Subject: Practice Success

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June 23, 2023
Dear Friend,

How not to boost Medicare reimbursement. 

That's the topic of this past Monday's blog post, A Bitter Pill: Pharmacy Settles FCA Claim. Physicians Can Suffer Side Effects. You can follow the link to read the post online, or just keep reading for the rest of the story.

On June 16, 2023, the U.S. Department of Justice announced the settlement of civil allegations arising from two related whistleblower lawsuits in which the government intervened.

The reported facts are in part odd and in part common. In any event, they should be highly interesting to you.

Pursuant to the settlement, two Jacksonville, Florida compounding pharmacies, Smart Pharmacy, Inc., and SP2, LLC, and their owner, Gregory Balotin, will pay a minimum of $7.4 million to resolve lawsuits filed in Jacksonville, Florida, alleging they violated the False Claims Act. Note that as is the case in any civil settlement, the claims asserted against the defendants are allegations only, and there has been no determination of liability.

The Odd Allegation

The odd allegation resolved in the settlement was that the defendants violated the False Claims Act by adding the antipsychotic drug aripiprazole to topical compounded pain creams to boost reimbursement.

Both Medicare Part D and TRICARE reimburse pharmacies for the individual ingredients included in compounded drugs.

The government alleged that, to increase their profit from those federal programs, the defendants crushed aripiprazole pills approved for oral use for psychological conditions such as schizophrenia and Tourette’s disorder and included them in compounded creams used topically for pain treatment, while knowing that there was not an adequate clinical basis to do so.

The DOJ’s announcement does nothing to satisfy several curious issues:

1. Were the medications adulterated in the sense that the underlying prescriptions didn’t (somehow) call for aripiprazole to be compounded into the creams?

2. Antipodally, did physicians actually write prescriptions for an antipsychotic drug to be added into a pain medication, and, if so, why?

3.Did the alleged scheme morph compounding pharmacies into pharmaceutical manufacturers?

The Common Allegation

The common allegation resolved in the matter, “common” in the sense that it’s far less mind blowing than the first allegation and that it likely occurs on a frequent basis, was that the compounding pharmacies improperly waived patient copayments to induce patients to accept the pain cream prescriptions.

Although copayments may be waived in certain circumstances, such as on the basis of an individualized assessment of a patient’s financial hardship, the defendants allegedly routinely waived copayments without regard to patient need.

Thoughts and Takeaways for You

1. Just because you don’t run a compounding pharmacy doesn’t mean that the allegation of adding an “ingredient” to bump up reimbursement doesn’t constitute a lesson for you. The compliance hall of shame is jamb packed with physicians who’ve routinely packed on completely analogous tests and procedures, for example, those who’ve urine tested (at their own labs) every patient who can pee, to bump up reimbursement.

2. Compounding pharmacies greatly contribute to patient care. The problem is that compounding compounds compliance issues. Because compounding is supposed to start with a prescription, compounding schemes and scams, especially when involving a telemedicine component, can pull unwitting, or perhaps witting, physicians into the mix. That is, until they cream out as co-conspirators, if not “just” for unprofessional conduct and, perhaps, the unlicensed practice of medicine in some foreign state.

3. Although you might stay miles away from anything related to compounded medication, the waiver of co-pay issue haunts many medical groups and other providers. Although most often thought of in relation to government reimbursement programs, waivers also implicate issues of insurance fraud in regard to commercial plans: Accepting $80 from a carrier together with $20 from Patient X, for a total reimbursement of $100 is one thing, but routinely waiving the $20 is easily seen as creating a claim “worth” only $80 for which the carrier alleges you defrauded it out of $16.

4. The original allegations underlying the government’s case in the lawsuit discussed above arose from two whistleblower actions filed, respectively, by Amy Sanchez and Ashok Kohli, two former employees of Smart Pharmacy. Beware of creating your own whistleblowers.
Wednesday - Physician Found Guilty on All Charges Stemming From Re-Use of Single-Use Medical Devices - Medical Group Minute

Watch the video here, or just keep reading below for a slightly polished transcript:

Although neither you nor I could hear the bars clank closed, Anita Louise Jackson, M.D.'s. current practice address is the cell in which she's being held pending formal sentencing.

Although indictments are often full of hot air, the January 5, 2022, indictment of Raleigh, North Carolina ENT Anita Louise Jackson, M.D. on multiple counts centering around her re-use, in more than 1,400 cases, of single use balloon sinuplasty devices [see Whether or Not Balloon Sinuplasty Indictment is Hot Air, its Lessons Apply to You] ended up in her January 27, 2023, conviction on all counts in the final indictment:

Count 1 – Device Adulteration 21 U.S.C. § 331(k), 21 U.S.C. § 333(a)(2) and 21 U.S.C. § 35l(a)(2)(A);

Counts 2-11 – Illegal Remunerations 42 U. S. C. § 1320a-7b(b)(2)(B) and 18 U. S. C. § 2;

Counts 12-14 – Making False Statements Relating to Health Care Benefits 18 U.S.C. § 1035(a)(2);

Counts 15-16 – Aggravated Identity Theft 18 U.S.C. § 102A(a)(1);

Counts 17-19 – Mail Fraud 18 U.S.C. § 1341;

Count 20 – Conspiracy 18 U.S.C. § 371.

At trial, it was shown that between 2011 and the end of 2017, Jackson preformed 1,555 balloon sinuplasty surgeries using the Entellus XprESS device on 99 Medicare beneficiary patients.

The Entellus XprESS device is cleared by the FDA to be used only on one patient, during one surgery. After that, the device must be discarded. However, the evidence showed that between 2012 and 2017, Jackson obtained, at most, 36 new Entellus devices, and that Jackson misled and did not inform her patients that they were receiving a procedure with an adulterated device. Jackson admitted on cross-examination that she had sufficient money to buy every patient a new device but chose not to do so.

Jackson induced patients to come to the office for a “free” sinus spa, and to receive a treatment they may not need, or may not have agreed to, had the full out-of-pocket cost to the patient been disclosed.

In an effort to continue obtaining patients for the procedure, Jackson wrote-off, or otherwise hid, the full cost of the procedure on any bills sent to the patient after their visit to her North Carolina practice, Greater Carolina Ear, Nose, and Throat. The patient portion of the sinuplasty surgery could be as high as $1,500 for Medicare beneficiaries, which the jury found was not disclosed to patients.

In some cases, she induced patients by not collecting co-pays, and was convicted on 10 counts of that behavior.

Jackson was also convicted of three counts of making false statements relating to health care benefits, two counts of aggravated identity theft, and three counts of mail fraud.

Between 2017 and 2018, Jackson became the subject of three audits by Medicare contractors. The jury found that she fabricated medical records supplied to auditors in an effort to keep more than $1.7 million that had already been paid to her by Medicare.

She was also convicted of two counts of aggravated identity theft counts related to the defendant’s knowing use of forged patient signatures on documents in which patients allegedly declared that they received surgeries from the defendant, and that they needed them.

Her mail fraud convictions pertained to her fraudulent use of fake medical records to deceive auditors, and to deceive a fellow ENT physician who was tricked into signing a sworn statement that her medical documentation supported her prior balloon sinuplasty surgeries.

The defendant was also convicted of conspiring with her staff to commit device adulteration, to pay illegal remunerations, to make false records, and to commit mail fraud.

Jackson faces a maximum term of imprisonment of 20 years for mail fraud, 10 years for paying illegal remunerations, and 5 years for conspiracy and making false statements, and three years for adulteration with the intent to defraud or mislead. Aggravated identity theft carries a 2-year mandatory prison sentence, consecutive to any other punishment. Jackson also faces fines exceeding $250,000.

Additionally, the jury ordered forfeiture in the amount of $4,794,039.31.

The Obvious and More Esoteric Lessons for You

1. Don’t adulterate devices or other items and then use or supply them as unadulterated.

2. Don’t subsequently lie about the bona fides of the devices or items.

3. Don’t bill for items that were not provided.

4. Don’t routinely write-off Medicare patient balances or even present Medicare patients with false bills that indicate no or a falsely low co-pay.

5. Don’t use template, or even worse, cloned medical records to support your claims, even if the services were completely, properly, and ethically performed.

6. Don’t falsify records and signatures or the date on which they were obtained.

7. Don’t lie to federal auditors.

And, perhaps the most important, don’t set yourself up to go to prison by thinking you are setting the government up to overpay you.
Listen to the podcast here, or just keep reading for the transcript.

I went to a food fair. You know, one of those "Taste of Fill-In-The Blank" fairs where restaurants of all sorts sell sample size versions of their food.

The whole idea for the restaurants is to get people interested in coming to their real place. They are never going to make any real money selling samples for $3.

Most of the restaurants sold their samples from booths. A few had fancy trailers with their names emblazoned on them. But the booths were really plain, like the kind at an elementary school fair that sells hot dogs or at which you lob a ping pong ball to try to get it into a fishbowl to win a goldfish. (It might not be PC to do that anymore but you are probably old enough to remember back to when it was OK to think the way you wanted to.)

Anyway, these restaurants must have paid a lot to rent space at the "Taste of" and in some cases they probably didn't make much or any profit at the $3 price tag. But what hit me is that while the booths had the restaurants' names on them, only a handful of them out of probably a hundred had their address. Good food? Check. Smiling faces? Check. Want to actually go to their restaurant and pay more for a whole lunch or dinner? Check. But where in heck are they located??!!

What are you doing to let people know where to find you?

You're probably not doing doctoring at the local "Taste of" or even at a health fair, but what I mean is what are you doing so that potential new facilities or potential new referral sources or potential new patients can find out about you and where you are located? Even if you're an employee of some hospital or large medical group, how can potential other employers find out about you?

What are you doing to advertise your fare?

Right now, it's time for dinner. I had a really great lamb in pita sandwich at the fair. Was it a Greek restaurant stand? Or maybe it was Turkish? I know I might be able to find it. Or not. I guess I'll just go to have pizza down the street. I know where that place is.
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