Legal & Regulatory Compliance
What We Do:
Legal & Regulatory Compliance
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 Legal & Regulatory Compliance practice focuses on resolving the thorny regulatory knots that stall or halt less determine healthcare industry players and summon the greatest creativity from healthcare industry innovators and disruptive pioneers.
These legal and regulatory compliance challenges include:
- Concierge medicine legal issues
- Corporate practice of medicine
- Healthcare fraud and abuse (anti-kickback, fee-splitting, Stark and state law self-referral prohibitions)
- Management Services Organization (MSO) issues
- Emerging Healthcare Technologies (wearable, AI, nanotech, mobile medical apps, and other healthcare technologies)
The healthcare industry is ever-evolving, as even establish 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 and, 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 FDA has called it) leading the way.
Our healthcare compliance lawyers track the changing healthcare legal and regulatory environment as well as the technological developments that drive and accelerate healthcare business. We have an eye for risk management and for mitigating exposure to the alphabet soup of regulatory agencies, both federal and state, as well as plaintiff law firms, that can snare a growing health and wellness business.
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.
Concierge Medicine Practices
Many physicians are creating concierge medicine practices, in order 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, also is 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.
Our concierge medicine legal team has set up many concierge and membership models, whether these are:
- Cash-based concierge medical practices
- Insurance-based concierge medical practices
- Hybrid (cash and insurance) concierge medical models
We understand the balanced decision-making that MDs, DOs, chiropractors, and other healthcare practitioners must make in titrating the requirements of legal compliance against the risk-taking in advancing models of healthcare.
Corporate Practice of Medicine
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)
and many other variations on the collaboration between physicians and non-physicians that cannot, by law, implicate the non-physicians in the clinical side of the venture.
We understand the exceptions to the corporate practice of medicine, as well as the nuances and ways to think creatively so as to mitigate risk of corporate practice of medicine exposure.
Healthcare Fraud & Abuse
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.
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);
- Regular compliance checks, including frequent tune-ups to existing HIPAA policies, procedures and forms.
Our HIPAA legal team has deep training in all that HIPAA requires, and can translate regulatory esoterica into practical action items to drill down into HIPAA compliance.
Management Services Organizations (MSOs)
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
Together with technological progress, healthcare practitioners are also driving innovation in the way they deliver care.
Our healthcare lawyers guide clients in the healthcare technology space and understand how to navigate current laws and legal models while clients pioneer advance in wearable health technology, AI and VR, nanotech, and other emerging, converging, and exponential technologies.