Subject: Practice Success

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February 10, 2023
Dear Friend,

Quick! How many times may you legally use a single-use medical device?

That's the subject of this Monday's blog post, Physician Found Guilty on All Charges Stemming From Re-Use of Single-Use Medical Devices. You can follow the link to read the post online, or just keep reading for the rest of the story.

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.

Tuesday - Think About Kickbacks. Then Think Again - Success in Motion

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

I was thinking about the indictment of a physician in connection with a compound pharmacy scam. I do a lot of work with compound pharmacy issues, including with physicians who prescribe compound medications.

It’s one thing to prescribe, but it’s another thing to get kickbacks in connection with those prescriptions. That might be obvious to you, but I promise you it's not obvious to everyone. 

The indictment involves a pain medicine physician who allegedly was prescribing compound medication creams regardless of whether the patients actually needed them or not. The motivation, per the indictment, was that the compounding pharmacy was making payments back to the physician.

Well, not exactly “back”. The payments where being made to a third-party entity, actually to a trust that was controlled indirectly by the same physician. 

If you're a frequent reader of my posts, you know that, in general, I think that the word "greed" is a loaded term, just like "fair share". Greed is often used to mean that someone thinks that you’re making too much so they want their "fair share" of it. On the other hand, there is really no other word than "greed", actual greed, to describe a situation in which someone is receiving cash kickbacks, here, disguised cash kickbacks, in exchange for prescribing compound medication, especially for patients who don't need it in the first place.

These illegal deals appear attractive because the physician who’s approached to receive the money becomes blinded by the dollar signs, say $20,000 to $40,000 a month. But if it sounds too good to be true, I can almost guarantee that it is.

It’s one thing to be aggressive. Many of my clients are aggressive. I don’t have a problem with that. But aggressive means coming up to the line; it doesn’t mean crossing it. 

If someone approaches you with one of these deals, think once, think twice, and then think trice. Get legal counsel in connection with the deal before you need criminal defense counsel because you did the deal.
Wednesday - Customer (Dis)Service - Medical Group Minute

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

Customers -- my clients generally refer to them as patients, but that doesn't make any difference -- expect service.  You might provide them with the world's best medical care, but if you piss them off they probably won't be back, and they will probably let others know about it.  If you piss them off before they even become customers, it's even worse.

So let me tell you a story.

Recently, I made a call in the course of looking for a new physician.  I was transferred from person to person three times within the multi-physician office before reaching the person who schedules appointments.  Each time I had to listen to the same recording about hanging up and dialing 911 if it were a medical emergency.

When I finally reached the scheduler, I gave her my name and told her that I had received Dr. X's name from my insurance carrier's online provider lookup, which indicated that he is taking new patients, and asked to make an appointment.

Her response: "Date of birth."  I said, "Excuse me?"  She deadpanned, "Date of birth."

My initial inclination was to say goodbye, but I was intrigued at how much worse it could get, so I gave her the information.  I suppose she was just trying to screen out Medicare patients contrary to all the warm and wonderful things it says about their group on their website.

She then informed me that Dr. X wasn't taking any new patients regardless of the fact that my carrier reports he is.  She told me my only choice was to see Dr. X's new associate, Dr. Y.  Wrong.  I had another choice --I hung up.

As I've written in other posts, this is the time for aggressive medical groups to grab the market.  I don't care how wonderful your claims of expertise are or even how wonderful your claims of  providing caring service are, if you can't properly treat your customers, whether present or potential patients, someone else will.  This is the case whether you're a solo office practice physician or the leader of a 100 member hospital-based group.

Think of it this way:  If you have to benchmark (although I hate the entire notion of benchmarking) don't benchmark to any other medical group.  Benchmark to the Four Seasons or Nordstrom.  If you don't get it, someone else will.
Listen to the podcast here, or just keep reading for the transcript.

Chasing down HIPAA violations isn’t just about enforcing compliance, it’s about the government collecting big bucks.

Earlier this year, the U.S. Department of Health and Human Services’ Office of Civil Rights (“OCR”), the branch charged with enforcement of HIPAA’s Privacy and Security Rules, settled with Florida-based Memorial Health System (“MHS”) for $5.5 million.

The charge? Alleged violations of the Privacy and Security Rules arising from the failure to properly control access to patients’ protected health information ("PHI”).

MHS operates six hospitals, an urgent care center, a nursing home, and a variety of ancillary health care facilities. It’s also affiliated with physicians’ offices through a HIPAA Organized Health Care Arrangement.

OCR alleged that the PHI of over 100,000 patients had been impermissibly accessed by MHS employees and impermissibly disclosed to affiliated physicians' office staff. Of those, 80,000 individuals’ PHI had been accessed by a single former employee whose login credentials hadn’t been terminated.

In a Success in Motion video, I previously discussed another OCR settlement, that one involving no alleged actual HIPAA breach, but only a potential breach.

That case involved Saint Elizabeth’s Medical Center, a hospital in Brighton, Massachusetts, that paid over $200,000 to OCR settle. The medical center’s employees were using hundreds of online applications to store or submit patients’ PHI. As a result PHI could have been disclosed.

In fact, it’s been reported that in the average large hospital setting there can be up to 900 cloud-based sharing apps being used by hospital employees. Who even knew there were that many cloud-based sharing applications!

The point here is that no matter what you think about HIPAA compliance, that it’s all make-work or even pure B.S., HIPAA is real and so is its enforcement.

Compliance with the Privacy and Security Rules takes both documentation and (surprise!) actual implementation.

And, it takes a large dose of introspection and auditing. What works in your particular instance, in the context of your ASC, other facility, or medical group? What is actually going on, day-to-day, in terms of PHI access and use among your employees, medical group partners, and subcontractors? Are their actions resulting in actual, or even in potential, HIPAA violations?

Compliance isn’t dry. It’s alive and active. And, the penalties for blowing it off or mistakenly blowing it are substantial.
Calibrate Your Compass

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The coronavirus crisis caused a short-term economic crisis for many medical groups. Our RedPaper shows you the way out. Plus, many of the concepts discussed are applicable during both good times and bad.


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We all hear, and most of us say, that the pace of change in healthcare is quickening. That means that the pace of required decision-making is increasing, too. Unless, that is, you want to take the “default” route. That’s the one is which you let someone else make the decisions that impact you; you’re just along for the ride. Of course, playing a bit part in scripting your own future isn’t the smart route to stardom. But despite your own best intentions, perhaps it’s your medical group’s governance structure that’s holding you back.
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