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CGX Compliance and Fraud Defense

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Doctors, testing laboratories, distributors, and other businesses are being aggressively targeted for their CGX billing practices in federal health care fraud investigations. If you bill Medicare for genetic cancer screenings, you need to make sure your practice or business is compliant in order to avoid severe penalties.

Medicare began providing limited coverage for genetic cancer screenings in 2018. Since then, the flood gates have been open. While CGX testing provides a critical new diagnostic and monitoring tool for physicians who treat cancer patients, it also provides laboratories, distributors, and other entities with a lucrative new line of federally-funded business, and this means that CGX has quickly become front-and-center in the government’s fight against health care fraud.

Regardless of the nature of your business or practice, if you have any involvement with Medicare-funded CGX testing, compliance needs to be a top priority. While it is entirely possible to bill Medicare for CGX testing (and related products and services) in full compliance with the applicable federal laws and regulations, it is also very easy to make mistakes. Although maintaining compliance might not protect you from being audited or investigated, it will provide you with an effective defense strategy in the event that you receive an audit letter or federal agents show up at your door.

Federal Health Care Fraud Defense Lawyers for CGX Compliance, Audits, and Investigations

Oberheiden, P.C. is a team of federal defense lawyers who focus their practice on representing health care providers and other entities in the health care industry. We provide compliance and defense representation, relying on centuries of combined experience on both sides of federal health care fraud matters. Whether you are thinking about incorporating CGX into your medical or laboratory practice, you are currently billing Medicare for CGX without an effective compliance program, or you are being targeted in a federal audit or investigation, we can help you, and we encourage you to schedule a complimentary assessment immediately to discuss your needs. 

Meet the federal health care fraud defense lawyers at Oberheiden, P.C.

Proven Compliance and Defense Representation for CGX Providers and Businesses

CGX Compliance: What Does it Take to Fend Off a Medicare Audit or Health Care Fraud Investigation?

If you bill Medicare for CGX (or related products or services), or if you work with providers that bill Medicare for CGX, you need to ensure that everything you do takes your compliance obligations into account. The penalties for Medicare fraud are severe; and, if you do not have a compliance program in place, federal agents and prosecutors are going to use this against you. If you have a CGX compliance program, you can show that you made good-faith efforts to comply and that someone within your business or practice made an honest mistake. If you don’t, the government will view this as a sign that you either intentionally overbilled Medicare or that you were willfully ignorant of your obligations.

So, what does it take to be compliant? At Oberheiden, P.C., we work closely with our health care and corporate clients to develop custom-tailored CGX compliance programs that address issues including:

1. Medicare Billing Compliance

Medicare billing compliance is an issue unto itself. Health care providers that bill Medicare need to have compliance programs that address all aspects of the Medicare billing guidelines, from coding issues to establishing medical necessity. 

With regard to CGX in particular, providers must choose the appropriate codes for the purposes for which they are conducting tests, and they must only bill for screenings that have received FDA approval. The issue of medical necessity is commonly raised in CGX audits and investigations as well, particularly when CGX is chosen over an alternative (and equally-suited) screening method that is not eligible for Medicare reimbursement. 

2. CGX Compliance Documentation

Documentation is a critical aspect of any health care compliance program. This includes not only documentation of the program itself, but also documentation of training, implementation, and enforcement; documentation of commercial agreements with third parties; and, documentation of the medical necessity of CGX testing. Doctors, laboratories, and other health care providers and businesses should systematically generate and store various forms documentation specifically with compliance in mind. 

3. Financial Relationships Between Doctors, Laboratories, and Distributors

Financial relationships between doctors, laboratories, and equipment distributors raise potential “red flags” under the federal Anti-Kickback Statute. Any financial relationship that involves the direct or indirect payment compensation in relation to Medicare beneficiary referrals must be carefully structured to fall within a specific Anti-Kickback Statute “safe harbor.” Similar to most other forms of health care fraud, Anti-Kickback Statute violations carry the potential for civil and criminal penalties. 

4. Telemedicine Compliance

CGX testing performed in relation to telemedicine practice is another “red flag” for federal authorities. While there is nothing inherently unlawful about ordering CGX based on a telemedicine consultation, the unique aspects of telemedicine make this a potentially risky proposition for all parties involved. 

5. Marketing Compliance (Purchasing Medicare Beneficiary Information)

Similar to telemedicine, while it is certainly legal to market CGX testing services, marketing presents a number of stumbling blocks for all types of providers. One of the most-common issues we see is the purchase of Medicare beneficiary information from unscrupulous marketers. Other marketing violations can create significant legal exposure as well, and doctors, laboratories, and other providers must have a clear and comprehensive understanding of what they are (and aren’t) permitted to do under federal law. 

6. CGX Compliance Program Implementation and Monitoring

Any compliance program is only as effective as its implementation. If a provider does not provide suitable training for its employees, if it does not consistently generate and store necessary documentation, or if it does not update its compliance program on an ongoing basis, it is going to be at risk in the event of a CGX fraud audit or investigation. 

7. CGX Compliance Program Enforcement

In addition to implementing and monitoring their CGX compliance policies, providers and businesses must rigorously enforce their policies as well. This means taking appropriate disciplinary action against employees who improperly bill Medicare, and it means taking appropriate remedial action at the first sign of a potential compliance violation.

CGX Audits and Investigations: What Should You Do if Your Business or Practice is Being Targeted?

Maybe you have an adequate compliance program, or maybe you don’t. In either case, you have been contacted an auditor or federal agent, and now your entire Medicare CGX billing history is under the microscope. What do you do now?

The first thing you need to do is contact a federal defense attorney. Facing a Medicare audit or investigation is an extremely serious matter, as an unfavorable result could mean facing recoupments, treble damages, fines, Medicare exclusion, and possibly even criminal prosecution. As a health care provider or business owner, you simply cannot afford to take chances by dealing with auditors or federal investigators on your own. At Oberheiden, P.C., we have a proven record of success in Medicare audits and federal investigations involving:

  • Zone Program Integrity Contractors (ZPICs)
  • Medicare Administrative Contractors (MACs)
  • Recovery Audit Contractors (RACs)
  • Centers for Medicare and Medicaid Services (CMS)
  • Federal Bureau of Investigation (FBI)
  • Internal Revenue Service (IRS)
  • U.S. Department of Health and Human Services Office of Inspector General (OIG)
  • U.S. Department of Justice (DOJ)
  • Medicare Fraud Strike Force
  • Other “fee-for-service” Medicare auditors
  • Other federal agencies and task forces

When you engage our firm to represent you during a Medicare audit or federal investigation involving CGX, our attorneys will:

1. Promptly Intervene in the Audit or Investigation

We will immediately make contact with the auditors or federal agents handling your case to let them know you are represented and to gather the information we need to make informed decisions about your defense. 

2. Assess All Available Defense Strategies

We will utilize our federal health care fraud experience to assess all available defense strategies and determine how we can most-effectively attack your case. 

3. Work Diligently to Secure a Pre-Charge Resolution

We will use the facts of your case and our in-depth knowledge of the federal health care laws and Medicare billing regulations to defend your CGX billings or your financial relationships with other entities, and we will work toward securing a favorable resolution before charges get filed. 

4. Fight to Protect Your Medicare Eligibility and Your Right to Practice

We know what your Medicare eligibility means to you, and we also know how devastating it would be for you to lose your right to practice. We will fight to make sure your practice is not put at risk as a result of the audit or investigation. 

5. Help You Address and Overcome Any CGX Compliance Deficiencies

Once we have dealt with the immediate needs of the audit or investigation, we will assist you in addressing any compliance deficiencies so that the future of your business or practice remains secure. 

Schedule a Free Initial Consultation to Learn More

Does your business or practice bill Medicare for CGX screenings? Do you have financial relationships with companies or other providers that offer CGX? To discuss your legal needs in confidence, call Oberheiden, P.C. at 214-469-9009 or request a free initial consultation online now. 

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