
Health Law Alliance is pleased to announce that a “fraud” self-disclosure filed under Anthony Mahajan’s oversight was recently accepted into OIG’s self-disclosure program, effectively limiting the provider’s liability for alleged improper billing.
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. Please read our article, “PBM Audit Strategy: Potential Windows of Opportunity,” available HERE, to learn more.
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 Provider’s OIG Disclosure
Per OIG’s announcement, following a self-disclosure submitted pursuant to the Self-Disclosure Protocol, Shore Orthopaedic University Associates, P.A., Charles N. Krome, D.O., and OrthoNJ, LLC, agreed to pay $333,645.83 for allegedly submitting claims to federal health care programs using code Q4206 for the use of Fluid Flow, an amniotic fluid growth factor injection product that treats orthopedic patients, to treat conditions which were not approved by Medicare.
In short, billing Medicare for products used to treat unapproved conditions exposes a provider to significant potential consequences. In this case, the decision was made to self-disclose after extensive consideration of many factors, including the calculation of damages, minimum settlement amounts, the conduct at issue, and the potential that the disclosure would not be accepted by OIG.
HLA Specializes in OIG Self-Disclosures
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 provide guidance and legal advice related to self-disclosures and assist with each step of the self-disclosure process. Contact us today for a free consultation.
MORE ARTICLES BY CATEGORY
Why PBMs are Investigating Provider-Patient Relationships—And What it Means for Your Pharmacy
PBMs are ramping up audit pressure in 2026, now targeting provider-patient relationships to justify recoupments and even network terminations. Without precise documentation, even well-established prescriptions can put pharmacies at serious financial and operational risk.
Read More >>HLA Wins Full Reversal of PBM Credentialing Denial for an Independent Pharmacy
This week, Health Law Alliance achieved full reversal of a PBM credentialing denial for a New York pharmacy—mere weeks after it received a termination notice. Read more to learn how Health Law Alliance’s tireless advocacy can help your pharmacy in credentialing disputes.
Read More >>From Prior Authorization to Network Termination: The PBM Audit Trend Independent Pharmacies Must Watch
PBMs are increasingly targeting pharmacies over their role in the prior authorization process, using vague allegations to justify massive recoupments and even terminations. Without airtight documentation and clear procedures, even compliant pharmacies can face serious financial and legal risk.
Read More >>Building a Regulatory Compliance Checklist for Ketamine Therapy Providers
Ketamine providers face growing regulatory scrutiny across prescribing, marketing, and care models. A focused compliance checklist is essential to reduce risk and stay ahead of enforcement.
Read More >>




