Interview with Drew R. Barnholtz

Interview with Drew R. Barnholtz


TRANSCRIPT


[Heath Hayder]:

Drew, thank you for taking the time to join us today.

[Drew Barnholtz]:

Morning, Heath, thanks for having me. It’s my pleasure.

[Heath Hayder]:

Hey, same here. To start, could you give us a brief overview of your career and how you became involved in healthcare law?

[Drew Barnholtz]:

Absolutely. I’ve been practicing healthcare law. It’s a passion of mine for the last 25 plus years. Studied it in law school, focused on it my whole career. I’ve been in house at several entities, Invacare Corporation and medical advice industry, university hospitals and the academic medical hospital industry. And I’ve had the pleasure and the benefit of having to have firsthand experience with a lot of the challenges and the healthcare regulatory issues that have shaped that field and allowed me to become very well versed in those types of things that face clients in our industry.

[Heath Hayder]:

That’s awesome. I see that you have a very diverse background. You worked in corporate law and as in-house counsel. So how has this experience influenced your approach to advising healthcare clients?

[Drew Barnholtz]:

I mean, healthcare clients, just like anybody else, are corporate clients, right? They have the gamut of corporate issues from formation to entity management to operating agreements and bylaws and all kinds of contracts and transactions. But the healthcare specific laws are of course more unique to them.

And so what I’ve gotten is the opportunity to blend those kinds of things and have private practitioner experience and in house experience and really see both sides of the aisle and be able to bring the negotiation experience and then the pragmatic, the practical experience and then the business orientation and solutions to my clients, to our clients, which has really, I hope, been a great benefit for them.

And I know it brings a lot of enjoyment to me when in practice of law, when I can give them the most practical advice that they can orient to and implement.

[Heath Hayder]:

I see. So, since we’re talking about the healthcare law, and I know that healthcare regulations can be quite complex, could you share some of the most challenging regulatory issues you’ve handled?

[Drew Barnholtz]:

Yeah. So, I’ve been involved throughout my career with the anti-kickback statute, which involves any type of payment that you may or may not give to a healthcare provider or someone else to get them to refer patients to you.

I’ve been involved with the Stark law, which involves the payment in either compensation or investment format to physicians when they’re involved. And there’s patients involved as well, particularly when Medicare and Medicaid and Tricare are involved, the government’s money. But also, I’ve been involved with FDA.

I’ve been involved not only with registration and listing requirements, but also with 483, which is basically the number that deals with investigations and observations and even all the way through to remediation and negotiation of a consent decree, which is the, basically the FDA saying, “hey, we’re going to bind you to not allow you to manufacture and sell certain medical devices through to consumers.”

So, these represent very significant challenges. I’ve also been involved in very complex regulatory reviews for mergers and acquisitions, for supplier agreements, joint ventures and the like. All those are pretty complex regulatory issues.

[Heath Hayder]:

I see. So, speaking of the FDA, you’ve also advised on matters like the False Claims act and Anti-kickback. What are some common pitfalls companies should avoid in those areas?

[Drew Barnholtz]:

For sure? I mean, look, there are situations where providers are accepting Medicare and Medicaid and Tricare money. And if you’re in that position, you don’t want to be in a spot where you are offering someone any type of what they call remuneration.

So, you don’t want to offer them any type of money or something of value to then give you what they call the volume or value of referrals. Right. So, it’s “give me more or give me a significant dollar value” of referrals. And there’s a way to structure these deals so that they fall well within what’s called a safe harbor or an exception to those rules. A common one would be their bona fide employee. They provide personal services. They’re a medical director. You’re doing it within in office. It’s called in office ancillary.

So, you’re providing the services within an office, and it meets those exceptions and there are specific tenants and terms to those. But you want to have policies and procedures and you want to have structure to the way that you enforce these and false claims act really means that you have rigor around the way in which you get reimbursed for your claims.

The way in which you submit those, the way in which you get reimbursed. You are ensuring that you’re coding things properly, that you’re not upcoding, that you’re not, splitting those claims apart, and that you’re being very careful and diligent about those things.

[Heath Hayder]:

I see. So, you drafted compliance programs and handled HIPAA related matters. With the rise of digital health technologies, what are some emerging compliance challenges that you see?

[Drew Barnholtz]:

Yeah, look, I’ve been around, I think, aging myself since HIPAA even became a law back in 2003, and compliance programs around for a very long time. First it was the seven elements, now it’s the eight elements. I think we’re going into some uncharted waters with AI and machine learning and these kinds of things, because now we’re dealing not just with people protecting and securing health information, now we’re dealing with the way in which a machine learns that information and artificial intelligence.

But I think the principles are still the same, right? The principles still apply. Are you using someone’s individual identifiable information or protected health information, IIHI or PII? Are you using that in the form in which they’ve authorized you to use that or disclose it?

And if you aren’t doing that, and if you’re using either AI or machine learning and you’re allowing it to use it beyond those specified authorized uses and disclosures, then there is the potential for a violation of HIPAA, and the office of Civil Rights could come in and could fine you for that.

And there’s even criminal violations with that as well. So really, the idea with these digital health technologies is to make sure that you’ve got bumpers in place, particularly with regard to marketing. Marketing is almost always an opt in, meaning you’re not just saying to someone, hey, I’m going to market to you.

I can market to you first party, my own types of things for the types of things that you’re already working for me with, whether it’s, you know, an appointment, right, appointment reminder, or the products that I’m already marketing you for. But if I’m going to include third parties, then you have to affirmatively say to me, yes, I want to receive those kinds of emails or other types of marketing materials.

[Heath Hayder]:

I see. And so, I got one last question for you. Finally, what do you find most rewarding about your work in healthcare law?

[Drew Barnholtz]:

Well, look, I mean, it’s, you could sell, we could sell widgets, right? Or just anonymous product, but healthcare is truly helping people. That the product itself, the thing that our clients are doing, whether it’s a physician or a hospital or a clinical trial or a management services organization or any type of organization in the healthcare continuum, it’s helping people, right? It’s making it better for someone, whether they’re at the beginning of their life or at the end of their life or in between.

When we help protect the providers themselves, they can deliver the best care to everyone that is in need of receiving that care. And so that makes a difference. And that’s very rewarding.

I’ve got healthcare providers in my family and in my friend circle, and I know that when I protect them and when our firm protects them, then that they are able to give the best care, deliver the best care to the patients. And that’s what makes it so rewarding.

[Heath Hayder]:

100% yeah, I agree with you. Well, thank you, Drew, for sharing your insights and experience with us today. It’s been a pleasure getting to know you and learning about your work in healthcare law.

[Drew Barnholtz]:

Likewise, Heath. Thank you so much. It’s been my pleasure speaking with you.

[Heath Hayder]:

Take care, Drew. I’ll talk to you later.

Testimonials

  • I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.

    Richard Freedland
    Richard Freedland GRAMedical, CEO
  • Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.

    James Riviezzo
    James Riviezzo Practice On Your Terms

Contact Us

discovery-call-cta-vertical

Start typing and press Enter to search