After Major Takedown, DOJ Continues to Target Cardiovascular Genetic Testing Fraud
As cardiovascular genetic testing continues to garner widespread use, the DOJ is targeting health care providers that fraudulently bill for predictive testing and preventative services.
In September 2019, the U.S. Department of Justice (DOJ) announced a major takedown involving doctors, testing laboratories, and telemarketing companies accused of fraudulently billing Medicare in excess of $2 billion for predictive genetic testing services. This followed the announcement just a month earlier of charges filed against three doctors accused of accepting more than $1 million in illegal kickbacks from cardiovascular genetic testing laboratories. While there has been comparatively little news of major takedowns since, it is clear that the DOJ is still actively targeting health care providers and toxicology laboratories suspected of fraudulently billing for hereditary cardiac testing and related medical services.
The DOJ is Scrutinizing Cardiovascular Genetic Testing Billings, Kickbacks, and Referral Fees
In the two cases reported above from late 2019, the DOJ targeted health care providers, testing laboratories, and telemarketing companies for their respective alleged roles in fraudulently billing Medicare for genetic testing services. As cardiovascular genetic testing continues to grow in terms of mainstream acceptance, the DOJ is paying particular attention to billings and financial relationships pertaining to these predictive tests and related preventative services.
In particular, fraudulent practices – both intentional and unintentional – that have the potential to lead to DOJ scrutiny in relation to cardiovascular genetic testing include:
1. Soliciting Patients for Unnecessary Cardiovascular Genetic Testing
Telemarketing relationships have long created problems for health care providers. While relationships with telemarketing companies can be completely legitimate and telemarketing companies can provide valid patient referrals, there have been many cases of health care providers facing civil – and in some cases criminal – charges for utilizing telemarketing companies’ services.
With regard to cardiovascular genetic testing, one of the primary concerns involves telemarketing companies soliciting patients for testing that is not medically necessary. Medicare, other government benefit programs, and private health insurers only provide coverage for medically necessary services—and this includes diagnostic testing. Since cardiovascular genetic testing is often used in a predictive manner without concerns about a specific diagnosis, questions of medical necessity will frequently arise.
In addition to being cautious about relying on telemarketing companies, health care providers must be careful in conducting their own marketing efforts as well. This includes “selling” cardiovascular genetic testing services directly to patients. If there is not medical justification for providing predictive testing to a particular patient, then there is a high risk that billing for such testing will be deemed fraudulent.
2. Billing for Medically-Unnecessary Hereditary Cardiac Testing
Even if the sales practices used to provide hereditary cardiac testing to a patient are legitimate, providers can still run the risk of having such testing deemed medically-unnecessary for reimbursement purposes. If a particular test is not medically necessary (as determined by the language of the pertinent billing guidelines, not necessarily the physician’s independent medical opinion), then it is not eligible for reimbursement.
Given the risk of having hereditary cardiac testing deemed medically-unnecessary, physicians who offer such testing to their patients will be well-served to carefully and comprehensively document their reasoning for recommending it. Ideally, this reasoning should reflect the language of the relevant program (or private health insurance company) billing guidelines; and, of course, it should be based on an actual patient exam. Physicians who recommend cardiovascular genetic testing based on cursory phone consultations have faced DOJ scrutiny in the past, and this remains a red flag for federal health care billing fraud.
3. Soliciting Patients and/or Billing for Medically-Unnecessary Preventative Services
In addition to facing DOJ scrutiny for soliciting patients for medically-unnecessary cardiovascular genetic testing, physicians and other providers can face scrutiny for providing unnecessary preventative services as well. Upon receiving the results of a hereditary cardiac test, doctors determine what follow-up services, if any, are eligible for reimbursement under the applicable billing rules.
Remember, what a doctor recommends might not necessarily be the same as what is eligible for reimbursement. This is true in all circumstances, but it is of particular concern when proposed medical services are preventative in nature. As a result, prior to seeking reimbursement, it is necessary to carefully assess the medical necessity (for billing purposes) of preventative services for conditions such as:
- All forms of arrhythmia
- All forms of cardiomyopathy
- Congenital Heart Defects
- Ehlers-Danlos Syndrome
- Familial Hypercholesterolemia
- Hereditary Hemorrhagic Telangiectasia
- Heterotaxy and Situs Inversus
- Marfan Syndrome
- Transthyretin Amyloidosis
4. Not Utilizing Cardiovascular Genetic Testing Results or Providing Them to Patients
Another issue that can lead to allegations of cardiovascular genetic testing-related billing fraud involves ordering tests but not utilizing test results or providing them to patients. If test results are not utilized for any medical purposes, then the DOJ will almost certainly question the medical necessity of those tests.
Here, too, documentation is critical to mitigating the risk of prosecution for federal health care fraud. Medical practices must document when they provide copies of test results to patients, and any follow-up services that are provided must be both (i) based on the test results obtained, and (ii) medically necessary within the confines of the applicable billing guidelines. If they are not, then providers will run the very real risk of both the initial hereditary cardiac test and the subsequent medical services being deemed ineligible for reimbursement.
5. Offering or Accepting Unlawful Payments for Patient Referrals
One of the primary allegations in each of the DOJ cases referenced above was that the parties involved paid and received unlawful kickbacks out of Medicare-reimbursed funds for cardiovascular genetic testing. The Stark Law and the Anti-Kickback Statute both prohibit the offering and acceptance of compensation for the referral of program beneficiaries, while the Eliminating Kickbacks in Recovery Act (EKRA) applies to all kickbacks, regardless of payor.
When referring patients to testing laboratories for hereditary cardiac testing, physicians and other providers must be extremely careful to avoid any indication that an unlawful referral fee is being paid. The Stark Law, Anti-Kickback Statute, and EKRA prohibit monetary compensation as well as other forms of direct and indirect remuneration; and, while each statute contains exceptions, these exceptions are very narrowly drawn. As a result, when it comes to anti-kickback compliance, providers must structure any financial relationships with a specific statutory exception in mind.
6. Improperly Billing for Cardiovascular Genetic Testing and/or Related Services
As with all aspects of health care billing, when it comes to billing for cardiovascular genetic testing and related services, providers must go to great lengths to ensure that their billings are accurate. This applies with respect to all services billed to all payors.
Billing compliance has long been a top enforcement priority for the DOJ (and other federal authorities) within the health care sector. Fraudulent billing costs the government and private insurers hundreds of billions of dollars per year, with offenses ranging from inadvertent coding errors to large-scale fraudulent billing schemes. Since cardiovascular genetic testing is a key focus for the DOJ as well, this means that providers can expect to face particularly-heavy scrutiny when seeking reimbursement for these tests and related services.
7. Failing to Establish Adequate Policies and Procedures to Prevent Hereditary Cardiac Testing Fraud
When conducting health care fraud investigations, one of the first issues that DOJ investigators examine is whether the provider in question has a comprehensive compliance program. If not, this will almost certainly trigger greater scrutiny, as the DOJ and other health care regulators expect all providers to adhere to policies and procedures that are designed to prevent fraud, waste, and abuse (FWA).
While many aspects of a provider’s compliance policies and procedures can be general in nature (i.e. general billing policies and procedures that apply regardless of the service or item being billed), providers must adopt policies and procedures that specifically address high-risk areas as well. This includes billing for predictive testing and preventative services—which may or may not satisfy the “medical necessity” requirement for reimbursement eligibility depending upon the specific circumstances involved.
What Can (and Should) Doctors and Other Providers Do to Mitigate Their Risk When Offering Cardiovascular Genetic Testing and Related Services?
Given the risks of facing DOJ scrutiny (which can lead to civil or criminal penalties), what can health care providers do to ensure billing compliance with regard to cardiovascular genetic testing and related services? The key is to develop and implement a comprehensive and custom-tailored health care compliance program. Not only will maintaining compliance mitigate the risk of facing DOJ scrutiny; but, in the event of a DOJ inquiry, being able to affirmatively demonstrate compliance can help facilitate a quick and favorable resolution.
Contact Oberheiden P.C. about Your Practice’s Cardiovascular Genetic Testing Compliance Needs
Is your medical practice offering cardiovascular genetic testing and related services? If so, it is extremely important for your practice to have a comprehensive compliance program in place. To discuss your practice’s needs with a senior federal health care compliance attorney at Oberheiden P.C., call 888-680-1745 or tell us how we can reach you online today.
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.