What Should I Do If My Practice Is Under Investigation for Sanexas Billing Fraud??

Medical providers utilizing the Sanexas pain treatment device should be aware of the ongoing initiative by the U.S. Department of Justice (DOJ) to uncover healthcare fraud with this medical device. DOJ is monitoring providers currently utilizing Sanexas and billing Medicare for reimbursement of services. Those under scrutiny risk recoupment of prior payments, Medicare exclusion, criminal fines, and in some cases federal prison.

Medicare does pay for pain management to a limited extent. To be eligible, however, the treatment must be deemed necessary for that patient, as judged by Medicare’s standards and not just the doctor’s opinion. And as the current situation demonstrates, billing the government for unnecessary services is a form of health care fraud.

Specifically, Part B does cover pain management services. There are several pain management medications that fall under the Part D prescription drug benefit. On its website, the Centers for Medicare & Medicaid Services, or CMS, has a list of services covered by Medicare for pain management. Services include:

• Behavioral health integration
• Physical therapy
• Occupational therapy
• Spinal manipulation, but only when needed to correct a subluxation
• Screening and counseling for alcohol misuse
• Depression screening
• Acupuncture, limited to low back pain

It’s not clear under what provision the Sanexas would fall. The manufacturer, RST, calls the machine’s technique “molecular resonance”. Is it an assistive device or physical therapy? Perhaps it could be classified as occupational therapy. Still, whatever it is, it’s not a drug and won’t be covered under Part D. At any rate, being able to prove that the machine’s use is medically necessary is vital.

RST markets the Sanexas as a major advance in pain care, describing the Sanexas as a safe, drug-free and noninvasive treatment. By its account, the science behind the Sanexas technology can be compared to tuning a piano.

The company’s analogy for explaining the device’s workings invokes a tuning fork and a piano string tuned to the same note: If you strike the tuning fork, the string will also vibrate. The Sanexas is said to cause the body’s cells to resonate the same way, so it can heal itself and rid the body of pain.

RST claims Sanexas reduces opioid use significantly and calls it a top-rated pain management system. It lists conditions the FDA cleared it for, including:

• Management of chronic intractable pain
• Increase local blood circulation
• Prevention or retardation of disuse atrophy
• Post-traumatic pain syndrome
• Post-surgical pain syndrome
• Maintaining or increasing range of motion
• Relief of muscle spasm
• Muscle reeducation
• Preventing blood clots in the veins

In various anecdotal reports, doctors say they use Sanexas for neuropathy, radiculopathy, osteoarthritis, fibromyalgia and more. Some providers appear to be adding it on top of pain medications, including opioids, and other treatments. Use of Sanexas as an add-on treatment almost surely deepens the government’s doubts about medical necessity.

An indication of the serious risk facing providers was a report on Law Street about a suit alleging RST misrepresented that Sanexas treatments were eligible for Medicare reimbursement and represented that the treatment was medically necessary for neuropathy and pain.

Potential Allegations

For a provider in a Sanexas investigation, the range of potential allegations is broad. Most cases are likely civil. Still, a provider who the DOJ’s evidence shows deliberately billed Medicare for non-covered services could face criminal charges.

These allegations could be brought under the False Claims Act and other federal fraud statutes. They could include any of the following, which is not a complete list, but only examples:

One likely allegation is billing for treatments not medically necessary. A technology so new would almost certainly invite questions about medical necessity, especially with other well-established pain treatments readily available.

Unless a treatment meets Medicare’s necessity guidelines, it’s not reimbursable. And that burden of proof falls squarely on the provider. So the need to produce proof is as important as the necessity itself.

Another charge could be the submission of claims without the proper records to back them up. Having to document all claims properly is part of the paperwork quagmire that always surrounds Medicare, and poor documentation is one of the most frequent problems that come to light in Medicare investigations. Without proper documentation, avoiding penalties gets tougher, especially when dealing with something so new as Sanexas. For Sanexas providers, they need records in their chart that they have properly diagnosed the patient’s pain, discussed different treatment options with the patient, and billed for the Sanexas therapy only when truly necessary.

Next up are billing and coding errors. Billing errors are unfortunately all too common and often raise red flags that kick off a government inquiry. For example, submitting the wrong codes, billing for longer treatment sessions than given, or unbundling services that are supposed to be bundled - all are typical errors but can result in years of billing getting reviewed.

One of the best ways for any practice to cut errors is by having a billing compliance program tailor-made for its needs. And the more evidence there is that you have the program and make good-faith efforts to comply with it, the better your chances that you’ll resolve the investigation as painlessly as possible. The absence of any compliance program tends to bring you under closer scrutiny.

Another allegation is double billing, which can bring civil or criminal liability. This often happens when patients have both Medicare and private insurance: Providers will submit the same bill to both insurance plans. Or they may charge a patient an inflated copay while at the same time billing Medicare.

Finally, there is the issue of kickbacks - or referral fees. The Anti-Kickback Statute and other federal laws ban paying for referrals with Medicare money. Offering, soliciting, paying or receiving anything in exchange for pain patient referrals, or for promoting Sanexas treatments, can bring stiff civil or criminal penalties.

If you’re a provider of Sanexas treatment, suppose your office is the one the U.S. Department of Justice has in its sights. How will you deal with these accusations?

The first thing you need to do, and right away, is hire a team of experienced federal health care defense lawyers. This isn’t the time to wait and see if the DOJ decides to bring charges. Don’t ignore the problem and pray it will vanish. Your defense team needs to step in, conduct an audit protected by attorney-client privilege, and build a strategy to protect your practice and your livelihood.

In addition to hiring a defense attorney, several other options can help protect you.

Go over your compliance plan with your attorney: Your lawyer will do this very thoroughly and go over it with you item by item. In addition, you should do your own review of your compliance records, flagging anything that could raise red flags. Share these concerns with your lawyer. Don’t downplay anything.

Records are your indispensable allies, so preserve every one. Even the ones that look bad. Failing to do so can lead to accusations of spoliation and obstruction of the government’s investigation.

Once you have the right team of lawyers, hold off on billing Medicare for more Sanexas services at least until your lawyers weigh in. Even if it means taking a hit financially for a while, continuing to bill may not be safe without legal review.

These are only a few of the steps you can take. In no way should this be considered an exhaustive list. Consult with your attorney for guidance tailored to your situation.