Improper Billing of “P-Stim” Devices Continue to be an Enforcement Priority

The U.S. Attorney’s Office for the Eastern District of Pennsylvania recently announced several False Claims Act settlements and a new complaint against a Kansas chiropractor concerning allegations of improper billing for the use of certain P-Stim devices.  This continues a trend of enforcement actions for these improper claims, which are likely to continue, and to expand beyond the Eastern District into other states.  Any provider who has used P-Stim devices should be aware that P-Stim billing is under scrutiny.  Notably, these cases derive not only potentially from qui tam (i.e., “whistleblower”) suits, but also from affirmative government investigations.

The P-Stim devices are sold under several brand names, including ANSiStim and Stivax.  The allegations stem from the actions of the manufacturers, who have allegedly encouraged fraudulent billing practices regarding these devices, and providers, who have submitted the improper claims.  The use of these non-FDA approved devices is not reimbursed by any federal programs.  However, the government alleges that in order to encourage the sale of their products, the defendant manufacturers advised their provider/customers to submit claims to Medicare and Tricare using billing codes that would pay thousands of dollars, but which are meant for more complex procedures that involve surgically implanting Neuro-stimulators to manage chronic pain.  In contrast, the P-stim devices are portable, temporarily adhere to a patient’s skin and provide electric stimulation through acupuncture needles.  They can be applied by a non-licensee with minimal training and without anesthesia, so they are obviously distinguished from surgical procedures.

These cases are examples of how overzealous manufacturers may influence unwary providers to engage in fraudulent activities that may create criminal liability for the providers.  If you have engaged in improper billing for a P-Stim device, you should consult with a competent healthcare attorney, who can help you consider the option of an OIG self-disclosure, which may help you avoid a civil or criminal action.