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In recent years, federal investigators have shown an increased interest in bringing healthcare fraud cases against providers who administer amniotic injections. The biggest issue facing providers is that, while amniotic injections have obtained approval from the Centers for Medicare and Medicaid Services for some purposes, they are not approved for pain management—which is one of the most common reasons providers administer these injections. Given the federal government’s interest in rooting out improperly billed amniotic injections, providers are not the only ones at risk of incurring federal scrutiny; related businesses that promote these injections are also at risk.
How Federal Investigators Pursue Amniotic Fluid Investigations
Although cases targeting providers who administer amniotic injections are a relatively new focus for the federal government, it appears that investigators are pursuing these investigations through the use of civil investigative demands. A civil investigative demand is an administrative subpoena that agencies such as the United States Department of Justice (DOJ) can issue without first obtaining judicial approval. In other words, investigators themselves determine when to issue a civil.
While a civil investigative demand does not require the government to obtain a judge’s approval, they carry the same force as other subpoenas. Thus, anyone in receipt of a civil investigative demand is legally compelled to respond. Otherwise, they could be held in contempt of court, which may give rise to additional penalties in addition to any punishment related to the underlying claim.
Healthcare Fraud Claims Related to Amniotic Fluid Injections
The federal government has a wide range of tools it can use to prosecute healthcare fraud. In the context of amniotic fluid injections, federal investigators seem to be bringing the following allegations:
Referral relationships, or kickbacks, are common throughout the healthcare industry. However, these relationships are subject to strict rules. Providers and other businesses who fail to structure referral relationships appropriately risk ending up in legal trouble. For example, The Stark Law, the Eliminating Kickbacks in Recovery Act (EKRA), and the Anti-Kickback Statute prohibit providers from paying or receiving anything of value for patient referrals when seeking reimbursement through Medicare or another federally funded healthcare program. While the Stark Law only applies to healthcare providers, EKRA and the Anti-Kickback Statute apply to non-providers as well. Thus, businesses that facilitate the promotion of amniotic injections, such as marketing a provider’s services, may get wrapped into a federal healthcare fraud lawsuit based on an illegal kickback relationship with providers.
Problems with Medical Necessity
To bill Medicare for any service provided, a healthcare practitioner must ensure that the reason for the service is covered under current Medicare guidelines. One component of this is determining whether a service is “medically necessary.” To qualify as “medically necessary” under Medicare billing requirements, a service must be “needed to diagnose or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.”
The medical necessity requirement is a particular problem for providers who administer amniotic injections for the purposes of pain management. This is because, while amniotic injections are approved for some purposes, they are not approved for pain management. Thus, a provider who gives a patient experiencing pain an amniotic injection may have done so for an approved reason, provided it is intended to treat the underlying condition and not the patient’s pain. This can put providers in a difficult position, as many patients most in need of amniotic injections are experiencing pain. CMS advises providers to maintain documentation of medical necessity for all billed services. This is especially important for providers administering amniotic injections, who may otherwise find themselves facing violations of the False Claims Act.
Amniotic injections are frequently used for pain management; however, the CMS has not approved these injections for this purpose. Federal investigators are aware of this and scrutinize providers’ billing records who administer amniotic injections. If a provider bills Medicare for an injection that was not covered, it may be a violation of the False Claims Act. Similarly, providers who bill for amniotic fluid injections under other covered services may also find themselves in violation of the False Claims Act.
If the federal government opens an investigation into a provider’s practice, the provider will be expected to provide the government with proof of a robust compliance program. Such a program may help convince investigators that a provider’s mistakes were accidental rather than intentional, reducing the chances of an ongoing investigation.
What to Do if You Received a CID Related to the Use of Amniotic Injections
Healthcare providers and other businesses operating in the amniotic injection space should develop a plan of action in the event they receive a civil investigative demand or other indication the federal government is investigating them. While every case requires a unique approach based on the surrounding circumstances, below is a basic framework for handling a claim related to the use of amniotic injections.
Implement an Immediate Legal Hold
The moment you receive a civil investigative demand, you should promptly ensure the preservation of all documents potentially related to the government’s investigation. While it may seem counterintuitive, preserving even potentially damning evidence is important. Federal investigators have ways of determining whether evidence has been destroyed, which can lead to inferences of guilt and possibly additional criminal charges.
Conduct an Internal Audit
When facing the prospect of an invasive government investigation, it’s best to conduct an internal audit in advance of the government’s investigation. This way, you can gain a better understanding of what, if anything, investigators will uncover.
Review the Civil Investigative Demand for Defects
While it is unlikely that the civil investigative demand is defective and unenforceable, it is possible. Thus, it is important to have an experienced federal healthcare fraud lawyer review the civil investigative demand to determine its validity before responding.
Prepare a Response
If you determine that the civil investigative demand is valid and enforceable, the next step is to determine a response plan. To do this, you will need to gather all documents covered under the civil investigative demand, as well as any others indicating overall compliance with the healthcare fraud laws.
Don’t Lose Sight of the Overarching Goal
When you first receive a civil investigative demand, it’s easy to lose sight of the fact that the civil investigative demand is just a tool used by the government to reach its end goal. Thus, you shouldn’t over-focus on the demand itself and should be sure to always keep in mind the end goal of defending against the government’s allegations of healthcare fraud.
When you receive a civil investigative demand, you should devote all efforts to defending against the very real possibility of an increasingly invasive investigation. Of course, this is challenging in practice, as your business doesn’t stop merely because the federal government has opened up an investigation into your practice. Thus, most providers who find themselves in receipt of a civil investigative demand secure the assistance of an experienced federal healthcare fraud lawyer. Doing so frees up your time and ensures that the situation is handled with the care and grace it requires.
Is the Government Looking into Your Billing Practices as They Relate to Amniotic Injections?
If you are a healthcare provider or a business dealing in amniotic injections and received a civil investigative demand or any other indication you are the subject of an ongoing federal investigation, reach out to The Criminal Defense Firm for immediate assistance. At The Criminal Defense Firm, we have centuries of experience providing top-notch legal representation to healthcare providers and others in the healthcare industry. We routinely represent doctors, practice groups, hospitals, pharmacists, marketing companies, telehealth providers, and more in a wide range of healthcare fraud cases. We’ve handled more than 500 federal healthcare fraud trials and over 1,000 other cases that were resolved without the need for a trial. To learn more about how The Criminal Defense Firm can help you defend against the allegations you face, give us a call to schedule a free consultation today.
Dr. Nick Oberheiden is a national litigation and trial criminal defense attorney who practices exclusively in the area of federal law.