Health, Department of

Wyoming Immunization Program

Effective Date: 02/07/2018 to Current

Rule Type: Current Rules & Regulations

Reference Number: 048.0071.2.02072018

The Wyoming Vaccinates Important People Program

Section 1. Authority

The Wyoming Department of Health (Department) promulgates this chapter under the authority granted by Wyo. Stat. Ann. §§ 35-1-240, 35-4-101, and 35-4-139.

Section 2. Purpose

This chapter establishes the Wyoming Vaccinates Important People (WyVIP) Program as the childhood immunization program contemplated under Wyo. Stat. Ann. § 35-4-139. This chapter also identifies the vaccines provided by the WyVIP Program and establishes patient eligibility criteria, provider eligibility criteria to enroll with the WyVIP Program, and the allowable administration fee.

Section 3. Applicability

This chapter applies to primary health care providers and their staff that are enrolled or seeking enrollment into the WyVIP Program.

Section 4. Establishment of the WyVIP Program

(a) The Department shall: (i) Administer the WyVIP Program; and (ii) Establish policies and procedures for participation in the WyVIP Program.

Section 5. Patient Eligibility

(a) A patient is eligible to receive a vaccine provided by the WyVIP Program if the patient is: (i) Eighteen (18) years of age or younger; (ii) A Wyoming resident; and (iii) Is not a “federally vaccine eligible child” under 42 U.S.C. § 1396s(b)(2) or subsequent similar federal enactment.

Section 6. Vaccine Advisory Board

The Vaccine Advisory Board (VAB) serves as the advisory group appointed by the Department Director as described in Wyo. Stat. Ann. § 35-4-139.

Section 7. WyVIP Vaccine Formulary

(a) The State Health Officer shall establish the WyVIP vaccine formulary. The WyVIP vaccine formulary must include those vaccines determined by the State Health Officer to be necessary for the healthy development of children pursuant to Wyo. Stat. Ann. § 35-4-139.

(b) The State Health Officer may, in accordance with this chapter, modify the WyVIP vaccine formulary including, but not limited to, adding or removing a vaccine antigen or brand.

(c) When deciding to modify the WyVIP vaccine formulary, the State Health Officer shall consider the following:

1. (i) Whether the vaccine is necessary for the healthy development of children;
2. (ii) The recommendations of the VAB; and
3. (iii) The availability of funds.

(d) When deciding to modify the WyVIP vaccine formulary, the State Health Officer may consider:

1. (i) The recommendations of primary health care providers; and
2. (ii) Other relevant medical and economic factors.

(e) The WyVIP vaccine formulary must include vaccines for the following vaccine-preventable diseases:

1. (i) Diphtheria;
2. (ii) Haemophilus influenza type b;
3. (iii) Hepatitis B;
4. (iv) Measles;
5. (v) Mumps;
6. (vi) Pertussis;
7. (vii) Polio;
8. (viii) Pneumococcal;
9. (ix) Rotavirus;

(x) Rubella;

(xi) Tetanus; and

(xii) Varicella.

(f) The WyVIP vaccine formulary is found at https://health.wyo.gov/publichealth/immunization/ and made available by the Department upon request.

(g) The Immunization Unit Manager or the manager's designee shall coordinate the purchase, distribution, and storage and handling of each vaccine included on the WyVIP vaccine formulary in accordance with the policies and procedures established by the Department.

Section 8. Provider Eligibility and Enrollment

(a) A primary health care provider is eligible to enroll in the WyVIP Program if the provider:

(i) Is employed by an organization enrolled with the WY IIS;

(ii) Has a valid license to administer vaccines within the State of Wyoming;

(iii) Is not included on the Office of Inspector General (OIG) List of Excluded Individuals and Entities (LEIE);

(iv) Has the capacity to order, receive, and manage vaccines, including proper vaccine storage and temperature monitoring capacity; and

(v) Agrees to program requirements, including participation in site visits and educational opportunities.

(b) To enroll as a provider in the WyVIP Program, an eligible provider must submit to the Department a provider profile on the form developed by the Department.

(c) Upon receipt of a complete provider profile, and prior to approving a provider for enrollment in the WyVIP Program, the Department shall conduct a site visit to evaluate the following factors:

(i) Availability for vaccine receipt;

(ii) Vaccine contacts;

(iii) Patient population;

(iv) Vaccine storage equipment; and (v) Vaccine temperature monitoring.

(d) The Department shall grant a provider enrollment in the WyVIP Program if the Department finds that:

(i) Funding and vaccine stock are available; and (ii) The provider is able to satisfy the duties imposed under this chapter.

(e) If a provider has been granted enrollment in the WyVIP Program, the provider shall complete the provider agreement before gaining access to the WyVIP vaccine formulary.

Section 9. Program-Enrolled Provider Responsibilities

(a) A program-enrolled provider shall utilize the IIS for the following:

(i) Vaccine orders, transfers, and returns; (ii) Patient demographic and immunization information; and (iii) Vaccine inventory.

(b) A program-enrolled provider shall:

(i) Store and handle vaccines in accordance with the vaccine insert made available with all vaccine boxes and the CDC Vaccine Storage and Handling Toolkit (June 2016), which has been incorporated by reference under Chapter 1 of these rules; (ii) Report storage unit temperatures using the forms and methods established by the Department; (iii) Distinguish between public and private vaccine stock; (iv) Develop and maintain complete, accurate, and separate stock records for both publicly and privately purchased vaccines; (v) Administer vaccines in accordance with the CDC Epidemiology and Prevention of Vaccine-Preventable Diseases (13th ed. 2015 & Supp. 2017), which have been incorporated by reference under chapter 1 of these rules; (vi) Screen for and document patient eligibility at each immunization encounter; (vii) Administer publicly-supplied vaccines to eligible patients only;

(viii) In accordance with the National Childhood Vaccine Injury Act (NCVIA) 42 U.S.C §§ 300aa-1 through 300aa-34, which has been incorporated by reference under Chapter 1 of these rules:

(A) Distribute the most current Vaccine Information Statement (VIS) each time a vaccine is administered; and

(B) Report clinically significant adverse events to the Vaccine Adverse Event Reporting System (VAERS);

(ix) Maintain all WyVIP Program related records for no less than three years and be able to provide records to the Department for review upon request;

(x) Comply with the Department’s Vaccine Restitution Policy (IMM-001) and Fraud and Abuse Policy (IMM-002) which have been incorporated by reference under Chapter 1 of these rules; and

(xi) Allow Department staff to conduct scheduled and unannounced site visits.

Section 10. Disciplinary Action

(a) The Department may take disciplinary action against a program-enrolled provider if the Department finds a provider failed to comply with the requirements of this chapter or the policies and procedures established by the Department. Disciplinary action may include a reprimand, conditions, restrictions, probation, suspension, termination, other appropriate action, or a combination thereof.

(b) The Department shall base its decision to terminate a program-enrolled provider from the WyVIP Program on the following factors:

(i) The provider’s compliance with this chapter, the provider agreement, and established policies and procedures;

(ii) The risk posed to patient health and safety;

(iii) The risk posed to vaccine viability; and

(iv) The impact of the provider’s fraud or abuse or vaccine waste, if applicable.

Section 11. Billing for Vaccine Administration

(a) A program-enrolled provider may charge an eligible patient a fee for the administration of a publicly-supplied vaccine.

(b) The administration fee charged to an eligible patient by a program-enrolled provider must not exceed twenty one dollars and seventy two cents ($21.72) multiplied by the number of antigens in the vaccine administered from the WyVIP Program.

(c) If a patient is unable to pay the administration fee, the program-enrolled provider shall waive the administration fee. Other visit or office fees may be charged as applicable.