Law360 (November 23, 2020, 4:06 PM EST) --
These shadowy operators, discussed by CBS News, NBC News, Vox, Mother Jones and on the Health Affairs Blog, receive commission-like payments — prosecutors have earned convictions demonstrating that these are kickbacks — for steering patients with substance use and opioid use disorders toward unethical and often dangerous addiction treatment centers.
These centers then proceed to collect tens of thousands of dollars in suspicious claims from health insurers often without providing the evidence-based care available through other reputable providers and clinics. EKRA was put in place by Congress to protect patients from these poor-quality treatment or fraudulent providers and promote evidence-based recovery.
Oct. 24 marked the second anniversary of the SUPPORT Act passage into law. The resurgence of opioid-related overdose and rising rates of substance use disorders, which may be exacerbated by COVID-19-related economic and other stressors, require a fresh look at EKRA.
COVID-19 Complicates the National Opioid Epidemic Response
The coronavirus pandemic has presented new threats in the national effort to combat the opioid epidemic.
An August morbidity and mortality weekly report issued by the U.S. Centers for Disease Control and Prevention found that 13% of respondents had started or increased their substance misuse or abuse during the pandemic with nearly one-third, 30.9%, noting the symptoms of pandemic-induced anxiety or depressive disorders. Two in 5 respondents, 40.9%, had greater than one mental or behavioral health symptom caused by COVID-19.
Even prior to the negative impacts of the COVID-19 pandemic on the mental health of Americans nationwide, the CDC's National Vital Statistics System had catalogued a precipitous rise in opioid-related overdose deaths in the first quarter of 2020. Driven primarily by fentanyl and other synthetic opioids, along with cocaine and methamphetamine, opioid-related overdose deaths have continued to creep upward and exceed historical averages even over the rolling 12-month estimates for February, 8.4%, January, 6.6%, and December 2019, 4.8%.
As of Oct. 4, National Vital Statistics System notes a 10% rise in overdose deaths over the rolling 12-months prior with predicted deaths nearing 75,600. Not only has this number increased significantly at the outset of the pandemic, these figures have completely reversed the drop in deaths demonstrated during 2018.
The confluence of the COVID-19 pandemic and opioid epidemic, coupled with the proliferation of polydrug use, has clearly impacted our national response to address the opioid epidemic, and understandably so. Evidence demonstrates the impact that both the pandemic and epidemic have in continuing to drive up opioid misuse and abuse.
However, these issues should not be looked at in isolation as the data above demonstrates. Instead, there must be continued, if not expanded, investments made to advance access to high-quality, evidence-based treatment and recovery services.
Over the course of the coming months, it is likely that we will see a continued uptick in overdose-related mortality, particularly through the beginning of next year's second quarter and perhaps beyond the abatement of the pandemic. With an estimated 10% of Americans able to access evidence-based care, the nation risks an overwhelming flood of patients seeking treatment during or after the pandemic. Coupled with increased access to care, the nation must leverage existing enforcement tools to mitigate harms posed by criminals who seek to profit off those seeking care.
Prosecuting Fraud and the Use of EKRA
While law enforcement in a handful of states have hit back hard against patient brokers, particularly in Florida, the use of EKRA, to date, has been underwhelming. We can only document two prosecutions under the law to date. The apparent lack of EKRA actions is concerning.
In some cases, this is because vigilant states have passed EKRA-like laws of their own and may prosecute bad actors under those authorities. But in other cases, we fear it is because states have not yet focused on the unethical practices occurring within their borders. However, the most recent action leveraging EKRA might serve as a model for future law enforcement actions against fraudulent treatment providers.
On Sept. 15, U.S. Attorney for the District of New Jersey Craig Carpenito announced that two California men admitted to participating in a multistate patient-brokering scheme spanning the country. In total, five defendants were named and charged for their respective roles in directing bribes towards individuals with substance use disorders for entrance into preselected rehab programs. Four of the five defendants — in California, New Jersey and Maryland — were charged with conspiracy to commit health care fraud. Three have since pled guilty to those charges and await sentencing.
One of the defendants was Dr. Akikur Mohammad, who was charged with conspiracy to violate the Eliminating Kickbacks in Recovery Act for his role as the owner/operator of a rehab facility paying referral fees to bring in patients. According to the information provided as part of the guilty plea, Mohammad engaged in a series of fraudulent bribes from late 2018 through late 2019 to direct patients to his rehabilitation center referenced as "Drug Treatment Center-1."
Throughout California, New Jersey and Maryland, Mohammad and the co-conspirators orchestrated a patient recruitment and brokering scheme that would incentivize particular marketing companies for directing patients to Mohammad's clinic. Across the nation, the marketing firm identified and flagged for Mohammad individuals with substance use and opioid use disorder who wished to enroll in care at a facility.
Prior to admittance, Mohammad attempted to verify the prospective patients' insurance coverage in order to ensure a funding source for excessive and suspect services. Patients deemed to be potentially profitable were brought from across the country to the Agoura Hills, California, facility.
Based upon the number of patients referred and the profitability of those entering treatment — based on level of treatment and health insurance coverage — Mohammad paid, on average, $5,000 per referral. Those employed by the marketing company were alleged to receive approximately 50% of the referral fee. It was alleged that Mohammad profited nearly $500,000 from health insurers based upon the illegal brokering activity.
Under Title 18 of the U.S. Code, Section 220, knowing and willful violation of EKRA — concerning the "[payment or receipt of] remuneration for referrals to recovery homes, clinical treatment facilities, and laboratories" — can result in no more than a $200,000 fine or 10 years imprisonment for each instance.
For these particular crimes, Mohammad faces a January sentencing date with the potential maximum penalty of five years imprisonment and a $250,000 fine — or twice the gross gain/loss from his actions.
The use of EKRA in enforcement actions against health care providers has been limited to-date with the only other prosecution occurring earlier this year.
In January, U.S. Attorney for the Eastern District of Kentucky Robert Duncan Jr. charged Theresa Merced with one count of violating EKRA amongst others for her role in soliciting kickbacks totaling $4,000 from a toxicology lab for referrals of urine drug tests. Merced subsequently lied to investigators and attempted to conceal her wrongdoing in altering the lab's financial records.
Why This Matters and Where to Go From Here
In late September, a multiagency, nationwide initiative led by the U.S. Department of Justice brought charges against nearly 350 individuals thought to be responsible for more than $6 billion in health care fraud. These efforts were launched as a continuation of the DOJ's ongoing commitment to addressing health fraud and the nation's opioid epidemic.
In particular, the takedown targeted more than a dozen individuals for their roles in patient brokering or fraudulent testing related to substance use disorder and opioid use disorder recovery totaling more than $845 million, including one of the largest sober home-related arrests in history. Defendants were found to have engaged in body brokering, illegal kickback schemes, fraudulent billing and unnecessary prescribing of controlled substances.
It is often difficult to access evidence-based treatment for substance use disorders, with 2.1 million receiving care in 2019 out of an estimated 21.6 million in need of care, according to the Substance Abuse and Mental Health Services Administration's 2019 National Survey on Drug Use and Health.
However, it remains clear, based upon the scope and significance of the DOJ's takedown, that the issue of substance use disorder and opioid use disorder treatment fraud remains a pervasive threat to ensuring public health and patient safety. EKRA can play a critical role in thwarting the diversion of individuals seeking treatment from entering programs that operate based upon referrals and volume, as was the case with Mohammad.
By more clearly defining illegal remunerations and those covered within the scope of EKRA, the law may effectively serve as an effective deterrent and enforcement tool alongside other fraud against federal health programs — such as Title 42 of the U.S. Code, Section 1320 — and can be enforced against those found seeking to illegally profit from substance use and opioid use disorder treatment-related services.
Looking ahead, opportunities exist for greater leverage of EKRA to identify and prosecute fraudulent actors and ensure that patients are not drawn away from the care they rightly deserve.
If the early numbers are any indication, the U.S. faces a rising tide of substance use disorder and opioid use disorder diagnoses stemming from the pandemic. Levers such as EKRA exist and can be used to mitigate some of these risks by effectively targeting and shutting down body brokers and others in the treatment industry that place profits above patients.
EKRA is a critical and, regrettably, an underused tool for removing the fraudsters who are profiting off vulnerable people and putting lives at risk. Looking ahead, it remains critical that law enforcement and allied partners identify barriers to EKRA enforcement amid and post-COVID-19 where we anticipate a continued need to ward off fraudulent actors.
As we face a potentially significant influx of Americans seeking treatment for substance use disorder and opioid use disorder, EKRA remains available to law enforcement to clamp down on those not seeking to provide care and risk worsening the epidemic.
Michael Adelberg is a principal and Matthew Rubin is a director at Faegre Drinker Biddle & Reath LLP.
Melissa Garrido is a research associate professor at Boston University.
Kiersten Strombotne, an assistant professor at Boston University, contributed to this article.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the organizations, their clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
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 See supra 6.
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