Martha M. Rumore, PharmD, JD, MS, LLM, FAPhA is Of Counsel at Health Law Alliance and a registered U.S. Patent Attorney

Frequently Asked Questions

Health Law Alliance is pleased to announce that a self-disclosure filed under Anthony Mahajan’s oversight on behalf of a pharmacy that allegedly dispensed Humira improperly was recently accepted by OIG. As we have noted, OIG self-disclosures may be an effective solution to PBM audit risk.

OIG’s Self-Disclosure Protocol

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), encourages providers to voluntarily report self-discovered evidence of potential fraud through the Health Care Fraud Self-Disclosure Protocol.

As we have written about in detail, a discrepant PBM audit may permit providers to learn about and resolve potential liabilities to government healthcare programs through the OIG self-disclosure process.

In short, self-disclosure often presents an excellent opportunity for providers to limit their exposure under administrative, civil, and maybe even criminal law, but the determination whether to make such a voluntary disclosure is extremely complex and must be carefully vetted by experienced healthcare defense attorneys.

The Pharmacy’s Self-Disclosure

In this case, following a PBM audit that identified discrepancies, our attorneys worked closely with the pharmacy to determine whether a self-disclosure was advisable.

The analysis is highly dependent on the specific facts of each case, and a collaborative decision was made that a self-disclosure would be the most effective manner in which to resolve potential liabilities under the False Claims Act and Civil Monetary Penalties law.

Accordingly, following a submission made pursuant to the Self-Disclosure Protocol, Delmar Pharmacy agreed to pay $218,129.26 for allegedly submitting claims to Medicare for Humira for a patient that was delivered by Delmar Pharmacy but not dispensed by the pharmacy.

HLA Specializes in PBM Audit Defense and OIG Self-Disclosures

PBM audits often target high-reimbursing products, such as Humira, and the cost of such products means that a provider’s liability can be extremely high if there are errors. OIG’s acceptance of the self-disclosure, however, effectively limits the pharmacy’s liability for the claims at issue.

In short, PBM audits may identify potential areas in which providers can use OIG’s Self-Disclosure Protocol to limit their exposure on government claims.

At Health Law Alliance, our experienced healthcare defense attorneys are specialists in all relevant self-disclosure protocols and procedures. Indeed, our attorneys possess the background and experience necessary to guide clients through these complex decisions and assist with each step of the self-disclosure process. Contact us today for a free consultation.

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