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Federal Register / Vol. 86, No. 85 / Wednesday, May 5, 2021 / Rules and Regulations
guidance in January of the calendar year preceding the benefit year for which the premium adjustment percentage is applicable, unless HHS proposes changes to the methodology, in which case, HHS will publish the annual premium adjustment percentage in an annual HHS notice of benefit and payment parameters or another appropriate rulemaking.

33. Section 156.295 is amended by a. Revising the section heading and paragraphs a introductory text, a1
and a2 introductory text, b. Removing paragraph a3; and c. Revising paragraph b introductory text.
The revisions read as follows:
156.295 Prescription drug distribution and cost reporting by QHP issuers.

a General requirement. In a form, manner, and at such times specified by HHS, a QHP issuer that administers a prescription drug benefit without the use of a pharmacy benefit manager 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 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 QHP issuer 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.

b Limitation on disclosure.
Information disclosed by a QHP issuer under this section shall not be disclosed by HHS, except that HHS may disclose the information in a form which does not disclose the identity of a specific QHP or prices charged for specific drugs, for the following purposes:

34. Section 156.420 is amended by revising paragraphs a1i, a2i and a3i to read as follows:
156.420

Plan variations.

a
1
i An annual limitation on cost sharing no greater than the reduced maximum annual limitation on cost
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sharing specified in the annual HHS
guidance or notice of benefit and payment parameters for such individuals, and

2
i An annual limitation on cost sharing no greater than the reduced maximum annual limitation on cost sharing specified in the annual HHS
guidance or notice of benefit and payment parameters for such individuals, and

3
i An annual limitation on cost sharing no greater than the reduced maximum annual limitation on cost sharing specified in the annual HHS
guidance or notice of benefit and payment parameters for such individuals, and

35. Section 156.480 is amended by revising the section heading and paragraph c to read as follows:
156.480 Oversight of the administration of the advance payments of the premium tax credit, cost-sharing reductions, and user fee programs.

c Audits and compliance reviews.
HHS or its designee may audit or conduct a compliance review of an issuer offering a QHP through an Exchange to assess its compliance with the applicable requirements of this subpart and 45 CFR 156.50. Compliance reviews conducted under this section will follow the standards set forth in 156.715.
1 Notice of audit. HHS will provide at least 30 calendar days advance notice of its intent to conduct an audit of an issuer under this section.
i Conferences. All audits will include an entrance conference at which the scope of the audit will be presented and an exit conference at which the initial audit findings will be discussed.
ii Reserved 2 Compliance with audit activities.
To comply with an audit under this section, the issuer must:
i Ensure that its relevant employees, agents, contractors, subcontractors, downstream entities, and delegated entities cooperate with any audit or compliance review under this section;
ii Submit complete and accurate data to HHS or its designees that is necessary to complete the audit, in the format and manner specified by HHS, no later than 30 calendar days after the initial audit response deadline established by HHS at the entrance conference described under paragraph
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c1i of this section for the applicable benefit year;
iii Respond to all audit notices, letters, and inquiries, including requests for supplemental or supporting information, as requested by HHS, no later than 15 calendar days after the date of the notice, letter, request, or inquiry;
and iv In circumstances in which an issuer cannot provide the requested data or response to HHS within the timeframes under paragraph c2ii or iii of this section, as applicable, the issuer may make a written request for an extension to HHS. The extension request must be submitted within the timeframe established under paragraph c2ii or iii, as applicable, and must detail the reason for the extension request and the good cause in support of the request. If the extension is granted, the issuer must respond within the timeframe specified in HHSs notice granting the extension of time.
3 Preliminary audit findings. HHS
will share its preliminary audit findings with the issuer, who will then have 30
calendar days to respond to such findings in the format and manner specified by HHS.
i If the issuer does not dispute or otherwise respond to the preliminary findings, the audit findings will become final.
ii If the issuer responds and disputes the preliminary findings, HHS will review and consider such response and finalize the audit findings after such review.
4 Final audit findings. If an audit results in the inclusion of a finding in the final audit report, the issuer must comply with the actions set forth in the final audit report in the manner and timeframe established by HHS, and the issuer must complete all of the following:
i Within 45 calendar days of the issuance of the final audit or compliance review report, provide a written corrective action plan to HHS
for approval.
ii Implement that plan.
iii Provide to HHS written documentation of the corrective actions once taken.
5 Failure to comply with audit activities. If an issuer fails to comply with the audit activities set forth in this section in the manner and timeframes specified by HHS:
i HHS will notify the issuer of payments received under this subpart that the issuer has not adequately substantiated; and ii HHS will notify the issuer that HHS may recoup any payments
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