May 15, 2023

According to a source on the history of idioms, there was a custom in ancient times of pouring a cauldron of boiling water onto unwelcome intruders or enemy soldiers from an upper window or castle wall to encourage their retreat. From at least the 1600s, to be “in hot water” meant to find oneself in some measure of trouble—usually as a result of your own ill-considered actions.

One of the things you want to avoid in the practice of medicine is bringing down the wrath of the state or federal government upon your head due to unethical or illegal conduct. It’s not enough to keep informed of the ever-changing coding and documentation rules; providers must also be keenly aware of the general healthcare compliance standards—especially those that directly affect their own specialty. With that in mind, it may prove beneficial for our chronic pain providers, in particular, to be aware of some recent court rulings that directly apply to interventional pain medicine.

Prescribing Excessive Opioids

One of the issues with serious compliance implications that is routinely faced by pain physicians is the administering and prescribing of controlled substances, such as opioids. According to the U.S. Drug Enforcement Agency (DEA), the Controlled Substances Act (CSA) places all substances which were in some manner regulated under federal law into one of five schedules. This placement is based upon the substance’s medical use, potential for abuse, and safety or dependence liability.

Over the past several years, multiple pain physicians have found themselves in hot water due to illegally prescribing opioids in violation of the CSA. Last year, the U.S. Supreme Court held that, in order to convict a pain physician for illegally prescribing drugs under the CSA, the prosecution must prove that the physician "knowingly or intentionally" dispensed a controlled substance in an unauthorized manner. (See Ruan v United States, June 27, 2022). The requirement in Ruan was revisited in February of this year by the U.S. 11th Circuit Court of Appeals. In its ruling, the 11th Circuit upheld a pain physician's conviction under the CSA based on a finding that she prescribed opioids without properly assessing the patient. The court determined that this amounted to the provider prescribing a controlled substance in an unauthorized manner.

The takeaway for chronic pain physicians is that they should be diligent in documenting a complete assessment of the patient before prescribing any opioids. Failure to do so could lead to an allegation that the provider knowingly or intentionally prescribed opioids in an unauthorized manner. It may be beneficial to incorporate within the assessment section of your visit template all of the necessary headings and prompts, so that you are reminded to address each required documentation element and thus ensure that the assessment is complete and in compliance with CSA mandates.

Dubious Devices

Many chronic pain providers have recently inquired about incorporating STIMWAVE (SW) stimulator products within their practice and the reimbursement potential for these products. The U.S. Department of Justice (DOJ) issued a press release back in March, announcing that it has indicted SW’s former CEO. According to the press release, the DOJ alleges that SW made a peripheral nerve stimulator that included an implantable receiver, referred to as the “Pink Stylet.” The Pink Stylet contained copper, which was used to transmit energy from an external battery to the implanted lead, which purportedly would have the effect of interrupting the patient’s pain.

Several physicians had complained that the Pink Stylet was too long and could not be placed in some patients. According to the DOJ, the CEO of SW knew that it could not be shortened and maintain its functionality. As a way of resolving the issue, the CEO allegedly directed the company to make a dummy, nonfunctioning stylet (the “White Stylet”) that would fit in the patient. The DOJ press release asserted that the former CEO oversaw the training of physicians in the use of the device and continued to call the White Stylet a “receiver” when, in fact, it was made entirely of plastic and contained no mechanism to interrupt the patient’s pain.

This is a reminder that not every shiny new product being dangled before the provider community is what the vendor claims it is. The above allegations, should they be proven to be true, demonstrate the breathtaking lengths some will go to make an extra buck. Let the buyer beware!

Lab Kickbacks

According to the U.S. Attorney’s Office for the Eastern District of Kentucky, several defendants were convicted for their roles in a conspiracy to violate the federal Anti-Kickback Statute. Specifically, the defendants were found to have been involved in a conspiracy to pay kickbacks to a chronic pain physician in exchange for his referral of urine drug testing to laboratories operated by one of the defendants. The pain physician also pleaded guilty to soliciting and accepting kickbacks as part of the same scheme.

The defendants admitted that they paid nearly $476,000 in kickbacks to the Houston-area pain physician and his wife. The kickbacks were often disguised as lease payments for office space owned by the pain physician and his associate. All of the defendants agreed that the labs billed the Medicare program for the urine drug testing that were associated with these kickbacks, and that Medicare paid the labs $325,739—an amount to which they were not entitled.

We realize that many pain physicians do not have a urine drug testing component to their practice; but, for those who do, you’ll obviously want to avoid even the appearance of these kinds of arrangements. For those who don’t, this is still a cautionary tale. There are many ways for pain providers to get into hot water—whether it be getting conned by unscrupulous product manufacturers or engaging in practices that run counter to the letter of the law. This is why it is important for our clients to keep abreast of the latest compliance materials that we provide and to consult with your own healthcare attorneys before entering into questionable business arrangements.

With best wishes,

Rita Astani President
Anesthesia