How to Setup a Cardiac Testing Program that is Legal and Compliant - Federal Lawyer
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How to Setup a Cardiac Testing Program that is Legal and Compliant

setup compliant cardiac testing program

Experienced Cardiac & Genetic Testing Fraud Defense Team

If you need advice regarding how to set up a cardiac testing program that is consistent and compliant with all applicable federal laws, do not hesitate to contact a health care fraud defense attorney right away.

Cardiac and genetic testing programs are on the rise both in terms of popularity and availability by different companies. But with this innovation and importance in health comes an increase in federal government scrutiny due to the potential for fraud.

Federal agencies such as the Federal Bureau of Investigation (“FBI”) and Department of Justice (“DOJ”) have made it their priority to investigate compliance and instances of health care fraud by cardiologists and lab executives—especially with respect to whether these testing programs are “medically necessary” for patients.

Such investigations can lead to significant penalties, civil and criminal fines, and even jail time. Do not wait to hire an attorney experienced in health care fraud defense.

At Oberheiden, P.C., our team of health care defense attorneys is experienced in navigating the complexities of a federal investigation, evaluating company compliance policies, and fighting for your rights to avoid liability and fines.

Put Oberheiden, P.C. on your side to protect your reputation, career, business, and liberty.

What Is Cardiac and Genetic Testing?

Cardiac testing analyzes an individual’s blood for certain genes that increase the risk of various forms of heart disease or other serious conditions relating to the health of the heart. These tests are meant to produce results regarding cardiac health regardless of whether the individual has a family history of heart conditions.

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Dr. Nick Oberheiden
Dr. Nick Oberheiden

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John W. Sellers

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U.S. Department of Justice

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Joanne Fine DeLena

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Joe Brown

Former U.S. Attorney & Former District Attorney

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Amanda Marshall

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Aaron L. Wiley
Aaron L. Wiley

Former Federal Prosecutor

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Roger Bach
Roger Bach

Former Special Agent (OIG)

Michael Koslow
Michael Koslow

Former Supervisory Special Agent (FBI)

Chris Quick
Chris Quick

Former Special Agent (FBI & IRS-CI)

Kevin M. Sheridan
Kevin M. Sheridan

Former Special Agent (FBI)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

Dennis A. Wichern
Dennis A. Wichern

Former Special Agent-in-Charge (DEA)

Genetic testing offers similar benefits—namely that it allows individuals to receive advance understanding of their chances of developing health-related conditions or whether they have an increased risk for certain medical conditions. This allows these individuals to start preparing by making lifestyle changing or taking certain prescribed medications.

Along with cardiac and genetic testing, some companies also offer pharmacogenetic testing, which is a test that identifies whether an individual has certain genes in their body that could affect the way their body responds to certain medicines. It is important to determine how a person would respond to medicines before taking them in order to best identify an effective drug for that person with the least amount of adverse side effects.

The Rise of Cardiac & Genetic Testing and Fraudulent Schemes

The increase in cardiac and genetic testing programs offered by companies will inevitably be accompanied by increases in fraud.

In fact, the federal government has already initiated hundreds of investigations into suspected fraudulent activities involving cardiac and genetic testing programs.

Because cardiac and genetic testing are relatively new forms of testing programs, Medicare has taken the position that such tests are only “medically necessary” in limited circumstances.

Medicare administrative contractors have announced this position in various local coverage determinations (“LCDs”). Having said that, the absence of an LCD does not automatically mean that the testing program is medically necessary.

In other words, no matter words, Medicare requires that the test be reasonable and medically necessary.

Fraudulent Testing Schemes and Federal Regulation

The presence of fraud involving cardiac, genetic, or other screening tests has increased, as fraudsters seek to profit from the anxiety of society by preying on health concerns of the elderly, as a notable example.

In cases where Medicare believes the testing program ordered fails to meet “medically necessary” standard, the DOJ will often be notified as to the possible testing program fraud by lab executives, cardiologists, or other medical professionals.

Therefore, physicians that order cardiac, genetic, or other screening tests for patients without a medical necessity easily alert federal agencies as to possible fraud.

In addition to physicians, laboratories that work with physicians who urge additional testing that is medically unnecessary may also face liability.

Over the years, this has become a serious problem for the FBI and DOJ, especially considering the fact that Medicare has paid billions of dollars for genetic testing despite little medical evidence, according to an article by the American Bar Association.

These federal agencies have responded by taking an aggressive approach towards investigating and prosecuting lab executives, cardiologists, and other medical professionals for engaging in health care fraud regarding testing programs.

This is why it is so important to retain legal counsel as soon as possible to ensure that your business has set up its testing program properly in accordance with federal law and is compliant with all regulations.

What Are Some Examples of Cardiac & Genetic Testing Fraud?

Cardiac and genetic testing program fraud are types of health care fraud. Health care fraud generally refers to situations where the individual or company defrauds the federal government, an insurance company, or a state or federal benefit program in order to receive some form of financial benefit from the wrongdoing.

Such charges can result in significant fines, civil and criminal penalties, and jail time.

Below are examples of cardiac, genetic, and screening testing fraud by cardiologists, lab executives, and other medical professionals:

  • Ordering testing programs for patients that are not medically necessary;
  • Ordering testing programs as a blanket policy for patients (testing patients for a wide range of tests with most of them being medically unnecessary);
  • Prescribing medicines that have no medical purpose or necessity;
  • Paying other physicians for referrals and disguising these payments as legal consultation fees and accepting kickbacks and referrals;
  • Billing for services not performed or for incorrect medical procedures;
  • Falsifying medical records of patients or defrauding insurance companies or state and federal benefit programs;
  • Maintaining an improper financial interest or other stake in a testing lab by the physician that is likely to lead to abuse;
  • Billing payors for medical procedures with improper coding to increase reimbursement—upcoding.
  • Billing medical procedures to patients in separate codes to increase reimbursement—unbundling.

The Importance of Properly Setting Up Testing Programs and Maintaining Compliance

Cardiac and genetic testing programs are transforming the world by giving individuals the information they need to understand whether they are at risk of developing critical health conditions in the future, therefore allowing them to start making lifestyle changes such as diet, exercise, and medication.

As more and more medical professionals and laboratories team up to provide these services, making sure the business is set up properly and compliant with federal law are critical considerations.

Failure to maintain compliance when developing and structuring a testing program could lead to significant fines, penalties, reputational harm, and sometimes imprisonment terms.

Below are key reasons why cardiologists, lab executives, and other medical professionals should make it their priority to ensure that their cardiac, genetic, and other screening testing programs are properly formatted, setup, and compliant with federal law:

  1. Proper setup and compliance reduce the possibilities of running afoul of federal law. Health care fraud is vehemently investigated and prosecuted by federal agencies. Fraudulent conduct such as improper billing or ordering tests that are medically unnecessary are prominent examples of health care fraud. Engaging in such behavior can make cardiologists, lab executives, and other medical professionals liable under various statutory provisions including the following: the False Claims Act; health care fraud under U.S. Code § 1347; the Anti-Kickback Statute; and aggravated identity theft, as some examples.
  • Ensuring adequate setup and continuous compliance will help reduce or prevent fines, penalties, and jail time. Even if the cardiologist, lab executive, or other medical professional is found liable for violating certain federal provisions, their penalties and imprisonment terms could be significant reduced by the presence of effective compliance policies and cooperation.
  • A federal investigation could risk loss of business contacts, patient base, and be accompanied by significant reputational harm. There is much negative attention associated with an ongoing federal investigation. The increased media coverage can dramatically affect the company’s relationships with its business contacts and patients. It can also leave the company and medical professionals with tarnished reputations.
  • A robust compliance policy, strong internal leadership, and a healthy corporate culture within the business can guard against internal fraud, abuse, and other misconduct. It is important to retain an attorney who is experienced in evaluating the effectiveness of a company’s compliance policy. The objective of an effective compliance policy is to identify internal weaknesses so that they can be promptly addressed.

Need Advice Regarding Cardiac & Genetic Testing?

Do you need legal advice to ensure that your company’s cardiac, genetic, or screening testing program is properly structured and compliant with federal law? If so, then you need to contact an experienced health care attorney right away.

The federal government is making it one of their main priorities to investigate alleged instances of fraud in connection with testing programs. This puts you and your business at risk of a federal investigation.

At Oberheiden, P.C., our health care fraud defense attorneys can evaluate your testing program for compliance with federal law to avoid liability and jail time.

We are experienced in defending clients against health care fraud allegations, especially regarding improper billing and ordering medically unnecessary tests.

Let us help you. We will fight for your business and reputation. Call or contact our office for a free consultation to protect your career and business.

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