Compounding pharmaceuticals, specific drugs for specific patients, offers tremendous benefit. The problems arise when the benefit is for the prescribing physician.
Tag: prescribe
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.
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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
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.
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Mark F. Weiss
I’m on my way to work. The speed limit on this road is 40. I’m not going to tell you how fast I’m going, but I will say that I’m going with the flow of traffic.
For argument’s sake, let’s assume what you already think: we’re all going a lot faster than 40 mph. Let’s also assume a policeman pulls over the guy in the silver Honda in front of me.
Do you think that Mr. Honda Driver will be successful arguing his way out of a ticket by exclaiming, “but, officer, everyone is speeding!”
Nope, that’s not going to work.
Even if that sort of argument were to work later in front of a judge, Mr. Honda Driver is still going to spend his day in court, and, depending on how far he’s willing to fight until he settles or gives up, hire a “speeding ticket defense lawyer.” And, then there’s the cost of increased car insurance when the ticket hits his driving record.
So, even if he wins, there’s a transaction cost to speeding, potentially a heavy one.
Most people understand that.
But yet, so many people – physicians and business people – engaging in arrangements involving sophisticated federal and state anti-kickback issues and self-referral issues, often simply point to someone else who’s doing what they claim is the same thing, as if that makes it acceptable.
“Everyone is giving up something for referrals.” “My friend from residency says that his group makes a fortune by doing it.” “No one is going to find out because people do it all the time.” “The hospital says we can do it, and they have a department full of lawyers.”
In other words, they point at all the other speeders.
Let’s, for the moment, give the others the benefit of the doubt: Even if it’s true that they are doing the same thing, it’s essential to remember this all-so-true adage in terms of healthcare compliance: “If you’ve seen one deal you’ve seen one deal.”
You don’t know if that deal was properly structured. And, if it were, you don’t know if the pivotal reason why the deal does work applies to your situation.
These days, unfortunately, physicians and other healthcare providers and their ventures have targets painted on their backs in terms of prosecution. There are federal, state, and even local law enforcement task forces aimed at healthcare fraud. Prosecutors are using new tricks to turn state crimes into federal ones. And, the transaction cost of defending against charges related to a questionable deal can easily exceed $500,000 or even $1 million, plus the attendant months or years of limbo, and the damage to your practice, reputation, and business while the wheels of justice turn slowly.
At the same time, changes in healthcare, especially in terms of new ventures that take advantage of the The Impending Death of Hospitals, bring tremendous opportunity to those willing to pursue it.
In pursuing those opportunities, you must think twice, no, thrice, about how those new ventures and other relationships are structured. If not, you’re inviting whistleblowers – enemies, jilted potential partners, former employees and observers – to simply drop the dime on you or even to file a claim against you under the False Claims Act.
Don’t skimp and save, trying to avoid an expense, when it might just be that the only place you have to spend it is in the federal prison commissary.
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Mark F. Weiss
Compounding pharmaceuticals, specific drugs for specific patients, offers tremendous benefit. The problems arise when the benefit is for the prescribing physician. Then, we’re dealing with analyses under the federal Anti-Kickback Statute (AKS), the Stark Law, and their state law counterparts.
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Mark F. Weiss
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This past week, the U.S. Department of Justice announced the arrest of ten additional defendants – doctors, pharmacy owners, and marketers – charged in connection with an alleged $100 million compounded pain and scar cream scam on TriCare.
The ten join two other defendants charged in the same scheme earlier this year.
The government alleges that the scheme involved the payment of kickbacks by the owners of a marketing/compounding pharmacy business to TriCare beneficiaries, to prescribing physicians, and to marketers.
The illegal payments to TriCare beneficiaries were said to be disguised as “grants” for participating in a (nonexistent) medical study. The government reported that the true purpose of the “study” was to compile a list of TriCare beneficiaries who had filled prescriptions so that the defendants could calculate how much to pay the beneficiaries.
A physician defendant served as the “Chief Medical Officer” for the marketing company and designed the so-called study. Another physician defendant was alleged to have been paid to prescribe compounded drugs to the TriCare beneficiaries. He wrote thousands of prescriptions for compounded drugs for patients he never met in person and for whom he conducted only a cursory consultation via telephone.
The government alleges that the compounding pharmacies paid kickbacks, disguised as employee wages, to individual defendants involved in the scheme in return for the referral of the pain and scar cream prescriptions.
Each of the defendants is charged with one count of conspiracy to commit health care fraud, which carries a maximum statutory penalty of 10 years in federal prison and a $250,000 fine.
Two of the defendants were also each charged with 14 counts of payment and/or receipt of illegal remuneration. Most of the remaining defendants were charged with at least one count of payment and/or receipt of illegal remuneration. The maximum statutory penalty, upon conviction for each of those counts is five years in federal prison and a $250,000 fine.
The court also has the power to order restitution of ill-gained profits, and the government has alleged the right to cause the defendants, upon conviction, to forfeit to the U.S. any property traceable to the offense, including real estate, funds in bank and investment accounts, numerous vehicles, boats and recreational vehicles, firearms, jewelry and artwork.
With lots of money at play (the government claims that more than $100 million was lost to the scamsters) it’s not hard to see how many who might otherwise have legitimate business and medical practice interests become attracted to fast and easy money.
With lots of money at play, it’s not hard to see why the government is motivated to investigate and prosecute in order to obtain huge fines and the benefit of the forfeiture (generally to the investigating agency) of scores of millions of dollars.
The take-away for you:
There are many legitimate ways for physicians to increase their practice income. They include, depending on state law, investments in compounding pharmacies and the direct dispensing of pharmaceuticals.
But any deal must be structured in compliance with the federal Anti-Kickback Statute, Stark, and various state law counterparts and other restrictions.
Go ahead, I encourage you, think entrepreneurially. But please be smart about it.
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Mark F. Weiss
I know. In light of tons of illegal profits, complying with the federal anti-kickback law (“AKS”) is a hard sell.
Podcast: Play in new window | Download
I know. In light of tons of illegal profits, complying with the federal anti-kickback law (“AKS”) is a hard sell.
But, it’s easier than a prison cell. And better than paying a $125 million fine.
The U.S. sales arm of pharmaceutical manufacturer Warner Chilcott agreed last week to plead guilty to felony charges of health care fraud including violation of the AKS. To resolve both criminal and civil liability, the company is paying $125 million.
Several individual defendants have plead out, too. Others, including the company’s former president as well as a physician who received remuneration from Warner Chilcott have been indicted. They’re looking at significant jail time.
Warner Chilcott plead guilty to paying kickbacks to doctors to encourage them to prescribe its medications. Those payments were in connection with “medical education events” and speaker programs. Held at expensive restaurants, the programs involved little or no actual education. Paid speakers often didn’t speak about any clinical or scientific topics, but were paid from $600 to $1,200 for each presentation. According to the government’s allegations, the company told some speakers they would not be paid for additional events unless they prescribed more medication.
Things For You To Think About
If you were plumbers, not physicians or pharmacists or physical therapists, there’d be nothing wrong with a plumbing fixture manufacturer taking you out to dinner at Chez Milliard Euros or paying you $600 to speak for five minutes at a meeting.
But you’re not plumbers and we’re talking healthcare not hot tubs, so it could mean jail.
The time to analyze your “business opportunity” is not when you’re waiting for the bail bondsman or when you’re planning your defense. It’s upfront.
Sure, you might be out $1,200 for a speech consisting of “thank you very much,” or still hankering for a bottle of Chateau Lafitte 1982. But you won’t have to be worrying about doing jail time, paying astronomical fines, or losing your medical license.
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Mark F. Weiss
