associate. The secretary shall review the results of
the criminal records check and may deny licensure for any violation
of this requirement. The facility shall complete a criminal
records check on any subsequent owner, physician, employee,
volunteer or associate of the clinic and submit the results to the
secretary for continued review.
(6) The clinic may not be owned by, nor may it employ or
associate with, any physician or prescriber:
(A) Whose Drug Enforcement Administration number has ever been
(B) Whose application for a license to prescribe, dispense or
administer a controlled substance has been denied by any
(C) Who, in any jurisdiction of this state or any other state
or territory of the United States, has been convicted of or plead
guilty or nolo contendere to an offense that constitutes a felony
for receipt of illicit and diverted drugs, including controlled
substances, as defined by section one hundred one, article one,
(7) A person may not dispense any medication, including a
controlled substance, as defined by section one hundred one,
article one, chapter sixty-a of this code, on the premises of a
licensed pain management clinic unless he or she is a physician or
pharmacist licensed in this state. Prior to dispensing or
prescribing controlled substances, as defined by section one
hundred one, article one, chapter sixty-a of this code, at a pain management clinic, the treating physician must access the
Controlled Substances Monitoring Program database maintained by the
Board of Pharmacy to ensure the patient is not seeking controlled
substances from multiple sources. If the patient receives ongoing
treatment, the physician shall also review the Controlled
Substances Monitoring Program database at each patient examination
or at least every ninety days. The results obtained from the
Controlled Substances Monitoring Program database shall be
maintained with the patient's medical records.
(8) Each clinic location shall be licensed separately,
regardless of whether the clinic is operated under the same
business name or management as another clinic.
(9) A pain management clinic shall not dispense to any patient
more than a seventy-two-hour supply of a controlled substance, as
defined by section one hundred one, article one, chapter sixty-a of
(10) The pain management clinic shall develop patient
protocols, treatment plans and profiles, as prescribed by the
secretary by rule, and which shall include, but not be limited by,
(A) When a physician diagnoses an individual as having chronic
pain, the physician may treat the pain by managing it with
medications in amounts or combinations that may not be appropriate
when treating other medical conditions. The physician's diagnosis
shall be made after having the individual evaluated by one or more
other physicians who specialize in the treatment of the area,
system or organ of the body perceived as the source of the pain unless the individual has been previously diagnosed as suffering
from chronic pain and is referred to the pain management clinic by
such diagnosing physician. The physician's diagnosis and treatment
decisions shall be made according to accepted and prevailing
standards for medical care.
(B) The physician shall maintain a record of all of the
(i) Medical history and physical examination of the
(ii) The diagnosis of chronic pain, including signs, symptoms
and causes;
(iii) The plan of treatment proposed, the patient's response
to the treatment and any modification to the plan of treatment;
(iv) The dates on which any medications were prescribed,
dispensed or administered, the name and address of the individual
to or for whom the medications were prescribed, dispensed or
administered and the amounts and dosage forms for the drugs
prescribed, dispensed or administered;
(v) A copy of the report made by the physician to whom
referral for evaluation was made.
(C) A physician, physician assistant, certified registered
nurse anesthetist or advanced nurse practitioner shall perform a
physical examination of a patient on the same day that the
physician initially prescribes, dispenses or administers a
controlled substance to a patient and at least four times a year
thereafter at a pain management clinic according to accepted and
prevailing standards for medical care.
(D) A physician authorized to prescribe controlled substances
who practices at a pain management clinic is responsible for
maintaining the control and security of his or her prescription
blanks and any other method used for prescribing controlled
substance pain medication. The physician shall comply with all
state and federal requirements for tamper-resistant prescription
paper. In addition to any other requirements imposed by statute or
rule, the physician shall notify the secretary in writing within
twenty-four hours following any theft or loss of a prescription
blank or breach of any other method for prescribing pain
(c) Upon satisfaction that an applicant has met all of the
requirements of this article, the secretary may issue a license to
operate a pain management clinic. An entity that obtains this
license may possess, have custody or control of, and dispense drugs
designated as Schedule II or Schedule III in sections two hundred
six or two hundred eight, article two, chapter sixty-a of this
§16-5H-5. Exemptions. (a) The following facilities are not pain management clinics subject to the requirements of this article: (1) A facility that does not prescribe or dispense controlled substances for the treatment of chronic pain; (2) A hospital licensed in this state, a facility located on the campus of a licensed hospital that is owned, operated or controlled by that licensed hospital, and an ambulatory health care facility as defined by section two, article two-d, chapter sixteen of this code that is owned, operated or controlled by a licensed hospital; (3) A physician practice owned or controlled, in whole or in part, by a licensed hospital or by an entity that owns or controls, in whole or in part, one or more licensed hospitals; (4) A hospice program licensed in this state; (5) A nursing home licensed in this state; (6) An ambulatory surgical facility as defined by section two, article two-d, chapter sixteen of this code; and (7) A facility conducting clinical research that may use controlled substances in studies approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protection programs. (b) Any facility that is not included in this section may petition to the secretary for an exemption from the requirements of this article. All such petitions are subject to the administrative procedures requirements of chapter twenty-nine-a of this code. WVC 16 - 5 H- 5 §16-5H-5. Exemptions.
(a) The following facilities are not pain management clinics
subject to the requirements of this article:
(1) A facility that is affiliated with an accredited medical
school at which training is provided for medical or osteopathic
students, residents or fellows, podiatrists, dentists, nurses,
physician assistants, veterinarians or any affiliated facility to
the extent that it participates in the provision of the
(2) A facility that does not prescribe or dispense controlled
substances for the treatment of chronic pain;
(3) A hospital licensed in this state, a facility located on
the campus of a licensed hospital that is owned, operated or
controlled by that licensed hospital, and an ambulatory health care
facility as defined by section two, article two-d, chapter sixteen
of this code that is owned, operated or controlled by a licensed
(4) A physician practice owned or controlled, in whole or in
part, by a licensed hospital or by an entity that owns or controls,
in whole or in part, one or more licensed hospitals;
(7) An ambulatory surgical facility as defined by section two,
article two-d, chapter sixteen of this code; and
(8) A facility conducting clinical research that may use
controlled substances in studies approved by a hospital-based
institutional review board or an institutional review board accredited by the association for the accreditation of human
research protection programs.
(b) Any facility that is not included in this section may
petition to the secretary for an exemption from the requirements of
this article. All such petitions are subject to the administrative
procedures requirements of chapter twenty-nine-a of this code.
WVC 16 - 5 H- 6 §16-5H-6. Inspection.
(a) The Office of Health Facility Licensure and Certification
shall inspect each pain management clinic annually, including a
review of the patient records, to ensure that it complies with this
article and the applicable rules.
(b) During an onsite inspection, the inspector shall make a
reasonable attempt to discuss each violation with the designated
physician or other owners of the pain management clinic before
issuing a formal written notification.
(c) Any action taken to correct a violation shall be
documented in writing by the designated physician or other owners
of the pain management clinic and verified by follow-up visits by
the Office of Health Facility Licensure and Certification.
§16-5H-7. Suspension; revocation. (a) The secretary may suspend or revoke a license issued pursuant to this article if the provisions of this article or of the rules promulgated pursuant to this article are violated. The secretary may revoke a clinic's license and prohibit all physicians associated with that pain management clinic from practicing at the clinic location based upon an annual or periodic inspection and evaluation. (b) Before any such license is suspended or revoked, however, written notice shall be given to the licensee, stating the grounds of the complaint and shall provide notice of the right to request a hearing. The notice shall be sent by certified mail to the licensee at the address where the pain management clinic concerned is located. The licensee shall be entitled to be represented by legal counsel at the hearing. (c) If a license is revoked pursuant to this article, a new application for a license may be considered by the secretary if, when and after the conditions upon which revocation was based have been corrected, and evidence of this fact has been furnished to the secretary. A new license may then be granted after proper inspection has been made and all provisions of this article and rules promulgated pursuant to this article have been satisfied. (d) All of the pertinent provisions of article five, chapter twenty-nine-a of this code shall apply and govern any hearing authorized and required by the provisions of this article and the administrative procedure in connection therewith. (e) Any applicant or licensee who is dissatisfied with the decision of the secretary as a result of the hearing provided in this section may, within thirty days after receiving notice of the decision, appeal the decision to the circuit court of Kanawha County, in term or in vacation, for judicial review of the decision. (f) The court may affirm, modify or reverse the decision of the secretary and either the applicant or licensee or the secretary may appeal from the court's decision to the Supreme Court of Appeals. (g) If the license of a pain management clinic is revoked or suspended, the designated physician of the clinic, any other owner of the clinic or the owner or lessor of the clinic property shall cease to operate the facility as a pain management clinic as of the effective date of the suspension or revocation. The owner or lessor of the clinic property is responsible for removing all signs and symbols identifying the premises as a pain management clinic within thirty days. (h) Upon the effective date of the suspension or revocation, the designated physician of the pain management clinic shall advise the secretary and the Board of Pharmacy of the disposition of all drugs located on the premises. The disposition is subject to the supervision and approval of the secretary. Drugs that are purchased or held by a pain management clinic that is not licensed may be deemed adulterated. (i) If the license of a pain management clinic is suspended or revoked, any person named in the licensing documents of the clinic, including persons owning or operating the pain management clinic, may not, as an individual or as part of a group, apply to operate another pain management clinic for five years after the date of suspension or revocation. (j) The period of suspension for the license of a pain management clinic shall be prescribed by the secretary, but may not exceed one year. WVC 16 - 5 H- 7 §16-5H-7. Suspension; revocation.
(a) The secretary may suspend or revoke a license issued
pursuant to this article if the provisions of this article or of
the rules promulgated pursuant to this article are violated. The
secretary may revoke a clinic's license and prohibit all physicians
associated with that pain management clinic from practicing at the
clinic location based upon an annual or periodic inspection and
(b) Before any such license is suspended or revoked, however,
written notice shall be given the licensee, stating the grounds of
the complaint, and the date, time and place set for the hearing on
the complaint, which date shall not be less than thirty days from
the time notice is given. The notice shall be sent by certified
mail to the licensee at the address where the pain management
clinic concerned is located. The licensee shall be entitled to be
represented by legal counsel at the hearing.
(c) If a license is revoked as herein provided, a new
application for a license shall be considered by the secretary if,
when and after the conditions upon which revocation was based have
been corrected and evidence of this fact has been furnished. A new
license shall then be granted after proper inspection has been made
and all provisions of this article and rules promulgated pursuant
to this article have been satisfied.
(d) All of the pertinent provisions of article five, chapter
administrative procedure in connection therewith.
(e) Any applicant or licensee who is dissatisfied with the
decision of the secretary as a result of the hearing provided in
this section may, within thirty days after receiving notice of the
decision, appeal the decision to the Circuit Court of Kanawha
County, in term or in vacation, for judicial review of the
(f) The court may affirm, modify or reverse the decision of
the secretary and either the applicant or licensee or the secretary
may appeal from the court's decision to the Supreme Court of
(g) If the license of a pain management clinic is revoked or
suspended, the designated physician of the clinic, any other owner
of the clinic or the owner or lessor of the clinic property shall
cease to operate the facility as a pain management clinic as of the
effective date of the suspension or revocation. The owner or
lessor of the clinic property is responsible for removing all signs
and symbols identifying the premises as a pain management clinic
(h) Upon the effective date of the suspension or revocation,
the designated physician of the pain management clinic shall advise
the secretary and the Board of Pharmacy of the disposition of all
drugs located on the premises. The disposition is subject to the
supervision and approval of the secretary. Drugs that are
purchased or held by a pain management clinic that is not licensed
may be deemed adulterated.
(i) If the license of a pain management clinic is suspended or
revoked, any person named in the licensing documents of the clinic, including persons owning or operating the pain management clinic,
may not, as an individual or as part of a group, apply to operate
another pain management clinic for five years after the date of
(j) The period of suspension for the license of a pain
management clinic shall be prescribed by the secretary, but may not
WVC 16 - 5 H- 8 §16-5H-8. Violations; penalties; injunction.
(a) Any person, partnership, association or corporation which
establishes, conducts, manages or operates a pain management clinic
without first obtaining a license therefor as herein provided, or
which violates any provisions of this article or any rule lawfully
promulgated pursuant to this article, shall be assessed a civil
penalty by the secretary in accordance with this subsection. Each
day of continuing violation after conviction shall be considered a
separate violation:
(1) If a pain management clinic or any owner or designated
physician is found to be in violation of any provision of this
article, unless otherwise noted herein, the secretary may suspend
or revoke the clinic's license.
(2) If the clinic's designated physician knowingly and
intentionally misrepresents actions taken to correct a violation,
the secretary may impose a civil penalty not to exceed $10,000,
and, in the case of an owner-operated pain management clinic,
revoke or deny a pain management clinic's license.
(3) If an owner or designated physician of a pain management
clinic concurrently operates an unlicensed pain management clinic,
the secretary may impose a civil penalty upon the owner or
physician, or both, not to exceed $5,000 per day.
(4) If the owner of a pain management clinic that requires a
license under this article fails to apply for a new license for the
clinic upon a change-of-ownership and operates the clinic under the
new ownership, the secretary may impose a civil penalty not to
(5) If a physician knowingly operates, owns or manages an
unlicensed pain management clinic that is required to be licensed
pursuant to this article; knowingly prescribes or dispenses or
causes to be prescribed or dispensed, controlled substances in an
unlicensed pain management clinic that is required to be licensed;
or licenses a pain management clinic through misrepresentation or
fraud; procures or attempts to procure a license for a pain
management clinic for any other person by making or causing to be
made any false representation, the secretary may assess a civil
penalty of not more than $20,000. The penalty may be in addition
to or in lieu of any other action that may be taken by the
secretary or any other board, court or entity.
(b) Notwithstanding the existence or pursuit of any other
remedy, the secretary may, in the manner provided by law, maintain
person, partnership, association, or corporation to restrain or
prevent the establishment, conduct, management or operation of any
pain management clinic or violation of any provisions of this
article or any rule lawfully promulgated thereunder without first
obtaining a license therefor in the manner hereinbefore provided.
(c) In determining whether a penalty is to be imposed and in
fixing the amount of the penalty, the secretary shall consider the
(1) The gravity of the violation, including the probability
that death or serious physical or emotional harm to a patient has
resulted, or could have resulted, from the pain management clinic's
actions or the actions of the designated or practicing physician, the severity of the action or potential harm, and the extent to
which the provisions of the applicable laws or rules were violated;
(2) What actions, if any, the owner or designated physician
took to correct the violations;
(3) Whether there were any previous violations at the pain
management clinic; and
(4) The financial benefits that the pain management clinic
derived from committing or continuing to commit the violation.
(d) Upon finding that a physician has violated the provisions
of this article or rules adopted pursuant to this article, the
secretary shall provide notice of the violation to the applicable
WVC 16 - 5 H- 9 §16-5H-9. Rules.
Resources, in collaboration with the West Virginia Board of
Medicine and the West Virginia Board of Osteopathy, shall
promulgate rules in accordance with the provisions of chapter
twenty-nine-a of this code for the licensure of pain management
clinics to ensure adequate care, treatment, health, safety, welfare
and comfort of patients at these facilities. These rules shall
(1) The process to be followed by applicants seeking a
(2) The qualifications and supervision of licensed and
non-licensed personnel at pain management clinics and training
requirements for all facility health care practitioners who are not
regulated by another board;
(3) The provision and coordination of patient care, including
the development of a written plan of care;
(4) The management, operation, staffing and equipping of the
pain management clinic;
(5) The clinical, medical, patient and business records kept
by the pain management clinic;
(6) The procedures for inspections and for the review of
utilization and quality of patient care;
(7) The standards and procedures for the general operation of
a pain management clinic, including facility operations, physical
operations, infection control requirements, health and safety
requirements and quality assurance;
(8) Identification of drugs that may be used to treat chronic
pain that identify a facility as a pain management clinic,
including, at a minimum, tramadol and carisoprodol;
(9) Any other criteria that identify a facility as a pain
management clinic;
(10) The standards and procedures to be followed by an owner
in providing supervision, direction and control of individuals
employed by or associated with a pain management clinic;
(12) Such other standards or requirements as the secretary
determines are appropriate.
(b) The rules authorized by this section may be filed as
emergency rules if deemed necessary to promptly effectuate the
WVC 16 - 5 H- 10 §16-5H-10. Advertisement disclosure.
Any advertisement made by or on behalf of a pain management
clinic through public media, such as a telephone directory, medical
directory, newspaper or other periodical, outdoor advertising,
radio or television, or through written or recorded communication,
concerning the treatment of chronic pain, as defined in section two
of this article, shall include the name of, at a minimum, one
physician owner responsible for the content of the advertisement.