Healthcare Legal & Compliance
Guidance
Guidance
Successful healthcare companies leverage the advice of legal counsel to maneuver through the thicket of regulatory and compliance challenges and puzzles that healthcare ventures must resolve to dominate market share. Our Healthcare lawyers focus on resolving the thorny regulatory knots that stall or halt less determined healthcare industry players and summon the greatest creativity from healthcare industry innovators and disruptive pioneers.
These legal and regulatory compliance challenges include:
The healthcare industry is ever-evolving, as even established companies in other markets (such as, for example, consumer goods, online sales, and communications) add on features that track various health metrics (from number of steps walked to ECGs). Increasingly, new business models are restructuring healthcare practices. Concierge, VIP, and membership models reduce physician availability and drive patients into more exclusive, packaged healthcare programs. Corresponding with this surge in healthcare as a VIP service deliverable by practitioners, many companies are delivering healthcare as a product or software. The brick-and-mortar visit to the doctor often now takes place as an online or mobile healthcare visit, with telemedicine and digital health (or “connected health” as the FDA has called it) leading the way.
From medical practices and medical spas to medical devices and emerging healthcare technologies, our healthcare compliance attorneys not only closely monitor trends; we are also leaders in pioneering the way for our clients who are courageous healthcare innovators.
Your Legal Partner in a Rapidly Evolving Healthcare Landscape
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Concierge Medicine Practice Lawyers
Many physicians are creating concierge medicine practices to reduce their patient load and concentrate more on a style and pace of patient care that suits the physician’s temperament and resources.
As well, many physicians focus on integrative medicine, functional medicine, anti-aging and longevity care, or holistic health and wellness. They specialize in addressing the root causes of disease with a systems-based approach to healthcare. These physicians find that a membership model of care works better than traditional cookbook medicine with declining insurance reimbursements.
Concierge medicine, while popular, is also vulnerable to a host of regulatory uncertainties. These include:
- Distinguishing between Medicare-covered and non-covered services to Medicare beneficiaries, where the physician is not opted out of Medicare.
- Understanding the extent to which bundling services in a health and wellness package or program raises anti-kickback flags.
- Designing a proper patient membership or subscription agreement with terms that protect not only against liability exposure, but also regulatory risk.
Corporate Practice of Medicine Lawyers
Corporate practice of medicine issues loom large in any venture involving a combination of physicians (MDs, DOs) and non-physicians.
The corporate practice of medicine doctrine prohibits corporations from either employing a physician, or, from practicing medicine. The prohibition against corporate practice of medicine derives from the statutory prohibition against unlicensed practice of medicine by individuals; and also, from the notion that physicians can only offer medical services through a professional medical corporation (or in some states, a professional limited liability company (PLLC) and not through a general business corporation.
States differ in the extent to which they articulate, and/or enforce, the corporate practice of medicine prohibition. This delta makes it challenging for healthcare companies that offer national services, given that state laws can vary so widely.
Our healthcare regulatory and compliance lawyers know how to guide national healthcare companies, as well as local medical practices and healthcare ventures, on thorny corporate practice of medicine issues. For example, we represent:
- Holistic health centers
- Medical spas
- Software diagnostic companies
- Telemedicine companies (including tele-dentistry, telepsychiatry, tele-dermatology, and other specialized areas)
Healthcare Fraud & Abuse Lawyers
Avoiding charges of healthcare fraud and abuse preoccupies many healthcare practices and businesses, given the strong emphasis that regulatory agencies place on enforcement.
Healthcare fraud and abuse laws and regulations include:
- Stark law
- State self-referral laws (such as California’s Physician Ownership and Referral Act, or PORA)
- The federal anti-kickback statute (AKS)
- State anti-kickback and fee-splitting laws
- State law prohibitions against patient brokering (for example, Florida’s Patient Brokering Act) or patient steering
The self-referral, anti-kickback and fee-splitting prohibitions are numerous and multifarious for the healthcare practice of business. With many statutory definitions and regulatory prongs, plus Office of the Inspector General (OIG) advisory opinions, judicial opinions, policy statements, and the array of heavy penalties for violation, the fraud abuse arena requires careful navigation.
Our Stark and anti-kickback lawyers understand the subtleties of fraud and abuse prohibitions, as well as the clear legal boundaries, and how they can entrap healthcare ventures whose innovative models can run afoul of legal tripwires. We advise on compensation arrangements, management services organization (MSO) models, Medicare billing and coverage issues, and related issues.
HIPAA Lawyers
Not surprisingly, enterprising healthcare businesses spearheaded a move to effectively translate HIPAA into English. Unfortunately, HIPAA remains one of those exceedingly complex, irritatingly nuanced, frustratingly layered, and fundamentally critical pieces of legislation and regulation that nearly every healthcare practice of business must fear and respect.
Many healthcare industry players mistakenly believe that they are “HIPAA-compliant,” simply because some vendor of HIPAA services has sold them a HIPAA Manual or package, or has created a fancy-looking gold seal that gives the illusion of protection against the HIPAA regulatory behemoth. Many of these promises of HIPAA compliance ultimately lack substance and turn out to be as dangerous as manhole covered by cardboard.
In fact, HIPAA compliance requires careful attention to the many different parts of the HIPAA Privacy Rule and HIPAA Security Rule. These days, even Business Associates are, technically speaking, subject to the full panoply of HIPAA regulation. A robust system of HIPAA compliance includes such things as:
- A HIPAA Manual of Policies & Procedures, tailored to the size, scale, complexity, and needs of the healthcare organization or Business Associate;
- Appointment of a designated Privacy Official and Security Officials;
- A risk management assessment by dedicated IT professionals;
- Regular HIPAA training for the workforce and an overall culture of risk mitigation with respect to inadvertent disclosure of protected health information (PHI);
Management Services Organizations (MSOs) Lawyers
While management services organizations (MSOs) were initially established to manage the business side of the brick-and-mortar medical practice, the MSO model is useful as a safe harbor to some core anti-kickback and fee-splitting risks.
As well, the MSO model conveniently separates the administrative, management and marketing functions of the medical practice, health and wellness center, or integrative medicine group, from the clinical side of the patient experience. In this way, when creatively deployed, the MSO model can serve as a protection against charges of corporate and unlicensed practice of medicine.
Among physicians, MSOs are sometimes in vogue and in some places considered anachronistic. Our healthcare MSO attorneys know how to utilize the MSO model and adapt its separation of business from clinical functions, in ways that can reduce overall compliance risk and strength the legal foundation of modern healthcare ventures.
Regulation of Emergent Technologies
Convergent, exponential technologies also advance the forefront of healthcare. These include:
- GNR (genetics, nanotechnology, robotics)
- Wearable health technology
- Mobile and digital healthcare
- Haptic technologies
- Virtual reality technologies
- Healthcare technologies powered by Artificial Intelligence (AI)
- Augmented intelligence technologies for healthcare
- Emerging technologies from neuroscience breakthroughs
- 3D printing
- Computational and mathematical breakthroughs
- Synthetic biology
- Advances in materials science
- Use of drones as healthcare delivery systems
- Continuous low-power, always-on sensors
- The Internet of Things
- Blockchain technology
- Other exponential innovations in healthcare
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
