Anti-aging Legal & Compliance
Guidance
Guidance
Whether using the term anti-aging medicine, aesthetic medicine, functional medicine, integrative medicine, longevity medicine, or anything other than “cookbook conventional care,” physicians, chiropractors, other providers, and clinical practices can buttress their legal fortress with solid legal and regulatory advice.
Anti-Aging and Functional Medicine Law
As with other emerging sectors of the multi-trillion dollar, health and wellness industry, the law governing anti-aging, longevity, and functional medicine practices continues to evolve as the emerging healthcare trend is away from cookbook, conventional medicine and toward personalized medicine with a systems-based approach.
Patients want their medical doctors to help them stay youthful, fit, radiant, and beautiful. Today’s patient is not interested in a pharmaceutical “magic bullet,” but rather understands health in its totality, as the synergistic result of multi-factorial inputs, including diet, nutrition, lifestyle, environment, mind-body-spirit health, attitude, habits, exercise, relationships, and everything else that impacts physical, mental, emotional and spiritual well-being.
As healthcare lawyers, we understand the multidimensional journey to health and the passion our healthcare clients have for different approaches to health and wellness, including:
- Aesthetic medicine
- Ayurvedic medicine
- Anti-aging medicine
- Bio-identical hormones
- Complementary and Alternative Medical (CAM) Therapies
- Cosmetics and Cosmeceuticals
- Dietetics and Nutrition
- Dietary Supplements and Herbal Medicine
- Energy medicine
- Functional medicine
- Genetics counseling and genetics or genomics based therapies
- Health and wellness lifestyle apps and mobile medical apps
- Integrative medicine
- Lifespan medicine
- Osteopathic medicine
- Physical fitness and integration of healthcare into fitness and gym settings
- Systems approaches to health
As published in Thomson Reuter’s Legal Executive Institute:
…As an area of focus for attorneys, some $200 billion was spent in 2018 in the anti-aging industry. And that level of spend is expected to grow much, much higher. With the aging of the world’s population, novel anti-aging medicines and treatments, such as 3D printed organs, young blood parabiosis, genome sequencing, senolytic therapeutics, stem cells, and new nutraceuticals to treat age-related diseases, are gaining ground fast. Indeed, the anti-aging field is fast becoming one of the next big disruptions in the healthcare market.
One of the few law firms that has staked out a position in this niche is the California-based Cohen Healthcare Law Group, which specializes in micro-niches like anti-aging practices, biotech and nutraceutical companies, medical device companies, telemedicine ventures, and emerging healthcare technologies. The firm handles matters such as medical practice business formations, mergers and dispute resolution, e-commerce, licensing agreements, and intellectual property protection.
The anti-aging micro-niche presents numerous opportunities for those practitioners who might choose to focus on developing this kind of legal practice. Skilled corporate lawyers can help companies with securities offerings, mergers and acquisitions, IPOs, and regulatory compliance, as well as drafting the needed contracts to form strategic alliances, spread financial risk, and other contractual agreements required during a product’s lifecycle….
Our Anti-aging and functional medicine lawyers provide legal advice to physicians and other clinicians involved in innovative and emerging diagnostic and therapeutic methods, including anti-aging medicine and functional medicine.
Functional Medicine and Insurance & Medicare Dilemmas
Functional medicine physicians and other clinicians have a particular dilemma, as pioneers in a medical system that is heavily dependent on healthcare insurance. As IFM notes, in Business and Practice Models for the Functional Medicine Clinician:
Providers are successfully applying the Functional Medicine model in many different settings: small, large, cash-based, insurance-based, institutional, and private. Some of the more common models in which Functional Medicine is being practiced are listed below. However, no single, optimal model for practicing Functional Medicine exists, and in reality, clinicians tend to practice a hybrid of two or more models.
Among other legal and regulatory challenges facing the functional medicine doctor is how to deal with insurance, when the functional medicine recommendations to the patient are much more encompassing than those insurance covers.
For the medical doctor who is participating (or even non-participating) in Medicare, their Medicare status poses an immediate legal challenge.
Unless opted out, a clinician within the Medicare system (par or non-par) cannot charge the patient for a Medicare-covered service. Where the functional medicine doctor is effectively practicing primary care, doing a wellness exam, or otherwise offering medical services that Medicare may cover, the functional medicine MD must take care not to double-bill the patient through a membership fee on one hand, and Medicare reimbursement on the other. When par or non-par, the MD can only offer clearly Medicare non-covered services to Medicare beneficiaries.
Often there is a slippery slope between covered and non-covered services and great legal care must be taken not to cross the line. As well, often physicians are not even aware of their Medicare obligations or that, unless opted out, they have such obligations to Medicare. Our healthcare lawyers have counseled physicians in Medicare fraud investigations, where the physician has received a letter from Medicare citing violations and raising the prospect of hefty penalties.
Some physicians have a cash-only practice, effectively eliminating risk that comes from participation in commercial insurance; however, they still have to navigate the patient agreement, legal issues governing subscriptions and automatic renewals, and even issues governing provision of superbills and liability and regulatory risk surrounding the membership-based practice.
Lawyers who Understand Functional Medicine
Our healthcare and FDA lawyers have represented many functional medicine doctors and functional medicine practices. Our founder, attorney Michael H. Cohen, has also served as Institute for Functional Medicine (IFM) faculty (IFM – Michael H. Cohen, JD, MBA).
Engaged in a collaboration with Dan Kalish and the Kalish Institute of Functional Medicine to develop online course materials specifically geared to functional medicine physicians. We understand that Functional Medicine addresses the underlying causes of disease, using a systems-oriented approach and engaging both patient and practitioner in a therapeutic partnership.
Some of the legal issues our healthcare legal team assists functional medicine doctors with, include:
- Anti-kickback, fee-splitting, Stark and self-referral legal issues
- Concierge practice legal issues
- Informed consent legal issues
- Health coaching and legal issues around MDs serving as “health coaches”
- Legal issues related to Telemedicine
- Patient agreement (subscription agreement; membership agreement)
- Practice Structure and Practice Management
- Telemedicine legal issues
Our deep experience in holistic healthcare, complementary and integrative medical therapies, and general well-being outside of (or integrated with) conventional, cookbook medicine and affinity for emerging therapies is a hallmark of our legal practice.
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.
