W. Va. Code R. § 69-8-3

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

Section 69-8-3 - Pain Clinic Definition and Exemptions

3.1. A pain management clinic is any privately owned, clinic, facility or office, not otherwise exempted, that treats patients for chronic pain as defined by W. Va. Code § 16-5H-2, and;

3.1.1. The primary component of the medical practice of the clinic, facility or office is treatment of chronic pain for non-malignant conditions;

3.1.2. More than 50 percent of patients in any one month of the clinic are provided treatment for chronic pain for nonmalignant conditions that are not terminal and are prescribed, administered or dispensed Schedule II opioid drug products or other Schedule II controlled substances for such diagnosis;

3.1.3. The calculation of more than 50 percent of patients will be calculated by dividing the number of unique patient encounters at the clinic, facility or office during any one month for a diagnosis of chronic nonmalignant pain for conditions that are not terminal and pursuant to such diagnosis of chronic nonmalignant pain for conditions that are not terminal were prescribed, administered, or dispensed Schedule II opioid drugs or other Schedule II controlled substances by the total number of all patient encounters at the clinic, facility, or office during any month; and

3.1.4. Patients receiving Schedule II opioid drug products or other Schedule II controlled substances for treatment of any injury or illness that lasts or is expected to last 30 days or less shall not be included in the calculation of more than 50 percent of all patients. Clinics below the 50 percent patient calculation threshold will be subject to continued monitoring by the Office of Health Facility Licensure and Certification for changes in the patient ratio. Failure to cooperate with requests for information to verify patient calculations may subject the clinic to penalties and equitable relief pursuant to section 18 of this rule.

3.1.5. A pain management clinic shall not offer a bounty, monetary, or equipment or merchandise reward, or free services for individuals in exchange for recruitment of new patients into the clinic. A pain clinic shall not recruit new patients for the purpose of attempting to circumvent the licensure requirement of this rule.

3.2. The following facilities are not pain management clinics subject to the requirements of this rule:

3.2.1. A facility that does not prescribe or dispense controlled substances for the treatment of chronic pain;

3.2.2. 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 W. Va. Code § 16-2D-2 that is owned, operated or controlled by a licensed hospital;

3.2.3. A physician practice owned or controlled, in whole or in part, by a licensed hospital or by an entity that owns or controls, in part, one or more licensed hospitals;

3.2.4. A hospice program licensed in this state;

3.2.5. A nursing home licensed in this state;

3.2.6. An ambulatory surgical facility as defined by W. Va. Code § 16-2D-2;

3.2.7. 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; and

3.2.8. Any other facility granted an exemption by the secretary pursuant to W. Va. Code § 16-5H-5(b), including, state-owned and operated hospitals otherwise exempted from state licensure pursuant to the provisions of W. Va. Code §§ 16-5B-1, et seq.

3.3. Any facility that is not exempted pursuant to this section may petition the secretary for an exemption from the requirements of this rule. All such petitions are subject to the administrative procedures requirements of W. Va. Code §§ 29A-1-1, et seq.

W. Va. Code R. § 69-8-3