How to be Compliant with Cardiac Testing for Lab Executives and Cardiologists
Experienced Cardiac & Genetic Testing Compliance Attorneys
Do you need compliance services for your cardiac or genetic testing program? Do you want to make sure that your business operations are properly safeguarded against federal liability? If so, it is time to hire an experienced health care compliance attorney.
The Federal Bureau of Investigation (“FBI”) and Department of Justice (“DOJ”) are the two main regulatory agencies responsible for investigating health care fraud. The DOJ has been particularly vigilant of instances of health care fraud such as ordering testing that is not medically necessary.
The legal and regulatory environment in the health care industry is constantly evolving, which can make it challenging to maintain full compliance. This can place your business at risk of increased federal scrutiny, especially as federal agencies grow increasingly eager to root out all instances of health care fraud.
The health care compliance attorneys at Oberheiden, P.C. are highly experienced in providing compliance-related services for cardiologists, lab executives, and other medical professionals to protect them against federal liability. We can evaluate your business’ operations to advise you on whether your testing programs are compliant with federal law.
Do not wait to get legal counsel and compliance services. Contact Oberheiden, P.C. today to protect your reputation, livelihood, and business.
Overview of Cardiac and Genetic Testing Programs and Federal Regulation
Cardiac and genetic testing programs offer patients the opportunity to discover whether they carry certain genes that make them more susceptible to developing certain health-related conditions later in life.
For instance, cardiac testing programs identify certain risk factors that are present in an individual’s tests which increases their likelihood of heart disease, heart attack, or other cardiac conditions. Genetic testing programs, generally, can identify whether the individual is predisposed to certain cancers or other diseases.
These tests are promoted because they help patients and their doctors develop solutions to avoid the onset of certain diseases, identify the right medications, and make important life changes.
With the advent of these new technologies and testing services comes an increased risk of fraud. Frauds regarding cardiac and genetic testing programs generally proceeds in similar manners such as by preying on the elderly to take tests to save their lives; offering free testing programs in exchange for insurance or medical identification numbers; or billing Medicare for services that were not provided.
These schemes allow the physicians to gain a substantial profit, which is sometimes shared by labs if they are working in concert with respect to ordering the medically unnecessary tests.
Therefore, cardiologists, lab executives, and other medical professionals need to make certain that every test they order for patients is medically necessary and that their internal operations are compliant with federal law. A health care attorney can help you achieve these objectives.
The Importance of Compliance for Cardiologists and Lab Executives
A compliance policy’s objective is to identify, prevent, and correct risks that are detected by conducting a thorough examination of the company’s internal operations.
Compliance policies are important because they help guard a company against federal liability for health care fraud—particularly against allegations under the False Claims Act.
Not only does a compliance policy demonstrate the company’s intent to maintain full compliance with the law, but it can also lead to leniency in charging decisions and can help lessen the severity of the potential liability—if any—that results from a federal investigation.
Key features of an effective compliance policy include a company-wide code of ethics and conduct; open corporate culture; leadership from senior management; risk assessment and due diligence procedures; training; strong internal controls; and monitoring, documentation, and recordkeeping.
Federal Liability for Cardiac & Genetic Testing Fraud
Health care fraud schemes are investigated and prosecuted aggressively by federal agencies. As new technologies and innovations are developed—including cardiac testing programs—the FBI and DOJ grow increasingly adamant about stopping fraudulent schemes before they develop.
As a result, many individuals and companies are heavily scrutinized, leading to multiple investigations, subpoenas, and sometimes fines and jail time.
Cardiologists, lab executives, and other medical professionals can be found liable under the following provisions for engaging in cardiac and genetic testing fraud, as some examples:
- The False Claims Act (31 U.S.C. §§ 3729 – 3733);
- Health care fraud (U.S. Code § 1347);
- Anti-Kickback Law (42 U.S.C. 1320a-7b);
- Aggravated Identity Theft; and
- Federal Conspiracy (18 U.S.C. 1349).
An effective compliance policy is vital to defend your business against federal allegations. Contact Oberheiden, P.C. today to have an experienced health care compliance attorney review your business operations for federal law compliance.
DOJ Prosecutions for Cardiac & Genetic Testing Fraud Schemes
The DOJ has been quite active in its pursuit to investigate and prosecute medical professionals for various health care fraud schemes, particularly those involving ordering medical testing that was not medically necessary and billing for services that were not provided.
The following cases are some recent examples:
- April 2020: A cardiologist and three medical practices for which he is associated agreed to pay $750,000 regarding allegations that they knowingly billed Medicare and TRICARE in violation of federal law prohibiting kickbacks. Specially, the cardiologist—who treated patients for peripheral arterial disease—induced patient referrals by providing ankle-brachial index testing (testing that is used to detect peripheral arterial disease) on patients under agreements with the referring physicians but without collecting the fair market value of the tests from the physicians.
- October 2019: The DOJ settled a claim involving the False Claims Act with a pharmacogenetic lab and three of its principals involving the paying of kickbacks in exchange for laboratory referrals for pharmacogenetic testing and for medically unnecessary tests. Specifically, the lab was alleged to have paid kickbacks to doctors and marketers as well as billed for medically unnecessary tests. The physician had disguised these tests as legitimate payments. The lab agreed to pay $41.6 million and the three individuals agreed to pay another $1 million.
- September 2019: Thirty-five defendants telemedicine companies and cancer genetic testing laboratories were charged for their participation in a health care fraud scheme involving the fraudulent billing of more than $2.1 billion of tests. In addition to allegations that these tests were deemed medically unnecessary, the federal investigation is also alleging the payment of illegal kickbacks and bribes.
- February 2019: GenomeDx Biosciences Corp. agreed to pay $1.99 million for allegedly violating the False Claims Act by submitting claims to Medicare for the genetic test for prostate cancer patients. These procedures were not medically necessary because the patients did not have risk factors that necessitated the test.
- January 2018: Primex Clinical Laboratories, LLC agreed to pay $3,500,000 for allegedly violating the False Claims Act by paying kickbacks in exchange for laboratory referrals for pharmacogenetic testing. In a related settlement, the CEO and owner of DNA Stat, LLC agreed to pay $270,000 to resolve similar allegations. The settlement with the lab involved allegations of entering into improper service agreements and submitting claims for patient pharmacogenetic tests that were not medically necessary, as some examples.
Thus, it is obvious that the government will stop at nothing to hold individuals and companies liable under federal law for engaging in such schemes if it deems these tests medically unnecessary.
How to Respond to a Federal Investigation or Indictment for Cardiac & Genetic Testing Fraud
Below we describe useful ways to respond to a federal investigation or indictment alleging cardiac or genetic testing fraud:
- Hire an experienced health care fraud defense attorney. An attorney can both evaluate the effectiveness of your compliance policy as well as defend you against allegations of health care fraud.
- Start gathering documentation to substantiate your defense. This includes documentation that supports whether the medical testing was medically necessary or whether the medical procedures were billed appropriately and accurately.
- Do not reveal information or documents to anyone without first discussing with your attorney. Sometimes federal agency staff members will contact individuals for information. Understand that you are under no legal obligation to reveal any information. Always first discuss with your attorney.
- Stay calm and maintain a cooperative attitude. Remember to stay calm and follow the direction of your attorney. Federal agencies will not appreciate a hostile attitude towards an investigation. In the long run, cooperation and an attitude towards negotiation can help lessen liability, if any.
Need Legal Advice Regarding Cardiac & Genetic Testing Compliance?
Are you concerned about compliance with federal law or potential liability? It is critical that you get in touch with a team of experienced health care compliance attorneys as soon as possible.
The DOJ has demonstrated its intent to investigate and prosecute medical professionals for engaging in cardiac and genetic testing fraud time and time again. Do not let your business fall prey to a federal investigation without first ensuring that you are compliant with federal law.
At Oberheiden, P.C., our attorneys include former FBI agents, former U.S. attorneys, and former prosecutors with substantial health care fraud defense experience.
Our health care compliance attorneys can evaluate the effectiveness of your compliance policy, determine its shortcomings, and develop a holistic approach. We will fight for your rights.
Call us today or contact our office for a free consultation to protect your career, liberty, and reputation.
Dr. Nick Oberheiden, founder of Oberheiden P.C., focuses his litigation practice on white-collar criminal defense, government investigations, SEC & FCPA enforcement, and commercial litigation.