5 Legal Issues Integrative Health Practitioners Need to Know for 2015

By Michael H. Cohen, JD

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h5. With 2015 right around the corner, here are 5 legal and regulatory issues that integrative health practitioners need to know.

h4. 1. No defined legal category

Integrative medicine remains outside the bounds of a professional category defined by law—unlike, say, “physical therapy” or “psychology.” This means that the rest of healthcare law has to be borrowed, modified, or adapted to fit integrative health.

For example, integrative medicine physicians must mitigate the risk of malpractice liability when practices such as say, functional medicine, move to the far edges of what would be considered standard of care or generally accepted medical practices. In some cases, integrative medicine doctors might be able to argue that functional medicine, hormonal therapies, and similar approaches, while not necessarily standard of care, represent an evolving standard that is accepted by a respectable minority of physician peers.

There are certainly credentialing mechanisms for integrative care practitioners, but they are separate from state licensing provisions. In order to practice, a practitioner must either be licensed by the state, or fall within a state statutory carve-out for non-licensed healthcare practitioners, if one exists.

h4. 2. Integrative medicine physicians should decide whether to embrace, or disclaim, primary care.

A key strategy our law firm has been using with physicians who incorporate complementary, alternative, and integrative medicine therapeutic approaches is to style the physician as a consultant or specialist, who disclaims primary care. For example, the physician may not treat the patient’s diabetes, but may review with the patient lifestyle choices that lead to or exacerbate diabetes.

Some integrative medicine physicians prefer the primary care doctor role. However, this means that they take responsibility for providing standard of care for primary care. If the physician is, for example, only providing consultative homeopathic care so as to improve overall health rather than treat symptoms and effectuate cure, then the physician may wish to disclaim primary care.

h4. 3. Kickback and fee-splitting issues represent a danger zone for integrative practice.

Because integrative health care is inherently collaborative, it presents dangers of kickbacks and fee-splitting, as well as prohibited self-referral. If Medicare- or Medicaid-reimbursed services are provided, then the integrative healthcare practitioner must consider federal law (i.e., Stark and federal anti-kickback law) as well as state law prohibitions against self-referral, kickbacks, and fee-splitting. If federal law does not apply, then state law still does.

In general, practitioners must be wary of arrangements that provide unlawful inducements for other providers within the integrative health referral group to refer to one another. Because practitioners may be referring back and forth (for example, integrative medicine physician to the acupuncturist or chiropractor, and the reverse), their compensation arrangements within an integrative care center should be legally reviewed to ensure that no compensation is dependent on the value or volume of referrals.

h4. 4. The MSO model is here to stay.

Our law practice has seen more and more management services organizations (MSOs) springing up, as a way for non-clinicians to capitalize on a portion of the stream of revenues from healthcare services.

Whenever non-licensees enter into arrangements with licensed healthcare professionals (such as medical doctors, nurses, psychologists), there are at least two legal risks: (1) that the arrangement will be perceived as illegal fee-splitting; and (2) that the arrangement will be seen as violating the corporate practice of medicine doctrine, which prohibits companies from intruding into the clinical domain.

The MSO model is one way to create a more compliant business structure. The basic idea is that the MSO performs administrative/management and marketing functions at fair market value for the clinical practice. The MSO may have authority over the bank account of the clinical practice, and extract its monthly management fee from the account. In some states (such as California), the management fee can be a percentage of gross revenues of the clinical entity, provided this represents fair market value for services rendered.

The MSO provides a vehicle for non-clinicians to jump into the integrative healthcare market, by finding integrative clinical practices to manage and develop.

h4. 5. Telemedicine, mobile health, and wearable health are emerging trends that will merge with integrative healthcare.

Many of the legal issues that are present in integrative health care also present themselves in the next technological evolution of medicine, telemedicine and mobile health (m-health).

In its most simple definition, telemedicine involves delivery of healthcare services online—for example, a doctor-patient encounter via Skype. Mobile health involves use of mobile apps to store, display, or transmit healthcare information, often as part of a clinical encounter.

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Some telemedicine companies, in order to mitigate risks of enforcement based on violations of corporate practice of medicine and fee-splitting prohibitions, style their services as informational and educational, and not clinical.

In general, the same standard of care as applies in physical delivery of healthcare services, also applies in telemedicine. Patients must also receive informed consent, and privacy and security rules (such as HIPAA) can apply.

Mobile health is even trickier, because the federal Food and Drug Administration (FDA) regulates “mobile medical apps” as medical devices. These are apps, among others, that purport to diagnose or treat disease.

Telemedicine and mobile health, like integrative health, can involve multidisciplinary approaches to health. Although telemedicine and mobile health refer to mechanisms for the delivery of healthcare and not to a philosophy of care, they are arguably very different than integrative care. At the same time, these are all aiming at the same thing: better health through means that include, but are not limited to, conventional therapeutic approaches. In other words, telemedicine and mobile health are in large part used to provide lifestyle, nutritional, and other approaches that are also central to the mind-body-spirit movement within integrative care.

Some day we may drop the notion of medicine being “integrative,” “tele-,” “mobile,” and so on, and simply see a spectrum of care, being delivered through a variety of technologies.

About FON

FON is a leading integrative health and medicine business development and strategy consulting firm. FON specializes in custom solutions for growing patient volume, developing programs, and increasing product sales. Our practical business models are driven by innovative marketing, clear messaging, and customer engagement via branded storytelling.

Contact us today to schedule a complimentary 30-minute consultation to discuss your business development or personal brand needs.

Author: Michael H. Cohen, JD

The Michael H. Cohen Law Group counsels health technology companies and providers on healthcare legal issues and FDA legal and regulatory matters. Legal counsel includes corporate and transactional healthcare matters, healthcare regulatory compliance, and healthcare litigation and dispute resolution. Attorney Michael H. Cohen is an internationally recognized author, speaker on healthcare law and FDA law, and expert in developing legal strategies for healthcare ventures, including integrative medicine, anti-aging and functional medicine, telemedicine and concierge medicine.

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