Allied Health Legal & Compliance
Guidance
Guidance
Our healthcare legal team is attuned to the specialized legal and regulatory needs of allied healthcare providers. Allied healthcare providers often have special legal needs because of their sheer diversity and the extent to which they are dependent on, or independent from, physicians (MDs and DOs).
Allied Healthcare Providers: Specialized Needs
More than half of the healthcare providers in the U.S. are allied healthcare providers. Increasingly, due to the shortage of primary care physicians, allied healthcare professionals are the front line of patient care.
The allied healthcare professionals that our healthcare lawyers serve, include:
Advanced Practice Nurses, Registered Nurses, and Nurse Practitioners
Audiologist and speech language pathologists
Clinical Psychologists
Dentists
Emergency medical personnel (EMTs, paramedics)
Genetic counselors
Health information technologists
Imaging specialists
Licensed Social Workers
Medical Assistants
Pharmacists
Physical Therapists
Physician Assistants
Allied healthcare professionals have special legal needs, because they are sometimes subject to legal rules that also affect physicians, yet are separately defined and operate under idiosyncratic legal structures.
Licensing of Allied Healthcare Professionals
According to 42 U.S.C. 295p:
The term “allied health professionals” means a health professional (other than a registered nurse or physician assistant)—
(A) who has received a certificate, an associate’s degree, a bachelor’s degree, a master’s degree, a doctoral degree, or postbaccalaureate training, in a science relating to health care;
(B) who shares in the responsibility for the delivery of health care services or related services, including—
(i) services relating to the identification, evaluation, and prevention of disease and disorders;
(ii) dietary and nutrition services;
(iii) health promotion services;
(iv) rehabilitation services; or
(v) health systems management services; and
(C) who has not received a degree of doctor of medicine, a degree of doctor of osteopathy, a degree of doctor of dentistry or an equivalent degree, a degree of doctor of veterinary medicine or an equivalent degree, a degree of doctor of optometry or an equivalent degree, a degree of doctor of podiatric medicine or an equivalent degree, a degree of bachelor of science in pharmacy or an equivalent degree, a degree of doctor of pharmacy or an equivalent degree, a graduate degree in public health or an equivalent degree, a degree of doctor of chiropractic or an equivalent degree, a graduate degree in health administration or an equivalent degree, a doctoral degree in clinical psychology or an equivalent degree, or a degree in social work or an equivalent degree or a degree in counseling or an equivalent degree.
Notwithstanding this federal law definition, state laws define the scope of practice for each allied health professional. And states vary in terms of the breadth and depth of scope of practice.
For example, some states have mandatory licensure for some professions, and only title licensure for other allied healthcare professions. For example, in California, anyone can provide nutritional advice, so long as they do not practice “medicine” or use a licensed professional title. California law requires that the practitioner giving nutrition advice, post this notice in a prominent place:
NOTICE
State law allows any person to provide nutritional advice or give advice concerning proper nutrition—which is the giving of advice as to the role of food and food ingredients, including dietary supplements. This state law does NOT confer authority to practice medicine or to undertake the diagnosis, prevention, treatment, or cure of any disease, pain, deformity, injury, or physical or mental condition and specifically does not authorize any person other than one who is a licensed health practitioner to state that any product might cure any disease, disorder, or condition.
Other states have stricter definitions. For instance:
“Dietetics or nutrition practice” means the integration and application of the principles derived from the sciences of nutrition, biochemistry, food, physiology, and behavioral and social sciences to provide nutrition services that include: (A) Nutrition assessment; (B) the establishment of priorities, goals, and objectives that meet nutrition needs; (C) the provision of nutrition counseling in health and disease; (D) the development, implementation and management of nutrition care plans; and (E) the evaluation and maintenance of appropriate standards of quality in food and nutrition.
Use of Allied Health Professionals in Healthcare Ventures
Healthcare ventures, too, face legal challenges when they incorporate allied health professionals in models of care.
For example, consider a medical spa formed by a nurse practitioner and physician. Legal questions arise, such as:
- Who must conduct the “good faith,” or initial patient examination?
- Who can own which part of the medical spa?
- Who owns the medical records?
- Which healthcare practitioner owns the intellectual property?
- What happens if there is a dispute between the parties—how do they separate? Which one can have access to the patient database in the Electronic Medical Record (EMR)?
- What is the best way to allocate their rights and responsibilities, contractually?
- What are the physician’s supervisory responsibilities? How often must the physician be on premises? Must the MD or DO sign off on all of the medical records, or only a certain percentage?
- What kind of corporate entity should run the clinical side, versus the administrative and business side, of the medical spa; and which person (MD, RN, NP, PA, and so on) can or should own what percentage of the LLC, general business corporation, or professional corporation?
- What are the corporate practice of medicine and fee-splitting issues associated with the medical spa venture, and how can regulatory and legal risk be mitigated?
Other questions arise as healthcare startups seek to use non-MD healthcare professionals, such as for example nurses or physician assistants (PAs), as the front line caregiver or diagnostician/triage person in their healthcare venture.
Our healthcare lawyers advise medical spas, telemedicine companies, mobile medical app developers, and other healthcare ventures on all of these issues, as well as issues that arise specifically related to the capabilities, legal scope of practice, reach, and deployment of allied health professionals in various enterprises.
Employment Agreements for Allied Health Professionals
Allied health professionals often need specialized employment or consulting agreements. For example, our healthcare lawyers can draft nurse employment agreements, or, an agreement for a staffing company that supplies nursing professionals to hospitals, medical groups, and other clinical facilities.
In these employment and staffing agreements, the nursing or other allied healthcare professional must commit to maintain their professional license in good standing; comply with all relevant laws and regulations, maintain a supervisory relationship with a supervising physician; complete appropriate medical charting notes and documentation in accordance with the employer’s policies and procedures; and inform the employer of any nursing board or other relevant agency investigation and discipline. There are also provisions related to confidentiality and maintenance of trade secrets.
If the nurse, physician assistant, or other allied health professional is also a shareholder of the professional medical corporation, then it is important to draft appropriate agreements including the shareholder agreement, stock purchase agreement, and other ancillary legal documents.
Our healthcare lawyers have handled many different kinds of healthcare ventures and situations. For example, one involved a healthcare company in which the nurse was giving patients specialized advice related to their use of cannabis (medical marijuana). Here the intersection of federal law and enforcement and state law requirements was particularly complex. As always, our legal documents and counsel are heavily dependent on our overarching regulatory knowledge, as the healthcare environment provides a rich, complicated, and ever-changing soil for entrepreneurial activity.
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.
