How Lawyers Defend Healthcare Fraud Cases Involving Compounded Medications

How Lawyers Defend Healthcare Fraud Cases Involving Compounded Medications

Compounded meds can be a legal minefield. With the right defense strategy, lawyers can beat fraud allegations. This article explains how.

What is Compound Medication Fraud?

First up – what is compound medication fraud? It involves scams like:

• Billing for unnecessary compounds
• Charging for compounds not dispensed
• Paying kickbacks for compound prescriptions
• Misrepresenting ingredients to hike reimbursements
• Producing copies of FDA-approved drugs

Most pharmacies follow the rules. But fraud does happen. And it brings huge fines plus criminal charges.

Question the Medical Necessity

A big defense is challenging whether the compounds were really medically unnecessary. Lawyers dig into records for proof of legitimacy. They’ll argue things like:

• “The patient’s diagnosis justified trying compounding.”
• “Standard meds had failed, so compounds were reasonable.”
• “The prescribing doctor believed compounds were needed.”

If lawyers show valid medical need, it weakens the fraud claims.

Attack the Prosecution’s Experts

Prosecutors use expert witnesses to prove medical necessity and standards. But the defense tries to undermine those experts by:

• Questioning if they have compounding expertise
• Pointing out lack of pharmacy experience
• Arguing the standard of care is subjective

Discrediting the prosecution’s experts makes it harder to show wrongdoing.

Allege Innocent Billing Errors

Lawyers may claim false billing was just innocent mistakes, not intentional fraud. They’ll argue things like:

• “The billing agent made errors but the pharmacy wasn’t involved.”
• “The rules are complex – this was an honest coding mistake.”
• “There was a miscommunication about the ingredients.”

While mistakes don’t justify false claims, it casts doubt on intent to defraud.

Try for a Favorable Settlement

Many fraud cases settle out of court. The pharmacy pays fines but avoids criminal charges. Lawyers negotiate the lowest settlement possible.

Settlements often have confidentiality clauses too. This helps the pharmacy avoid bad publicity.

Question the Necessity of FDA Approval

Lawyers argue that just because a drug exists doesn’t mean compounds are illegal copies. They claim things like:

• “The FDA-approved version didn’t work for this patient.”
• “The compound has clinically meaningful differences.”
• “Doctors can legally prescribe compounds off-label.”

There are grey areas here. The defense tries casting doubt on intent to break the law.

Highlight Compliance Efforts

The pharmacy can demonstrate it tried to prevent fraud by showing evidence of:

• Regular staff compliance training
• Internal audits to catch improper billing
• Policies to verify medical necessity

This aims to prove the pharmacy actively avoided fraud.

Blame Rogue Employees

One tactic is shifting blame to rogue staffers claiming:

• “Management had compliance policies but employees acted alone.”
• “The fraud was done without the pharmacy’s knowledge.”

This tries to insulate the pharmacy from liability.

Use Sentencing Guidelines for Leniency

If facing criminal conviction, lawyers use sentencing guidelines to argue for leniency. Factors like having a compliance program, cooperating with investigators, and accepting responsibility can significantly reduce sentences.

Summary of Defense Strategies

In summary, lawyers defending compound medication fraud cases often pursue strategies like:

• Questioning medical necessity
• Undermining the prosecution’s experts
• Alleging innocent billing errors occurred
• Seeking a favorable settlement
• Arguing FDA approval may not be needed
• Highlighting compliance efforts
• Blaming individual rogue employees
• Using sentencing guidelines for leniency

With an experienced legal team, pharmacies can often either defeat charges or mitigate penalties even when fraud occurred.