Subject: Practice Success

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November 20, 2020
Dear Friend,

Here's an oversized Federal Anti-Kickback Statute tip.

That tip's the subject of Monday's blog post, Medtronic Pays $9.21 Million Tip (Settlement)
For Meals at Surgeon's Restaurant
. Follow that link to the blog, or keep reading for the
entire post.

Over a nine-year period, Medtronic USA Inc., the mega-sized Minnesota-based medical device manufacturer, paid for over 100 events held at a Sioux Falls, South Dakota restaurant.

They must've loved the food and, of course, the service, because they've just left a $9.21 million tip. Well, not an actual tip, but a payment to settle alleged violations of the federal Anti-Kickback Statute and of the federal Open Payments Program.

According to the U.S. Government's allegations, Medtronic agreed to the requests of South Dakota neurosurgeon, Wilson Asfora, M.D., to pay for over 100 social events, including scores of expensive meals, at Carnaval Brazilian Grill, a restaurant Medtronic knew Dr. Asfora owned. The Government claims the sponsored events were social gatherings for which Dr. Asfora selected and invited his social acquaintances, business partners, favored colleagues, and potential and existing referral sources, with Medtronic picking up the tab.

Why? Well, the story as told by the Government is a familiar one: They allege that the events were payments to benefit Dr. Asfora and induce him to use Medtronic’s SynchroMed II intrathecal infusion pumps.

As you know, the federal Anti-Kickback Statute prohibits directly or indirectly offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, TRICARE, and other federal healthcare programs.

CMS’ Open Payments Program requires that device manufacturers such as Medtronic report their financial relationships with healthcare providers.

On October 29, 2020, the DOJ announced that Medtronic agreed to pay $8.1 million to resolve the AKS allegations related to paying kickbacks to Dr. Asfora, and that the company also agreed to pay an additional $1.11 million to resolve allegations that it violated the Open Payments Program by failing to accurately report payments it made to the neurosurgeon.
As is always the case in connection with settlements of this sort, the claims resolved are allegations only, and there has been no determination of liability.

Over the years, I've seen "disguised" AKS violations in all shapes and sizes, from demands for free services and free personnel to the payment of "rent" for storage cabinets to payments for speeches that lasted a few moments, if that. Are others so "disguised" that they haven't been discovered? I'm sure that's the case. But when they are discovered, there's hell to pay: violation of the AKS is a crime. People are in jail, right now, for violating it. And, violation of the AKS serves as the grounds for civil action under the False Claims Act, including those cases brought by whistleblowers, to recoup not only the amount of the related, tainted claims for federal health care program reimbursement but also treble damages plus five-figure per claim penalties.

Medtronic may have pushed away from the table, but the meal's not over for Dr. Asfora. He and two of his other companies are defendants in a separate False Claims Act lawsuit in which the U.S. Government filed a complaint in November 2019, alleging that Dr. Asfora received kickbacks to use certain implants in his spinal surgeries.
Business Life in the Time of Coronavirus Mini-Series 

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

[If you haven't already seen them, follow this link to watch our entire series.]


Watch Tuesday's video here, or just keep reading below for a revised, more polished transcript:

Let's talk about why you should be working like Richard Branson.

What do I mean by saying that? Well, a couple of things. 

First, as you may recall, back in April or so, Branson was pleading with the government for money to help keep his Virgin airline alive. He was going to lose it all unless he got public funding. 

Fast forward and Branson is apparently back on his feet. But he is still looking for money,
just in a different way. He's now looking for billions in connection with his space launch vehicle venture.

So, one thing about Branson is that the guy never quits. He may be down, but he's never out.

But that's not really the main point I want you to think about in connection with Mr. Branson. 

Branson owns hundreds of businesses. But Branson doesn't run any of the businesses. Branson hires people to run them for him. And most importantly, Branson hires people to work for him in those businesses.

Money like Branson's isn't made by doing. It's made by orchestrating those who do.

Now, in some professions, this is seemingly abhorrent. It's a manifestation of what I call the "colleagues disease". It's the thinking that all of one's coworkers are colleagues, that all should have input, and that all should have ownership. 

Well that's fine, but you're never going to break out of the box thinking like that. And even more certainly, you'll never break out of the box if all you are doing is the work itself

The work that you do as a physician is, of course, valuable. But it's not as valuable in terms of money, in terms of building a business empire large or small, as orchestrating those who do the doing.

Think about building something bigger for yourself.

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Wednesday - Let's Find the Cure for Surprise Physician Stealing

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

There is a crisis. But it's not the one you've
heard about.

It's time to fix that. It's time to change the conversation.

But to do that, you have to change the frame.

From the framers of the constitution, to the framing around that velvet Elvis, to what's in
and, therefore, what's out of a Robert Frank photograph, framing controls the point of
view. Framing, too, controls a conversation and, therefore, the argument, and, therefore,
the outcome.

Tucked away in the wallet of Merry Mittleklass, our avatar patient, is her Blue United Free From Worry Plan insurance card. She's been covered by Blue United for years, but had never (as she says, “Bless my stars!”) seen the inside of a hospital.

That is, until last Tuesday at 7:44 a.m., when she had surgery at Community Memorial St. Mark’s Hospital to repair a hernia.

Community Memorial St. Mark’s and the surgeon were in-network with Blue United. But the anesthesiology group wasn’t. And, so the story goes, Merry was “surprised” when she found out that Blue United had paid the group $200 and that she was “stuck” with a bill for the remaining balance, $1,375.

The popular press, the press of payors, and the populism of politicians all frame this as the out-of-network hospital-based group’s problem. Or, they allege with glee, a problem caused by the out-of-network physicians’ predatory practices.

The name for this frame? “Surprise medical billing”. The resulting cure? Force the group to take, as payment in full, an amount to which they never agreed, the so-called “average.”

But let’s take a closer look.

Earlier this year, the press was abuzz with coverage of the fact that UnitedHealth was not renewing its contracts with Mednax for services in 4 states because those agreements pay Mednax more than UnitedHealth now wants to pay. Come the termination dates, Mednax’s anesthesiologists and neonatologists will be out-of-network. Out-of-network wasn’t Mednax’s strategy. It’s just a fact. As a result, under the common frame, patients will be “surprised” . . . and it will be spun as Mednax’s fault; every one of their bills will be deemed a “surprise medical bill”.

Let’s take a look from another angle. Last week, a radiology group determined that the 80% cut proposed by payor X was unacceptable. (They actually used a different term.) They will not sign the offered contract nor is there any legal or moral reason for them to do so. They will soon be out-of-network, which wasn’t their strategy. It’s just a fact. As a result, under
the common frame, patients will be “surprised” . . . and, once again, it will be spun as the group’s fault.

One more view: Some group of anesthesiologists, let’s call them the “Live Free or Die Group” doesn’t want to contract with any payor. They are out-of-network by choice. And, that makes them an outlier. Once again, under the common frame, patients will be “surprised.”

The "cure" proposed, even legislated, by those constructing the frame of "surprise medical billing" is to force non-contracted physicians, whether those physicians are out-of-network by reason of choice or by coercion, to work for a rate to which they never agreed, the so-called "average" rate.

Why? What's the philosophy, the morality, behind that frame, the frame of "surprise medical billing”? Why should anyone be forced to work for a rate to which they didn’t agree?

Almost at the same time that the UnitedHealth/Mednax story broke, the news was awash with a new round of what's become a familiar story, one that “activists,” even musicians, rail against: people being forced to work for wages to which they didn't agree. Only those folks are, it is said, constructing iPhones and computer parts.

In that context, stealing one’s labor is seen for what it is, coercion and theft.

Yet, in a leap over the moral chasm, I'd be surprised if we could find one of those activists who sees forcing physicians to work for rates to which they didn't agree as the equivalent.

In the context of any of our avatar hospital-based medical groups, Mednax which has
been tossed out of network, the radiology group which refused to take an 80% cut, or
the anesthesia group which doesn't want to contract with any payor, is there someone,
some entity, which has in fact contracted to provide coverage to the patient, to our avatar Merry Mittleklass?

You bet there is. For one can't be out-of-network unless there is a network. And that network is a result of Blue United’s contract to provide coverage to Merry Mittleklass.

If Blue United were a general contractor instead of an insurer or health plan, and they contracted to build Merry Mittleklass’s house for $500,000, but then couldn’t get tradespeople to do the actual work for less than $600,000, it would be Blue United’s problem.

If general contractor Blue United can’t force plumbers and electricians to work for less than they’ll agree to accept, why would anyone think that payor Blue United can force pathologists and radiologists to work for less than what they’ll agree to accept? After all, it would be surprise physician services stealing.

Unless the frame is changed as I suggest, that being forced to work for a rate that wasn’t agreed to is theft, hospital-based physicians will never be able to succeed in battling against working for “average” in a universe in which payors throw higher paid groups out-of-network to reduce the resulting average. That’s a spiral to the bottom, which in turn, will sooner or later cause a bigger crisis, the unavailability of, or reduction in quality of, hospital-based services and hospital-based providers.

Over 160 years ago, Frederic Bastiat, the French politico-economic thinker, warned of the danger of quick fixes like the one we’re seeing for “surprise billing.” In his essay, That Which is Seen, and That Which is Not Seen, he wrote that:

“ . . . a law, gives birth not only to an effect, but to a series of effects. Of these effects, the first only is immediate; it manifests itself simultaneously with its cause — it is seen. The others unfold in succession — they are not seen . . . . Between a good and a bad [politician] this constitutes the whole difference — the one takes account of the visible effect; the other takes account both of the effects which are seen and also of those which it is necessary to foresee. Now this difference is enormous, for it almost always happens that when the immediate consequence is favorable, the ultimate consequences are fatal . . . .”

For hospital executives and office-based physicians who think that the legislated cure to surprise medical billing is simply a hospital-based physician problem, think again: I recently heard someone refer to his larger than expected share of in-network care as “surprise medical billing.” Yes, it’s a slippery slope.

Re-frame the issue for what it really is before it is too late: Surprise physician
services stealing.
Listen to the podcast here, or just keep reading for the transcript.

What's a laptop cost? How about $1,040,000? Nope, it's not the world's first quantum computing MacBook. It's just a regular old one. Heck, it's even used!
And therein lies the problem.

That's the price that Rhode Island based non-profit, Lifespan Health System Affiliated Covered Entity (“Lifespan”) agreed to pay the government as the penalty for the theft
of a single stolen laptop that might have contained unencrypted PHI to which the thieves
had access.

The story started out on a Saturday like many others. A hospital employee parked in a public lot. But then, thieves broke into the parked vehicle and stole, among other things, a MacBook laptop used by the employee for work. The laptop was never seen again. Neither were
the thieves.

Now here comes the "might have, sort of” part, the part that should really scare you. There doesn't appear to be any actual evidence that anyone illegally accessed PHI. Nor, for purposes of HIPAA violation, does there have to be.

Upon investigation, it was determined that the employee's work emails might have been cached in a file on the device's hard drive, and that the thieves “had access to” patient names, medical record numbers, demographic information, including partial address information, and the name of one or more medications that were prescribed or administered to patients.

Despite all of those might haves, the loss of the laptop constituted a HIPAA breach because the PHI on that single MacBook was not encrypted.

According to a press release issued on July 27, 2020, by the U.S. Department of Health and Human Services’ agency charged with HIPAA enforcement, the Office for Civil Rights ("OCR"), upon investigation, it was determined that there was systematic noncompliance with the HIPAA Rules within Lifespan. Among the noncompliance was the failure to encrypt ePHI on laptops after Lifespan determined that it was reasonable and appropriate to do so. The investigation also revealed a lack of device and media controls.

Mobile devices, from laptops to cell phones, are stolen every day. Cars containing those devices, even ones locked “securely,” or so we think, in their trunks, are broken into or themselves stolen every day. Other such devices are simply misplaced.

That's why ePHA on those devices must be encrypted.

The settlement highlights the fact that simply having a HIPAA compliance plan, even one that requires encryption, is worthless, if it is not enforced, and it is less than worthless if you have a plan that you know if not being complied with and you do nothing about it.

The sad story also highlights the issue of the security of any PHI, electronic or on paper,
that is exposed to theft, or even loss, in transit, whether the transit is via a car, a pocket,
or a briefcase.

In addition to the $1,040,000 payment, Lifespan entered into an agreement with the government requiring a corrective action plan including two years of monitoring.

For help with both crafting your compliance plan and creating an actual working compliance program, email me now. I can guarantee that it will cost you less than $1,040,000, plus a corrective action plan, plus attorneys fees, plus bad publicity, plus exposure to other
potential liability.
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Books and Publications
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.
In fact, it’s very likely that the problem is systemic. The Medical Group Governance Matrix introduces a simple four-quadrant diagnostic tool to help you find out. It then shows you how to use that tool to build your better, more profitable future. Get your free copy Free.
Whenever you're ready, here are 4 ways I can help you and your business:

1. Download a copy of The Success Prescription. My book, The Success Prescription provides you with a framework for thinking about your success. Download a copy of The Success Prescription here.

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3. Book me to speak to your group or organization. I’ve spoken at dozens of medical group, healthcare organization, university-sponsored, and private events on many topics such as The Impending Death of Hospitals, the strategic use of OIG Advisory Opinions, medical group governance, and succeeding at negotiations. For more information about a custom presentation for you, drop us a line

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