CAMLAW: Complementary and Alternative Medicine Law Blog : Complementary, Alternative, & Integrative Medicine Law, Regulation, Ethics & Policy (Alternative and Complementary Medicine, Medical Spa Information, Holistic Health Attorney, and Legal Resources)

• Email This
• Print
• Share Link

Many business owners think that handling Stark, kickback and fee-splitting issues in the medspa or integrative care clinic is simply a matter of drafting standard contracts for independent contractors or employees.

Creating Legally Successful, Multidisciplinary Health Care Practices: Fee-Splitting, Kickbacks, Stark Analysis, Corporate Practice of Medicine, Unlicensed Practice, Employment, and Other Issues

Many law firms will try to compete by offering a cut-rate, but legal services are not like selling a used car.  The cost today may be cheap but the price tomorrow steep.

Our law firm has a track record of serving clients in the medical spa, wellness, and complementary / alternative / integrative medicine industries. We do not stop with drafting a standard contract.  Nor do we build out cookie-cutter corporations, when the law may call for more complex arrangements.  For example, when advising on appropriate entities, we will look at the intersection of state laws governing the corporate of medicine, incorporation laws, and rules of the applicable state professional board (e.g., medical board, cosmetology board, board of dentistry, nursing board, etc.). The goal is to account for the complexity inherent in the law without making matters unduly complicated.  Complexity without complication equals proper service to the client--documents that will hopefully withstand the test of later regulatory scrutiny.

Some of the services our law firm provides are:

• Analysis of proposed compensation arrangements (including revenue-sharing) with regard to Stark, anti-kickback and fee-splitting issues, and recommendations concerning use of "Mall" vs. "Center" model.
• Draft of a legal memorandum analyzing Stark, anti-kickback and fee-splitting issues and outlining compliant compensation arrangements, to serve as back-up justification in case of later regulatory action or lawsuit.
• Legal analysis and advice regarding state law self-referral and anti-kickback issues and design of flow-of-payments accordingly.
• Review and legal advice concerning legal issues surrounding designation as "medical director."
• Legal advice concerning degree of supervision necessary for spa or other therapies.
• Drafting of contract between MD/DO and Center/Clinic/Practice/Spa; drafting of contracts with health care practitioners; drafting of other employment agreements; legal analysis of independent contractor vs. employee arrangement.

• Review and analysis of malpractice liability risks relating to therapies the practitioner offers.
• Assessment of practice or entity's liability (vicarious liability) for acts of associated and affiliated practitioners and recommendations regarding legal structure to help create protection.
• Review and analysis of claims and/or guarantees made in the practice.
• Review and analysis of clinical use of any potential “medical devices” under the federal Food, Drug & Cosmetic Act.

• Review and analysis of legal issues pertaining to dietary supplement / nutraceutical / cosmesecutical recommendations by clinicians.
• Review and legal analysis of issues pertaining to dietary supplement sales by the physician or other clinician, or clinical practice, or clinic or spa.

• Review and legal analysis of FDCA risks relating to therapies that could be considered off-label or experimental.
• Proper accounting for role of physician as primary care doc vs. specialized care (i.e., integrative medicine, aesthetic medicine, etc.).

• Legal advice concerning potential disciplinary issues (including standard of care issues inherent in novel or non-standard therapies).
• Scope of practice issues involving non-physician providers including both allied health practitioners (such as nurse, physician assistant, psychologist) in the clinic and CAM providers (such as acupuncturist, massage therapist, chiropractor, energy healer); issues relating to non-licensed healer, hypnotherapist, homeopath, naturopath, and others.

• Review and legal advice concerning insurance arrangements, including Medicare status (par v. non-par v. opted out) and expected patient population.
• Draft Medicare ABN Notice and Patient Assignment or Waiver Forms.
• Draft non-participation letter for insurance companies with whom MD/DO has contract through medical school or hospital affiliation, managed care or MSO contracts.
• Legal advice with regard to insurance arrangements such as proper CPT and E&M coding for the super-bill; discussion of issues of upcoding, unbundling, medical necessity, scope of practice, discounts and waivers, fraud and abuse “incident to” billing, all of which can present unintentional regulatory traps.
• Recommendations regarding professional liability insurance.
• Draft letter to malpractice carrier regarding coverage of CAM.
• Discussion of patient's insurance coverage of CAM and aesthetic medical therapies; whether therapies can be deemed medically necessary v. experimental.
• Recommendations concerning general liability insurance (e.g., spa liability;  general business liability; employee benefits liability; group health insurance; healthcare billing errors and omissions; directors and officers; employment practices; workers compensation).

• General Informed Consent Form for medicine, chiropractic, acupuncture, massage, etc. (or non-licensed practitioner if state law mandates disclosures).
• Draft Nutrition Notice (if applicable—e.g., CA).

• Review of confidentiality practices
• Draft of Privacy Form (non-HIPAA, mirror form; or state-specific, compliant HIPAA Manual if billing electronically).

• Review of marketing materials including website for FTC (Federal Trade Commission) and other potential liability issues.
• Legal review with regard to FDA (Food and Drug Administration) issues concerning claims and labeling.

The list of issues can expand or contract accordion-like according to the particular project. However, it takes experience and judgment to decide which issues should be flagged and which can be deferred, and strong business judgment in consultation with a health care lawyer versed in medical spa and integrative medicine legal issues to determine how to proceed.  

The best way to build trust with your health care legal expert is to briefly describe your project and have the attorney highlight areas of concern that are best addressed before opening your center.  Feel free to contact our law office to see how we can help.  Sometimes a short call can establish the list of priorities, and at other times an initial consult is a valuable way to forge the relationship that will launch your enterprise.

**

For those who are always looking to be within budget, we strive to be cost-effective and efficient, without the layers of usual law firm bureaucracy.  However, do not compete on price but on value.  We hope our work will stand the test of time, and that you will find our services so amazing that, like many satisfied clients, you will happily refer everyone you know. 

**

Michael H. Cohen is an attorney providing business legal advice to green entrepreneurs and companies, and health care law advice to businesses and physicians, acupuncturists, naturopaths, homeopaths and others in the holistic health, wellness, and green industries. As a founding attorney of the Global Vision Law Group, he represents businesses poised for vertical lift, whose leaders are conscious, intuitive, and committed to shaping a better world. Michael also advises medical spas and integrative medicine clinics, physicians, chiropractors, naturopathic physicians, massage therapists, energy healers, nutritionists and herbalists, dietary supplement and cosmetics companies, and businesses with bio-energy and other technologies and medical devices. Michael offers the Entrepreneur’s Legal Toolkit as a series of legal guides to businesses. The first legal e-book deals with Contract Essentials, giving legal tips every business needs to negotiate its legal agreements; the second addresses legal issues faced by multi-level marketing companies and individuals involved in multilevel marketing and direct sales; and a HIPAA Regulations and Privacy Manual.

• Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services. 

  Read reviews of Michael’s work on the Complementary Complementary and Alternative Medicine Law Blog. And visit the Flat Rate Legal Services page for information on legal services where a  flat rate or project fee can be discussed (such as incorporation for entrepreneurs, review and drafting of business contracts, trademark, and health law services for CAM providers and others).

  Michael’s clientele  through the Global Vision Law Group includes businesses not only in California, New York, Maryland, Massachusetts, Washington, D.C., and other U.S. states, but also abroad.  Our firm also provides special expertise to attorneys and law firms whose clients are involved in wellness industry projects or who require guidance regarding fee-splitting, Stark, anti-kickback, medical board discipline, and other health law and regulatory compliance issues.

  To speak with a lawyer about health care law issues pertaining to complementary and alternative medicine, or to consult a business lawyer about laws and legal issues for entrepreneurs and new enterprises that are seeking legal advice, contact the Global Vision Law Group today.