Defense for specialty pharmacies facing PBM and manufacturer audits of LDD, REMS, oncology, and biologic claims.
Request a Free Case ReviewSpecialty pharmacy claims represent a disproportionate share of every PBM's audit selection. Limited distribution drugs (LDDs), REMS-restricted programs (Risk Evaluation and Mitigation Strategies), oncology dispensing, biologics, and high-cost specialty drugs all carry concentrated audit risk.
Auditors review each NDC against tier placement and manufacturer protocol, and pharmacies that dispense to 340B covered entities face an additional parallel review track.
A single flagged claim can trigger six- and seven-figure recoupments, network termination, and parallel manufacturer LDD network exclusions that cut off the pharmacy's access to the underlying drug. Health Law Alliance defends specialty pharmacies before the audit closes. The defense framework starts with the LDD agreement and the REMS protocol.
Federal regulators are increasingly delegating Medicaid enforcement to the states. State Medicaid Fraud Control Units and state Attorneys General are now the primary enforcement vector for pharmacy Medicaid claims - and have grown significantly more aggressive since 2023. The defense framework starts with the state regulatory regime.
Anthony's background as a former federal prosecutor and executive for major healthcare companies provided a level of expertise and insight that made all the difference. His deep understanding of healthcare law, particularly in litigation and compliance matters, helped navigate complex legal issues with ease.
With upmost professional respect, I will be forever grateful to have such caring individuals as Attorney Anthony Mahajan and Attorney Diana Yastrovskaya who come into my life, even though I am a business owner but I always felt I was treated as a friend and was made reaching out to them with ease.
I had a great experience working with Health Law Alliance. From the very beginning, their team was incredibly helpful, responsive, and professional. They answered all of my questions quickly and kept me informed throughout the entire process.
Anthony and his staff have gone above and beyond. His proactive communication and ability to handle complex legal scenarios effectively have been a significant asset. Highly recommended attorney.
Top-notch attorneys with an unparalleled scope of experience and breadth of knowledge. You will want them in your corner.
Had nothing but great experience from them. Knowledgeable and professional in all aspects. They have a vast knowledge in health care cases, great to be on your side against insurances.
Trustworthy and experienced.
A PBM audit runs on the deadlines in your network agreement. What you produce, and when, becomes the record the PBM uses to set findings, chargebacks, and any network action.
Our bench includes a former federal prosecutor who served as Chief Compliance Officer of UnitedHealth Group, OptumRx’s parent company.
Within 24 hours: parse every deadline in the audit notice, place a litigation hold on the claims at issue, and preserve adjudication logs before the PBM rotates them out.
Claim-by-claim reconstruction: prescriber PA rationale, plan criteria at time of fill, BMI/A1C/comorbidity support, step-therapy chain, and compounding regulatory posture. Every flagged script gets its own defense memo.
We draft and file the written appeal, quantify the PBM's extrapolation errors, and negotiate directly with the auditor and network relations.
If the PBM refuses a reasonable resolution, we file in federal court and pair the suit with regulatory defense at DEA, FDA, and the state board - so a PBM dispute does not escalate into a license action.
Health Law Alliance handles the response and any parallel appeal, licensing matter or referral as one coordinated matter, so the strategy does not change hands as the matter moves between forums.
The bench includes a former Assistant U.S. Attorney nominated for the DOJ Director's Award, senior healthcare-company counsel, and attorney-providers with experience across healthcare audits and investigations.
Agency and company marks identify former professional experience of individual HLA team members. They do not imply affiliation, endorsement, or a client relationship.
Before you write a single page of your written response, have a privileged conversation with attorneys who have overseen 2,000+ audits - from both sides of the table. Free, confidential, no retainer.