DOJ and CMS Investigations Pertaining to Amniotic Fluid Injections

Categories: Medicare Lawyer

Amniotic Fluid Injections

In recent months, the federal government has shown an increased interest in opening investigations into practices that administer amniotic fluid injections. Many cutting-edge physicians have been prescribing amniotic fluid injections to patients to help them with pain management with great success. However, because amniotic fluid injections are not currently covered under Medicare for this purpose, any provider who bills Medicare for an injection for the purpose of pain management may face healthcare fraud allegations.

At the federal healthcare fraud defense law firm of Oberheiden, P.C., we have extensive experience helping physicians, practice groups, healthcare marketing agencies, and others in the amniotic fluid injection space avoid federal scrutiny. Along those lines, we are also frequently called upon by clients to assist them through federal investigations into their practice. We have centuries of healthcare fraud experience and command an unrivaled knowledge of the complex and ever-changing regulations that you face as a provider.

What Is an Amniotic Fluid Injection, and Why Is the Government Focusing on Them?

An amniotic fluid injection involves injecting healthy amniotic cells into damaged tissue in hopes that the cells assist in the regrowth and recovery of damaged tissues. While there are various medical reasons why a physician may order an amniotic fluid injection, most recently, they’ve been used to reduce a patient’s chronic pain. Doctors regularly rely on these injections to treat pain associated with the following conditions:

  • Torn ACLs and MCLs,
  • Tendonitis,
  • Tendinosis,
  • Epicondylitis,
  • Herniated discs,
  • Acromioclavicular joint inflammation, and
  • Plantar fasciitis.

Additionally, amniotic injections have been shown to facilitate post-surgical recovery. However, the use of amniotic fluid injections is not yet widespread, and some have called into question the effectiveness of the treatment.

The problem with amniotic fluid injections is that they are not yet approved for general use under Medicare. Thus, if a provider administers an amniotic fluid injection and then bills Medicare for their service, problems can—and often do—arise.

In terms of pain management, the reason the Centers for Medicare and Medicaid Services does not cover amniotic fluid injections is that these injections are not considered medically necessary.

To qualify as “medically necessary” under Medicare regulations, a service must be “needed to diagnose or treat an illness, injury, condition, disease, or its symptoms.” According to CMS, an amniotic fluid injection is administered to treat a patient’s pain—not the underlying medical condition. Thus, amniotic fluid injections are deemed medically unnecessary, at least when used for pain management.

However, in recent years, as the benefits of amniotic fluid injections have become more widely accepted, more doctors have begun incorporating them into a patient’s treatment regimen. As a result, there has been a corresponding increase in the number of physicians who bill Medicare for amniotic fluid injections, even though they are not covered. Thus, the CMS, along with the Department of Justice, is cracking down on providers in an effort to curb improper billing practices.

What Is at Stake in an Investigation into a Practices Amniotic Fluid Injection Billing Procedures?

CMS assumes that all healthcare providers who bill for services under Medicare command a knowledge of the billing and coding regulations. While this is a fair assumption on some level, it is also a tremendous burden to stay abreast of the constant changes to the regulatory environment. However, a lack of knowledge is only a defense to certain criminal actions; civil liability can still attach to innocent conduct that violates the law.

When it comes to amniotic fluid injections, providers face the following risks, each of which can be addressed in advance.

Fraudulent Medicare Billing Practices

As a practical matter, a single incorrect claim submitted to Medicare is unlikely to result in a healthcare fraud claim. However, if federal investigators pick up on a pattern of Medicare billing violations, that can change quite quickly. Similarly, when investigators are reviewing a practice’s billing records, they will be on the lookout for any signs of healthcare fraud. For example, investigators may scour records looking for any indication that a provider billed for amniotic fluid injections under another covered service or falsely claimed that amniotic fluid injections were provided for a covered purpose when they were actually given for pain management.

In either of these cases, a provider’s actions will be taken as willful disregard of the Medicare regulations, which may form the basis of criminal enforcement action.

False Claims Act Violations

The False Claims Act considers it a violation anytime a provider submits a false claim for reimbursement to Medicare or any other federally funded program. CMS considers billing for amniotic fluid injections administered for pain management purposes to be a violation of the False Claims Act. This is because amniotic fluid injections are not covered under Medicare. Thus, any claim filed on this basis is false because it is non-reimbursable.

Of course, this puts providers who believe that an amniotic fluid injection would truly help a patient in a difficult position. On one hand, an amniotic fluid injection could help the patient. On the other hand, billing for the service puts the provider at risk of violating the False Claims Act. Physicians who order amniotic fluid injections for purposes other than pain management must keep detailed, comprehensive records of medical necessity to justify any inquiries regarding the use of the treatment.

Improper Kickbacks

Federal healthcare fraud laws have a lot to say about kickbacks and referrals. For example, the Anti-Kickback Statute, Eliminating Kickbacks in Recovery act (EKRA), and the Stark Law all preclude providers from paying compensation for patient referrals when Medicare is footing the bill. Additionally, the Anti-Kickback Statute and EKRA equally apply to non-providers, such as marketing agencies, telemedicine companies and referral companies all run the risk of violating these laws if they deal with a physician who improperly bills for amniotic fluid injections.

From the provider’s perspective, it is imperative that any referral relationship is structured such that it adheres to the current healthcare fraud laws.

What Should I Do if the federal Government Is Looking into My Practice?

When the CMS suspects that a provider is improperly billing for amniotic injections, it will typically reach out to the Department of Justice to conduct a coordinated investigation. DOJ prosecutors may then issue a Civil Investigative Demand (CID) to the practice. A CID is an administrative subpoena, meaning it carries the force of a subpoena but does not require judicial approval. Providers in receipt of a CID should take care in how they address the demands made in the CID, keeping in mind the following:

Do Not Destroy, Hide or Alter Evidence

Upon receiving a CID, it is imperative to immediately institute a legal hold across the organization. This involves a coordinated effort to preserve all evidence that may be relevant to the federal investigation. The purpose of a legal hold is to ensure that potentially relevant evidence is not inadvertently destroyed through the normal course of business. This is extremely important, as investigators will assume that any missing records or documents would have implicated the provider, making them look guilty regardless of the facts.

Conduct an Internal Audit

The uncertainty surrounding any federal investigation is hard to tolerate. You may not know what investigators are looking for and, even if you have some idea of what they will find, it’s impossible to know until you take the time to conduct an internal audit. The focus of an internal audit should be on the specific nature of the allegations contained in the CID. For example, if the DOJ is investigating your practice for an improper referral relationship, you should focus the audit on all third-party relationships.

Review the CID for Defects of Overbreadth

Federal prosecutors typically know what they are doing when they issue a CID. However, although rare, on occasion, there are defects in a CID that render it unenforceable. An experienced healthcare fraud attorney can also recognize if the demands made in a CID are overbroad in that they require you to hand over documents that exceed the scope of the investigation. Through negotiation with investigators, you may be able to limit the scope of the CID.

Assemble all Responsive Documents

Once you and your attorney determine that the CID is valid, the next step is to organize your response. This can be a monumental task, depending on the contents of the CID. However, it is essential that you go about fulfilling the requests in a methodical manner. The last thing you want is to appear disorganized to investigators, who may take disorganization as a sign that you play fast and loose with the rules.

Remember the Big Picture

When you receive a CID, it is important to remember that the CID is just the first step in the investigative process and not to lose sight of the bigger picture. Federal authorities use CIDs to gather information. Once they obtain information through a CID, they will then determine whether to bring healthcare fraud charges. While you should spend significant effort understanding, responding to, and maybe even challenging the CID, it should not detract from the time you put into developing a comprehensive defense strategy to the charges you may face down the road.

Frequently Asked Questions:

Why Do We Not Call Ourselves the “Best” Amniotic Fluid Investigation Defense Attorneys?

While we consider ourselves to be some of the most dedicated and knowledgeable healthcare fraud attorneys, we refrain from marketing ourselves as the best amniotic fluid injection fraud lawyers for a few reasons. First, everyone values different things in a lawyer. For some, the outcome is all that matters. However, for others, selecting a lawyer is a much more personal experience, and while we think we’re easy to get along with, we don’t want to make that call for you. Additionally, the ethical rules that all lawyers must abide by frown upon using language such as the “best lawyer” because it can be misleading.

What Is at Stake in an Amniotic Injection Fraud Case?

The primary enforcement mechanisms for amniotic fluid injection fraud are the False Claims Act and the Anti-Kickback Statute. Liability under the False Claims Act can be civil or criminal, while a violation of the Anti-Kickback Statute is criminal in nature. A civil violation of the False Claims Act carries a penalty of triple damages and a fine of up to $ 11,000 per claim. Criminal False Claims Act violations can result in up to a five-year prison sentence and a fine of up to $250,000 for individuals and $500,000 for businesses. Violations of the AKS are punishable as a felony with a maximum fine of $25,000 and up to five years in federal prison per count. Violation of the AKS is also grounds for substantial civil monetary penalties and/or exclusion from the Medicare program. At Oberheiden, P.C., our skilled amniotic injection fraud attorneys are here to help you avoid these consequences.

What Should I Look for in an Amniotic Injection Investigation Defense Lawyer?

Whenever you are looking for an attorney to handle an area as complex as Medicare fraud related to amniotic injections, the most important thing to consider is the attorney’s experience. Attorneys are known for touting their experience; however, not all experience is equal. If you face a federal investigation, you want an attorney who has successfully helped providers through similar investigations. What you don’t want is an attorney with 50 years of experience, 45 of which were as a tax lawyer. At Oberheiden, P.C., we are a healthcare fraud defense law firm, and that is where we get our experience. We’ve assembled a team of some of the country’s most well-respected healthcare fraud lawyers, many of which previously worked in high-ranking positions within the federal government. This is the type of experience you can rely on.

Contact Oberheiden, P.C to Discuss Your Amniotic Fluid Injection Practice Today

Is your healthcare practice facing investigation under the Anti-Kickback Statute or False Claims Act for amniotic injection fraud? Do you have concerns about your practice’s promotion or administration of amniotic injections? If so, reach out to the experienced federal healthcare fraud defense lawyers at Oberheiden, P.C. as soon as possible. Our team of former federal healthcare fraud prosecutors and investigative agents are available 24/7 to discuss your case and offer our assistance. We are available to get to work defending your practice immediately.

To request a consultation, call 888-680-1745 or connect with us through our online contact form.