W. Va. Code R. § 114-99-5

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

Section 114-99-5 - Responsibilities and Prohibited Acts

5.1. A PBM shall not cause or knowingly permit the use of any advertisement, promotion, solicitation, representation, proposal or offer that is untrue, deceptive or misleading.

5.2. An auditing entity conducting a pharmacy audit or person acting on behalf of the auditing entity may not seek any fee, charge-back, recoupment or other adjustment for a dispensed product, or any portion of a dispensed product, unless one of the following has occurred:

5.2.1. Fraud or other intentional and willful misrepresentation as evidenced by a review of the claims data, statements, physical review or other investigative methods;

5.2.2. Dispensing in excess of the benefit design, as established by the plan sponsor;

5.2.3. Prescriptions not filled in accordance with the prescriber's order; or

5.2.4. Actual overpayment to the pharmacy.

5.3. Any fee, charge-back, recoupment, or other adjustment is limited to the actual financial harm associated with the dispensed product, or portion of the dispensed product, or the actual underpayment or overpayment as set forth in the criteria in section 5.2 of this rule.

5.4. To assist healthcare consumers in making informed decisions, so called "gag clauses" in contracts between pharmacies and PBMs are prohibited. A pharmacy, pharmacist or pharmacy technician shall have the right to provide a consumer information relating to lower cost alternatives, and a pharmacy, pharmacist or pharmacy technician shall not be penalized by a PBM for discussing information in W. Va. Code § 33-51-9 or the regulation of PBMs thereunder, or for selling a lower cost alternative, if one is available, without using a health insurance policy.

5.5. To prevent overcharges to consumers or insureds purchasing prescription drugs, so called "claw-back" provisions in contracts between pharmacies and PBMs are prohibited and a PBM shall not collect from a pharmacy, a pharmacist or a pharmacy technician a cost share or co-pay charged to a covered individual that exceeds the total submitted charges by the pharmacy or pharmacist to the PBM.

5.6. A PBM that reimburses a 340B entity for drugs that are subject to an agreement under 42 U.S.C. § 256b shall not reimburse the 340B entity for pharmacy-dispensed drugs at a rate lower than that paid for the same drug to pharmacies similar in prescription volume that are not 340B entities, and shall not assess any fee, charge-back, or other adjustment upon the 340B entity on the basis that the 340B entity participates in the program set forth in 42 U.S.C. § 256b. For purposes of this section, the term "other adjustment" includes placing any additional requirements, restrictions or unnecessary burdens upon the 340B entity that results in administrative costs or fees to the 340B entity that are not placed upon other pharmacies that do not participate in the 340B program, including affiliate pharmacies of the PBM, and further includes but is not limited to requiring a claim for a drug to include a modifier or be reprocessed or resubmitted to indicate that the drug is a 340B drug. Nothing in section 5.6 of this rule shall be construed to prohibit the Medicaid program or a Medicaid managed care organization ("MCO") as described in 42 U.S.C. § 1396b(m) from preventing duplicate discounts as described in 42 U.S.C. § 256b(a)(5)(A)(i). The provisions of section 5.6 of this rule are applicable to the West Virginia Public Employees Insurance Agency ("PEIA").

5.7. With respect to a patient eligible to receive drugs subject to an agreement under 42 U.S.C. § 256b, a PBM shall not discriminate against a 340B entity in a manner that prevents or interferes with the patient's choice to receive such drugs from the 340B entity. This section does not apply to the state Medicaid program when Medicaid is providing reimbursement for covered outpatient drugs, as that term is defined in 42 U.S.C. § 1396r-8(k), on a fee-for-service basis. This section does apply to a Medicaid-managed care organization as described in 42 U.S.C. § 1396b(m). For purposes of this section, it shall be considered a discriminatory practice that prevents or interferes with a patient's choice to receive drugs at a 340B entity if a PBM places additional requirements, restrictions or unnecessary burdens upon a 340B entity that results in administrative costs or fees to the 340B entity that are not placed upon other pharmacies that do not participate in the 340B program, including affiliate pharmacies of the PBM, and further includes but is not limited to requiring a claim for a drug to include a modifier or be reprocessed or resubmitted to indicate that the drug is a 340B drug. Nothing in section 5.7 of this rule shall be construed to prohibit the Medicaid program or a Medicaid MCO as described in 42 U.S.C. § 1396b(m) from preventing duplicate discounts as described in 42 U.S.C. § 256b(a)(5)(A)(i). The provisions of section 5.7 of this rule are applicable to PEIA.

5.8. A PBM may not reimburse a pharmacy or pharmacist for a prescription drug or pharmacy service in an amount less than the NADAC price for the prescription drug or pharmacy service at the time the drug is administered or dispensed plus a dispensing fee of $10.49. If the NADAC price is not available at the time a drug is administered or dispensed, a PBM may not reimburse in an amount that is less than the wholesale acquisition cost of the drug as defined in 42 U.S.C. § 1395w-3a(c)(6)(B) plus a dispensing fee of $10.49.

5.9. Payment Parity. -- A PBM may not reimburse a pharmacy or pharmacist for a prescription drug or pharmacy service in an amount less than the amount the PBM reimburses itself or one of its affiliates for the same prescription drug or pharmacy service.

5.10. A PBM shall utilize the most recently published NADAC price as a point of reference for the ingredient drug product component of a pharmacy's reimbursement for drugs appearing on the national average drug acquisition cost list.

5.11. A PBM shall not discriminate in reimbursement, assess any fees or adjustments, or exclude a pharmacy from the PBM's network on the basis that the pharmacy dispenses drugs subject to an agreement under 42 U.S.C. § 256b.

5.12. A PBM shall not engage in any practice that:

5.12.1. Bases reimbursement for a drug on patient outcomes, scores, or metrics. This prohibition does not apply to reimbursement for pharmacy care, including dispensing fees, from being based on patient outcomes, scores or metrics so long as the terms are disclosed and agreed to by the pharmacy in advance;

5.12.2. Imposes a point-of-sale fee or retroactive fee; or

5.12.3. Derives any revenue from a pharmacy or insured in connection with performing pharmacy benefits management services. This prohibition shall not prohibit a PBM from processing coinsurance, deductibles or co-payments that have been approved by a covered individual's health benefit plan.

5.13. A PBM shall offer a health benefit plan the option of pass-through pricing and file with the Commissioner an attestation that such offer has been made to each health benefit plan that the PBM provides pharmacy benefit management services for as described in subsection 4.2.18 of this rule. However, pass-through pricing is required in regard to a PBM that contracts with a health benefit plan administered by or on behalf of the state or a political subdivision of the state.

5.14. A covered individual's defined cost sharing for each prescription drug shall be calculated at the point-of-sale based on a price that is reduced by an amount equal to at least 100% of all applicable rebates received, or to be received, in connection with the dispensing or administration of the prescription drug up to the amount of a covered individual's defined cost sharing.

5.14.1. All rebates should be calculated by the PBM or third-party based upon the actual rebate amount negotiated between the PBM or health benefit plan and the manufacturer and provided, or to be provided, by the manufacturer to the PBM or health benefit plan.

5.14.2. Any price reduction based upon a rebate received, or to be received, must be completely reflected in the price of the prescription drug at the time the pharmacy dispenses it to the patient.

5.14.3. Any rebate that is calculated by the PBM or third-party to be over and above, or in excess of, a covered individual's defined cost sharing may not be retained by the PBM but must be passed on to the health benefit plan and must be used by the health benefit plan to reduce the cost of premiums.

5.14.4. The Commissioner may request information deemed necessary by the Commissioner from the pharmacy, PBM, third-party or health benefit plan to determine compliance with these point-of-sale rebating requirements as needed to investigate complaints and as set forth in the annual reporting requirements in section 6 of this rule.

5.14.5. Nothing precludes an insurer from decreasing a covered individual's defined cost sharing by an amount greater than that set forth in section 5.14. of this rule.

5.14.6. A PBM shall be responsible for calculating a covered individual's defined cost sharing for each prescription drug. No PBM shall charge or deduct from a pharmacist or pharmacy any fee, recoupment, charge back, or other monetary penalty, amount or adjustment due to the PBM's miscalculation of a rebate or defined cost sharing amount.

5.15. A PBM's contract with a participating pharmacist or pharmacy shall not prohibit, restrict or limit disclosure of information to the Commissioner, law enforcement, or state and federal governmental officials investigating or examining a complaint or conducting a review of a PBM's compliance with the requirements under this rule or Article 51, Chapter 33 of the West Virginia Code.

5.16. Termination of a pharmacy or pharmacist from a PBM network shall not release the PBM from the obligation to make any payment due to the pharmacy or pharmacist for pharmacist services that are authorized for payment under the terms and conditions of the contract and rendered prior to the termination of the pharmacy or pharmacist from the PBM network.

W. Va. Code R. § 114-99-5