Pharmacy compliance audit checklist

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U.S. Dept. of Health & Human Services

Guidance for Pharmacists to help them make fewer mistakes, reduce the risk of audit, and save time. It includes Pharmacy self-auditing toolkit, pharmacy prescribing and billing toolkit, off label pharmaceutical marketing toolkit.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: July 07, 2020

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Pharmacy Toolkits

The resources in these three toolkits will help pharmacy professionals make fewer mistakes, reduce the risk of audit, and save time.

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Pharmacy Self-Auditing Toolkit

This four-part self-auditing toolkit covers prescribing practices, controlled substances management, invoice management, and billing practices. Each module contains an educational video, a handout to accompany the video, and a booklet with a self-audit checklist. We have also provided a resource guide and a summary checklist for all four modules.

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Resource Guide (PDF)
A list of resources for further information about this topic.
(5 pages)

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Checklist, Modules 1-4 (PDF)
Provides all of the checklists, without explanatory content, for all 4 modules.
(11 pages)

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Pharmacy Prescribing and Billing Toolkit

The resources in this toolkit will help you avoid specific dispensing and billing errors that have occurred frequently in Medicaid claims.

Billing Job Aids for Certain Dosage Forms

Explain the correct way to count billing units and days’ supply for certain dosage forms.

Injectable ProductsPharmaceutical KitsOral ProductsOther Dosage Forms
21 pages (PDF)14 pages (PDF)8 pages (PDF)15 pages (PDF)

Dosing Charts and Booklets for Certain Drug Classes

To help you dispense certain complicated drug es correctly, we have created pediatric and adult dosing charts as well as fact sheets. The fact sheets summarize the indications, treatment guidelines, and adverse reactions and risks of each drug .

Educational Resources for Enoxaparin

The of drugs known as Enoxaparin is often problematic in Medicaid claims. These resources will help you accurately dispense and bill for this drug .

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Off-Label Pharmaceutical Marketing Toolkit

“Off-label” drug use is when drugs are used for unapproved symptoms or conditions, in unapproved patient groups, or in unapproved dosages. Promoting off-label drug use may negatively affect quality of care. Anyone who promotes such use may be liable for the resulting false Medicaid claims.

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.

Date Published: 12/31/2020