Telemedicine and Cardiovascular Genetic Testing: What Do You Need to Know?
While telemedicine is gaining widespread acceptance – due in no small part to the impacts of the COVID-19 pandemic – when it comes to billing for telemedicine services, providers still face many challenges.
Telemedicine billings often face enhanced scrutiny, and there are various issues that do not exist when providing in-person consultations and treatment. When providing services that are typically subject to enhanced scrutiny as well (i.e. cardiovascular genetic testing), telemedicine billings can quickly get providers into trouble if they are not dutifully focused on compliance.
When it comes to recommending cardiovascular genetic testing during telemedicine consultations, even minor miscues can have serious consequences. Telemedicine and cardiovascular genetic testing both raise various red flags for the Centers for Medicare and Medicaid Services (CMS) and its Medicare Administrative Contractors (MACs), and combining them increases the risk of facing an audit or investigation. While there is nothing inherently wrong with recommending cardiovascular genetic testing as part of a telemedicine practice, providers that do so must be careful to ensure that they are not running afoul of the applicable billing rules and federal laws.
10 Issues that Can Lead to Trouble for Providers that Recommend Cardiovascular Genetic Testing During Telemedicine Consultations
What types of issues can get providers into trouble when it comes to recommending cardiovascular genetic testing during telemedicine consultations? The list is longer than you might think. Here are 10 examples of issues that can lead to allegations of health care fraud during a MAC audit or government investigation:
1. Recommending Cardiovascular Genetic Testing Without Conducting an In-Person Exam
By its nature, telemedicine requires providers to consult with patients without conducting an in-person exam. In lieu of conducting an in-person exam, providers must conduct remote exams that are designed, to the extent possible, to provide the same level of insight into a patient’s medical condition.
In many cases, providers will face allegations of failing to adequately examine their patients prior to providing testing and treatment recommendations via telemedicine. Without sufficient information about their patients’ conditions, providers cannot make accurate determinations of medical necessity (more on this below). Since questions regarding the medical necessity of cardiovascular genetic testing can arise even in the traditional in-person health care context, the apparent failure to establish medical necessity during a telemedicine consultation is of particular concern for CMS and its MACs.
2. Recommending Cardiovascular Genetic Testing to Out-of-State Patients
Another issue that is largely specific to telemedicine is the issue of providing unlicensed services to out-of-state patients. While telemedicine companies share responsibility for ensuring that they pair patients with practitioners who are licensed in their state, providers have an obligation to ensure that they are practicing within the geographical constraints of their license as well.
As a general rule, unlicensed health care services are not eligible for Medicare reimbursement. This is true regardless of how appropriate and necessary the services might otherwise be. Unlicensed practice can, of course, lead to professional disciplinary action as well. With this in mind, prior to recommending cardiovascular genetic testing (or providing any other services during a telemedicine consultation), providers must follow documented protocols to ensure that they are only serving patients in the state(s) in which they are licensed to practice.
3. Entering Into Unlawful Relationships with Marketers and Telemedicine Companies
Most providers rely heavily on marketers or telemedicine companies to connect them with patients who require telemedicine services. Here, too, there is nothing inherently wrong with this approach, but entering into unlawful relationships can lead to allegations of Medicare fraud as well as allegations of violating one or more of the federal anti-kickback statutes.
Under the Medicare billing guidelines, the Anti-Kickback Statute (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA), health care providers are prohibited from using Medicare-reimbursed funds to provide remuneration for patient referrals. While providers can pay marketers and telemedicine companies for legitimate services, they are prohibited from paying for referrals of Medicare beneficiaries.
As a general principle, it must be clear that any compensation paid is not based on the volume of patients referred to the provider for telemedicine consultations or related services, and contracts with marketers and telemedicine companies must be structured accordingly. In order to demonstrate compliance when called upon to do so, providers should structure their contracts with these entities with a specific focus on avoiding the prohibitions under the AKS and the EKRA.
4. Entering Into Unlawful Relationships with Testing Laboratories
The Medicare billing guidelines, AKS, and EKRA also prohibit health care providers from accepting kickbacks in exchange for referrals to testing laboratories. When recommending cardiovascular genetic testing to patients, providers must ensure that payments received from laboratories, if any, fall outside of the applicable regulatory and statutory prohibitions.
This particular financial relationship is often heavily scrutinized by MAC auditors and federal health care fraud investigators. Accepting unlawful referral fees can lead to civil enforcement action without evidence that the provider was aware that a particular financial arrangement was unlawful. When there is evidence of knowledge and intent, accepting unlawful referral fees can lead to criminal charges under the AKS and/or EKRA.
5. Consistently Recommending Cardiovascular Genetic Testing to Telemedicine Patients
From the perspective of MAC auditors and federal agents, consistently recommending cardiovascular genetic testing to telemedicine patients suggests that providers are not providing patient-specific recommendations that are based on appropriate examinations and determinations of medical necessity. Thus, any Medicare billings related to such testing will often be either denied or subject to recoupment. When charged with fraudulently recommending cardiovascular genetic testing to telemedicine patients, providers can face fines and other penalties as well.
Due to what is perceived as a high risk for Medicare fraud in the telemedicine setting, and the risk of Medicare and other payors being billed for medically-unnecessary services in particular, apparently non-specific recommendations are viewed skeptically in almost all cases. Since cardiovascular genetic testing raises concerns with regard to medical necessity on its own, a high volume of hereditary cardiac testing recommendations is ripe for allegations of federal health care fraud.
6. Repeatedly Referring Telemedicine Patients to the Same Testing Laboratory
In addition to a large number of billings for cardiovascular genetic testing, repeatedly referring telemedicine patients to the same testing laboratory can raise red flags as well. This signals to auditors and investigators the possibility of an unlawful referral-based relationship, and it raises concerns about the medical necessity of the tests being ordered as well.
7. Billing for Cardiovascular Genetic Testing Without Documentation of Medical Necessity
As mentioned above, one of the key concerns when it comes to billing for cardiovascular genetic testing recommended during telemedicine consultations is the risk of such testing being deemed medically unnecessary. Since hereditary cardiac testing can be used for predictive, rather than diagnostic, purposes, there are circumstances in which it will not meet the definition of medical necessity under the Medicare billing guidelines.
In order to defend against allegations of Medicare fraud pertaining to the medical necessity of cardiovascular genetic testing, providers must thoroughly document all medical necessity determinations. This documentation should be stored in the patient’s file, and it should be easily accessible for purposes of demonstrating compliance in the event of an audit or investigation.
8. Using the Wrong Billing Codes (Even Inadvertently)
Coding errors are among the most-common issues that lead to recoupments and other penalties during MAC audits and Medicare fraud investigations. As there are CPT codes that are specific to telemedicine and CPT codes that are specific to cardiovascular genetic testing, providers must carefully ensure that they are billing appropriately in all circumstances.
9. Not Having Documented Telemedicine and Cardiovascular Genetic Testing Compliance
Protocols and Procedures
When it comes to Medicare billing, it is critical for providers to adopt comprehensive compliance policies. These policies should establish protocols and procedures that touch on all aspects of their practices, from patient intake (to confirm appropriate licensure) to billing administration (to ensure proper CPT code use).
For providers that provide cardiovascular genetic testing recommendations and related services via telemedicine consultations, it is critical to adopt protocols and procedures that are specific to this aspect of their practice as well. As noted above, telemedicine and hereditary cardiac testing both present unique compliance obligations, and providers need to update their compliance policies accordingly.
10. Not Being Prepared to Defend Against a MAC Audit or Federal Health Care Fraud Investigation
Finally, when it comes to avoiding recoupments and other penalties for alleged Medicare billing violations and unlawful financial relationships, providers must be prepared to defend against MAC audits and federal health care fraud investigations when necessary. In many instances, it is only a matter of time until a provider’s Medicare billings will come under scrutiny. By being prepared to take a proactive stance during an audit or investigation and work to prevent an unfavorable outcome, providers can significantly mitigate their risk of facing civil or criminal penalties.
Schedule a Complimentary Compliance or Defense Consultation at Oberheiden P.C.
Does your practice provide cardiovascular genetic testing services to telemedicine patients? If so, we encourage you to speak with one of our senior attorneys about your practice’s compliance or defense needs. To schedule a complimentary consultation at your convenience, call 888-680-1745 or get in touch with us 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.