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First Healthcare Compliance CONNECT April 2023

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<strong>CONNECT</strong><br />

<strong>April</strong> <strong>2023</strong><br />

<br />

A Quarterly Publication for the <strong>Healthcare</strong> <strong>Compliance</strong> Community<br />

Infographic:<br />

<strong>Healthcare</strong> <strong>Compliance</strong>:<br />

Costs vs Benefits<br />

<strong>Healthcare</strong> <strong>Compliance</strong><br />

Policies: Best Practices for<br />

Management and Distribution<br />

Legal Risks With Health<br />

Data Sharing: Q&A<br />

Transcatheter Valvular<br />

Procedure Code Set<br />

Updates<br />

How to Protect Your<br />

<strong>Healthcare</strong> Assets: Q&A<br />

1st Talk <strong>Compliance</strong>:<br />

DMEPOS –<br />

In <strong>Compliance</strong> with CMS


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experience. It’s a simple way to help us grow and<br />

improve.<br />

We appreciate your support and look forward to<br />

hearing from you!<br />

In This Issue:<br />

Infographic: <strong>Healthcare</strong> <strong>Compliance</strong>: Costs vs<br />

Benefits<br />

<strong>Healthcare</strong> <strong>Compliance</strong> Policies: Best Practices<br />

for Management and Distribution<br />

Legal Risks With Health Data Sharing: Q&A<br />

Transcatheter Valvular Procedure Code Set<br />

Updates<br />

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Panacea <strong>Healthcare</strong> Solutions LLC © <strong>2023</strong>


<strong>Compliance</strong> Super Ninja <br />

Mia Higgins<br />

Director, Client Services, McEwen and Associates<br />

How would you describe your experience with <strong>First</strong> <strong>Healthcare</strong><br />

<strong>Compliance</strong>?<br />

Terrific! It has made my work life so much easier. <strong>First</strong> <strong>Healthcare</strong> <strong>Compliance</strong> has<br />

everything you need in one space. It would take me hours at times to search for answers but with their free<br />

resources you find everything you need with ease!<br />

What do you enjoy most about working with McEwen and Associates?<br />

The people. My team is so important to me, we are a family. I enjoy watching my team grow and building longlasting<br />

relationships with our clients.<br />

Would you rather be completely invisible for one day or be able to fly for one day?<br />

Why?<br />

I’d rather be completely invisible for one day. I love Halloween and being invisible would allow me to scare my<br />

family and pull a few pranks on them. I get motion sickness so flying would be out of the question!<br />

How to Protect Your <strong>Healthcare</strong> Assets: Q&A<br />

1st Talk <strong>Compliance</strong>: DMEPOS – In <strong>Compliance</strong><br />

with CMS<br />

Contact Toll Free: 888-54-FIRST 3


FAQ Corner<br />

How should we handle employees who won’t complete training as assigned?<br />

<strong>Compliance</strong> should be a condition of employment. And as part of the Code of Conduct sample we provide,<br />

employees are required to complete compliance training. Employers may wish to enforce their training<br />

requirements through discipline. Discipline may include a verbal warning, written warning, suspension, up to and<br />

including termination. Of course, if your organization has a progressive discipline policy, it must be followed when<br />

disciplining employees (we provide a sample compliance program disciplinary action policy within the <strong>Compliance</strong><br />

Policies and Procedures Sample). It is also important to be consistent in meting out discipline so as not to run<br />

afoul of discrimination laws.<br />

Explore the FAQs tab in your compliance solution<br />

to find answers to your compliance questions!<br />

CLIENT<br />

ALERT<br />

Navigating Workplace Violence<br />

Prevention Under OSHA<br />

Workplace violence is a serious issue, especially<br />

in healthcare facilities. The OSHA workplace<br />

violence prevention guidelines help employees and<br />

employers alike by providing the necessary steps<br />

to maintain a safe work environment.<br />

DOWNLOAD NOW<br />

4<br />

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<strong>Healthcare</strong> <strong>Compliance</strong>:<br />

Costs vs Benefits<br />

Within the healthcare industry, the focus has increasingly turned toward compliance, and<br />

there are multiple regulations that prompt the need for implementation of an effective program.<br />

COSTS of Being Reactive<br />

BENEFITS of Being Proactive<br />

It's the law, so criminal<br />

charges come into play.<br />

Enforcement has been<br />

increased over the last<br />

several years.<br />

Reputation matters more<br />

than ever. News travels fast<br />

and a physician's reputation<br />

has a direct impact on the<br />

success of the practice.<br />

Patient outcomes<br />

may be affected by<br />

lack of safety.<br />

Staff confidence and<br />

morale will benefit from<br />

extra training and knowledge.<br />

"Knowledge is power" is<br />

especially applicable in<br />

any medical setting.<br />

Showing that you've<br />

commited time and<br />

resources to compliance<br />

shows the community and<br />

your staff that you believe<br />

in doing things the right way.<br />

The impact may be<br />

monetary via fines<br />

and penalties.<br />

Having a full compliance<br />

program in place leads<br />

to better communication<br />

and uncovering potential<br />

problems.<br />

Comprehensive <strong>Healthcare</strong><br />

<strong>Compliance</strong> Management Solutions<br />

CONFIDENCE INCLUDED<br />

Creating confidence among<br />

compliance professionals through<br />

education, resources, and support<br />

Contact Toll Free: 888-54-FIRST 5


<strong>Healthcare</strong> <strong>Compliance</strong><br />

Policies: Best Practices for<br />

Management and Distribution<br />

<strong>First</strong> <strong>Healthcare</strong> <strong>Compliance</strong> Staff<br />

Purposes of Policies in <strong>Healthcare</strong> Organizations<br />

Many healthcare organizations operate under a comprehensive set of policies and procedures that address<br />

a wide range of compliance-related issues, including physician relationships, conflicts of interest, OSHA and<br />

HIPAA Privacy and Security. These policies and procedures should be available to every employee and provider.<br />

Specific standards set by an entity as well as the elements of an effective compliance program provided by OIG/<br />

HHS offer frameworks for roles and committees to ensure consistency and integration of compliance activities<br />

and the effectiveness of the overall compliance program.<br />

A well-managed set of policies is critical to the well-being of any healthcare institution. Proper policies support<br />

activities by communicating expectations, establishing a culture of compliance, protecting in litigation matters,<br />

and ensuring the welfare of patients and staff.<br />

Important purposes of policies in the healthcare setting include:<br />

1. Provide the framework for the key elements of the compliance program<br />

2. Promote and support ethical behavior among staff<br />

3. Exhibit commitment to compliance and all regulations governing the organization<br />

Management and Distribution of <strong>Healthcare</strong> <strong>Compliance</strong> Policies<br />

In addition to creating, communicating, and maintaining policies within a healthcare organization, it is imperative<br />

to take steps to manage and distribute the policies effectively.<br />

Assign Responsibility<br />

An individual should be responsible for managing policies within the healthcare organization. Depending on<br />

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the size of the entity, it may be either a full or part time position.<br />

Control Access<br />

For the purposes of efficiency and privacy and security, the administrator should have full control when it<br />

comes to providing access for reading and editing policies.<br />

Track Policy Updates<br />

Tracking policy changes becomes a necessity to provide accurate information to compliance questions or<br />

auditors.<br />

<strong>First</strong> <strong>Healthcare</strong> <strong>Compliance</strong> offers several solutions that provide customizable sample Policies and Procedures.<br />

In addition, our Document Storage zone allows compliance personnel to upload, organize and distribute<br />

documents via the Training Zone for employee attestation. To learn more contact us today!<br />

The Most Comprehensive<br />

<strong>Healthcare</strong> <strong>Compliance</strong> Course<br />

The Fundamentals is a<br />

user-friendly, four-module<br />

online course designed to<br />

help healthcare professionals<br />

understand the essential<br />

principles and practices of<br />

compliance.<br />

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Contact Toll Free: 888-54-FIRST 7


Legal Risks<br />

With Health<br />

Data Sharing:<br />

Q&A<br />

Catherine Short<br />

Iliana L. Peters, Shareholder at Polsinelli PC, believes<br />

good data privacy and security is fundamental to<br />

ensuring patients’ trust in the health care system, and to<br />

helping health care clients succeed in an ever-changing<br />

landscape of threats to data security. She is recognized<br />

by the health care industry as a preeminent thinker and<br />

speaker on data privacy and security, particularly with<br />

regard to HIPAA, the HITECH Act, the 21st Century Cures<br />

Act, the Genetic Information Nondiscrimination Act (GINA),<br />

the Privacy Act, and emerging cyber threats to health data.<br />

For many years, Iliana both developed health information<br />

privacy and security policy, including on emerging<br />

technologies and cyber threats, for the Department<br />

of Health and Human Services, and enforced HIPAA<br />

regulations through spearheading multi-million dollar<br />

settlement agreements and civil money penalties pursuant<br />

to HIPAA. Iliana also focused on training individuals in<br />

both the private and public sector, including compliance<br />

investigators, auditors, and State Attorneys General, on<br />

HIPAA regulations and policy, and on good data privacy<br />

and security practices.<br />

As a member of the <strong>First</strong> <strong>Healthcare</strong> <strong>Compliance</strong> Editorial<br />

Council, Iliana is a frequent presenter at educational<br />

events. For more information regarding this topic please<br />

view the related webinar for further discussion and<br />

learning.<br />

Below, Iliana answers some common questions<br />

and provides explanations related to the education<br />

surrounding Health Data, A Value Proposition: Legal Risks<br />

with Innovative Data Sharing Projects.<br />

Can you give us an overview of the health data value<br />

proposition, what some of the legal risks are with<br />

data sharing projects?<br />

This is a new and evolving area of practice, particularly<br />

because we have many different entities that are very<br />

interested in engaging in innovative data sharing projects<br />

that result from the need to do research of all different<br />

types. This includes research with a small “r,” in terms<br />

of research and development within entities, and the of<br />

development of new products and services. And this also<br />

includes Research with a big “R,” that is human subjects<br />

research, as defined under the law, that may be used to<br />

determine new therapies, new drugs, new devices for<br />

patients, as well. There are all kinds of research projects<br />

going on related to the use of data, and for many different<br />

important reasons. And as a result, we’re seeing a lot<br />

of questions about the legal requirements and risks<br />

associated with those types of projects, and particularly<br />

the agreements that are necessary and being put in place<br />

between business partners related to those projects.<br />

Can you give us a summary of the legal issues<br />

involved in data sharing projects and do you think<br />

there are serious legal risks associated with some of<br />

these issues and projects?<br />

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The short answer is, yes, there is serious legal risk. There<br />

are state, federal or international legal requirements<br />

related to how we can use and disclose data. That<br />

includes a general prohibition on the sale of data. Many<br />

of these innovative projects include some kind of benefit<br />

to the entity originating the data, because the entity is, in<br />

fact, contributing data to an important project that’s going<br />

to arguably result in a new service or a new application.<br />

As a result, these agreements contemplate direct or<br />

indirect remuneration, that is, some kind of benefit to<br />

the entity that’s originating the data. This is considered<br />

a sale of data. That would necessitate consent from the<br />

individuals whose data is being using for these projects.<br />

It is important that entities understand what this looks<br />

like, from a legal perspective, because of those risks. As<br />

a result, a lot of entities are anonymizing data so that we<br />

can use data for projects involving remuneration without<br />

implications for patient privacy, because the patients are<br />

arguably not identifiable, or we don’t know who those<br />

patients are as part of those projects, because we’ve<br />

anonymized the data.<br />

Obviously, if we’re going to do that, we have to make sure<br />

that we do that properly, in a way that doesn’t allow for<br />

those individuals to be identified, doesn’t allow business<br />

partners or downstream users of that data, to re-identify<br />

or recombine data with other data sets to figure out who<br />

those people are. This is not easy; it’s a difficult issue.<br />

Additionally, we have contractual requirements with our<br />

own clients and business partners that may significantly<br />

restrict how we can use data, how we can put data<br />

together and datasets, and how we can anonymize the<br />

data. For example, Centers for Medicare and Medicaid<br />

Services have significant prohibitions in agreements<br />

related to Medicare and Medicaid beneficiary data that we<br />

have to be aware of when we’re aggregating data or deidentifying<br />

it. We generally can’t use CMS data in that way.<br />

That’s just one example from a contractual perspective.<br />

And then, of course, we have data breach issues. Anytime<br />

we’re putting together lots of data into a big data set, that<br />

becomes a target for a cyber-criminal or threat actor. We<br />

have to be very cognizant of the risks there, particularly<br />

if we’re providing that data outside our entity, to another<br />

Risk Management Considerations for the<br />

<strong>Healthcare</strong> <strong>Compliance</strong> Officer:<br />

Training, Incident Management,<br />

Governing Boards, and Measures Unique<br />

to COVID-19<br />

It’s no secret that healthcare is one of America’s<br />

most heavily regulated industries with substantial<br />

fines and penalties for non-compliance. Complex<br />

regulations and mandates make compliance<br />

management a necessity.<br />

DOWNLOAD NOW<br />

Contact Toll Free: 888-54-FIRST 9


usiness partner, who’s then going to have our data and<br />

be subject to those risks.<br />

Finally, there’s always a reputational issue, even if we do<br />

everything in a legal way. Even if we protect the data from<br />

a data security perspective, individuals could still find out<br />

about how we’re using their data, because maybe it’s not<br />

identifiable, maybe it’s anonymized data, but it still came<br />

from them originally. And they can feel very strongly about<br />

how we’re proposing to use data for a particular project.<br />

Maybe they don’t agree with a particular project, for<br />

whatever reason. That could also create reputational risks<br />

for us.<br />

These are all these risks that we have to consider, from<br />

an underlying legal perspective, a contractual perspective,<br />

about data ownership, and about data licensure; all of<br />

those important controls that we put in place for data<br />

security purposes. Then just considering what the<br />

consumer would feel about a particular data project to<br />

make sure that we consider their viewpoints on these<br />

projects as well.<br />

What are the most important risks to consider in<br />

innovative data sharing projects?<br />

I think the most important risks are the risks associated<br />

with how the business partners that you’re working<br />

with are going to use your data. At the end of the day,<br />

making sure that we understand the data ownership and<br />

licensure issues, particularly with regard to the type of<br />

data that we’re using for any particular project is critical,<br />

so that we can ensure the right controls for that data. We<br />

want to make sure that we appropriately take care of that<br />

data. Arguably, we can control how we use our own data.<br />

It’s really about when we share that data with business<br />

partners, how we do our best to make clear to those<br />

business partners how we expect them to use and share<br />

our data and how we expect them to protect it. It’s about<br />

making sure they understand our ownership of the data,<br />

what the license to the data looks like, for purposes of a<br />

particular project, and how they’re going to protect the<br />

data, as they hold it. I would say that’s the largest risk,<br />

when we share that data outside of our own institutions.<br />

COVID-19 <strong>Healthcare</strong><br />

<strong>Compliance</strong> Updates<br />

In response to the global outbreak of the novel<br />

coronavirus disease (COVID-19), the Secretary<br />

of Health and Human Services declared a public<br />

health emergency on January 31, 2020. Federal<br />

agencies have taken action by issuing updates and<br />

guidance to navigate the crisis. This ebook provides<br />

healthcare providers with important developments<br />

and resources that impact federal healthcare laws.<br />

DOWNLOAD NOW<br />

10<br />

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Have you heard<br />

our big news?<br />

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Contact Toll Free: 888-54-FIRST 11


Transcatheter<br />

Valvular Procedure<br />

Code Set Updates<br />

New Technologies and the<br />

Codes You Should Capture<br />

Catherine Short<br />

Over the last decade, one of the most exciting areas<br />

of development in healthcare has been the growth<br />

of structural heart and interventional cardiology<br />

programs—specifically, the advancement of<br />

transcatheter valvular procedure techniques.<br />

There has been significant scientific advancement<br />

in these techniques since the transcatheter valvular<br />

procedure code set was initially developed, including<br />

the establishment of clinical trials testing new<br />

treatment methods and devices. The complex<br />

nature of these treatment programs and the rapid<br />

advancements in treatments and technology have led<br />

to the development of some very complicated coding<br />

rules and coverage requirements from CMS and other<br />

payers.<br />

As the ability to treat a larger population using<br />

these novel techniques expands, so must<br />

our understanding of the nuances involved in<br />

navigating the current rules and regulations from<br />

both the clinical and revenue cycle perspectives.<br />

In case you missed our webinar on the subject, you<br />

can review the material covered during the live session<br />

by referencing an eBook of the presentation content.<br />

Read through for an overview of the following topics:<br />

• How transcatheter techniques are reshaping<br />

treatment options<br />

• Cardiac anatomy<br />

• Transcatheter valve procedures and clinical trials/<br />

data registry requirements<br />

• Successful clinical trial information capture<br />

• Sample claims<br />

• CPT code set<br />

• Key resources<br />

READ MORE<br />

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Referral Appreciation Program<br />

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<strong>First</strong> <strong>Healthcare</strong> <strong>Compliance</strong> is delighted to offer a<br />

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helping us to continue to grow. For each new 1st<br />

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LEARN MORE<br />

Contact Toll Free: 888-54-FIRST 13


How to Protect<br />

Your <strong>Healthcare</strong><br />

Assets: Q&A<br />

Catherine Short<br />

Highly-regarded attorneys Sean McKenna, Lauren<br />

Nelson, and Vincent Aiello of Spencer Fane LLP<br />

recently held the comprehensive webinar Preserving<br />

and Protecting Assets in <strong>Healthcare</strong> joined by Catherine<br />

Short and <strong>First</strong> <strong>Healthcare</strong> <strong>Compliance</strong>. Please see their<br />

bios at the end of this page.<br />

Continue reading for Sean, Lauren, and Vince’s lively<br />

question and answer session related to enforcement<br />

and liability proceedings with asset protection, and<br />

explore government and private litigation matters.<br />

What do you need to do in order to protect<br />

yourself from government investigations?<br />

Lauren:<br />

The government has really ramped up their civil and<br />

criminal investigations over the last year or two. And<br />

they have new initiatives that are really focused on<br />

recovering money spent on these alleged fraudulent<br />

claims. In the last year, they’ve really been focusing<br />

on telehealth claims submitted by labs, as well as<br />

pharmacies. And they’ve started the investigations into<br />

COVID funding and billing, as well as your PBMs. We<br />

expect the government will continue to ramp up the<br />

investigations in these areas as well as other potential<br />

areas. In addition, the different licensing boards<br />

have also resumed their unannounced surveys and<br />

inspections of provider sites.<br />

To help protect yourself from investigations, the first<br />

thing is to have a full understanding of what these<br />

different potential risks are. To do this, you need to do<br />

a comprehensive and very strategic assessment of all<br />

potential risks throughout your organization. Frequently<br />

people talk about enterprise risk management. It really<br />

is a great approach because it looks at every different<br />

department of a health care system. And it’s important<br />

that not only do you do these risk assessments in<br />

each department, but you need to have the different<br />

groups communicate and work together. So, there’s<br />

coordination and a real appreciation for what those<br />

risks are.<br />

Lauren, can you speak to the risk factors<br />

or components of a smaller organization<br />

versus those of a large institution or national<br />

company?<br />

Lauren:<br />

Yes, absolutely. It’s really about understanding what<br />

those potential risks are. If you can coordinate the<br />

efforts of these assessments, with the different<br />

departments you’re in, you will end up putting less<br />

strain and demand on the individual departments. And<br />

that results in a better understanding of the potential<br />

risks. It also gives you the capability of improving<br />

those potential problems that you can identify. One<br />

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ig area, as a defense attorney, I frequently deal with<br />

are patient medical records, and I always deal with<br />

risk management. What can be a little problematic<br />

is when there’s a lack of coordination between the<br />

IT department or the records department, and risk<br />

management. So, it’s important that everyone’s on the<br />

same page, and has a good understanding of what<br />

information is available.<br />

What are common compliance issues you see<br />

in your practice, Lauren?<br />

Lauren:<br />

So, common compliance issues that we see… and<br />

I’m not going to list out every single one of these, but,<br />

common problems are issues with inappropriately<br />

providing copay assistance, not adhering to a contract,<br />

having a commercially unreasonable arrangement,<br />

retroactive payments or adjustments and things like<br />

that.<br />

Sean, I’m sure you see a lot of this in your<br />

practice, right?<br />

Sean:<br />

Yes, absolutely. One of the biggest concerns from a<br />

compliance perspective that translates into potential<br />

monetary damages are these per click percentagebased<br />

arrangements. Those have been frowned on,<br />

they’ve been deemed non-compliant by Department of<br />

Justice and OIG in various states. We’re seeing a lot of<br />

those cases. Also, joint ventures. Those will continue<br />

to be at risk, the OIG has said. For decades, these<br />

are all Hot Topic issues along with those sectors that<br />

are being scrutinized that could result in some sort of<br />

monetary penalty or financial hit, not just monetary,<br />

but could be institutional, goodwill, morale, etc., all<br />

could have an impact on providers’ bottom line and<br />

could result in some sort of default, or some sort of<br />

other potentially private liability on the quality side.<br />

Vince, can you discuss enforcement and<br />

potential liability, especially during the<br />

pandemic and onwards? What can you talk<br />

to us about kind of what individuals and<br />

executives and company’s clinicians can do to<br />

protect and preserve their assets?<br />

Absolutely. Before we get going into asset protection<br />

trusts, and some asset protection strategies, there’s<br />

a few caveats: one, asset protection, asset protection<br />

strategies work best when planning ahead. If you’re<br />

thinking that you’re going to set up an asset protection<br />

trust, at the last minute, after a claim has been filed,<br />

after an investigation has started, that’s generally a<br />

huge red flag.<br />

If you’re not setting these trusts up at least a minimum<br />

of two years before any potential claim, then there’s a<br />

risk that they may not work. Also, these types of trusts<br />

aren’t a panacea to simply skirt liability and somehow<br />

say that you can engage in nefarious conduct or things<br />

that are criminal in nature. They don’t function in that<br />

capacity. With those sort of basic caveats in mind, I<br />

can kind of walk through the process of setting up<br />

an asset protection trust and what it is and what’s<br />

involved with that. Asset protection trusts have been<br />

around for quite some time, in their simplest way to<br />

think about them, they are a contract, there is a trust<br />

agreement, and they are a creature of statute, they are<br />

almost always an irrevocable trust. They are set up<br />

under the laws of particular states. Legislatures have<br />

expanded the scope of protections in various states<br />

and offer various degrees of creditor protection for the<br />

individuals that are setting up an asset protection trust.<br />

An asset protection trust, essentially is a contract<br />

document. It allows you to preserve your assets, retain<br />

beneficial interests of those assets, and protect the<br />

assets from creditors. It’s highly effective if they’re<br />

set up ahead of time for entrepreneurs setting up all<br />

sorts of businesses, medical practices, medical service<br />

organizations, for business owners, for the individual<br />

employees that are functioning as directors or officers,<br />

CEOs, for doctors, and generally used for individuals<br />

with higher net worth. You’re not going to see an asset<br />

protection trust set up in a scenario where you are<br />

trying to preserve a few $100,000 in assets. Usually,<br />

these are going to be folks who have a few million<br />

dollars at risk and you’re setting it up to mitigate any<br />

potential risk of liability seizure and forfeiture that<br />

may come from all the things that Lauren and Sean<br />

discussed.<br />

Contact Toll Free: 888-54-FIRST 15


You mentioned potential red flags. What are<br />

the consequences when you see all these red<br />

flags? What can happen?<br />

Vince:<br />

Oftentimes, folks will come to me and they’ll say I<br />

want to set up an asset protection trust and I want to<br />

control everything. That’s a huge red flag. You’re going<br />

to have to be comfortable with moving your assets into<br />

an irrevocable asset protection trust, to preserve those<br />

assets for your benefit, but you can’t retain too much<br />

control over those assets. And this is sort of where<br />

Catherine nuances Short of state law and trust drafting come into<br />

play. And really, it goes to how these documents aren’t<br />

formulaic. They need to be set up for the individual<br />

business owner, the professional doctor or person that<br />

is potentially subject to the to the liability of running a<br />

medical organization, doctor’s office and whatnot.<br />

So, there are lookback periods, and the red flag that<br />

happens is that the doctor or business owner comes<br />

in and they say, “I think I’m under investigation, but<br />

I’m not sure.” And then, all of a sudden, they’ll say,<br />

“We need to take certain steps to protect my assets.<br />

I’ve never done that before, I have an LLC, but I’m<br />

concerned, I may have some liability.” If you race to set<br />

up an asset protection trust after the fact, both a civil<br />

attorney and a criminal prosecutor can file motions to<br />

have the judge look at the transfers into those trusts<br />

and set those transfers aside, essentially unwinding<br />

the value in the benefit the trust offers.<br />

So, for example, in Nevada, and several other states,<br />

the look back period is two years. If a client comes<br />

to me today, and they want to start a new medical<br />

practice group, and they’re concerned about potential<br />

liability, perhaps they’ve invested a million dollars into<br />

the business, and they don’t want to lose the balance<br />

of their investments and holdings, they will want to set<br />

up this trust. As long as they’re doing that two years<br />

before they incur any potential liability, then they’re fine.<br />

Sean, could you discuss on civil forfeiture<br />

because of your background and what you<br />

focus on in your practice?<br />

Sean:<br />

Civil forfeiture essentially means that we think there<br />

may be some sort of illegal, ill-gotten gains, and<br />

we’re going to take it until you claim it, and then have<br />

to justify how it’s not. And so now the burden shifts<br />

entirely on the individual whose funds have been<br />

seized. And this is a favorite of local law enforcement,<br />

as well as the feds, they can go in, along with a search<br />

warrant, or just on their own and seize a bank account,<br />

for instance. And then you must administratively make<br />

a claim and then litigate it as a mini trial and basically<br />

justify your existence. So, it’s extremely burdensome<br />

for an individual or business to try and justify and<br />

explain. It’s an exorbitant amount of time and effort<br />

to try and do a tracing or not tracing. Sometimes you<br />

can negotiate it and sometimes you can’t. But civil<br />

forfeiture is a very powerful tool for the Department<br />

of Justice (DOJ) and its agencies. You know, DEA, FBI,<br />

IRS, are the ones that typically use is the most.<br />

What’s ahead, Lauren, any predictions for the<br />

year?<br />

Lauren:<br />

Sure. So, there are predictions that due to patients<br />

delaying receiving care, over the last couple of years,<br />

because of the pandemic, health care providers are<br />

anticipating an increased need for care, especially in<br />

the long-term care sector as well as care for chronic<br />

diseases, as well as behavioral health. And one thing<br />

that will be interesting to watch over the rest of the<br />

year, is the further integration and diversification of<br />

how that care is being provided. So, through telehealth,<br />

the integration from wearable devices and things like<br />

that, which, those issues, raise cybersecurity questions.<br />

There’s also a thought that there will be a greater level<br />

of investigation by the government and there’ll be<br />

greater scrutiny for FCA and AKS.<br />

16<br />

Panacea <strong>Healthcare</strong> Solutions LLC © <strong>2023</strong>


Vince, do you have further thoughts on our<br />

topic?<br />

Vince:<br />

I think my final thought is to plan for the future. In my<br />

practice, that’s key. If you’re in business now, and you<br />

haven’t planned, and you’ve got a concern, if you think<br />

you’ve got exposure, still plan now. It’s not too late.<br />

Whatever the big scary liability is that that is out there,<br />

there are ways to deal with that. It’s very unfortunate<br />

when folks come to my office too late. There’s very<br />

little we can do after the fact. So, that that’s my<br />

suggestion.<br />

Sean McKenna, Lauren Nelson, and Vincent<br />

Aiello of Spencer Fane LLP<br />

With 24 years of experience,<br />

Sean McKenna is a nationallyrecognized<br />

defense attorney<br />

who focuses his practice<br />

on defending executives<br />

and providers in healthcare<br />

enforcement, litigation, and<br />

regulatory issues, under civil or administrative<br />

investigation by the U.S. DOJ, OIG, and Attorneys’<br />

General Medicaid Fraud Control Units, as well as in<br />

criminal investigations and matters involving federal<br />

and state governments. As a former ten-year Assistant<br />

United States Attorney, Associate Counsel to the<br />

Inspector General, and General Counsel for the U.S.<br />

Department of HHS, Sean also assists clients with<br />

internal investigations, compliance reviews, as well<br />

as advising on their compliance with state and federal<br />

fraud and abuse rules.<br />

Lauren M. Nelson has 16-years<br />

of experience litigating<br />

across the country on behalf<br />

of healthcare providers<br />

and executives, including<br />

hospital systems, physicians,<br />

rehabilitation centers and other<br />

providers in complex medical malpractice actions,<br />

licensing matters, and other business disputes. She<br />

specializes in a variety of cases, from catastrophic<br />

birth and spinal cord injuries to misdiagnoses and<br />

failures to treat. Lauren also counsels and represents<br />

physicians and nurses before State and federal<br />

regulators and licensing boards in all manner of<br />

investigations, reviews, and inquiries.<br />

Vincent Aiello helps business<br />

owners solve legal problems<br />

to secure revenue flow and<br />

reduce business risks. As a<br />

lawyer and business owner<br />

he has firsthand experience<br />

handling complex commercial<br />

litigation and transactional matters for his clients. His<br />

client base spans a broad spectrum of businesses<br />

including household-name consumer brands, banks,<br />

construction companies and family ventures. As legal<br />

counsel, he advises personal family foundations on<br />

managing and protecting their wealth. While each of<br />

his clients may take on a unique shape or size, they all<br />

face complex legal and business challenges, which is<br />

precisely where Vincent has focused his commercial<br />

legal practice.<br />

Contact Toll Free: 888-54-FIRST 17


hosted by Catherine Short<br />

1st Talk <strong>Compliance</strong> features guest Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at<br />

Law, P.L.L.C., on the topic of DMEPOS – In <strong>Compliance</strong> with CMS. Rachel joins our host Catherine Short<br />

to discuss special payment rules associated with durable medical equipment, prosthetics, orthotics and<br />

supplies. DMEPOS products must meet quality standards, suppliers need to be accepted by Medicare to<br />

participate, similar to providers, and are subject to fraud, waste, and abuse laws. This episode will provide<br />

an overview of participation and quality requirements, relay the latest compliance and requirements updates,<br />

and discuss the consequences of non-compliance, as well as submitting false and fraudulent claims.<br />

Listen weekdays at<br />

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Contact Toll Free: 888-54-FIRST 19


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Technologies and the Codes You Should Capture<br />

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