CMS and DOJ Target Healthcare Providers Offering Sanexas Pain Management and Treatment Services

The Centers for Medicare and Medicaid Services (CMS) and U.S. Department of Justice (DOJ) are targeting healthcare providers that offer Sanexas pain management and treatment services to their patients. Targeted healthcare providers face substantial risks—including the risk of recoupment liability, Medicare exclusion, criminal fines, and even federal imprisonment in some cases.

While Medicare provides some coverage for pain management and treatment services, this coverage is limited. As discussed in detail below, one of the most significant limitations is Medicare’s overarching requirement for “medical necessity.” If a pain management or treatment service does not qualify as medically necessary (according to Medicare’s guidelines, not individual providers’ determinations), it is not eligible for reimbursement, and billing Medicare for the service constitutes health care fraud.

Specifically, pain management and treatment services are covered under Medicare Part B (Medicare Part D covers qualifying pain management medications). As listed by CMS, covered services include:

• Behavioral health integration services
• Physical therapy
• Occupational therapy
• Manual manipulation of the spine if medically necessary to correct a subluxation
• Alcohol misuse screenings and counseling
• Depression screenings
• Acupuncture for lower back pain

RST, the manufacturer of the Sanexas device, describes its treatment offering as “molecular resonance.” As such, it isn’t clear where on the list of Medicare Part B-covered pain management treatment services Sanexas treatments would fall—though physical and occupational therapy appear to be the most likely candidates. RST also promotes Sanexas as a “non-pharmaceutical treatment,” indicating that it is not eligible for coverage under Medicare Part D. This presents a fundamental issue for healthcare providers as well, and it accentuates the importance of being able to demonstrate a medically-necessary use of Sanexas treatment when billing the federal government for reimbursement.

About RST Sanexas Pain Management Treatment Devices

According to RST, Sanexas represents “a breakthrough in pain management treatment.” The company describes Sanexas as, “safe, effective, non-invasive, non-pharmaceutical treatment for pain, circulation and neuromuscular rehabilitation,” and it likens the effects of Sanexas to tuning a piano:

“When a piano tuner strikes a tuning fork next to the piano, the specific piano string will vibrate when it is correctly tuned to the same frequency. Similarly, [with Sanexas,] cells resonate and transfer energy between molecules to promote healing effects.”

RST’s website also indicates that Sanexas treatment reduces patients’ reliance on opioids by approximately two-thirds over a 60-day period. The company claims that Sanexas is, “[t]he number one rated pain and circulatory treatment system,” and is appropriate for the following FDA clinical indications:

• Chronic intractable pain
• Decreased local circulation
• Disuse atrophy
• Post-traumatic pain syndromes
• Post-surgical pain conditions
• Loss of range of motion
• Muscle spasms
• Neuro-muscular disorders
• Phlebothrombosis prevention

Anecdotal evidence suggests that doctors have used RST Sanexas pain management devices for treatment of conditions including neuropathy, radiculopathy, osteoarthritis, and fibromyalgia, among others. In some cases, it appears that Sanexas treatment is being offered in addition to pain medications (including opioids) and other treatment modalities. This supplemental use of the treatment almost certainly raises additional questions about its medical necessity in the minds of CMS and the DOJ.

Notably, RST has faced lawsuits alleging that it fraudulently misrepresented that treatments provided using its Sanexas devices qualified for reimbursement through Medicare. As reported in Law Street, a lawsuit against the company claims that it, “represented . . . Sanexas treatments were considered to be medically necessary for treating, inter alia, peripheral neuropathy and chronic pain, and thus covered by Medicare and other insurance plans.”

Potential Allegations in CMS and DOJ Sanexas Investigations

Healthcare providers targeted for offering Sanexas pain management and treatment services could face multiple allegations. While most of these allegations are likely to be civil in nature, DOJ prosecutors may choose to pursue criminal charges if they find evidence of intent to fraudulently bill Medicare for non-reimbursable services.

Examples of potential allegations under the False Claims Act and other federal health care fraud laws include:

Lack of Medical Necessity

The primary issue CMS and the DOJ appear to be targeting is lack of medical necessity. Since Sanexas treatments are still relatively new and involve relatively novel technology, questions regarding medical necessity are par for the course. This is especially true given that there are other well-established and readily available pain management and treatment options available.

If a service does not qualify as medically necessary according to Medicare’s guidelines, it is not eligible for reimbursement. When billing Medicare for services, it is up to providers to prove medical necessity. As a result, in many respects, when it comes to Medicare billing compliance, proof of medical necessity is just as important as medical necessity itself.

Inadequate Documentation

Inadequate documentation is one of the most common issues that leads to trouble for healthcare providers during CMS and DOJ investigations. If a provider cannot prove compliance with documentation it has on hand, it is going to struggle to avoid penalties. Regarding Sanexas, providers must have documentation to show that they have appropriately diagnosed their patients’ pain, that they have consulted with their patients regarding possible treatment options, and that they have accurately billed for medically necessary pain management or treatment services.

Billing and Coding Errors

Billing and coding errors are also common issues in healthcare fraud investigations. In many cases, it will be these errors that raise red flags and trigger the government’s inquiry. Using the wrong code and billing for a treatment session that was longer than the session actually conducted, unbundling related pain management services, and other common mistakes can lead to intensive government reviews of years’ worth of providers’ Medicare billings.

Implementing an effective billing compliance program can significantly reduce the risk of billing and coding errors involving Sanexas and other services. It can also have an immediate and direct impact on the trajectory of a CMS or DOJ investigation. If a provider can demonstrate good-faith efforts to adhere to a custom-tailored compliance program, this can help steer an investigation toward a favorable outcome. Conversely, if a provider does not have an appropriate billing compliance program in place, this can lead to enhanced scrutiny of the provider’s Medicare billing record.

Double Billing

Healthcare providers can face civil or criminal penalties under the False Claims Act for double billing Medicare and other payors. This mistake is particularly common when patients have Medicare and private insurance coverage. But, providers can also face allegations of double billing for charging inflated copays and deductibles—or billing patients for the full amount of their service while also seeking Medicare reimbursement.

Kickbacks and Referral Fees

Kickbacks involve payments for patient referrals paid using Medicare-reimbursed funds. They are prohibited under the Anti-Kickback Statute and other federal laws. If health care providers offer, solicit, pay, or receive prohibited payments (or other forms of “remuneration”) in exchange for pain management patient referrals or for promoting Sanexas, this alone can lead to substantial civil or criminal penalties.

What To Do if Your Practice is Under Investigation for Sanexas Billing Fraud

Let’s say CMS or the DOJ is targeting your practice for Sanexas billing fraud. What should you do?

When facing a federal healthcare fraud investigation, the first thing to do is engage experienced defense counsel. You should not wait any longer than necessary—and certainly not until the DOJ decides to pursue charges. When you engage defense counsel, your lawyers can intervene in the government’s investigation, conduct an attorney-client privileged audit to assess your liability exposure, and then execute a defense strategy focused on favorably resolving the investigation before charges get filed.

In addition to engaging federal healthcare fraud defense counsel, providers targeted in Sanexas billing fraud investigations should also:

• Review Your Medicare Billing Compliance Program – While your defense counsel will need to review your practice’s compliance program in detail, you will also want to review the relevant documentation and begin thinking about whether there may be issues you need to discuss with your legal team.
• Preserve All Relevant Records – When facing federal healthcare fraud investigations, providers must be careful to preserve all relevant records. Failure to do so can lead to allegations of “spoliation” and attempting to obstruct the government’s investigation.
• Avoid Submitting Potentially Problematic Billings to Medicare – Prior to billing Medicare for any additional Sanexas pain management or treatment services, providers should consult with their legal counsel to determine if it is safe to do so.

These are just a few examples of the numerous steps healthcare providers need to take to protect themselves during CMS and DOJ investigations. If CMS or the DOJ is targeting your practice for Sanexas billing fraud, or if you are concerned that you may be at risk for facing a Sanexas billing fraud investigation, we encourage you to contact us promptly for more information.

Speak with a Federal Health Care Fraud Defense Lawyer in Confidence

Do you need to speak with a federal health care fraud defense lawyer about your practice’s Sanexas billings? If so, contact us to arrange a complimentary consultation at Oberheiden P.C. To schedule an appointment as soon as possible, call 888-680-1745 or tell us how we can reach you online now.