Cardiovascular Genetic Testing Compliance: What Do Doctors Need to Know? - Federal Lawyer
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Cardiovascular Genetic Testing Compliance: What Do Doctors Need to Know?

Cardiovascular genetic testing is a rapidly-growing, and extremely valuable, area of modern medicine. Providers seeking to offer these services to their patients must prioritize billing compliance in order to avoid recoupments, pre-payment review, and other penalties for health care fraud.

For health care providers that offer cardiovascular genetic testing (hereditary cardiac testing), billing compliance is an important concern that requires careful consideration. Medicare has not issued any local coverage determinations (LCDs) for coverage under Medicare Part A or Part B, and reimbursements are currently coming from Medicare Administrative Contractors (MACs)—including specifically Novitas Solutions Inc. (“Novitas”) and First Coast Service Options Inc. (“First Coast”).

While health care providers that receive reimbursements for cardiovascular genetic testing through Novitas and First Coast (and potentially other MACs as well) are not necessarily at greater risk than providers that bill for other tests and services, billing compliance with respect to hereditary cardiac testing needs to be a priority. As genetic testing for cardiovascular disorders (and other conditions) continues to play a greater and greater role in our health care system, Medicare billings for these tests are going to come under greater and greater scrutiny as well.

What are the Key Compliance Concerns with Cardiovascular Genetic Testing?

What are the primary compliance concerns for doctors who offer cardiovascular genetic testing to their patients? As with all areas of health care billing compliance, the compliance concerns with regard to hereditary cardiac testing fall into several different categories. The main categories include:

1. Proof of Medical Necessity

As a tool for identifying long-term health risks and preparing for (and potentially preventing) future medical needs, cardiovascular genetic testing raises concerns in the area of medical necessity. While the benefits of cardiovascular genetic testing may seem obvious to you as a physician, from a billing compliance perspective, there are serious questions as to what is – and isn’t – eligible for reimbursement.

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Even though hereditary cardiac testing can be used to predict and prepare for medical conditions ranging from aneurysms to congenital heart conditions, and from coronary heart disease to congestive heart failure, this still does not automatically mean that it qualifies as a form of “medically necessary” testing for purposes of billing compliance. The billing rules regarding medical necessity are extremely strict, and physicians must be extremely careful to ensure that they are only billing Novitas or First Coast when permitted to do so under the relevant set of program billing guidelines.

2. Use of Proper CPT Codes

When cardiovascular genetic testing qualifies as medically necessary, identifying the correct Current Procedural Terminology (CPT) code for billing presents the next major challenge. There are numerous CPT codes that can potentially be used, including (but nearly not limited to):

  • CPT Code 81403
  • CPT Code 81405
  • CPT Code 81406
  • CPT Code 81407
  • CPT Code 81408
  • CPT Code 81413
  • CPT Code 81414
  • CPT Code 81439
  • CPT Code 81442
  • CPT Code 81479

But, while there may be numerous codes that physicians and other health care providers can use to bill for various forms of hereditary cardiac testing, when billing Novitas or First Coast, providers must select the right CPT code. Even if cardiac genetic testing services are eligible for reimbursement, if they are not billing appropriately, physicians and other providers can still face serious allegations of federal health care billing fraud.

As you can see from the sampling of potentially-applicable CPT codes listed above, several of the CPT codes used to bill for cardiovascular genetic testing are very similar. Despite this being the case, any mistakes can lead to fraud allegations (which can lead to recoupments, pre-payment review, and other penalties)—including honest human errors such as incorrect keystrokes and transposing of numbers.

3. Other Billing and Coding Violations

In addition to lack of medical necessity and the inadvertent misuse of incorrect CPT codes, there are various other billing and coding issues that can lead to trouble for health care providers that offer cardiovascular genetic testing to their patients. This includes many of the same issues that can lead to trouble with respect to other types of government program and private health insurance billings. For example, when billing Novitas or First Coast for hereditary cardiac testing, physicians and other providers must be careful to avoid (or ensure that their in-house billing personnel or third-party billing administrators avoid) mistakes such as:

  • Double Billing – Providers that bill Novitas or First Coast for cardiovascular genetic testing services must be careful to ensure that these services are not also billed to a private health insurer or other state or federal government health care benefit program.
  • Upcoding and Unbundling – For testing services that are required to be bundled with other services, failing to bundle (or “unbundling”) can lead to allegations of health care fraud. The same is true of billing for cardiovascular genetic testing services at an inflated rate (or “upcoding”).
  • “Phantom” Billing – Phantom billing refers to billing for testing services that were not actually provided. While this can involve intentional efforts to defraud payors, more often than not these allegations arise out of inadvertent mistakes, such as using the wrong CPT code or billing a test for the wrong patient.
  • Failure to Maintain Patient Records – In order to establish medical necessity and all other aspects of billing compliance, providers must maintain comprehensive patient records pertaining to consultation, testing, diagnosis, and treatment. Failure to do so can lead to serious problems in the event of a MAC audit or federal health care fraud investigation.
  • Billing for Ineligible Services – Due to lack of medical necessity (as determined by applicable program billing guidelines) and other issues, various genetic testing-related services will not be eligible for reimbursement. Billing for ineligible services – whether intentionally or inadvertently – can lead to problems for physicians and other health care providers as well.

4. Unlawful Compensation Arrangements with Genetic Testing Providers

Another concern that often goes overlooked when talking about medical billing compliance is the concern of entering into unlawful compensation arrangements with genetic testing providers. Under the Stark Law, Anti-Kickback Statute and Eliminating Kickbacks in Recovery Act (EKRA), there are strict limitations on the nature of financial relationships that medical offices, clinics, and hospitals can enter into with testing laboratories and other third-party providers. For providers that routinely order hereditary cardiac tests from the same testing laboratories, a key aspect of compliance will involve clearly establishing (with appropriate documentation) that no unlawful compensation (or other form of “remuneration”) is being provided.

What Can Medical Practices Do to Establish Compliance with Regard to Hereditary Cardiac Testing?

Given these concerns, what can physicians and other health care providers that offer cardiovascular genetic testing services do to establish compliance and avoid unwanted scrutiny from their MACs—or from federal authorities such as the U.S. Department of Health and Human Services Office of Inspector General (DHHS-OIG)? Some of the key components of an effective hereditary cardiac testing compliance program will include:

  • Billing Compliance Policies and Procedures – All health care providers must have comprehensive billing compliance policies and procedures. While certain aspects of these policies and procedures can be general in nature (although they should still be custom-tailored to the provider’s specific practice), other aspects will need to address specific compliance concerns, such as billing for hereditary cardiac testing.
  • Billing Compliance Implementation and Auditing – Compliance policies and procedures are useless if not implemented effectively. Implementation is a crucial component of compliance, as is auditing providers’ compliance efforts on an ongoing basis. Once implemented, cardiovascular genetic testing compliance policies and procedures should be reviewed regularly to ensure that both: (i) they are being utilized effectively; and, (ii) they are still current in light of any changes in the provider’s practice or applicable law.
  • Third-Party Contract Compliance Management – From financial relationships with cardiovascular genetic testing laboratories to service contracts with third-party billing administrators, providers that offer hereditary cardiac testing must ensure that their contractual relationships both: (i) are lawful under the Stark Law, Anti-Kickback Statute, and EKRA; and, (ii) provide adequate liability protection in the event of a health care billing fraud audit or investigation.
  • Telemedicine Compliance – For providers that offer cardiovascular genetic testing as part of a broader telemedicine practice, the offering of such testing must be specifically addressed in their telemedicine compliance programs as well.
  • Ongoing Compliance Documentation – Finally, as discussed above, providers that offer hereditary cardiac testing must maintain thorough patient records and billing records on an ongoing basis. Patient records should clearly establish medical necessity based on the terminology utilized in the relevant program billing guidelines, and both patient and billing records should be stored in a secure but easily accessible location in case they are needed in order to prove compliance during a MAC audit or federal health care fraud investigation.

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Do you have questions about cardiovascular genetic testing compliance? If so, we encourage you to get in touch. To schedule a free initial consultation with one of our senior federal health care compliance attorneys, please call 888-680-1745 or request an appointment online today.

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