Legal Update, July 2019

Legal Update

Recordkeeping and Retention: If You Can’t Prove It; It Didn’t Happen
By Elizabeth "Issie" Karan

Hemophilia Treatment Centers (HTCs) must comply with numerous recordkeeping standards, and we regularly get questions regarding how long to maintain records. Importantly, if something is not recorded, it doesn’t exist. This includes policies and procedures, audits, meetings, and anything else an HTC wants to document occurred for compliance reasons. Do not let perfection be the enemy of the good when it comes to recordkeeping. If a call or meeting occurs for which an HTC wants a record, take notes, record the date, and include who participated. If an incident occurs that an HTC investigates, create a memorandum to file documenting these efforts. If an auditor comes to your HTC, they cannot take your word that something happened. They will expect documentation.

The Office of Pharmacy Affairs (OPA) puts a premium on maintenance of auditable records by Covered Entities (CEs) participating in the 340B discount drug program (340B Program). In guidance from May 1994, OPA required CEs to keep purchasing records for all drugs acquired in the 340B Program. Additionally, the 340B statute requires CEs to have records for audit purposes. Specifically, the 340B statute reads:

340B(a)(5)(C) AUDITING.—A covered entity shall permit the Secretary and the manufacturer of a covered outpatient drug that is subject to an agreement under this subsection with the entity (acting in accordance with procedures established by the Secretary relating to the number, duration, and scope of audits) to audit at the Secretary’s or the manufacturer’s expense the records of the entity that directly pertain to the entity’s compliance with the requirements described in subparagraphs (A) or (B) with respect to drugs of the manufacturer.

The references to subparagraphs (A) and (B) in the above text relate to the prohibition on duplicate discounts and diversion. Therefore, in addition to maintaining purchasing records, CEs must be able to show, during an audit, that they have not diverted 340B purchased drugs or provided them to Medicaid fee-for service patients (unless the CE has an agreement in place with the state to do so and has notified HRSA of such an arrangement). In guidelines related to manufacturer audits, HRSA indicated that CEs should maintain records to demonstrate the distribution and use of covered drugs for a period of not less than 3 years. This may sound simple in theory but can be complex in practice.

The Health Resources and Services Administration (HRSA) created a peer-to-peer program and documented best practices from the field in its 340B Compliance Improvement Guide. This guide covers many aspects of 340B Program compliance, including recommendations for recordkeeping. Please note that these best practices are not necessarily required but may assist in practically approaching recordkeeping in the 340B Program. In addition, we recommend keeping documentation of any communications with the government and Apexus and taking screenshots of important registration pages and windows. Just because something exists online now, does not mean it will in the future.

HTCs must comply with other record retention standards, including for HIPAA, federal grants compliance, and other areas of relevant law. The following chart summarizes some of these standards. We encourage HTCs to review these standards, keeping in mind the operational and other unique characteristics of your organization. As always, please contact us with questions or concerns.

Also in this Issue…

Notes from Joe
· A Penny for your Thoughts

Alliance Update
· Meet our New Board Members: Laurie Reger and Chris Guelcher

Payer Update
· TAP, TAP, TAP: How Healthy is your Contract Pharmacy Portfolio?

Notes from the Community
· VWD Connect Foundation Annual Conference Recap


Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns:

Name Email Phone
Joe Pugliese joe@hemoalliance.org 215-439-7173
Sean Singh sean@hemoalliance.org 727-388-7326
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jeff Amond amond@hemoalliance.org 608-206-3132
Johanna Gray, MPA jgray@dc-crd.com 202-484-1100
Elizabeth Karan ekaran@feldsmantucker.com 202-466-8960
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA george@gloetal.com 573-230-7075
Ellen Riker eriker@dc-crd.com 202-484-1100
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org
Karen Bowe
Joel Bellucci webmaster@hemoalliance.org 727-504-0491