W. Va. Code R. § 69-8-6

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 69-8-6 - Organization and Management

6.1. All owners, employees, volunteers or associates of the clinic shall be subject to the provisions of the West Virginia Clearance for Access: Registry and Employment Screening Act, W. Va. Code §§16-49-1, et seq., and W. Va. Code R. §§69-10-1, et seq.

6.2. The clinic may not be owned by, nor may it employ or associate with, any physician or prescriber:

6.2.1. Whose Drug Enforcement Administration number has ever been revoked;

6.2.2. Whose application for a license to prescribe, dispense or administer a controlled substance has been denied, restricted or denotes any disciplinary action by any jurisdiction; or

6.2.3. Who, in any jurisdiction of this state or any other state or territory of the United States, has received an ineligible employment fitness determination from the West Virginia Clearance for Access: Registry and Employment Screening unit of the Department of Health and Human Resources and has not received a variance.

6.3. Owner.

6.3.1. The owner of a pain management clinic is any person, partnership, association, or corporation named in the application for licensure of a pain management clinic. A pain management clinic may have more than one owner.

6.3.2. At least one owner of the pain management clinic shall be a physician actively licensed to practice medicine and surgery or osteopathic medicine and surgery in this state.

6.3.3. Each owner is responsible for the general establishment and licensure of the pain management clinic and is subject to all applicable federal and state laws, rules, and regulations.

6.3.4. The owner or owners and administrator shall meet at least annually to review the pain management clinic's total operation and document the meeting by signed meeting minutes. The review shall include, at a minimum, policy review; review of utilization and quality of patient care, quality assessment, and performance improvement reports and actions; review of assets and funds; and any other reviews necessary to determine adequate care, treatment, health, safety, and welfare of patients.

6.4. Designated physician owner.

6.4.1. Each pain management clinic shall have a designated physician owner who shall practice at the clinic and who will be responsible for the operation of the clinic pursuant to the federal, state, and local laws and the requirements in this rule.

6.4.2. The designated physician owner shall:

6.4.2.a. Have a full, active, and unencumbered license to practice medicine and surgery or osteopathic medicine and surgery in this state;

6.4.2.b. Meet one of the following training requirements:

6.4.2.b.1. Complete a pain medicine fellowship that is accredited by the Accreditation Council for Graduate Medical Education (ACGME) or such other similar program as may be approved by the secretary in consultation with the appropriate licensing board; or

6.4.2.b.2. Hold current board certification by the American Board of Pain Medicine (ABPM), the American Board of Interventional Pain Physicians, or the American Board of Anesthesiology (ABA); hold current subspecialty certification in pain management by the American Board of Medical Specialties; hold a current certificate of added qualification in pain management by the American Osteopathic Association Bureau of Osteopathic Specialists; hold Competency Certification in Controlled Substances Management; or hold current board certification from such other program as may be approved by the secretary;

6.4.2.c. Practice a minimum of 32 hours per week at the licensed pain management clinic for which the physician has assumed responsibility;

6.4.2.d. 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;

6.4.2.e. Develop operation and clinical policies and procedures;

6.4.2.f. Supervise all medical services offered by the pain management clinic;

6.4.2.g. Ensure the pain management clinic is in compliance with all applicable federal, state, and local laws, rules, and regulations;

6.4.2.h. Approve the basic and continuing educational programs of all physicians and clinic staff employed by or volunteering at the pain management clinic;

6.4.2.i. Periodically conduct appraisals of the medical staff as defined by clinic policy;

6.4.2.j. Periodically examine credentials of candidates for medical staff membership;

6.4.2.k. Supervise all clinical quality assessment and performance improvement activities;

6.4.2.l. Be responsible for complying with all requirements related to the licensing and operation of the clinic; and

6.4.2.m. Hold a 25 percent ownership interest in the clinic. The designated physician owner shall not be a contracted individual.

6.4.3. Within 10 days after the withdrawal or termination of a designated physician owner, the remaining owners of the clinic shall notify the secretary of the identity of another designated physician for that clinic. During the interim, not to exceed 60 days, another licensed physician shall be present during all hours of operation and shall assume the duties of the designated physician owner on a temporary basis until such time as a new designated physician owner is identified and begins work at the clinic. The interim physician may be another owner of the clinic or a physician employed by or associated with the clinic.

6.5. Administrator.

6.5.1. The administrator is responsible for the day-to-day non-clinical business operation of the pain management clinic.

6.5.2. The administrator shall be qualified by education and training as specified in a job description developed by the owners.

6.5.3. Duties of the administrator include:

6.5.3.a. Maintenance and security of the clinic;

6.5.3.b. Employment, credentialing, evaluation, scheduling, training, and management of staff;

6.5.3.c. Responsibility for the compliance process;

6.5.3.d. Protection of patient rights as outlined in section 9 of this rule;

6.5.3.e. Conformity of the clinic's program with state and federal confidentiality requirements;

6.5.3.f. Security of medication storage and safe handling of medications; and

6.5.3.g. Management of the clinic budget.

W. Va. Code R. § 69-8-6