Compounding pharmaceuticals, specific drugs for specific patients, offers tremendous benefit. The problems arise when the benefit is for the prescribing physician.
Tag: drug
In a turn of events that’s surprising to some but was expected to happen by those well versed in television crime dramas and real life federal prosecutions, former CEO Michael Babich pleaded guilty last week to charges related to the plethora of kickback allegations surrounding Insys Therapeutics, Inc., and its fentanyl drug, Subsys.
On Thursday, June 28th, the DOJ and HHS announced the largest ever health care fraud enforcement action. It resulted in charges against 601 defendants across 58 federal districts, including 165 doctors, nurses and other licensed medical professionals, for their alleged participation in health care fraud schemes involving more than $2 billion in false billings.
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Mark F. Weiss
Ride along with Mark as he discusses the recent indictment of a slew of doctors and pharmacists for pushing millions of oxycodone pills. But what’s great law enforcement has a chilling impact on the legitimate practice of pain medicine.
Comment or contact me if you’d like to discuss this post.
Mark F. Weiss
On Thursday, June 28th, the DOJ and HHS announced the largest ever health care fraud enforcement action. It resulted in charges against 601 defendants across 58 federal districts, including 165 doctors, nurses and other licensed medical professionals, for their alleged participation in health care fraud schemes involving more than $2 billion in false billings.
The cases were coordinated by the Medicare Fraud Strike Force, a partnership between the DOJ’s Criminal Division, U.S. Attorney’s Offices, the FBI and HHS-OIG. Other federal and state agencies participated.
The prosecutions have a heavy opioid/dangerous narcotics focus: Of those charged, 162 defendants, including 76 doctors, were charged for their roles in prescribing and distributing those drugs.
Importantly, in addition to targeting schemes billing Medicare, Medicaid, and TRICARE, the feds also went after defendants who focused on billing private insurance companies for medically unnecessary prescription drugs and compounded medications that often were never even purchased and/or distributed to beneficiaries.
The defendants allegedly participated in schemes to submit claims for treatments that were medically unnecessary and often never provided. Patient recruiters, beneficiaries and other co-conspirators were allegedly paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could then submit fraudulent bills to Medicare.
The federal investigation was coordinated with a number of states’ Medicaid Fraud Control Units. As a result, in the states of Arizona, Arkansas, California, Connecticut, Delaware, Florida, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, Nevada, New York, Oklahoma, Pennsylvania, Texas, Vermont, and Washington, 97 defendants were charged with defrauding the Medicaid program out of over $27 million.
From the many examples of alleged facts in the DOJ announcement:
- An indictment in a compounding pharmacy fraud case alleges an attorney/marketer paid kickbacks and offered incentives such as prostitutes and expensive meals to two podiatrists in exchange for prescriptions written on pre-printed prescription pads, regardless of the medical need for the prescriptions. Once the prescriptions were filled, members of the conspiracy submitted approximately $250 million in fraudulent claims to federal, state, and private insurers for the compounded drugs.
- In another case, defendants are a pharmacy chain owner, managing partner, and lead pharmacist charged with a drug and money laundering conspiracy. According to the indictment, the coconspirators used fraudulent prescriptions to fill bulk orders for over one million pills of hydrocodone and oxycodone, which the pharmacy, in turn, sold to drug couriers for millions of dollars.
- A prosecution alleges a home health fraud and kickback conspiracy which resulted in more than $6.2 million paid by Medicare based on fraudulent billings.
- A physician/owner of a pain management clinic was charged with unlawfully prescribing more than two million dosage units of Oxycodone.
- Twelve defendants, including five medical professionals, were charged in various schemes involving health care fraud, unlawful distribution of controlled substances, aggravated identity theft, and money laundering. One of the schemes involved the operation of two false-front medical clinics.
The feds also announced that since this time last year, they excluded 2,700 individuals from participation in Medicare, Medicaid, and all other Federal health care programs, of whom 587 were excluded for opioid diversion and abuse. Over the past fiscal year, the DOJ has won or negotiated over $2 billion in judgments and settlements related to matters alleging health care fraud.
For those interested in the full press release, it can be found here. Additionally, documents (photos, links to indictments, and more) relating to the cases can be found here.
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Mark F. Weiss
Ride along while Mark discusses the expanding case involving Insys Therapeutics and kickbacks paid to induce prescription of its drug, Subsys.
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Mark F. Weiss
The federal Anti-Kickback statute makes it illegal to receive anything of value for the referral of federal health care program patients. How are you managing this potential pitfall?
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Mark F. Weiss
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On October 25, 2017, another physician, Jerrold Rosenberg, M.D., pleaded guilty to charges related to the plethora of kickback prosecutions emanating from Insys Therapeutics, Inc., and its fentanyl drug, Subsys.
Couch and Ruan Sent to Prison
In February of this year, I wrote in my post Pain Medicine Doctors Alleged to Have Received $115,000 in Kickbacks … Plus $40 Million in Illicit Profit, about the cautionary tale of two Mobile, Alabama pain medicine doctors, Drs. John Couch and Xiulu Ruan, both then in the midst of their federal court trial for, as was then alleged, receiving $115,000 in kickbacks from Insys in connection with Subsys.
Among the allegations:
• That Couch and Ruan prescribed, and also sold through their owned pharmacy, large quantities of Subsys, based on misleading diagnoses, defrauding payors.
• That their profit of $40,000,000 from dispensing Subsys and other controlled substances was an illicit profit from a “pill mill.”
• That they received “speaking fees” from Insys based on the number of Subsys prescriptions they wrote.
Subsequently, Couch and Ruan’s trial moved forward to guilty verdicts and then to sentencing: Crouch was sentenced to prison for 240 months and Ruan received an even stiffer sentence, 252 months behind bars.
Neither of the Mobile, Alabama physicians currently reside in the state: Dr. Couch passes (or, does) time at the Federal Correction Institute in Forrest City, Arkansas, while Dr. Ruan enjoys the view from behind bars at the Federal Correction Institute in Oakdale, Louisiana.
In addition to their lengthy prison sentences, the duo was ordered to make restitution of $6,282,023.00 to Medicare, $3,649,092.97 to Blue Cross/Blue Shield of Alabama, $2,285,170.70 to Tricare, and $1,695,929.00 to United Heath Group.
Fanto, Seth, and Gingerich Indicted
In my post dated September 5, 2017, Drugs, Sentencing, and Lock (and Roll on to Another Kickback Prosecution), I wrote about criminal charges brought by the State of Arizona against three pain medicine physicians, Steve Fanto, M.D., Nikesh Seth, M.D., and Sheldon Gingerich, M.D.
The allegations: That the physicians collected sham educational “speaker fees” in exchange for writing prescriptions for Subsys.
The criminal complaint claims that from March 2012 to April 2017, more than $33 million, or 64 percent of Subsys sales in Arizona, came from prescriptions written by Fanto, Seth, and Gingerich.
In additional echoes of the Couch and Ruan prosecution, it was alleged that Drs. Fanto, Nikesh, and Gingerich gave insurers false and misleading information, including that patients had cancer when they did not, to obtain prior authorization for Subsys prescriptions.
Rosenberg Pleads Guilty
And now, in the most recent echo of Subsys “addiction” (addition, that is, to illegally gained money), Jerrold Rosenberg, M.D., a Providence, Rhode Island physiatrist, pleaded guilty last week to federal charges that he committed healthcare fraud and conspired to receive kickbacks in the form of “speakers fees” from Insys in order to induce him to prescribe Subsys.
In their case against Dr. Rosenberg, the United States Attorney General’s office alleged that between 2012 and 2015, he entered into an illegal scheme to take kickbacks from Insys. Specificially the payments were disguised as speaker’s fees from Insys. The “fees” were then a major factor in Rosenberg’s decision to prescribe Subsys to patients.
In an echo of the charges brought against Drs. Couch and Ruan, it was also alleged that Dr. Rosenberg upped his prescriptions of Subsys by fraudulently representing to insurers that his patients suffered from cancer pain when they did not.
Dr. Rosenberg is set to be sentenced to prison in January. Pursuant to a plea deal, the now 63 year old physician could spend up to the next 15 years in prison, perhaps actually a life sentence.
He also agreed to pay $754,736 in restitution to healthcare benefit programs.
Insys Executives Indicted
Just so that you don’t think that physicians were the only targets of Insys/Subsys related prosecutions, in December 2016, the federal government indicted a slew of now-former Insys executives for conspiracy to commit racketeering, mail and wire fraud, and conspiracy to violate the anti-kickback law, relating to what the U.S Attorney alleges was a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe Subsys and defraud payors.
The indicted executives are Michael L. Babich, the former CEO and President of Insys Therapeutics, Alec Burlakoff, the former Vice President of Sales, Richard M. Simon, the former National Director of Sales, Sunrise Lee and Joseph A. Rowan, both former Regional Sales Directors, and former Vice President of Managed Markets, Michael J. Gurry. Each pleaded not guilty to the charges.
Insys as Target
And, the company itself, Insys Therapeutics, Inc., has already paid $9.45 million to resolve state level investigations into the kickback-related affairs.
The Federal Anti-Kickback Statute and Other Prohibitions
In general terms, the federal Anti-Kickback Statute (“AKS”) prohibits the offer, demand, payment, and acceptance of remuneration—that is, of anything of value—for referrals
The federal government, and many courts, interpret the AKS to apply even when an arrangement may have many legitimate purposes; the fact that one of the purposes is to obtain money for the referral of services or to induce further referrals is sufficient to trigger a violation of the law.
State laws differ in their treatment, scope and interpretation, but generally contain similar provisions barring remuneration for referrals, sometimes expressed as anti-kickback or fee-splitting prohibitions.
In addition, federal laws such as wire fraud statues and the Travel Act turn what are “simple” violations (a huge simplification!) of state laws into federal criminal offenses. The federal Controlled Substances Act permits prescribing and dispensing only for legitimate purposes, not in respect of “pill mill” and other massive prescribing activities. Additionally, the federal statute of healthcare fraud makes it a crime to defraud a healthcare benefits program, including a commercial insurer.
The Takeaways for You:
1. Money: The are many legitimate ways for physicians to increase their practice income. They include, depending on state law, investments in pharmacies and the direct dispensing of pharmaceuticals.
2. Structure: But any deal must be structured in compliance with the federal Anti-Kickback Statute, the Controlled Substances Act, Stark, and numerous other federal laws, as well as with various state law counterparts and other restrictions. Your investment in structuring things correctly is an investment in yourself and your jail-free future.
3. Compliance Auditing: No matter how well structured, it’s essential that you engage in periodic compliance audits coordinated through legal counsel. Laws change and actual behavior impacts all of the structure and planning. Even the best planning can be made worthless if illegal conduct takes place within the context of what was planned to be a proper structure.
4. Investigations: If you learn that you (or any person or entity connected to the operation) are under investigation, immediately engage a team of experienced healthcare attorneys and criminal defense counsel. Many potential prosecutions are resolved at this stage.
5. Indictment and trial: Again, immediately engage a defense team of healthcare and criminal defense counsel.
Comment or contact me if you’d like to discuss this post.
Mark F. Weiss
Back in February of this year, I wrote in my post Pain Medicine Doctors Alleged to Have Received $115,000 in Kickbacks … Plus $40 Million in Illicit Profit, about the cautionary tale of Drs. John Couch and Xiulu Ruan, both then in the midst of their federal court trial for, as was then alleged, receiving $115,000 in kickbacks from Insys Therapeutics, Inc. in connection with its fentanyl drug, Subsys.
Among the allegations:
- That Couch and Ruan prescribed, and also sold through their owned pharmacy, large quantities of Subsys, based on misleading diagnoses, defrauding payors.
- That their profit of $40,000,000 from dispensing Subsys and other controlled substances was an illicit profit from a “pill mill.”
- That they received “speaking fees” from Insys based on the number of Subsys prescriptions they wrote.
As I commented then, the federal Anti-Kickback statute makes it illegal to receive anything of value for the referral of federal health care program patients. Wire fraud statues, the federal Travel Act and other laws turn what are “simple” violations (a huge simplification!) of state laws into federal criminal offenses. The federal Controlled Substances Act permits prescribing and dispensing only for legitimate purposes, not in respect of “pill mill” activities. Federal healthcare fraud makes it a crime to defraud a healthcare benefits program, including a commercial insurer.
Update
Over the ensuing months, Couch and Ruan’s trial moved forward to guilty verdicts and then to sentencing: Crouch was sentenced to prison for 240 months and Ruan received an even stiffer sentence, 252 months behind bars.
In addition, the duo was ordered to make restitution of $6,282,023.00 to Medicare, $3,649,092.97 to Blue Cross/Blue Shield of Alabama, $2,285,170.70 to Tricare, and $1,695,929.00 to United Heath Group.
And Another Subsys Prosecution
Just last week, the State of Arizona brought criminal charges in state court against three pain medicine physicians, Steve Fanto, M.D., Nikesh Seth, M.D., and Sheldon Gingerich, M.D., as well as against Insys and Insys executives.
The allegations: That the physicians collected sham educational “speaker fees” in exchange for writing prescriptions for Subsys.
The criminal complaint claims that from March 2012 to April 2017, more than $33 million, or 64 percent of Subsys sales in Arizona, came from prescriptions written by Fanto, Seth, and Gingerich.
In additional echoes of the Couch and Ruan prosecution, it’s alleged that Drs. Fanto, Nikesh, and Gingerich gave insurers false and misleading information, including that patients had cancer when they did not, to obtain prior authorization for Subsys prescriptions.
Once Again, the Takeaways for You:
1. Money: The are many legitimate ways for physicians to increase their practice income. They include, depending on state law, investments in pharmacies and the direct dispensing of pharmaceuticals.
2. Structure: But any deal must be structured in compliance with the federal Anti-Kickback Statute, the Controlled Substances Act, Stark, and numerous other federal laws, as well as with various state law counterparts and other restrictions. Your investment in structuring things correctly is an investment in yourself and your jail-free future.
3. Compliance Auditing: No matter how well structured, it’s essential that you engage in periodic compliance audits coordinated through legal counsel. Laws change and actual behavior impacts all of the structure and planning. Even the best planning can be made worthless if illegal conduct takes place within the context of what was planned to be a proper structure.
4. Investigations: If you learn that you (or any person or entity connected to the operation) are under investigation, immediately engage a team of experienced healthcare attorneys and criminal defense counsel. Many potential prosecutions are resolved at this stage.
5. Indictment and trial: Again, immediately engage a defense team of healthcare and criminal defense counsel.
We’ve established a strategic alliance with noted white collar defense attorney Lawrence Brown and his firm, Brown PC, in order to bring a wider set of skills and experience to select clients at the auditing, investigation and indictment/trial phase. Please contact me for additional information.
Comment or contact me if you’d like to discuss this post.
Mark F. Weiss
Oh what a tangled web they weave; multiple professionals caught up marketing an ineffective medicine in return for disguised kickbacks. If it sounds too easy and quick, think twice, don’t endorse unknown medicine to real people suffering with real pain.
Comment or contact me if you’d like to discuss this post.
Mark F. Weiss
