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The United States And Tennessee Resolve Claims With Three Providers For False Claims Act Liability Relating To "P-Stim" Devices For A Total Of $1.72 Million

Publication date: 
Monday, January 4, 2021

NASHVILLE, Tenn. – January 4, 2021 – Don Cochran, U.S. Attorney for the Middle District of Tennessee, and Herbert Slatery III, Attorney General for the State of Tennessee, announced today that James P. Anderson, M.D. (“Dr. Anderson”), as owner of Affiliated Neurologists, PLC; Charles F. Spencer, D.C., as owner of Total Family Physicians Center PLLC d/b/a Total Family Health & Wellness (“Total Family”); and Mitchell P. Shea, D.C., as owner of Chiro2Med of Tennessee P.C. (“Chiro2Med”), agreed to pay the United States and Tennessee a total of $1.72 million to resolve liability under the False Claims Act for the alleged improper billing for electro-acupuncture using a peri-auricular stimulation device known as “P-Stim” that does not qualify for reimbursement under Medicare or TennCare.

P-Stim is an electro-acupuncture device that, pursuant to manufacturer’s instructions, is affixed behind a patient’s ear using an adhesive. Needles are inserted into the patient’s ear and affixed using another adhesive. Once activated, the device then provides intermittent stimulation by electrical pulses. It is a single-use, battery-powered device designed to be worn for approximately four days until its battery runs out, at which time the device is thrown away. Medicare and TennCare do not reimburse for such acupuncture devices, nor do Medicare and TennCare reimburse for P-Stim as a neurostimulator or as implantation of neurostimulator electrodes. Other brand names for this device include Stivax, NeuroStim, ANSiStim, E-Pulse, and NSS-2 Bridge. 

From May 2016 through November 2018, Dr. Anderson, Total Family, and Chiro2Med billed for, and were reimbursed by the United States for acupuncture using P-Stim devices under HCPCS Code L8679, which instead requires implantation of a neurostimulator with anesthesia in a surgical setting by a physician, typically a surgeon.  Dr. Anderson, Total Family, and Chiro2Med separately billed for, and were reimbursed by, Medicare and/or TennCare for these devices over a two year period. 

On June 10, 2020, Tennessee brought suit in the Chancery Court of Davidson County against Dr. Anderson under the Tennessee Medicaid False Claims Act for the false claims he submitted to TennCare.  Under the terms of the settlement, Dr. Anderson agreed to pay $1 million to the United States and Tennessee over five years.  Dr. Anderson also agreed to enter into an Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services that will require regular monitoring of its billing practices for a period of three years.

Dr. Spencer and Total Family agreed to pay the United States $700,000 over five years.

Dr. Shea and Chiro2Med agreed to pay the United States $20,000 over five years.

“These settlements are part of a nationwide effort to hold accountable those providers who were paid improperly for non-reimbursable acupuncture under the guise of a surgically implanted neurostimulator,” said U.S. Attorney Cochran.  “Working closely with our partners at CMS’s Center for Program Integrity, the Department of Health and Human Services Office of the Inspector General, our sister U.S. Attorney’s Offices, and the Tennessee Attorney General’s Office, we were able to identify those who profited from the submission of these false claims and negotiate resolutions that resulted in a significant recovery of taxpayer dollars.”

“This Office will not tolerate medical device fraud in Tennessee, whether it is the P-Stim as in these cases, or any type of fraud,” said General Slatery.

“Every dollar saved is critical to the sustainability of our Medicare program and the needs of our beneficiaries,” said Centers for Medicare and Medicaid Services Administrator Seema Verma. “We thank our partners at the Department of Justice and Department of Health and Human Services Office of Inspector General for working hard with us to identify, investigate, and eliminate waste, fraud and abuse in our federal health care programs.”

“These providers disregarded Medicare and Medicaid rules to bill acupuncture services as P-Stim devices in order to pad their bottom line,” said Derrick L. Jackson, Special Agent in Charge at the U.S. Department of Health and Human Services, Office of Inspector General in Atlanta.  “Our agency, working closely with our law enforcement partners, will continue to protect patients and the federal health care programs that serve them.”

These cases were handled by the United States Attorney’s Office for the Middle District of Tennessee and the Tennessee Attorney General’s Office, Medicaid Fraud and Integrity Division, with assistance from the Tennessee Bureau of Investigation Medicaid Fraud Control Unit and the Department of Health and Human Services, Office of Inspector General.  Assistant U.S. Attorney Kara F. Sweet represented the United States.  Deputy Attorney General Tony Hullender represented Tennessee. 

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Additional Details
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Component
USAO - Tennessee, Middle;
OIG
Department of Health and Human Services OIG