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CGX Compliance

While Medicare now covers use of genetic cancer screening as a diagnostic tool, providers who bill for CGX testing both pre- and post-diagnosis continue to face close scrutiny from federal authorities. In order to avoid costly penalties (including the potential for Medicare exclusion), providers that order and provide CGX screenings must pay close attention to Medicare compliance.

Last year, the Centers for Medicare and Medicaid Services (CMS) announced revisions to the Medicare billing guidelines that allow for reimbursement of diagnostic genetic cancer screening, including CGX testing. However, reimbursement is still only permitted under limited circumstances. As explained in a CMS press release:

“CMS finalized a National Coverage Determination that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer). CMS believes when these tests are used as a companion diagnostic to identify patients with certain genetic mutations that may benefit from U.S. Food and Drug Administration (FDA)-approved treatments, these tests can assist patients and their oncologists in making more informed treatment decisions. Additionally, when a known cancer mutation cannot be matched to a treatment then results from the diagnostic lab test using NGS can help determine a patient’s candidacy for cancer clinical trials.”

As a result, while CGX testing has the potential to play a game-changing role in the diagnosis and treatment of life-threatening cancers, healthcare providers must still limit their use of this new innovative screening method. Healthcare providers and testing laboratories must be cautious when structuring commercial relationships between themselves in relation to CGX testing as well, as even lawful reimbursement requests for genetic cancer screenings can trigger federal scrutiny if they involve unlawful payments of “remuneration” to third parties.

3 Key Compliance Considerations for Doctors and Labs Using CGX

1. Medicare Billing Compliance Related to CGX

There are a few notable aspects of the current limited CMS approval for genetic cancer testing. First, it applies only in circumstances where a patient has already been diagnosed with an advanced stage of cancer. This means that genetic testing cannot be used as a screening tool (and reimbursed by Medicare) for non-cancer patients.

Second, the approval applies only to screenings that are FDA-approved. This includes CGX, but it excludes many other testing options that are currently available to healthcare providers. As a result, providers may choose to order CGX screenings instead of non-reimbursable alternatives; and, depending upon the circumstances involved, this may raise questions of medical necessity under the Medicare billing guidelines.

Third, CGX testing remains fairly expensive, costing thousands of dollars per screening. This, combined with the other limitations just discussed, means that CMS and its audit contractors (as well as other federal authorities such as the U.S. Department of Health and Human Services’ Office of Inspector General (OIG)) are likely to pay very close attention to any providers or testing labs that consistently order a high volume of tests.

2. Anti-Kickback Statute Compliance Related to CGX

Under the Anti-Kickback Statute, it us unlawful to offer, pay, solicit, or receive a referral fee, rebate, or any other form of “remuneration” in relation to either:

  • “[R]eferring [a patient] for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal healthcare program, or
  • “[P]urchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal healthcare program.”

Unlawful payments for referring a patient for CGX screening or ordering a test have the potential to trigger civil or criminal penalties under the Anti-Kickback Statute, and they will also typically trigger scrutiny under the False Claims Act as well.

Does this mean that all types of compensation-based relationships between physicians and testing laboratories are illegal? No, not necessarily. However, in order to avoid having a financial relationship trigger penalties under the Anti-Kickback Statute, it must be structured to satisfy the conditions of one of the statute’s “safe harbor” provisions.

3. Telemedicine Compliance Related to CGX

In many cases, CGX testing will lie at a crossroads with telemedicine. Similar to the newly-approved genetic cancer screenings, telemedicine is one area in particular where federal authorities are devoting significant resources to Medicare fraud enforcement. As a result, telemedicine practitioners who order CGX testing and labs that provide CGX screenings pursuant to telemedicine orders must be especially attuned to the compliance issues involved.

Here, there are a number of issues that can lead to issues for doctors and testing laboratories. These include questions of improper financial relationships, as well as questions of medical necessity. In many cases, telemedicine companies will direct patients with similar needs to the same physicians over and over again, and this can lead to a high volume of testing orders—a factor which in itself is often viewed by federal authorities as a “red flag” for Medicare fraud.

Adding CGX Compliance to Your Practice’s or Business’s Existing Compliance Program

Due to these (and other) considerations, physicians and testing laboratories that order and perform CGX screenings must update their compliance programs to ensure that they adequately address the legal risks associated with billing Medicare for genetic cancer screenings. For those who order and provide CGX testing in the context of telemedicine practice, the telemedicine-related compliance aspects (including use of telemedicine-specific HCPCS/CPT codes) will need to be addressed as well.

While every physician’s and testing laboratory’s compliance program should be custom-tailored to the unique aspects of its Medicare business, the core aspects of a CGX compliance program will typically include:

  • Critical Assessment of Compliance Needs – As mentioned above, every practice’s and business’s compliance needs are unique. In order to develop an appropriate CGX compliance program, it is first necessary to determine where your risks lie and what steps are necessary in order for your practice or lab to avoid violations of the Medicare billing regulations and the Anti-Kickback Statute.
  • Comprehensive Compliance Policies and Procedures – Once your practice’s or lab’s needs have been identified, then existing compliance documentation should be updated to address the relevant aspects of CGX compliance. For example, policies and procedures specific to CGX should generally cover topics such as Medicare billing, documentation of the patient’s current condition, determinations of medical necessity, and third-party compensation for testing orders or referrals.
  • Organization-Wide Compliance Training – CGX compliance policies and procedures should be distributed throughout the organization, and appropriate training should be provided to all relevant personnel. Training programs should be well-documented, as should employees’ successful training completion.
  • Auditing, Assessments and Reporting – As with all aspects of federal healthcare compliance, CGX compliance efforts should be subject to regular auditing and assessments, and employees should be encouraged to report potential violations (and be allowed to do so anonymously if desired). Typically, auditing and assessment of CGX compliance should be administered by a dedicated compliance officer.
  • Response and Remedy – In the event that a potential compliance issue is identified, response efforts should be swift and targeted, and appropriate efforts to remedy the issue should be commenced as soon as possible. Response and remedy measures should be clearly outlined in the CGX compliance policies and procedures.
  • Medicare Audit and Investigation Defense – Compliance documentation should also provide guidance for the initial steps to take in the event of a Medicare audit or investigation. When faced with an audit or investigation, acting promptly can be critical to avoiding unnecessary consequences, and having a defense plan in place can aid greatly in mitigating the costs and risks involved.

Full-Service Federal Healthcare Compliance Representation for Doctors, Labs, and Other Providers

Lynette Byrd
Attorney Lynette S. Byrd
Healthcare Team Lead
Former Federal Prosecutor

Our firm provides full-service federal healthcare compliance representation for doctors, laboratories, telemedicine companies, and other Medicare-participating providers. With a team that includes attorneys who have devoted their entire careers to private practice in the areas of federal compliance and defense as well as former senior healthcare fraud prosecutors with the U.S. Department of Justice (DOJ), we offer extensive knowledge and deep insights for developing compliance programs focused on avoiding federal liability. Whether you are confident in your existing compliance program and simply need to expand it to cover CGX, or you need to build (or rebuild) your compliance program from the ground up, we can help make sure your business or practice is fully compliant with all applicable federal healthcare laws and regulations.

Due to the significant risks involved with facing a Medicare audit or investigation, if you are currently ordering CGX testing or providing genetic cancer screenings, it is important that you address your compliance needs promptly. To learn more about what is necessary, contact us to schedule a free initial consultation today.

Schedule a Free Initial CGX Compliance Consultation

Our federal healthcare lawyers provide compliance representation for doctors, testing labs, and other healthcare clients nationwide. If you would like more information about CGX compliance, we invite you to call 888-680-1745 or contact us online for a complimentary consultation.

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