N.Y. Comp. Codes R. & Regs. tit. 11 § 459.2

Current through Register Vol. 46, No. 53, December 31, 2024

Section 459.2 - Conduct of an audit

(a) A pharmacy benefit manager conducting a remote audit of a pharmacy shall notify the pharmacy no later than 15 days before the start date of a remote audit, which notice shall be mailed or delivered by registered mail or other trackable method of delivery and include the list of specific prescription numbers to be included in the audit that may or may not include the final two digits of the prescription numbers.

(b) A pharmacy benefit manager conducting either an in-person or remote audit of a pharmacy shall:

(1) in addition to the requirements set forth in Public Health Law section 280-c(2)(b) and subdivision (a) of this section, include in the notice of audit to the pharmacy the reason for the audit and a list of documents, records and claims, including specific prescription numbers and the number and date of any refills, that are to be audited;

(2) except for audits initiated to address an identified problem, or where fraudulent activity or other intentional or willful misrepresentation is reasonably suspected, conduct no more than one audit every six months;

(3) include in its provider manual and on its website the procedures and processes for audits of pharmacies, including:

(i) a list of documents and records that a pharmacy shall maintain that may be subject to audit and the period of time a pharmacy must maintain such documents and records;

(ii) a direct telephone number and email address that a pharmacy can use to contact an individual or entity charged with answering questions related to the audit. The telephone number shall allow for the delivery of a voice message if there are insufficient staff to immediately answer and respond to inquiries from pharmacies. Any such inquiry shall be acknowledged within three business days of receipt of the initial voicemail or email and provide a timeframe for when the pharmacy benefit manager will respond to any such inquiry by the pharmacy;

(4) when using written and verifiable records pursuant to Public Health Law section 280-c(2)(d) to validate pharmacy records, consider prescriber notations such as "as directed" or "as needed", which require the professional judgment of the pharmacist to determine that the dose dispensed is within normal guidelines;

(5) conduct any audit that involves clinical or professional judgment in consultation with a pharmacist;

(6) audit each pharmacy using the same standards and parameters as the pharmacy benefit manager uses to audit a similarly situated affiliated pharmacy;

(7) permit its auditors to enter the area behind the pharmacy prescription counter only when accompanied or authorized by a member of the pharmacy's staff; and

(8) provide all audit documents and records in an electronic format or by certified mail to the pharmacy, upon request by an audited pharmacy.

(c) A pharmacy benefit manager conducting either an in-person or remote audit shall not:

(1) conduct such audit on federal or state holidays unless requested or consented to by the pharmacy;

(2) interfere with the delivery of pharmacist services to a consumer or fail to make a reasonable effort to minimize the inconvenience and disruption to the pharmacy operations during the audit process;

(3) use fax to send a pharmacy notice of an audit unless requested by the pharmacy; or

(4) permit documents or records from an audit to be shared with or used by another auditing individual or entity, except as required by state or federal law.

N.Y. Comp. Codes R. & Regs. Tit. 11 § 459.2

Adopted New York State Register November 27, 2024/Volume XLVI, Issue 48, eff. 11/27/2024