West Virginia Code of State Rules
Agency 69 - Health And Human Resources
Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Series 69-09 - Neonatal Abstinence Centers
Section 69-9-3 - CERTIFICATION, LICENSURE, APPROVAL AND EXEMPTION

Universal Citation: 69 WV Code of State Rules 69-9-3

Current through Register Vol. XLI, No. 38, September 20, 2024

3.1. The intent of the neonatal abstinence syndrome center, or center is to:

3.1.a. Treat symptoms of withdrawal in patients who have been prenatally exposed to drugs using both pharmacological and non-pharmacological interventions;

3.1.b. Educate families, legal representatives, and/or foster families in the appropriate care needs of a patient with neonatal abstinence syndrome; and

3.1.c. Support families through the recovery process.

3.2. Unless otherwise exempted by this rule, all individuals or other entities operating as a neonatal abstinence syndrome center shall meet the requirements of applicable state statutes and rules, and shall be licensed by the designated state oversight agency.

3.3. Hospitals licensed under "Hospital Licensure" (64 CSR12), behavioral health centers licensed under "Behavioral Health Centers Licensure" (64 CSR 11), and opioid treatment facilities licensed under "Regulation of Opioid Treatment Programs" (69 CSR 7), and which provide opioid treatment to adults, 18 years or older, are exempt from this rule.

3.4. Licensed neonatal abstinence centers are exempt from state licensure rules regulating hospitals (64 CSR 12), behavioral health centers (64 CSR 11), nursing homes (64 CSR 13), chronic pain management clinics (69 CSR 8) and opioid treatment centers (69 CSR 7).

3.5. Licensure Process.

3.5.a. Before establishing, operating, maintaining or advertising a neonatal abstinence syndrome center within the state of West Virginia, the center shall:
3.5.a.1. Have an approved certificate of need pursuant to W. Va. Code § 16-2D-1, et seq.; and

3.5.a.2. Obtain from the state oversight agency a license authorizing the operation of the neonatal abstinence syndrome center.

3.5.b. For neonatal abstinence syndrome centers in operation in the state of West Virginia on June 7, 2015, they must make an application for license to the state oversight agency within one year of the effective date of this rule.

3.6. License Application.

3.6.a. All applications for an initial or renewed license for a neonatal abstinence syndrome center shall include:
3.6.a.1. A completed application as established by the state oversight agency;

3.6.a.2. A copy of the approved certificate of need pursuant to W. Va. Code § 16-2D-1, et seq.;

3.6.a.3. Copies of all required policies and procedures; and

3.6.a.4. The applicable filing fee.

3.6.b. The program sponsor shall submit all required information for the initial application not less than 30 days and not more than 60 days prior to the anticipated initiation of services.

3.7. License Fees and Inspection Costs.

3.7.a. All initial and renewal fees shall be assessed by the Secretary and shall include a non-refundable license fee in the amount of $250, and an application fee of $400. The license and application fee must be paid to the Secretary in full prior to the issuance of the license.

3.7.b. The neonatal abstinence syndrome center shall pay for the cost of the initial inspection made by the state oversight agency prior to issuing a license. The cost of the initial inspection shall be billed to the applicant within five business days after the inspection. The cost of the initial inspection fee must be paid in full by the applicant before a license may be issued.

3.8. Initial Inspection and Issuance of License.

3.8.a. Upon receipt of an application for an initial license to operate as a neonatal abstinence syndrome center, the state oversight agency shall make an unannounced inspection of the center. This inspection will determine whether the program has satisfied all of the state requirements for licensure.

3.8.b. If the inspection reveals violations, deficiencies or shortcomings on the part of the neonatal abstinence center, the state oversight agency shall advise the program sponsor. The program sponsor may submit a written plan of correction demonstrating compliance with the cited deficiencies or request a variance. The state oversight agency may conduct follow up inspections, if required.

3.8.c. Following an application review, onsite inspection or inspections, approval of any subsequent written plans of correction, or the granting of a variance, if there is substantial compliance with the requirements of this rule and the cost of the inspection and license has been paid in full, the state oversight agency shall issue a license in one of three categories:
3.8.c.1. An initial license, valid for six months from the date of issuance, shall be issued to program establishing a new unlicensed program found to be in substantial compliance on initial review with regard the provisions of this rule.

3.8.c.2. A provisional license shall be issued when a program seeks a renewal license and is not in substantial compliance with this rule, but does not pose a significant risk to the rights, health and safety of the patient. A provisional license expires not more than six months from the date of issuance, and shall be consecutively reissued upon action of the state oversight agency for a period not to exceed 12 months, unless the provisional determination is that of the state fire marshal.

3.8.c.3. A renewal license shall be issued annually when a neonatal abstinence syndrome center has successfully completed the survey process. Renewal licenses expire not more than one year from the date of issuance.

3.9. Denial of License.

3.9.a. The state oversight agency may deny an application for an initial or renewed license when:
3.9.a.1. The state oversight agency determines the application is deficient in any respect;

3.9.a.2. The neonatal abstinence syndrome center will not be or is not operated in accordance with state standards, rules, and procedures;

3.9.a.3. The neonatal abstinence syndrome center will not permit an inspection or survey to proceed or will not permit access to relevant records or information in a timely manner; or

3.9.a.4. The neonatal abstinence syndrome center has made misrepresentations in obtaining certification or licensure.

3.9.b. If the state oversight agency determines not to issue a license, the Secretary shall notify the applicant in writing by regular mail of the denial and the basis for the decision.

3.9.c. A neonatal abstinence syndrome center may protest the denial of a new or renewed license pursuant to the administrative procedures in section 3, subsection 11 of this rule.

3.10. Renewal or Modified License.

3.10.a. Renewal License. The program sponsor of a neonatal abstinence syndrome center shall submit an application for a renewed license to the state oversight agency not less than 60 days prior to the expiration of the current license.
3.10.a.1. After the state oversight agency receives a complete renewal application with the required fee, the existing license shall not expire until the new license has been issued or denied.

3.10.b. Modified License. The program sponsor shall notify the Secretary 30 days prior to a change in name, a change in the geographic location or services, or a change in the substantial nature of the center, and shall simultaneously apply for modification of the license.

3.11. Administrative Due Process.

3.11.a. Any person aggrieved by an order by the state oversight agency based on this rule may request in writing a hearing by the Secretary.

3.11.b. All hearings shall be conducted in accordance with the Department of Health and Human Resources rule, "Rules of Procedure for Contested Case Hearings and Declaratory Rulings" (69 CSR 1), a copy of which may be obtained from the Secretary of State.

3.12. Variances.

3.12.a. The Department may grant a variance from any provision of this rule if is determines:
3.12.a.1. Strict compliance would impose a substantial hardship on the licensee;

3.12.a.2. The licensee will otherwise meet the intent of the rule; and

3.12.a.3. A variance will not result in less protection of the health, safety and welfare of the patients.

3.12.b. A variance shall not be granted from a provision pertaining to patients' rights.

3.12.c. Requests for variances from the West Virginia fire safety and building construction requirements shall be addressed with the appropriate authorities.

Disclaimer: These regulations may not be the most recent version. West Virginia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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