Statutes, codes, and regulations
West Virginia Administrative Code
Agency 114 - Insurance CommissionTitle 114 - LEGISLATIVE RULE INSURANCE COMMISSIONER
Series 114-99 - Pharmacy Auditing Entities and Pharmacy Benefit Managers
Section 114-99-10 - Specialty Drug Complaints

W. Va. Code R. § 114-99-10

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Current through Register Vol. XLI, No. 50, December 13, 2024
Section 114-99-10 - Specialty Drug Complaints
10.1. A covered individual, beneficiary, pharmacy or pharmacist may file a specialty drug complaint with the Commissioner alleging that a PBM or health benefit plan has prohibited or otherwise limited access to a covered prescription drug from a pharmacy or pharmacist enrolled with the health benefit plan by unreasonably designating the drug as a "specialty drug," as that term is defined in W. Va. Code § 33-51-3 and section 2.24 of this rule.
10.2. The specialty drug complaint should be filed on a form provided by the Commissioner and state with specificity the following:
10.2.1. The name and dosage of the prescription drug that has been designated as a specialty drug;
10.2.2. The name of the PBM;
10.2.3. The name of the health benefit plan or insurer, if known;
10.2.4. The name and group number of the health benefit plan, specifically including any separate group number for the health benefit plan's pharmacy plan;
10.2.5. The name of the covered individual or beneficiary of the health benefit plan, and the covered individual's or beneficiary's plan identification number;
10.2.6. The RxBIN for the health benefit plan or pharmacy plan;
10.2.7. The name of any individual or other entity involved in the alleged unreasonable designation of the drug as a specialty drug; and
10.2.8. Any other information the Commissioner may require.
10.3. Upon receipt of a sufficiently complete specialty drug complaint, the Commissioner shall provide a copy to the PBM and health benefit plan. The PBM shall have 15 working days to respond. A separate response may also be required of the health benefit plan. The Commissioner will advise a health benefit plan if it is required to respond separately from the PBM. A health benefit plan required to respond shall also have 15 working days to respond.
10.4. If the specialty drug complaint is resolved before the time period for a response expires, the PBM and/or health benefit plan must advise the Commissioner in writing that the specialty drug complaint has been resolved and specifically advise the Commissioner of what steps or actions were taken to resolve the complaint. If the PBM and/or health benefit plan intends to take no action to resolve the complaint, the PBM and/or health benefit plan shall advise the Commissioner accordingly, in writing, and provide the Commissioner with a substantive response to the allegations in the specialty drug complaint. Nothing in this section in any way limits the authority of the Commissioner to investigate and take action against a PBM which the Commissioner has reason to believe has unreasonably designated a covered prescription drug as a specialty drug or limited a beneficiary's access to a specialty drug in violation of the provisions of W.Va. Code § 33-51-11(a)(7) or (8) or subdivisions 9.2.1.g or 9.2.1.h of this rule, but thereafter has consistently resolved each specialty drug complaint prior to the final resolution thereof by the Commissioner in accordance with section 10.8 of this rule.
10.5. If the specialty drug complaint remains unresolved, the Commissioner shall send a copy of the specialty drug complaint, and the response(s) thereto, to the Board of Pharmacy to make a determination as to whether the covered prescription drug meets the definition of specialty drug, as that term is defined in W. Va. Code § 33-51-3 and section 2.24 of this rule.
10.6. The West Virginia Board of Pharmacy will review the complaint, and the response(s) thereto, and may refer the matter to a committee for determination as to whether there are valid clinical and/or therapeutical reasons for the covered prescription drug to be designated as a specialty drug. The Board of Pharmacy will consider whether the covered prescription drug is used to treat rare or chronic and complex medical conditions, and whether it requires special handling, administration, provider care coordination, or patient education that cannot be provided otherwise by a non-specialty pharmacy.
10.7. The Commissioner may also obtain additional information from the PBM and/or health benefit plan regarding the circumstances surrounding the designation of the covered prescription drug as a specialty drug and whether access to a covered prescription drug is being limited in violation of W. Va. Code § 33-51-11(7) and (8). Additional information may include, but is not limited to, an assessment of network adequacy and the availability or conveniency of access for West Virginia residents to obtain the covered prescription drug, the number of mail-order pharmacies and physical pharmacies located in West Virginia that are permitted to dispense the covered prescription drug, the special handling, administration and/or provider care options or necessities that the PBM's specialty pharmacies offer that is not otherwise available at non-specialty pharmacies, and the circumstances surrounding the designation of the covered prescription drug as a specialty drug.
10.8. Upon completion of the review by the Commissioner and the Board of Pharmacy, the Commissioner will, in consultation with the Board of Pharmacy, make a determination as to whether the covered prescription drug meets the definition of specialty drug and whether a beneficiary's access is being prohibited or limited in violation of W. Va. Code § 33-51-11(7) and (8). The Commissioner may then undertake the following actions:
10.8.1. Close the specialty drug complaint and take no further action by finding that the covered prescription drug meets the definition of specialty drug and that a beneficiary's access is not being prohibited or limited in violation of W. Va. Code § 33-51-11(7) and (8);
10.8.2. Find that the subject prescription drug does not meet the definition of specialty drug and that a beneficiary's access is being prohibited or limited in violation of W. Va. Code § 33-51-11(7) and (8), and further order that the covered prescription drug be removed from the PBM and/or health benefit plan's specialty drug list; or
10.8.3. Set the matter for administrative hearing and further determination as to whether the covered prescription drug meets the definition of specialty drug and whether a beneficiary's access is being prohibited or limited in violation of W. Va. Code § 33-51-11(7) and (8).
10.9. Any party to an administrative proceeding regarding a specialty drug complaint has the right to contest the decision made pursuant to section 10.8 of this rule. If a decision is made pursuant to subsection 10.8.1 or 10.8.2 of this rule without hearing, any party may make a written demand for a hearing pursuant to the provisions of W. Va. Code § 33-2-13. A hearing on a specialty drug complaint shall be scheduled to be held within 45 days from the date of the hearing request, unless continued by agreement of all parties or by the Commissioner and Board of Pharmacy for good cause. Good cause includes, but is not limited to, a determination by the Commissioner and Board of Pharmacy that additional investigation is necessary.
10.10. The Commissioner shall assign a time and place for a hearing and shall mail written notice of the hearing to the parties at least 10 days in advance thereof.
10.11. To the extent such provisions are not in conflict with this rule, hearings shall be conducted in accordance with the procedures set forth in 114CSR13.
10.12. An order entered by the Commissioner and Board of Pharmacy after a hearing conducted pursuant to subsection 10.8.3 or section 10.9 of this rule, or an order entered denying a party's request for a hearing, is subject to judicial review.

W. Va. Code R. § 114-99-10