Do Discounted Vitamin Shots Create Legal Risk of Enforcement?

Are Vitamin Shots for Health—Legally Healthy?

Anti-aging and longevity medicine is everywhere these days.  From California to Florida and everywhere in between, the health, wellness and beauty industry beckons people toward the promise of greater youth, vitality, and greatness in the body.

Vitamin shots, or vitamins IVs, are part of this trend.

Many of our clients are healthcare ventures, working with one anti-aging or longevity medicine therapy or another.  We see all sides, including:

  • The medical or osteopathic doctor (MD or DO), nurse practitioner (NP), naturopathic physician (NP), physician assistant (PA), or health coach, who wants to put together a wellness clinic.
  • The entrepreneur or investor, or app developer, who has the idea and puts together the team to create a mighty brand.
  • The management company (MSO), again deploying marketing and branding to build the enterprise, and seeking legal strategies for interfacing with the licensed healthcare professionals in a compliant way.
  • Nursing and other healthcare staffing companies.
  • Companies with FDA-regulated products, such as dietary supplements and cosmetics aimed at anti-aging and wellness.

In this article we’ll explore some of the legal risks these ventures face, and address some legal strategies to tackle these issues.

Legal Issues around Offering Discounts for Vitamins Shots

Recently our healthcare attorneys came across a warning against receiving discounts for B12 Shots.

The California Naturopathic Doctors Association states in its Membership FAQs:

B12 Happy Hours. You cannot offer a lower price for B12 shots for those who are able to come during a set period of time. You CAN offer a B12 Happy Hour where patients can come without having an appointment, but they must pay the same fees you charge at other times of the week.

Groupon. This constitutes a fee for referral service and is against current law.

Package Deals with an Expiration Date. You cannot require that a patient get a medical treatment or service within a specific period of time.

Monthly Discounts. Similar to B12 Happy Hours, you are not allowed to offer different patients different fees. This includes monthly specials for all patients of a certain type.

See our prior post:

Do online coupons for discounts to physician and other clinician services violates Stark, anti-kickback and fee-splitting laws?

The CNDA is taking a strong position here with respect to practices that may be common among naturopathic physicians (as well as medical doctors).  Let’s dig in to the law a bit more.

Unprofessional Conduct

The big risk here isn’t necessarily a patient malpractice (professional negligence) lawsuit.  It’s professional discipline.

California Business & Professions Code, Section 4260 (Unprofessional Conduct – Naturopathic Medical Physicians) – includes in the definition of unprofessional conduct:

(a) The obtaining of any fee by fraud or misrepresentation.

(b) The aiding or abetting of any unlicensed person to practice naturopathic medicine.

(c) The aiding or abetting of a licensed person to practice naturopathic medicine unlawfully.

(d) The practice of accepting or receiving any commission or the rebating in any form or manner of fees for professional services, radiograms or prescriptions supplied to patients. This subdivision shall not apply to other services or articles supplied to patients if written disclosure is provided prior to the supplying of the services or articles.

(e) Advertising in violation of Section 651 of the Code.

Let’s stop there and go to the reference in (e) to Section 651 of the California Business & Professions Code.

Advertising Issues for Naturopathic Physicians

Section 651 is hefty.  The main prohibition is against:

any form of public communication containing a false, fraudulent, misleading, or deceptive statement, claim, or image for the purpose of or likely to induce, directly or indirectly, the rendering of professional services or furnishing of products in connection with the professional practice or business for which he or she is licensed. A “public communication” as used in this section includes, but is not limited to, communication by means of mail, television, radio, motion picture, newspaper, book, list or directory of healing arts practitioners, Internet, or other electronic communication.

Whenever you see a string of words separated by a comma, you know the statute means business.  Here we’re talking about a “fraudulent, misleading, or deceptive statement, claim, or image” in connection with an offer for professional services.  Sure enough, there’s a long laundry list of actions that can constitute a fraudulent, misleading, or deceptive statement, claim, or image.

Specific prohibitions include a claim that:

(4) Relates to fees, other than a standard consultation fee or a range of fees for specific types of services, without fully and specifically disclosing all variables and other material factors.

(5) Contains other representations or implications that in reasonable probability will cause an ordinarily prudent person to misunderstand or be deceived.

(6) Makes a claim either of professional superiority or of performing services in a superior manner, unless that claim is relevant to the service being performed and can be substantiated with objective scientific evidence.

(7) Makes a scientific claim that cannot be substantiated by reliable, peer reviewed, published scientific studies.

(8) Includes any statement, endorsement, or testimonial that is likely to mislead or deceive because of a failure to disclose material facts.

There is also a general prohibition against any advertising that is “likely to mislead because of a failure to disclose material facts.”

Among the penalties for violations of these provisions, the Attorney General can commence legal proceedings to enjoin the advertisement (i.e., game over … additional enforcement will likely ensue); there can be an administrative fine of $10,000 “per event” (and do the math to multiply the number of “events” times $10,000 to come up with an impossible-to-pay penalty).

Legal Risks Applicable Across the Board

The Bureau of Naturopathic Health defines naturopathic medicine as “a distinct and comprehensive system of primary health care that uses natural methods and substances to support and stimulate the body’s self-healing process”. Currently, there are 14 states including California and Washington D.C. that have licensing laws regarding naturopathic doctors. This practice of medicine sees an inherent healing process in the person that is ordered and intelligent.

In fact, the body is fully capable of healing itself if anything in the way of its healing were removed. Naturopathic medicine works to prevent diseases while treating the whole person. The physician acts as the teacher, as physicians who practice naturopathy remember the definition of doctor is “teacher”. A fundamental of this medical practice is to teach the patient how to properly care for themselves.

Doctors in the naturopathy practice provide this service to their patients through private practice in an office. They often work along with medical doctors and have been licensed to practice medicine for several years. They are not afraid to refer patients to medical doctors if the need to do so arises.

The advertising prohibitions of Section 651 apply to naturopathic medical physicians just as they do to licensed medical doctors, osteopathic physicians, nurse practitioners, registered nurses, chiropractors, psychologists, physician assistants, and others.

Importantly, these prohibitions have to be kept in mind not only in clinical practice, but also in advertising any:

  • Health and wellness center where a licensed professional performs healthcare services;
  • Multi-disciplinary healthcare clinic;
  • Medical spa;
  • Anti-aging and longevity or aesthetic medicine practice.

Intersecting Legal Rules

The advertising prohibitions are important, because they provide one general source of legal authority for an enforcement action, and one that the average licensed healthcare practitioner may not always keep top of mind.

Naturally, legal risks can come from a variety of sources, including not only the advertising prohibitions, but also:

  • Standard of care
  • Informed consent violations (see this video).
  • HIPAA and other privacy and security violations
  • In cases where the practitioner is also a manufacturer or distributor of FDA-regulated products, violations of FDA and FTC legal rules
  • Disciplinary issues such as:
    • substandard care (blatant misdiagnosis, negligent treatment of the patient, delay in the treatment, etc.)
    • prescribing issues (excessive or not enough medication)
    • sexual misconduct
    • impairment (such as alcohol, drugs, or physical)
    • unlicensed medical practice
    • aiding and abetting an unlicensed medical practice
    • unprofessional conduct (i.e. breach of confidentiality, record tampering, fraudulent insurance claim filing, misleading advertising, your arrest, or your conviction)
    • office practice issues (i.e. failure to provide medical records to your patient, failing to sign a death certificate, or patient abandonment)

See some of our prior posts such as:

Physician Advertising of Medical Services: Avoiding 5 Legal Traps

When medical doctors advertise their professional medical services (including online advertising) they can easily run afoul of legal and regulatory traps. Watch out for these 7 legal traps in […]

Integrative medicine advertising legal review: does a flyer need legal review or just “wordsmithing”?

Integrative medicine advertising legal review: does a flyer need legal review or just “wordsmithing?”

Does your concierge medicine advertising create legal jeopardy and liability?

Advertising and marketing are two areas that concierge medicine practices frequently neglect when assessing liability risk.

Again, if you have healthcare products, then you will probably need legal advice based on Food and Drug Administration (FDA) and Federal Trade Commission (FTC) advice.

See:

FTC false advertising legal traps – walk the compliant side of marketing healthcare products

FTC false advertising legal traps can hurt any business, small or established.  Here’s how to walk the compliant side of marketing healthcare products.

Legal Counsel Can Help

If you’re interested in providing a program or range of services to patients based on anti-aging therapies such as those involving B12 shots, IV infusion therapies, or other longevity or health and wellness treatments, beware first of all of discounts, as these can attract enforcement scrutiny.  Get legal counsel at your back, preferably with experience in healthcare as well as FDA law.  And contact us with any questions.

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Michael H Cohen Healthcare & FDA Lawyers

Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

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