From McGuireWoods, by Renee Kumon, Timothy Fry and Brett Barnett:
The District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to prevail in Anti-Kickback Statute (AKS) and False Claims Act (FCA) actions.
The District Court’s ruling contributes to the growing split between the Third Circuit, which requires a mere causal connection between kickbacks and referrals, and the Sixth and Eighth Circuits, which require but-for causation between the kickback and the federal claim.
This split relates to the per se fraud clause added to the AKS in 2010, which provides “a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim” for purposes of the FCA.
From GibsonDunn, by Winston Chan, Jonathan Phillips, Gustav Eyler, John Partridge, Christopher Rosina, Carlo Felizardo, and Nicole Waddick:
The FDA approval process for digital health “cyber devices” requires that premarket submissions contain cybersecurity information, including the company’s plans to address cybersecurity vulnerabilities, processes to provide a reasonable assurance that the devices are cybersecure, a software bill of materials, and other information as the Secretary requires.
As of October 1, 2023, the FDA expects companies to comply with these new cybersecurity requirements.
False statements related to these disclosures could give rise to false statements and subsequent risk based on the “fraud-on-the-FDA” theory of liability.
Companies should take significant care in their statements in premarket submissions regarding their cybersecurity practices and procedures.
From ArentFox Schiff LLP, by D. Jacques Smith , Randall A. Brater , Michael F. Dearington , Nadia Patel , Heather M. Zimmer:
Chief Judge Dennis Saylor of the US District Court for the District of Massachusetts ruled that the federal government must demonstrate but-for causation in order to prove that Regeneron Pharmaceuticals, Inc., the manufacturer of the drug Eylea, submitted false claims resulting from violations of the Anti-Kickback Statute (AKS).
The 2010 amendments provide that any Medicare claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA.
The government urged that the court to adopt the “exposure” theory of causation set forth in United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89, 96-98 (3d Cir. 2018) — that once the government has proven an AKS violation occurred, to demonstrate causation, it need only prove a causal link that (1) a patient has been “exposed to an illegal recommendation or referral” and (2) that the provider has submitted a reimbursement claim for that patient.
In contrast, Regeneron argued for the stricter “but-for causation standard — that the government must demonstrate that an AKS violation occurred and that the remuneration actually caused the provider to provide different medical treatment and thus caused the false claims.
The court held that the adoption by Congress of the ‘resulting from’ language in the AKS statute required a finding that the appropriate standard is but-for causation.
The Supreme Court declined to resolve a circuit court split on the issue of causation, to wit, when a provider’s claim for reimbursement results from a violation of the Anti-kickback Statute (“AKS”) for purposes of liability under the False Claims Act (“FCA”).
Remuneration: A hospital’s decision not to hire an ophthalmologist in return for a general commitment of continued surgery referrals from another ophthalmologist was not “remuneration” covered by the AKS.
Causation: The term “resulting from” means that there must be “but-for” causation, *i.e.*, the claim for reimbursement would not have been submitted but-for the violation of the AKS.
Francis C. Oroszlan, Brett Barnett and Timothy Fry, for McQuireWoods:
Generally, a complaint will survive a motion to dismiss if it states a plausible claim and allows a court to reasonably infer the defendant’s liability for the allegations made therein. Merely reciting the elements of a cause of action followed by a general statement of liability is insufficient. Further, where a complaint alleges claims under the FCA, Rule 9(b) of the Federal Rules of Civil Procedure (“Rule 9(b)”) applies and requires that the complaining party “state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). As noted by the court, Rule 9(b) imposes a more exacting pleading standard and requires the complaint to allege facts as to time, place, and substance of the defendant’s alleged fraud, specifically the details of the defendant’s allegedly fraudulent acts, when they occurred, and who engaged in them.” (Citing Hopper v. Solvay Pharms., Inc., 588 F.3d 1318, 1324 (11th Cir. 2009)).
For much of the past decade, peripheral neurostimulator devices have been used liberally by some practitioners to treat chronic pain. In addition to pain relief, any manufacturers also promise providers that these devices are reimbursable by Medicare.
This combination of relief and reimbursement has proven irresistible. Why not use a device that gives patients relief from chronic pain? The fact that Medicare reimburses roughly $6500 for a device that only costs $250 – $700 makes it even more attractive.
The problem is that this simply is not true. Medicare rules do not allow for reimbursement of these devices and never have. Providers who submit these neurostim claims to the Centers for Medicare and Medicaid Services (CMS) are submitting false claims to the government.
The government has taken notice and is cracking down.
If you have billed Medicare for electro-acupuncture devices, such as P-Stim, ANSiStim, or Stivax, you will be audited by CMS or prosecuted by the OIG. If you have not yet been contacted by the government, there are proactive steps you can take to try to minimize your exposure. If you have been contacted by the government, you need experienced counsel. Contact Wade Emmert at wemmert@ccsb.com or (214) 855-3040 for experienced advice.
Types of Nerve Stimulation
Using mild electrical current to treat nerve pain is not new. There are several treatment modalities designed to focus electrical signals at pain-causing nerves to interfere with the way nerves relay information about pain to the brain.
One method is called TENS, which has been in use for decades and is well-proven. TENS stands for Transcutaneous Electrical Nerve Stimulation. Transcutaneous simply means that the electrical pulse is transferred across the depth of the skin.
TensUnits.com
Another modality is PENS, or Percutaneous Electrical Nerve Stimulation, which combines the concept of TENS with acupuncture. Percutaneous means that the electrical pulse is transferred through or into the skin by way of a needle. Instead of transferring the electrical pulse across the skin, PENS uses small needles to penetrate into the skin and deliver current closer to the nerves or the muscles beneath the skin, making the nerves less sensitive to pain. PENS is less proven and many insurance companies consider percutaneous neuromodulation therapy (PNT), to be investigational.
Patient getting electro dry needling on his back in clinic via IslandLifeAcupuncture.com
Auricular Peripheral Nerve Stimulation (APNS) takes the concept of PENS a step farther. With APNS, acupuncture needle electrodes are inserted into the patient’s ear to direct electric pulses to the nerve cluster in the ear.
Unlike PENS, where the needle electrodes are placed in proximity to the nerve serving the area of chronic pain, in APNS the placement of the needles is based on the flow of the person’s life-giving force called ‘qi’ (pronounced ‘chee’).
In concept, the ear has different zones and the placement of the needle electrodes in a particular combination of zones can treat conditions such as migraines, neck pain, occipital neuralgia, pelvic pain, insomnia, knee pain, tinnitus, TMJ pain, low back pain, mid back pain, post-surgical pain and edema, complex regional pain syndrome, shoulder pain, sphenopalatine ganglion neuralgia, chemical-induced peripheral neuropathy, chest wall / intercostal pain, foot pain, fibromyalgia, elbow pain, chronic fatigue, depression, and smoking cessation.
ANSiStim by DyAnsys is worn behind to relieve chronic pain without narcotics or side effects. Treatment typically takes ten to twelve weeks. (PRNewsFoto/DyAnsys)
The device is designed to be worn by the patient for several days. It is affixed by an adhesive behind the ear, on the neck, or shoulder. Electrodes run from the device to the patient’s ear where they are placed into the skin and secured by an adhesive covering. The protocols vary, but each device remains affixed for 4-14 days and patients can receive multiple devices in sequence over time.
APNS devices are sold under brand names like P-Stim™, ANSiStim®, and Stivax.1 Many of these devices are considered investigational, though a few have received marketing clearance by the U.S. Food and Drug Administration’s (FDA) for use in treating acute or chronic pain by a qualified practitioner of acupuncture.
That does not mean, however, that they are reimbursable by Medicare.
Obfuscation and Deception
The FDA classifies PENS and APNS devices as electro-acupuncture devices. Medicare does not cover acupuncture for any condition other than chronic low back pain.2 But that did not stop manufacturers from implying, or outright misrepresenting to providers, that these devices were legally reimbursable.
Providers were encouraged to use certain codes to report APNS to Medicare:3
CPT 64555
CPT 63663
CPT 95970-95972
HCPCS L8679
Unfortunately, none of these codes properly describe APNS because none of these procedures or devices involve implantation and because Medicare does not reimburse for electro-acupuncture.
CPT Code 64555
CPT Code 64555 is the procedure code for percutaneous implantation of the neurostimulator electrode array. This is the code to claim reimbursement for the physician to perform the procedure. Practitioners would bill around $1,000 per procedure using this code.
The American Medical Association (AMA) defines Code 64555 as a “percutaneous implantation of neurostimulator electrode array, peripheral nerve (excludes sacral nerve).” A percutaneous procedure is any procedure or method where access to inner organs or other tissue is performed via needle-puncture of the skin, rather than by using an “open” approach where inner organs or tissue are exposed (typically with the use of a scalpel.4
This diagnostic procedure which involves stimulation of peripheral nerves by a needle electrode inserted through the skin is performed only in a physician’s office, clinic, or hospital outpatient department. Therefore, it is covered only when performed by a physician or incident to physician’s service. If pain is effectively controlled by percutaneous stimulation, implantation of electrodes is warranted.
PNS refers to the placement of a lead by a physician (via open surgical or percutaneous approach) near the known anatomic location of a peripheral nerve. … It is preferable that the physicians performing the PNS trials will also perform the permanent implant. If the physician implanting the trial PNS does not or cannot implant the permanent neurostimulator(s), the patient should be informed of this in writing and given the name of the referral surgeon who will implant the permanent neurostimulator(s).
Neurostim treatments are recoverable only when the electrodes are implanted percutaneously by a physician, typically performed in an outpatient setting at an ambulatory surgical center. Even then, such procedures are recoverable only when other, less invasive procedures have failed.
APNS devices are never percutaneously implanted and therefore do not meet the definition for CPT 64555.
CPT 63663
CPT Code 63663 is the procedure code for the revision or replacement of percutaneous spinal neurostimulator electrodes. With spinal cord stimulation (SCS), mild electrical stimulation is delivered to nerves along the spinal column, modifying or blocking nerve activity to minimize the sensation of pain reaching the brain.
The pulse generator for SCS is a small device that is implanted near the spine in the same way a cardiac pacemaker might be implanted to treat abnormal heart rhythms.
As we discussed regarding CPT 64555, electro-acupuncture devices are not implanted and have little involvement with the spine. They do not meet the description for CPT 63663.
CPT 95970–95972
These procedure codes allow for the electronic analysis of implanted neurostimulator pulse generators/transmitters. As we discussed regarding CPT 64555, electro-acupuncture devices are not implanted. Since they are not implanted, providers cannot bill for analysis of the devices as if they were. These codes are not appropriate for electro-acupuncture devices.
HCPCS L8679
HCPCS Code L8679 is the device code for an “implantable neurostimulator, pulse generator.”5 This is the code to claim reimbursement for the device itself. The device was priced at $10,000 for which Medicare reimbursed around $6,500.
Incidentally, these devices cost the provider only $250-$700 per device.
Similar to CPT 64555, to be reimbursable, the neurostimulator must be “implantable.” Again, neither the electro-acupuncture device nor the electrodes are implanted.
Some providers would also add Modifier 25 to Code L8679 procedures to increase reimbursement even more. Modifier 25 is defined as “a significant, separately identifiable Evaluation and Management (E/M) service by the same physician or other qualified health care professional on the same day of the procedure or other service.”6 It allows a provider to capture a separate, significant procedure performed on the same day as another procedure that would not otherwise be reimbursed.
Even if electro-acupuncture was properly coded as L8679, Modifier 25 would not be appropriate.
Providers in the Dark
Sales representatives for these electro-acupuncture devices knew they could sell more devices if the providers thought they could get reimbursed. When the providers started asking questions, some manufacturers doubled-down. They brought in consultants to coach providers on how to document the procedure in the medical records and code the treatment so that Medicare would pay the claim.
One sales representative, in response to “several inquiries recently from clients across the country regarding Stivax coding” offered a memo as “a way to proceed forward.” He stated:
After working closely with our compliance team over the past few weeks we are very happy to announce a new coding set that is to be used effective immediately.
The memo, entitled, “Coding for the Stivax Stimulator,” suggested tracts for Medicare billing using the codes previously debunked: L8679, 95970-95972, and 63663.
Other sales representatives suggested billing for the implantation of the electrodes rather than the device, by using CPT code 63650 and supply code E1399. Those codes require implantation too, which the APNS electrodes are not.
I have represented several providers who were duped into believing that these devices were legally reimbursable. While they were enticed by the opportunity to make money, none of them understood that these codes were improper. Some went as far as to hire a “compliance consultant” who was to make sure that everything they were doing was legal. Unbeknownst to them, this “compliance consultant” was also working with the manufacturer.
Medicare Crackdown
Based on these “stealth coding” practices advocated by some manufacturers, Medicare reimbursed many providers as if they had performed an implantation procedure of an implanted device.
CMS was slow to recognize the improper coding but responded early enough that manufacturers and sales representatives knew that these procedures and devices were not reimbursable by Medicare.
The CPT code 64555, does not describe the procedure of auricular acupuncture stimulation and it should be coded using the NOC CPT code 64999 – unlisted procedure, nervous system.
Novitas noted that the FDA classifies APNS as “electro-acupuncture devices” because they stimulate auricular acupuncture points. As such, they “are non-covered by Medicare in that Acupuncture is not a covered Medicare benefit[.]”
The article directs providers to bill these devices only with the CPT procedure code 64999, which describes an unlisted procedure for the nervous system. Using this CPT code properly conveys to Medicare that the service provided is not otherwise classified (NOC). In practice, this means that the procedure will not be reimbursed.
More recent CMS publications have warned against claims based on the other codes.
The Centers for Medicare & Medicaid Services (CMS) is aware that some providers are submitting claims incorrectly to Medicare using HCPCS code L8679. This article reminds providers of Medicare policy regarding these devices. Make sure your billing staff are aware of the correct policy. …
Providers are inappropriately coding electro-acupuncture devices as implantable neurostimulators (HCPCS L8679 – implantable neurostimulator, pulse generator, any type), which are Medicare-covered devices that require surgical implantation into the central nervous system or targeted peripheral nerve, and are usually implanted via procedures performed in operating rooms (see CMS Publication 100-03, National Coverage Determination (NCD) Manual, Section 160.7). While both devices can be used to treat chronic pain, the electro-acupuncture devices are non-invasive (that is, do not require surgical implantation and/or an incision), and have an external battery source. Electro-acupuncture devices and implantable neurostimulators are two separate devices, and coding electro-acupuncture devices as implantable neurostimulators is incorrect.
This article is to notify providers of the initiation of a widespread service specific targeted review for Healthcare Common Procedure Coding System (HCPCS) L8679, implantable neurostimulator, pulse generator, any type. The article further provides instruction on the use of the Noridian Medical Review website to facilitate proper submission of appropriate records and Medical Review contact information.
Recoveries by the Department of Justice and Office of Inspector General
CMS, the Department of Justice (DOJ), and the Office of Inspector General (OIG) have initiated False Claims Act prosecutions to recoup payments for electro-acupuncture treatments. The number and frequency of these actions are increasing.
In most cases, recoupment starts with a CMS audit of medical and billing records for claims involving CPT 64555 and HCPCS L8679. At the conclusion of the audit, CMS will either request recoupment of funds or turn the matter over to the OIG who, with the assistance of the DOJ, will prosecute a civil action (though sometimes criminal action) against the provider.
An Assistant United States Attorney assigned to the matter will issue one or more Civil Investigative Demands (CID) to the provider. A CID is a discovery device used to obtain written answers and documents relevant to their investigation or prosecution. These CIDs are often hand-delivered by OIG or FBI agents directly to the provider in the provider’s office.
The provider will need to hire competent legal counsel if they have not already done so. The provider’s attorney will either work to resolve the matter as cost-effectively as possible or prepare the case for trial.
In False Claims Act cases, the government can seek three times the amount of the Medicare reimbursement plus penalties per claim. For example, if the provider was reimbursed $500,000 for 80 devices, damages at trial could be:
Depending on the facts of the case, the government will usually start settlement discussions at double damages with little or no penalties. With the specter of trial and significant damages, many providers are motivated to resolve the matter prior to trial.
The reported number of settlements over the past two years is steadily increasing and Texas has become fertile ground for recoveries. These types of cases have proven irresistible to politically motivated U.S. Attorneys as the cases involve significant recoveries and public opinion is on the government’s side.
February 2021, U.S. Attorney’s Office for the Southern District of Texas. Chiropractor in an integrated practice agreed to pay $273,000 to settle allegations that he improperly billed. Medicare for implantation of ANSiStim and Stivax devices.
January 2021, U.S. Attorney’s Office for the Northern District of Texas. Chiropractor in an integrated practice agreed to pay $90,000 to settle allegations that he improperly billed Medicare for implantation of ANSiStim and Stivax devices.
January 2021, U.S. Attorney’s Office for the Eastern District of Texas. Clinic agreed to pay $330,898 to settle allegations that it improperly billed Medicare for the implantation of 41 neurostimulator devices in an office setting.
September 2020, U.S. Attorney’s Office for the Eastern District of Pennsylvania. A neurosurgery practice, its surgeon and director agreed to pay more than $1 million to resolve allegations that the practice, among other things, billed Medicare for the implantation of the P-Stim and Stivax devices. The neurosurgeon has since sued the marketers who allegedly pushed him to bill federal healthcare programs for the use of these devices.
August 2020, U.S. Attorney’s Office for the Southern District of Georgia. A medical practice had been ordered to pay more than $4.3 million, and the practice’s owner and chiropractor ordered to pay $700,000, to resolve claims that they billed Medicare for implantation of hundreds of P-Stim devices.
Medicare rules do not allow for reimbursement of electro-acupuncture devices and never have. Providers who file these claims with CMS under the guise of implanted neurostimulators are submitting false claims to the government. The government has taken notice and is actively targeting providers to recoup payments. The number of False Claims Act settlements has increased and there is no reason to believe they will slow down.
If you have billed Medicare for electro-acupuncture devices, such as P-Stim, ANSiStim, or Stivax, you will be audited by CMS or prosecuted by the OIG. If you have not yet been contacted by the government, there are proactive steps you can take to try to minimize your exposure. If you have been contacted by the government, you need experienced counsel.
Contact Wade Emmert at wemmert@ccsb.com or (214) 855-3040 for experienced advice.
Spinal Decompression Clinic of Texas (“SDCT”) has agreed to pay $330,898.00 to resolve liability under the False Claims Act for the alleged improper billing of electro-acupuncture device neurostimulators.
SDCT received reimbursement from Medicare in the amount of $177,051.15 for these procedures. SDCT, however, did not perform these surgeries, and instead applied P-Stim devices in an office setting, without surgery or anesthesia. P-Stim is an electric 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 does not reimburse for acupuncture or for acupuncture devices such as P-Stim, nor does Medicare reimburse for P-Stim as a neurostimulator or as implantation of neurostimulator electrodes.
A physician and two chiropractors 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.
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.
Dr. Anderson agreed to pay $1 million over five years, Dr. Spencer and Total Family agreed to pay $700,000 over five years and Dr. Shea and Chiro2Med agreed to pay $20,000 over five years.
The former owner of Providence Home Health and Providence Hospice has agreed to pay $1.05 million to settle claims she knowingly and willfully paid improper kickbacks for referrals of Medicare patients to her businesses, announced U.S. Attorney Ryan K. Patrick along with Special Agent in Charge Miranda Bennett of the Department of Health and Human Services – Office of Inspector General (DHHS-OIG).
This is a whistleblower case filed by two employees. They alleged that Teresita Alquero paid kickbacks to a medical director for Providence. The payments exceeded fair market value, so as to induce him to refer Medicare patients to Providence for home health and hospice services.
Alquero also allegedly submitted false claims under the name of a physician who was apparently incarcerated at the time. Thus, he could not have performed the services for which she was reimbursed.
An 11-count indictment unsealed on Friday charges former Kindred Home Health employee Amber Price, 37, and Christopher Cruz, 46, owner of a medical marketing business, CP Cruz Management Group, LLC (Cruz), with one count of conspiracy to violate the federal anti-kickback law.
Under the alleged scheme, Price and Cruz would create fraudulent prescriptions using actual hospital patient data. They would either forge the physicians’ signatures on the prescription forms or use pre-signed or photocopied forms. Price and Cruz would then provide fraudulent prescriptions to pharmacies or labs for submission to Medicare and private payors for reimbursement. When the pharmacies and labs got reimbursed, they would pay a percentage of the reimbursement to Price and Cruz.
The submission of false prescriptions is a violation of the civil False Claims Act. No doubt, Price and Cruz were charged with conspiracy to violate the Anti-Kickback Statute in order to impose criminal liabilities on top of the civil penalties under the FCA.
