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.
MORE ARTICLES BY CATEGORY
Health Law Alliance Secures Major Victory as Federal Court Dismisses Lawsuit Against Independent Pharmacies
Health Law Alliance secured a major win for independent pharmacies with the dismissal of Cardinal Health’s lawsuit, exposing it as a baseless attempt to intimidate smaller providers. This outcome reinforces the firm’s commitment to protecting healthcare businesses from corporate overreach.
Read More >>DOJ’s 2025 National Health Care Fraud Takedown: What it Means for Telehealth Providers
The DOJ’s 2025 National Health Care Fraud Takedown charged 324 people in schemes totaling $14 billion in intended losses, including $1.17 billion tied to telemedicine and genetic‑testing fraud that implicated 49 defendants - signaling the government’s continued crack‑down on virtual‑care abuses. The surge in criminal and civil actions, coupled with CMS suspensions and the new DOJ‑HHS False Claims Act Working Group, warns telehealth providers to rigorously audit their compliance practices or risk severe penalties and exclusion from federal programs.
Read More >>Telehealth Audit Season: OIG Found 7 Percent Error Rate in Pandemic-Era E/M Billing
A 2024 OIG study found that 7% of E/M services billed during the pandemic were noncompliant with Medicare billing requirements. We break down OIG’s findings and explain what they mean in an era where RPM audits are on the rise.
Read More >>Health Law Alliance Earns Reinstatement for DME Supplier Whose Medicare Billing Privileges Were Unjustly Revoked
Due to Health Law Alliance’s advocacy, a prominent DME vendor in Texas had their billing privileges reinstated this week, without having to jump through the arduous, costly hoops of a fair hearing in front of an Administrative Law Judge or a Departmental Appeals Board review.
Read More >>