(September 26, 2019):
Over the past year, both State and Federal law enforcement investigators and prosecutors have gone to considerable lengths to publicize the government’s fight against opioid abuse. While much of this fight has focused on the manufacturers of prescription opioid products, the improper prescribing practices of physicians and other medical professionals found to be prescribing these drugs “without any legitimate purpose and outside the usual course of professional practice”
have been repeatedly highlighted in criminal prosecutions by U.S. Attorney’s Offices around the country. A recent case against a Philadelphia-area cardiologist provides a classic example of how improper opioid prescribing practices can lead to criminal prosecution, civil penalties AND severe administrative sanctions (in this case, exclusion from participation in Federal health care programs). The article examines how the cardiologists was identified and steps you should take to reduce your level of risk in this regard.
I. Background of the Case:
Like many big cities, Philadelphia has a problem with illegal drugs. Despite the city’s efforts to curb illicit drug use, unintentional drug overdoses have steadily grown since 2010 and have only slightly tapered-off from their all-time high since 2017.
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While the percentage of opioid-related deaths changes from quarter to quarter, it is estimated that approximately 80% of all unintentional drug deaths in Philadelphia are due to opioid misuse and overdose. In response to the opioid abuse crisis in Philadelphia and other areas of the country, a multi-agency team of Federal and State investigators and prosecutors, known as the Medicare Fraud Strike Force
(Philadelphia Strike Force) has been targeting physicians, nurse practitioners and other medical professionals who have been improperly prescribing and / or distributing opioids. In this particular case, the prescribing practices of this Philadelphia cardiologist (defendant) were identified by the Philadelphia Strike Force as warranting further review. Upon investigation, the government alleged that from 2016 to 2018, the defendant wrote a number of prescriptions for oxycodone and / or benzodiazepine to patients without a legitimate medical purpose.
In light of the allegations presented, the U.S. Attorney’s Office pursued both civil and criminal claims against the cardiologist. It is important to keep in mind that the Department of Justice has long instructed its prosecutors to pursue parallel criminal and civil actions against a defendant, when appropriate. As Title 9, Section 27 of the Justice Manual
“Department policy is that criminal prosecutors and civil trial counsel should timely communicate, coordinate, and cooperate with one another and agency attorneys to the fullest extent appropriate to the case and permissible by law, whenever an alleged offense or violation of federal law gives rise to the potential for criminal, civil, regulatory, and/or agency administrative parallel (simultaneous or successive) proceedings. By working together in this way, the Department can better protect the government’s interests (including deterrence of future misconduct and restoration of program integrity) and secure the full range of the government’s remedies (including incarceration, fines, penalties, damages, restitution to victims, asset seizure, civil and criminal forfeiture, and exclusion and debarment).” (emphasis added).
The Justice Manual guidance further notes that:
“Courts have recognized that “[t]here is nothing improper about the government undertaking simultaneous criminal and civil investigations“ provided that we use those proceedings and associated investigative tools for their proper purposes and in appropriate ways.” (emphasis added).
II. Criminal Prosecution for Violations of 21 USC §841(a)(1) and (b)(1)(C):
In March 2019, the defendant pleaded guilty to eight felony counts of the unlawful distribution and dispensing of a controlled substance, in violation of 21 USC §841(a)(1) and (b)(1)(C). The defendant’s sentencing is scheduled to take place later this year. As a result of the criminal conviction, the defendant may be sentenced to prison for a significant period of time AND assessed criminal fines for his unlawful conduct.
III. Civil Liability under the False Claims Act, 31 USC §3729:
Notably, it does not appear that the defendant entered into a “global” settlement at the time he decided to plead guilty to the criminal charges discussed above. As a result, any civil and / or administrative actions that the government might choose to pursue remained active. On July 1, 2019, the defendant agreed to enter into a False Claims Act settlement with the government and pay $107,584
in penalties and damages to the government.
IV. Administrative Actions Taken Against the Defendant:
As part of his civil settlement reached with the government, the defendant cardiologist agreed to:
- Surrender his medical license and Drug Enforcement Administration Certificate of Registration and further agreed not to seek to renew or reinstate either one in the future.
- Be excluded from participation in Federal Health programs.
As HHS-OIG’s records reflects, the defendant was excluded from participation in Federal health care programs on July 18, 2019. The basis for exclusion cited by the government is Section 1128(b)(6) of the Social Security Act – Quality of Care.
As you will recall, under Section 1128 of the Social Security Act, if an individual or entity is convicted of certain crimes, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) is required by law to exclude the individual or entity from participation in Federal health care programs. These types of actions are referred to as “Mandatory Exclusions.” The bases for imposing a mandatory exclusion are set out in Section 1128(a)(1) through Section 1128(c)(3)(G)(ii). In contrast to mandatory exclusion actions, there are also a number of “Permissive Exclusion” authorities that may be used (at the agency’s discretion) by HHS-OIG to bar an individual or entity from participating in Federal health benefit programs. The permissive exclusion authorities that may be exercised by HHS-OIG are covered in the Social Security Act from Section 1128(b)(1)(A) through 1128(b)(16). HSS-OIG may also exercise its permissive exclusion authority under Social Security Section 1156, if a provider fails to meet its obligations to provide medically necessary services that meet the professional recognized standards of care.
In this particular case, HHS-OIG chose to exercise its permissive exclusion authority under Section 1128(b)(6) of the Social Security Act – Quality of Care. This particular basis for excluding an individual or entity can be assessed if a defendant or target is alleged to have submitted:
“Claims for excessive charges, unnecessary services or services which fail to meet professionally recognized standards of health care, or failure of an HMO to furnish medically necessary services.”
Under this statutory provision, an individual or entity can be excluded for a minimum period of one year. In light of the allegations presented, the defendant cardiologist was excluded from participation by HHS-OIG for a total of seven years.
V. Impact of Medicare Exclusion on the Defendant’s Career:
As the case synopsis above reflects, Federal law enforcement prosecuted the defendant in this case to the full extent of their abilities. In addition to facing incarceration, the defendant was also assessed penalties and damages of more than $107,000 under the False Claims Act. While the criminal and civil actions taken against the defendant are quite serious, the cardiologist’s problems are further magnified by the fact that he has also been excluded from participation in Federal health care programs. At the end of the day, it is quite conceivable that the U.S. Sentencing Guidelines, the defendant’s criminal sentence will be relatively brief. Depending upon the terms of his civil / administrative settlement, he may be free to seek licensure in another state upon his release from jail.
VI. Final Thoughts:Even assuming that the defendant regains licensure in another state, the administrative exclusion action taken against him will effectively bar him from enrolling in Federal health care benefit programs for the entire period that he remains excluded. While excluded, he will not be eligible to work for any provider or supplier who participates in one or more Federal health care plans. Should a health care provider or supplier choose to employ the defendant (an excluded party), each of the claims submitted to Medicare, Medicaid and other government plans may be subject to significant civil monetary penalties.
How can you protect your practice? Consistent with your obligations under the law, it is imperative that you screen your employees, agents, contractors and vendors against all of the 43 exclusion databases currently in operation. Unfortunately, it is practically impossible for a medical practice or other entity to screen one or more of its employees against all 43 databases. Luckily, the folks at Exclusion Screening can take this time-consuming (and often frustrating) task off of your shoulders.
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The government’s Medicare Fraud Strike Force is primarily composed of Federal agents and investigators of the Department of Health and Human Services, Office of Inspector General (HHS-OIG) and the Federal Bureau of Investigation (FBI), along with Federal prosecutors working for U.S. Attorneys Offices around the country. First established in March 2007, the Strike Force has been instrumental in investigating and prosecuting cases of health care fraud, waste and abuse.