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Federal Register / Vol. 86, No. 85 / Wednesday, May 5, 2021 / Rules and Regulations deadlines set forth in 158.240e and 158.241a2 and in advance of submitting the MLR report required in 158.110 to the Secretary. Issuers that choose to prepay a portion or all of their rebates must do so for all eligible enrollees in a given state and market in a non-discriminatory manner, and consistently with State law or other applicable state authority. If, after submitting the MLR report required in 158.110, an issuer determines that its rebate prepayment amount in a given state and market is at least 95 percent, but less than 100 percent, of the total rebate amount owed for the applicable MLR reporting year to enrollees in that state and market, the issuer may, without penalty or late payment interest under paragraph f of this section, provide the remaining rebate amount to those enrollees no later than the rebate deadlines in 158.240e and 158.241a2 applicable to the following MLR reporting year. If the total rebate owed to an enrollee for the MLR
reporting year is above the de minimis threshold established in 158.243a, the issuer cannot treat the remaining rebate owed to an enrollee after prepayment as de minimis, even if the remaining rebate is below the de minimis threshold.
54. Section 158.241 is amended by revising paragraph a2 to read as follows:
158.241

Form of rebate.

a
2 For each of the 2011, 2012, and 2013 MLR reporting years, any rebate provided in the form of a premium credit must be provided by applying the full amount due to the first months premium that is due on or after August 1 following the MLR reporting year. If the amount of the rebate exceeds the premium due for August, then any overage shall be applied to succeeding premium payments until the full amount of the rebate has been credited.
Beginning with the 2014 MLR reporting year, any rebate provided in the form of a premium credit must be provided by applying the full amount due to the first months premium that is due on or after September 30 following the MLR
reporting year. If the amount of the rebate exceeds the premium due for October, then any overage shall be applied to succeeding premium payments until the full amount of the rebate has been credited. Beginning with rebates due for the 2020 MLR
reporting year, any rebate provided in the form of a premium credit must be provided by applying the full amount due to the monthly premium that is due no later than October 30 following the
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MLR reporting year. If the amount of the rebate exceeds the monthly premium, then any overage shall be applied to succeeding premium payments until the full amount of the rebate has been credited.

55. Subchapter E as added in final rule published on November 27, 2019
84 FR 65524 and effective on January 1, 2021 is amended by adding part 184
to read as follows:
PART 184PHARMACY BENEFIT
MANAGER STANDARDS UNDER THE
AFFORDABLE CARE ACT
Sec.
184.10 Basis and scope.
184.20 Definitions.
184.50 Prescription drug distribution and cost reporting by pharmacy benefit managers.
Authority: 42 U.S.C. 1302, 1320b23.
184.10

Basis and scope.

a Basis. 1 This part implements section 1150A, Pharmacy Benefit Managers Transparency Requirements, of title XI of the Social Security Act.
2 Reserved b Scope. This part establishes standards for Pharmacy Benefit Managers that administer prescription drug benefits for health insurance issuers that offer Qualified Health Plans with respect to the offering of such plans.
184.20

Definitions.

The following definitions apply to this part, unless the context indicates otherwise:
Health insurance issuer has the meaning given to the term in 144.103
of this subtitle.
Plan year has the meaning given to the term in 156.20 of this subchapter.
Qualified health plan has the meaning given to the term in 156.20 of this subchapter.
Qualified health plan issuer has the meaning given to the term in 156.20 of this subchapter.
184.50 Prescription drug distribution and cost reporting by pharmacy benefit managers.

a General requirement. In a form, manner, and at such times specified by HHS, any entity that provides pharmacy benefits management services on behalf of a qualified health plan QHP issuer must provide to HHS the following information:
1 The percentage of all prescriptions that were provided under the QHP
through retail pharmacies compared to mail order pharmacies, and the percentage of prescriptions for which a
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generic drug was available and dispensed compared to all drugs dispensed;
2 The aggregate amount, and the type of rebates, discounts or price concessions excluding bona fide service fees that the pharmacy benefits manager PBM negotiates that are attributable to patient utilization under the QHP, and the aggregate amount of the rebates, discounts, or price concessions that are passed through to the QHP issuer, and the total number of prescriptions that were dispensed.
i Bona fide service fees means fees paid by a manufacturer to an entity that represent fair market value for a bona fide, itemized service actually performed on behalf of the manufacturer that the manufacturer would otherwise perform or contract for in the absence of the service arrangement, and that are not passed on in whole or in part to a client or customer of an entity, whether or not the entity takes title to the drug.
ii Reserved 3 The aggregate amount of the difference between the amount the QHP
issuer pays its contracted PBM and the amounts that the PBM pays retail pharmacies, and mail order pharmacies, and the total number of prescriptions that were dispensed.
b Limitations on disclosure.
Information disclosed by a PBM under this section shall not be disclosed by HHS or by a QHP receiving the information, except that HHS may disclose the information in a form which does not disclose the identity of a specific PBM, QHP, or prices charged for drugs, for the following purposes:
1 As HHS determines to be necessary to carry out section 1150A or part D of title XVIII of the Act;
2 To permit the Comptroller General to review the information provided;
3 To permit the Director of the Congressional Budget Office to review the information provided; or 4 To States to carry out section 1311
of the Affordable Care Act.
c Penalties. A PBM that fails to report the information described in paragraph a of this section to HHS on a timely basis or knowingly provides false information will be subject to the provisions of section 1927b3C of the Act.
Dated: April 27, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.
FR Doc. 202109102 Filed 43021; 8:45 am BILLING CODE 415028P

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