1. Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse New York & California Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

2. Magnifying Reputation & Impact Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

3. Today’s Learning Objectives Knowledge is Power - Risk Management -   Objective: Chart a course to avoid the risks and pitfalls in an integrative medicine clinical practice Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

4. Ignorance of the Law No Defense “To know that you do not know is the best. To pretend to know when you do not know is a disease.” Lao Tzu Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

5. What Does Legal Audit of Integrative Medicine Practice Cover?   Risk Management   Licensing   Scope of Practice   Standard of Care   Informed Consent   Advertising, Website, Online Use, Email   New Technologies & Telemedicine Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

6. Other Legal Aspects of Integrative Medicine Practices   State Corporate Practice of Medicine Laws   Anti-Kickback – Fed’l & State   Physician Self-Referral Laws _ Fed’l/State   Patient Inducement or Solicitation Laws   Fee Splitting Laws – State   Cost Report Rules – Medicare & Medicaid   Complex Medicare/caid Reimbursement Rules Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

7. Other Legal Issues of Integrative Medicine Practices   Right of access to treatments   HIPAA & HITECH Privacy Laws   Third Party Reimbursement   Healthcare Fraud   Dietary Supplements, FDA & FTC   Medical Record Documentation   Board Guidelines Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

9. Risk to of Advising on IM/CAM   When advising patients concerning IM/CAM therapies, major legal risks are: 1. Professional discipline by medical board 2. Exceeding Scope of Practice 3. Civil action for medical malpractice Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

11. What Can you be Disciplined For? “Unprofessional Conduct” defined as:   Any departure from, or failure to conform to, the minimum standards of acceptable and prevailing medical practice.   “Flamboyant or extravagant claims concerning professional excellence or treatment protocols”   Negligence in the Standard of Care Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

12. Licensure – Don’t Mess Around   Unlicensed practice – whether medicine, psychology, therapists, naturopaths, acupuncturists, herbalists, nutrition, dietetics, or massage therapy – is criminal in most states.   What is the unauthorized practice of medicine? Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

13. Licensure in CAM   1904: Chiropractic   1910’s: Naturopathy   1960’s: Massage Therapy   1970’s: Acupuncture Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

14. # of States Licensing CAM Providers Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law Source: http://nccam.nih.gov/health/decisions/credentialing.htm

15. # of Licensed Practitioners Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

16. Licensure v. Scope of Practice   Licensure – the legal authority granted by a governmental entity to practice a profession.   Scope of Practice –what the providers are legally authorized to do – the boundaries of licensed practice (how far a provider can and can’t legally go) Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

17. Licensure: Practicing Medicine (MD & DO only) Diagnosis Treatment Prevention Cure Prescribe Disease Injury Physical Mental Condition Practice of Medicine Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

18. Scope of Practice (Boundaries)   Licensed non-MD providers who exceed their scope of practice can be prosecuted for the unlicensed practice of medicine.   Be careful not to cross line between authorized licensed or unlicensed scope of practice and unlicensed practice of medicine.   MDs in an integrative care center can be guilty of crime of aiding and abetting unlicensed practice or engaging in unprofessional conduct. Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

19. Liability in Multidisciplinary Practice   Shared Liability & Discipline, Scope of Practice   Medical Mall – Keep practices separate   Shared Practice – Vicarious Liability   Failure to/Neglignt Supervise,   Negligent Credentialing   Kickbacks, fee-splitting   Corporate Practice of Medicine Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

20. Nutrition Advice, Vitamins What are the Legal Issues?   Is nutrition within the scope of practice of a licensed CAM provider?   Could a CAM provider be held to have practiced medicine unlawfully, merely for recommending vitamins?   Ethical Conflict of Interest? Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

21. Many States License Nutritionists and Dieticians:   Nevada: AB289 would make it a crime to “practice dietetics” or provide “nutrition services” unless you are licensed as a dietitian. Because “nutrition services” and “dietetics” are so broadly defined in the bill, this would mean that in practical terms, anyone who gives advice or recommendations on foods or nutritional supplements could be at risk of prosecution for a misdemeanor and a civil fine of up to $10,000. Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

22. CAM & Allied Health Health Freedom Laws  Allow non-licensed alternative health professionals the freedom to advertise and practice their occupation (no treatment or diagnosis) if they give notice that they are not licensed & follow certain rules. Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

23. Health Freedom Laws   Arizona 32-2911 amended 2008   California SB 577 in 2001   Idaho 54-1804 in 1976   Louisiana 20-37 VI-B in 2005   Minnesota Statute 146A 1999   New Mexico Unlicensed Health Care Practice Act 2009   Oklahoma 59-480 1994   Rhode Island – 23-75 in 2003   Source: http://www.nationalhealthfreedom.org/InfoCenter/laws_passed.html

24. Nutritional Advice 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.” - California’s solution CA Bus & Prof. Code s. 2068. Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

25. State Regulation for Clinicians Selling Dietary Supplements  Regulation –many states regulate clinicians’ sale of dietary supplements.  Regulation – many states regulate clinicians’ sale of dietary supplements.  Some states prohibit the practice  Others require disclosure of financial interest  Other states allow sale with appropriate disclosure and state-mandated limit on acceptable percentage of profits.  Medical Agencies Rules & Guidelines too Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

26. Ethical Issues Conflicts of Interest   “Due to the potential for patient exploitation, physicians should not sell, rent or lease health-related products or engage in exclusive distributorships and/or personal branding.”   “Physicians should provide a disclosure statement with the sale of any goods, informing patients of their financial interest.” FSMB, Model Guidelines on the Use of Complementary and Alternative Medical Therapies Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

27. Ethical Issues – Conflict of Interest  "In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own."  AMA Policy E-8.063 unambiguously states: "In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own." Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

28. Ethical Issues – Scientific Validity  "Physicians who choose to sell health- related products from their offices should not sell any health-related products whose claims of benefit lack scientific validity. When judging the efficacy of a product, physicians should rely on peer-reviewed literature and other unbiased scientific sources that review evidence in a sound, systematic, and reliable fashion.” AMA Opinion Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

29. Conflicts of Interest Sample Language   “My office sells dietary supplements to you at a ___% markup from cost. This still represents a discount to you of % from what you would pay for the same products as a retail customer. “   “However, you are under no obligation to purchase these products from my office; you may purchase the same products elsewhere; and your quality of care in my office will not be affected by your decision to purchase or not purchase products from my office.” Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

30. Strategy to reduce risk from selling Dietary Supplements  What evidence on safety and efficacy?  Also  1) determine the clinical risk level;  2) document the literature supporting the therapeutic choice;  3) provide adequate informed consent;  4) monitor the patient conventionally; and  5) for referrals, inquire about the competence of the CAM provider.  6) watch out for fee-splitting/kickbacks Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

31. Dietary Supplements Bottom Line   Be aware of claims you can and can’t make regarding dietary supplements.   Have legal review of your marketing materials (including website) for claims and benefit statements.   Use Best Practices, and   Display prominent notices about your practices Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

32. Malpractice Risk for a Clinician Selling Dietary Supplements  In malpractice cases, court has found selling supplements enhances appearance of defendant clinician’s culpability.  Profiting from supplement sales can influence jury into finding of negligence in malpractice case Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

33. Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

34. Elements of Malpractice   Did the health provider’s conduct violate the Standard of Care? - and -   Has it injured the Patient? Must show both. Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

35. Has the Practitioner Breached the Standard of Care? Negligence in doing what? persuading patient to forego conventional care failing to refer to a MD failing to realize CAM is not appropriate Performing CAM procedure negligently Failure to diagnose, then improper treatment Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

36. What is the Standard of Care for Integrative Medicine? Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

37. Standard of Care Integrative Medicine “It would seem that no practitioner of alternative medicine could prevail on such a question as the reference to the term ‘non- conventional’ may well necessitate a finding that the doctor who practices such medicine deviates from ‘accepted’ medical standards.” Charell v. Gonzales Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

38. Defenses to Malpractice?   Respectable Minority?   Informed Consent and Assumption of the Risk? Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

39. What Standard of Care?

40. Managing Decision-Making To Avoid Malpractice Imagine 4 scenarios for treatment

41. Risk Management Tool #1: Determine the clinical risk level. Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

42. Disclaimer These slides are for general informational purposes only and are not legal advice or counsel, and they may not reflect the most current legal developments. They are not intended to create, nor does your viewing of them, constitute, an attorney-client relationship. You should not act upon any information in these slides without seeking professional counsel from an attorney licensed in your state. These slides are not intended to be advertising and Ellen Stiefler does not wish to represent anyone desiring representation based on viewing this presentation in a state where these slides fail to comply with all laws and ethical rules of that state. Ms. Stiefler does not provide any warranties or representations, express or implied. To the fullest extent permissible under applicable law, Ms. Stiefler disclaims any and all implied warranties and representations, including, without limitation, any warranties of merchantability, fitness for a particular purpose, title, and non- infringement. If you are dissatisfied or harmed by anything relating to these slides, you may stop viewing them and this will be your sole and exclusive remedy. Ellen Stiefler is a member of the Bars in California and New York and does not practice law in any other state.