What Doctors Need to Know Before Billing for Cardiovascular Genetic Testing
When billing Medicare and other payors for cardiovascular genetic testing, a key issue is whether the testing is “medically necessary” under the applicable billing guidelines.
Cardiovascular genetic testing is a breakthrough form of diagnostic screening that allows doctors to help patients plan for – if not prevent – potentially-serious health conditions. It can be used to identify risk factors for numerous types of cardiovascular conditions that can lead to stroke, heart failure, and death, and it affords the opportunity to reduce the costs of care by treating conditions before they worsen.
Yet, in many cases, cardiovascular genetic testing is not considered “medically necessary” for purposes of billing Medicare or other payors.
As a result, many physicians and other health care providers have faced allegations of health care fraud in relation to their reimbursement requests for cardiovascular genetic testing and related services in recent years. The U.S. Department of Justice (DOJ), U.S. Department of Health and Human Services Office of Inspector General (DHHS-OIG), Centers for Medicare and Medicaid Services (CMS), and Medicare Administrative Contractors (MACs) working with CMS are all closely scrutinizing providers’ billings related to hereditary cardiac testing. This scrutiny often focuses on the medical necessity of the tests performed and follow-up services provided, and providers accused of fraudulently billing Medicare and other payors are facing substantial penalties in many cases.
5 Important Facts about Billing for Cardiovascular Genetic Testing
With this in mind, as a doctor that provides predictive cardiovascular genetic testing and preventative services, what do you need to know about billing compliance? Specifically, what do you need to know about the “medical necessity” requirement for purposes of establishing reimbursement eligibility?
The simple answer is, “More than you might think.” Despite its obvious benefits, cardiovascular genetic testing will not qualify as medically-necessary in all cases. This means that, in order to ensure billing compliance, doctors must know when hereditary cardiac tests are eligible for reimbursement and when they are not; and, in order to avoid penalization by the DOJ, DHHS-OIG, CMS, and their MACs, doctors must thoroughly document their compliance efforts on an ongoing basis.
Here are five important facts about billing compliance for doctors who provide hereditary cardiac testing and related medical services:
1. Medicare Has Not Issued Any Local Coverage Determinations (LCDs) for Cardiovascular Genetic testing
To date, Medicare has not issued any local coverage determinations (LCDs) for cardiovascular genetic testing. This means that coverage determinations are being made by Medicare Administrative Contractors—including specifically Novitas Solutions Inc. (“Novitas”) and First Coast Service Options Inc. (“First Coast”). This inherently means a lack of standardization, and this in turn means an increased likelihood of coverage disputes, recoupment demands, and claim denials.
Yet, many doctors are receiving reimbursements for cardiovascular genetic testing. So, how are they doing so?
One of the keys to securing payment (and avoiding allegations of federal health care billing fraud) is to proactively manage billing compliance. By understanding when cardiovascular genetic testing is eligible for reimbursement (and when it is not), by establishing policies and procedures to ensure that only eligible tests are billed to Medicare, and by monitoring to ensure billing compliance on an ongoing basis, doctors can safely bill for hereditary cardiac testing.
With appropriate policies, procedures, and auditing and enforcement mechanisms in place, doctors can confidently bill their MACs—and they can respond confidently in the event that questions are raised. Unless and until Medicare begins issuing LCDs for cardiovascular genetic testing, doctors will need to focus on satisfying their MACs’ billing conditions and being prepared to demonstrate compliance when necessary.
2. The Federal Definition of Medical Necessity Excludes Preventive Services (with Some Exceptions)
Many doctors who are unfamiliar with the federal Medicare billing regulations are surprised to learn that Medicare generally does not cover predictive testing and preventive medical services. Medicare only provides coverage for items and services that are “medically necessary,” which CMS defines as follows:
“Health care services or supplies needed to diagnose or treat an illness, injury, condition, disease, or its symptoms and that meet accepted standards of medicine.”
As you can see, predictive and preventative services are not included within this definition. However, CMS has established a number of exceptions under the Medicare billing guidelines which provide coverage for items and services that do not meet this strict definition. This includes annual wellness visits, certain types of screenings, and the “Welcome to Medicare” preventive visit.
So, what about cardiovascular genetic testing? As we alluded to above, cardiovascular genetic testing can meet the requirement of medical necessity in some circumstances. Determining whether a test qualifies for Medicare reimbursement requires an examination of factors including (but not necessarily limited to):
- Did the doctor perform a comprehensive in-person exam?
- Why is the testing being conducted?
- For which specific health condition(s) is the patient being screened?
- What is the patient’s current age and health condition?
- Is the patient predisposed to cardiomyopathy or other cardiac risks or disorders?
Beyond these patient-specific factors, when examining the medical necessity of cardiovascular genetic testing, MACs will examine other practice-related factors as well. For example, if a doctor recommends cardiovascular genetic testing as a matter of course, this is far more likely to raise questions regarding medical necessity and the possibility of Medicare billing fraud. Likewise, if a doctor routinely recommends cardiovascular genetic testing to a specific patient population or during telemedicine consultations, while this is not necessarily indicative of billing fraud, MACs will generally consider these types of factors to be “red flags.”
3. Financial Relationships with Testing Laboratories Can Lead to Intensive Scrutiny (and Substantial Penalties) for Doctors
In addition to lack of medical necessity, another issue that can – and frequently does – lead to scrutiny for doctors involves entering into prohibited financial relationships with testing laboratories. This includes financial relationships with both independent testing laboratories and labs that physicians wholly or partially own.
Three federal statutes prohibit the payment of referral fees, kickbacks, and other forms of remuneration when ordering cardiovascular genetic tests for Medicare beneficiaries. These are: (i) the Stark Law, (ii) the Anti-Kickback Statute, and (iii) the Eliminating Kickbacks in Recovery Act (EKRA).
Each of these laws is slightly different in its scope and application. Each law imposes different penalties as well. For doctors who own testing laboratories and for those who are seeking to enter into financial relationships with independent testing laboratories, it is imperative to ensure that the terms of the relationship fall within a specific safe harbor or exception.
4. Not Providing Follow-Up Treatment Services (or Providing Ineligible Treatment Services) Can Call the Medical Necessity of Hereditary Cardiac Testing Into Question
Another important consideration with regard to medical necessity determinations for cardiovascular genetic testing is whether and to what extent the test results are utilized for subsequent treatment recommendations. If test results are ignored and/or not provided to the patient, this will typically raise questions regarding the medical necessity of the test. Likewise, if a doctor routinely orders cardiovascular genetic testing but does not provide follow-up treatment, this can raise questions about whether the testing was truly medically necessary as well.
In this same vein, providing treatment services that are ineligible for reimbursement due to lack of medical necessity (as determined by the Medicare billing guidelines) can also raise concerns about the reimbursement eligibility of a hereditary cardiac test. If a test is used as the basis for providing an ineligible service, then this may suggest (at least to MAC auditors) that the test itself should be deemed ineligible as well.
5. Mitigating the Risk of Billing Fraud Charges Requires Careful Attention to Compliance and a Commitment to Maintaining Adequate Documentation
When it comes to federal health care billing compliance, maintaining thorough documentation serves two equally-important purposes: (i) it allows medical practices to consistently comply with the Medicare billing regulations; and, (ii) it serves as a first line of defense during MAC audits and federal health care fraud investigations.
With regard to billing Medicare for cardiovascular genetic testing, a comprehensive compliance program will touch on several issues. These issues include (but are not limited to):
- Making determinations of medical necessity based upon the Medicare reimbursement eligibility criteria;
- Documenting all determinations of medical necessity in a consistent manner that demonstrates due consideration of the Medicare reimbursement eligibility criteria;
- Ensuring that patients receive copies of their test results and that treatment recommendations are made in a timely manner once the test results are received;
- Ensuring that any follow-up services provided subsequent to cardiovascular genetic testing meet Medicare’s medical necessity requirement and are provided, documented, and billed appropriately;
- Ensuring that any financial relationships with testing laboratories fall within the safe harbors and exceptions established under the Stark Law, Anti-Kickback Statute, and EKRA;
- Adhering to documented policies and procedures for choosing the correct Current Procedural Terminology (CPT) codes and avoiding issues such as upcoding and unbundling; and,
- Auditing Medicare billing compliance and generating and storing documentation of compliance on an ongoing basis.
Discuss Your Practice’s Cardiovascular Genetic Testing Compliance Needs with a Senior Health Care Attorney at Oberheiden P.C.
If your practice offers cardiovascular genetic testing services to patients, we encourage you to schedule a free compliance assessment at Oberheiden P.C. One of our senior federal health care compliance attorneys will be happy to review your practice’s current compliance efforts one-on-one. To schedule an appointment at your convenience, call us at 888-680-1745 or tell us how you would like to be contacted 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.