Cardiovascular Genetic Testing Fraud - Oberheiden, P.C.
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Cardiologist Defense: Cardiovascular Genetic Testing Fraud

patient and cardiologist

For cardiologists, the introduction of cardiovascular genetic testing presents both new opportunities and new risks. Already, many cardiologists are facing scrutiny for Medicare billing fraud, and financial relationships with testing laboratories and other entities are leading to federal enforcement actions as well.

As a cardiologist, anything you can use to help your patients avoid diagnoses and prevent complications is a good thing. From this perspective, the introduction of cardiovascular genetic testing was a boon for many cardiologists. Not only does cardiovascular genetic testing allow for the early detection of many different types of cardiac disorders, but it allows for the prediction and prevention of cardiovascular risks in many cases as well.

However, despite its virtues, utilizing cardiovascular genetic testing in the patient setting has proven to be somewhat of a challenge. This has nothing to do with hereditary cardiac testing itself, but rather with the pertinent billing rules and requirements. Specifically, the Centers for Medicare and Medicaid Services (CMS) have not yet issued local coverage determinations (LCDs) for cardiovascular genetic testing, and cardiologists are frequently running into the issue of this testing being deemed “medically unnecessary” by their Medicare administrative contractors (MACs).

Could You Be Guilty of Cardiovascular Genetic Testing Fraud?

So, as a cardiologist, could you be guilty of cardiovascular genetic testing fraud? Despite the connotations of the word “fraud,” it does not take much to face fraud allegations under federal law. This is especially true in the healthcare setting, where fraudulent billing practices cost Medicare and other government healthcare benefit programs hundreds of billions of dollars every year.

While most cardiologists (and other healthcare providers) think of “fraud” as an intentional act, proof of intent is not necessary in order to prove civil fraud. Under the False Claims Act, any “false” (i.e. incorrect or unauthorized) billing is considered fraudulent for purposes of healthcare law compliance. With regard to cardiovascular genetic testing, one issue that has come up in particular is the issue of this testing being used for allegedly “medically unnecessary” purposes.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden



Lynette S. Byrd
Lynette S. Byrd

Former DOJ Trial Attorney


Brian J. Kuester
Brian J. Kuester

Former U.S. Attorney

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney

Local Counsel

John W. Sellers
John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara
Linda Julin McNamara

Federal Appeals Attorney

Aaron L. Wiley
Aaron L. Wiley

Former DOJ attorney

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (DOJ)

Chris Quick
Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow
Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

Lack of Medical Necessity as a Form of Medicare Fraud

Medicare only provides coverage for medical tests, services, equipment, and supplies that are medically necessary. For Medicare billing purposes, medical necessity is not a matter of a cardiologist’s discretion. Instead, medical necessity is judged based on the criteria established in the Medicare billing guidelines—one of which is that a test, service, or other item must be used to “diagnose or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.”

Predictive testing largely falls outside of this definition. While there are some exceptions, this has been among the primary issues leading to allegations of cardiovascular genetic testing fraud. Many other healthcare benefit programs and private payors use similar definitions; and, as a result, cardiologists can often find it difficult to successfully (and lawfully) bill any payor other than the patient when such testing services are provided.

Prohibited Financial Relationships as a Form of Medicare Fraud

Another concern for cardiologists is the risk of being charged with Medicare fraud under the Stark Law, Anti-Kickback Statute (AKS), or Eliminating Kickbacks in Recovery Act (EKRA). Each of these statutes prohibit various types of financial relationships involving the referral of Medicare (and other healthcare benefit program) beneficiaries, although they do so in different ways. The Stark Law applies specifically to “physician self-referrals”—financial relationships between medical practices and testing laboratories which physicians own or control. The AKS and EKRA are much broader in scope, and they both allow for criminal enforcement.

When entering into relationships with laboratories that provide cardiovascular genetic testing services, cardiologists must be very careful to ensure that the terms of these relationships do not run afoul of the Stark Law, AKS, or EKRA. Typically, this involves structuring each individual relationship with a specific statutory exception or “safe harbor” in mind. This is a critical aspect of Medicare compliance, and it is one that both (i) often goes overlooked, and (ii) often leads to trouble during Medicare fraud audits and investigations.

Billing and Coding Errors as a Form of Medicare Billing Fraud

In addition to issues pertaining to medical necessity and permissible financial relationships, billing and coding issues can lead to cardiovascular genetic testing fraud allegations for cardiologists as well. In the circumstances in which it is permissible to bill for hereditary cardiac testing, cardiologists must ensure that their billing personnel (or third-party billing administrators) have a clear understanding of the correct current procedural terminology (CPT) codes to be used.

With regard to CPT codes, there are several different codes that can be used with several different forms of cardiovascular genetic testing. For example, all of the following have more than one associated CPT code, and the applicable codes for many of the following overlap:

  • Arrhythmogenic Right Ventricular Cardiomyopathy
  • Catecholaminergic Polymorphic Ventricular Tachycardia
  • Comprehensive Arrhythmia
  • Comprehensive Cardiomyopathy
  • Congenital Heart Defects
  • Dilated Cardiomyopathy
  • Ehlers-Danlos Syndrome
  • Familial Hypercholesterolemia
  • Hypertrophic Cardiomyopathy
  • Long QT/Brugada Syndrome
  • Marfan Syndrome
  • Short QT Syndrome

Here, too, even inadvertent mistakes can lead to allegations of fraud. Even if these allegations are civil in nature, they can still lead to substantial recoupments and fines, as well as payment denials, pre-payment review, and other consequences. MACs such as Novitas Solutions Inc. (“Novitas”) and First Coast Service Options Inc. (“First Coast”) aggressively enforce cardiologists’ and other providers’ Medicare compliance obligations, and MAC audits require careful defense strategies in order to mitigate any potential penalties to the greatest extent possible.

What Should Cardiologists Do When Facing Allegations of Cardiovascular Genetic Testing Fraud?

Given the risks and challenges involved with facing allegations of cardiovascular genetic testing fraud, cardiologists who are facing allegations from their MACs, CMS, or other federal authorities need to take a comprehensive approach disputing unfounded allegations and avoiding liability. This involves taking steps including:

1. Intervening in the Government Investigation or MAC Audit

When faced with a government investigation or MAC audit, it is imperative not to simply let the inquiry run its course. Intervening slows down the process, and it helps ensure that you will have the time and opportunity you need to steer the inquiry toward a favorable result. With that said, it is still important to move quickly, and your practice will need to engage legal counsel to oversee the inquiry and interject when necessary.

2. Identifying the Specific Allegations at Issue

As noted above, Medicare fraud audits and investigations can target a wide variety of allegations. This is true even with regard to cardiovascular genetic testing in particular. Allegations of lack of medical necessity, unlawful referral relationships, and billing miscues all require very different defenses; and, at the same time, you need to avoid unnecessarily providing records in an attempt to defend against allegations that are not actually on the table.

3. Conducting a Comprehensive Internal Compliance Assessment

Once you know what allegations are at issue, then you need to know whether (and to what extent) your cardiology practice is at risk. The only way to do this is to conduct an internal compliance assessment and see where your practice’s vulnerabilities lie. Are there issues with regard to evidence of medical necessity that need to be addressed? Do your practice’s relationships with testing providers raise red flags? Are your practice’s billing administrators not following proper protocols and procedures? If there are shortcomings that require fixing, it will be important to address them proactively before they are discovered by auditors or investigators.

4. Building a Comprehensive and Cohesive Defense

Once you know what your MAC or federal investigators are looking for and whether they will find it, then you can build a comprehensive and cohesive defense strategy. Your defense strategy should address all possible allegations of cardiovascular genetic testing fraud, and it should do so on an individualized basis. In addition, when building your practice’s defense strategy, it is important to ensure that all of the various arguments you assert (or your legal counsel asserts on your behalf) work with one another. You do not want to be in a position where an argument you make in response to one allegation ends up being used against you with respect to another.

5. Executing a Defense Strategy Focused on Avoiding or Mitigating Liability and Other Consequences

At this stage, your focus should still be on securing a favorable pre-charge resolution. This allows you to have a say in the final outcome, and it limits the risk of any negative publicity. It is important to continue taking a proactive approach, and you will need your legal counsel to continue working with your MAC or the government’s investigators on a day-to-day basis. At Oberheiden P.C., we regularly represent cardiologists and other providers in MAC audits and government healthcare fraud investigations, and we have protected the vast majority of our clients against facing civil and criminal charges.

Speak with a Healthcare Fraud Defense Lawyer at Oberheiden P.C.

Is your cardiology practice under scrutiny for alleged cardiovascular genetic testing fraud? If so, we encourage you to speak with one of our senior healthcare fraud defense lawyers promptly. Our healthcare fraud defense attorneys assist service providers and businesses under investigation for alleged Qui Tam Lawsuit, Stark Law, False Claims Act, or Anti-Kickback violations. To schedule a complimentary case assessment at Oberheiden P.C., call 888-680-1745 or tell us how we can help online now.

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