Diverse healthcare legal needs require that law firms deploy specialized healthcare law guidance across multiple legal and regulatory domains

Because the healthcare industry is a complicated, multi-trillion-dollar gargantuan, legal needs within the health and wellness market cover a broad range and require that a healthcare law firm deploy its specialized knowledge across multiple domains.

To help focus our prospective clients and law firm clients on the right questions and issues, we typically ask them to answer four questions during intake:

1. What legal or business challenge brings you to our Firm?
2. What are your most immediate concerns or questions?
3. What specifically made you decide to contact us?
4. What have you done so far to resolve this?
5. What will it cost you in terms of Time, Money, or Reputation if you don’t take action?

As we represent hundreds of different health and wellness industry clients each year, we find that these questions get healthcare clients to tell us what is most important about their legal puzzle or problem, let us know what they have tried to resolve their situation and why this has not worked (often this involves getting conflicting or inadequate advice from previous attorneys), and, what is at stake in getting a healthy resolution to their legal situation.

Although we can group our client base into the mix below, each healthcare businesses or practice each these questions differently.  Our base includes:

• Allied health providers (such as dentists nurses, psychologists)
• Physicians (anti-aging, functional medicine, integrative medicine)
• Behavioral & mental healthcare providers & life coaches
• Biotechnology & life sciences companies
• Cannabis ventures
• Complementary & integrative medicine providers (chiropractors, acupuncturists, massage therapists, healers)
• Physicians engaged in direct primary care and concierge medicine
• Cosmetics companies / cosmeceuticals
• Dietary supplement & nutraceutical companies
• Digital & mobile health companies
• Emerging healthcare companies (nanotech, healthcare software, AI)
• Healthcare facilities (hospitals, labs, DME, imaging, pharmacies)
• Management services organizations (MSOs)
• Medical device companies
• Medical groups, medical centers
• Medical spas
• OTC & homeopathic drug companies
• Telemedicine ventures

We find that when we task our healthcare clients with filling out the Intake form, the narrative they quickly produce naturally leads to igniting the legal strategies and solutions that can inform their businesses.

Without divulging the specifics of any given business or practice, we would like to give you a sense of the flavor of some requests we have received.  This is to showcase the breadth of our healthcare and FDA law practice and the ways healthcare industry players understand the costs of not figuring out the legal and regulatory blueprint and trajectory for their healthcare enterprise.  Even though we quote some of our Intakes forms, the information below is generic and encapsulates more generalized concerns around the kinds of legal problems and puzzles people bring to us and what their exposure concerns are more generally.

1. What legal or business challenge brings you to our firm?

• I want to start a cosmetics manufacturing, need the proper guidance.
• We are launching a new product and want to know if there are any restrictions on the ingredients. Also, we want to outline our legal strategy and get an understanding of legal obstacles.
• General Integrative Healthcare, Nutritional Supplement business regulatory and legal issues.
• I need to confirm that a mobile phone app I have created fits the FDA guidance.
• I want to know whether I need to do anything about the products I have already sold. The FDA gave me no guidance. It only states the next shipment could be subject to detention.
• Integrating a Chiropractic practice with an MD and a NP.
• Guidelines and legal questions regarding my naturopathic office.
• Restructuring my corporations and possibly into if a Delaware LLC would serve me to protect from a frivolous lawsuit as well as distance myself from my billing company by having no personal liability.
• Questions: (1) Can I continue to work as a pool physician with a larger health care organization, while beginning my own practice? Currently, I am transitioning from employed role to a private provider Functional Medicine practice. I have gone to a pool position, however, this position remains is as a W-2 employee. I am scheduled at this time into June but was hoping to continue in this reduced role while starting my own practice to maintain income as I build my client base. (2) How should I set up my company structure? S-corp? MSO? I will start out as an individual, however, would like to see this potentially grow into a clinic/retreat/spa in the future and I want to set it up appropriately from the start. (3) As I get started, I would like to contract with/hire a health coach and I need to identify the best way to do this.
• I was a chiropractor for 20 years and then went to medical school … I am now considering a supervising physician position for medical-chiropractic integrated practices.
• SB577.
• I am starting a telemedicine healthcare practice. I have been practicing for 20+ years and have been using functional medicine for the past 8 years. I am certified in functional medicine and currently work in an office setting, It has been a lifelong dream of mine to practice more holistic medicine and have my own practice.
• A physician and I are partnering to open a functional/traditional medical practice. We have questions we need to discuss with a knowledgeable attorney. Issues include: 1) best structure for corporate considering a physician and non-physician partnership; 2) All things to consider if physician chooses to only take cash, especially if physician is working under another TIN where he accepts insurance 3) What if physician sees patients in different states 4) What do we need to consider if seeing patients via telemedicine platform? specifically in relation to #2 and #3 5) If only coaching sessions or consultation is offered via telemedicine, are these considered ‘practicing under the TIN’ as a medical visit or other? 6) What are the documentation and external review laws around telemedicine if nothing is being submitted to insurance? 7) If we start services only via telemedicine – consultations, etc. is this considered traditional medical care according to legal medical care? vs. if we saw a patient in person, in an office? 8) What are the rules and regulations around selling product out of the office (supplements, other services like coaching, cooking classes, yoga, massage, energy work)? 9) How do malpractice insurance needs and requirements vary across business model options (fee for service consultation/telemedicine only, membership in virtual/electronic group, membership in group with physical location, other)?
• Fee splitting and questions regarding my law quit re practicing medicine w/o a license.

2. What outcome would you ideally like? What are your most immediate concerns or questions?

• I need a letter from your organization confirming that the app is indeed compliant with FDA guidance.
• Guidelines for marketing, affiliating, mobile nebulizer treatments, and shipping vitamin injections.
• What is allowed and not allowed.
• Having full understanding of legal compliance.
• (1) To continue to work as a pool physician in my current situation to maintain income while setting up my own practice. (2) Start with what would be the best organizational structure of the company, preventing any issues or having to go back and change later. (3) Felt that contracting with, paying a certain amount to them for each patient.
• To be told step by step the things I must do and how to do it.
• A fair and equitable contract with the integrated practices which I am supervising and all protections therein required for myself consistent with applicable law.
• Operating a weight-loss and wellness center without violating the law.
• I would like good, soundproof, and well planned-out legal help – who I am allowed to help, in what capacity, etc…. I need all legal documents (i.e. disclaimers, patient/physician contracts, etc.) … I need my website reviewed to make sure I am using the right language so as to not mislead anyone, etc.
• Walk through each of our questions and fully understand all legal considerations so we can set up our practice compliantly and a structure that best support a successful model.
• My Amazon business is a very small side hustle and I don’t want to deal with complicated medical items until I am ready to go larger.

3. What specifically made you decide to contact us?

• Your experience working with the FDA.
• A colleague of ours uses your firm.
• Contacted several attorneys, researched the Internet.
• Searching for legal aspects of MD/DO and DC integrated practices.
• Specific industry and regulatory knowledge and experience as listed on your website.

4. What have you done so far to resolve this?

• Previously I received such a letter from another attorney in New York.
• We have consulted another attorney briefly.
• Legal research.
• Potentially not getting my chiropractic license back and additionally $150,000.00 for a frivolous lawsuit.
• (1) Not certain there is a resolution with the Medical/Medicare regulations as I understand them. (2) Have looked into the options of organizational structures but looking for advice.
• Read information online.
• I am currently enrolled in the Kalish Institute and have done a lot of work on my own and with the help of a family business tax lawyer. I have opened up an S-Corporation in CA, have started on the website and involved in marketing – but nothing officially done yet until I get legal advice. I also have my website’s name being trademarked as we speak.

5. What will it cost you in terms of Time, Money, or Reputation if you don’t take action?

• This is for marketing of the app – difficult to determine but it is not significantly important to the success of the venture.
• Delay in opening office.
• Company closure.
• Inability to move forward with my own practice until I resolve these basic issues, costing all 3. I can’t start to see functional patients, other than the little help I can provide when I am in the office at my current employer, losing time on getting my practice started. Overall, losing time, money and if don’t figure these basic structural issues out could it could impact my reputation in the eyes of my current employer if it is not done properly and I would be unable to develop a reputation in the functional medicine world.
• It could be a crushing blow financially. We have already invested $900,000.00 to get the first location operational.
• I will get in a lot of trouble if I don’t do things right the first time. I have a list of questions and can’t wait to talk to work with the legal team to help sort out the confusion behind some of this telemedicine “grey zone.”
• We want to make sure we set up the practice correctly as we launch.

As you can see, some of the questions are quite specific (and some have quite a long list of healthcare and FDA legal questions).  Others are more about figuring out their model; or, perhaps, deciding whether to make a move from what they are currently doing toward a more robust investment of time, energy and money into their healthcare venture.  Still others are looking for a feasibility assessment of their healthcare enterprise idea.

Similarly, some people realize that the cost to not figuring it out is enormous.  A few will mention specific penalties, such as those that attach to HIPAA breaches, anti-kickback and corporate practice of medicine violations, or violations involving other legal rules.  Some cannot move forward without this initial legal guidance.  Still others recognize that a regulatory setback of liability exposure could be a “crushing financial blow.”

Wherever you are in your healthcare legal journey, now is a good time to book your Legal Strategy Session.  Start exploring your legal options by talking to an experienced healthcare and FDA attorney at Cohen Healthcare Law Group today.