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Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia LegalAspectsofIntegrativeMedicine.com.

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Presentation on theme: "Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia LegalAspectsofIntegrativeMedicine.com."— Presentation transcript:

1 Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia 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 Risk Management 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 What Does a Legal Audit of the Risks in an Integrative Medicine Practice Cover?   Licensing   Scope of Practice   Standard of Care   Informed Consent   Advertising, Website, Online Use,   New Technologies & Telemedicine Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

5 More 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

6 Still More 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   Implementation of new rules under PPACA & more Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

7 Top Issues 1. Licensure 2. Professional discipline by medical board 3. Exceeding Scope of Practice 4. Civil actions for medical malpractice Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

8 Ignorance of the Law is 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

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

10 Crackdown on Medical Spas   New CA law increasing penalties (to $50K or double amount of fraud years in prison) for medical spa owners who violate corporate practice of medicine & engage in unlicensed medical practice   Personal and Vicarious Liability   also for aiding and abetting   Enforcement is going beyond cease & desist letters to criminal sanctions. Assembly Bill 1548, amends Section to the Business and Professions Code,

11 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

12 How to Analyze Licensing Issue   Threshold question: What is the lawful practice of specialty or medicine?   whether a health offering by a non MD or a non DO is   unauthorized practice of medicine, or   legally sanctioned, non-licensed, healing art?

13 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

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

15 State by State License Laws   Every state restricts scope of practice for non- medical health care professionals. Chiropractors are licensed in every state Acupuncturists & massage therapists in over 40 Nutritionists & Dieticians in many states Naturopathic Physicians in over 15 states Homeopathy in fewer states

16 # of States Licensing CAM Providers Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law Source:

17 # 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

18 Importance of Licensure under Affordable Care Act ► Health insurance plans must cover more preventive services ► Medicare covers more wellness and preventive care ► Insurance companies can’t put annual dollar limits on health coverage ► Insurance companies can no longer deny anyone health coverage because of a pre-existing condition ► Section 2706 requires that insurance companies “shall not discriminate” against any health provider with a state- recognized license & shall reimburse licensed health care providers in health insurance plan Legal Aspects of Integrative sMedicine Copyright © 2013 Stiefler Law

19 CAM Licensure After Affordable Care Act   CAM practitioners are included in community-based, interdisciplinary health teams.   CAM healthcare covered only if providers are licensed professionals   Only standard medical screenings & immunizations delivered by licensed medical personnel will be covered   Can use HSA funds to pay CAM practitioners not covered by traditional insurance

20 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

21 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

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 set forth in the state’s safe harbor or health freedom law. Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

23 States with Safe Harbor Health Freedom Laws   Arizona amended 2008   California SB 577   Colorado 2013, SB   Idaho in 1976   Louisiana VI-B in 2005   Minnesota 1999-Safe Harbor Exemption 146A   New Mexico Unlicensed Health Care Practice Act 2009   Oklahoma   Rhode Island – in 2003 Source:

24 Health Freedom Laws

25 California’s Health Freedom Law   a person engaging in certain medical treatments who makes specified written disclosures to a client shall not be in violation of certain provisions of the Medical Practice Act unless that person engages in specified diagnosis, treatment, and other activities.   NOTICE requirement: The bill would require a person who advertises himself or herself as performing the services that are subject to those requirements to state in the advertisement that he or she is not licensed by the state as a healing arts practitioner. SB 577,CA Bus & Prof. Code s

26 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

27 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

28 Nutrition Advice Often Presents Special Rules CA law allows any person to provide nutritional advice or give advice concerning proper nutrition and as to the role of food and food ingredients, including dietary supplements. CA 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.” CA Bus & Prof. Code 2068 Dietary supplement recommendation is the unlawful practice of medicine

29 Nutritional Supplements Legal and Regulatory Update Copyright © 2013 Stiefler Law

30 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

31 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

32 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 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

33 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

34 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

35 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

36 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

37 Liability in Multidisciplinary Practice   Shared Liability & Discipline, Scope of Practice – Direct & Vicarious Liabilities:   Medical Mall – Liability Separate Too   Integrated Practice – Vicarious Shared Liability   Failure or Negligent Supervision,   Negligent Credentialing   Kickbacks, fee-splitting   Corporate Practice of Medicine Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

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39 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

40 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

41 Standard of Care – Conventional Medicine Minimally Competent Care Each physician may be expected to possess or have reasonable access to such medical knowledge as is commonly possessed or reasonably available to minimally competent physicians in the same specialty or general field of practice throughout the U.S. To exercise minimally adequate medical judgment, each physician has a duty to have a practical working knowledge of the facilities, equipment, resources, and options reasonably available to him. A physician may incur civil liability only when the quality of care he renders (including judgment calls) falls below minimally acceptable levels. Hall v. Hilbun (MS 1985)

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

43 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

44 What Standard of Care?

45 Second Theory of Malpractice Informed Consent:   The duty to disclose and discuss all material treatment alternatives and their potential risks and benefits with patients.   Availability, benefits and risks.   Applies to medicine & across all professions   Reasonable Doctor Standard (majority)   Reasonable Patient (minority view)

46 Provide Adequate Informed Consent   Informed consent requires disclosure of:   Material (significant) risks   Benefits   Reasonable alternatives

47 Third Theory of Malpractice ► ► Failure of Duty to Refer ► ► Typically there is liability where the non-MD fails to refer to MD where the patient’s condition is outside the provider’s education, training & skill Legal Issues IM Copyright © 2012 Stiefler Law

48 Malpractice & Duty to Refer   Duty for ND, CAM to refer to MD, not other way around.   MD’s risk of liability for malpractice of ND or CAM practitioner.   MD malpractice much higher than for CAM providers (source: JAMA article)

49 Malpractice & Duty to Refer General Rule: MD is not liable for referring to a specialist Exceptions: Referral delayed or deferred necessary conventional medical treatment Referring provider knew or should have known they were referring to someone who was incompetent Person referring to is MD’s agent either because State Law requires supervision or extended consultation or there is joint treatment

50 Manage Your Relationship ► ► Patients sue when relationships with caregivers deteriorate. ► ► Liability = bad outcome + bad relationship ► ► Statistically, probability of malpractice liability correlates to clinician’s arrogance compared to their competence.

51 Risk Management Tool #5: Document the literature supporting the therapeutic choice. ► ► Poor documentation often compounds disciplinary and malpractice problems.

52 Defenses to Malpractice?   Informed Consent   Assumption of the Risk (express assumption of risk is complete defense to negligence) Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

53 Respectable Minority Rule “Where two or more schools thought exist among competent members of the medical profession concerning proper medical treatment for a given ailment, each of which is supported by responsible medical authority, it is not malpractice to be among the minority in a given city who follow one of the accepted schools” Chumbler v. McClure The respectable minority rule allows for variation in clinical judgment: a physician does not incur liability merely by electing to pursue one of several recognized courses of treatment. The instruction (as to the rule) is intended for those situations where medical experts may disagree among themselves

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

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

56 Legal Issues Integrative Medicine Copyright © 2012 Stiefler Law

57 What Entity to Form? seek advice about the most tax-effective form of incorporation, possible application of the corporate practice of medicine within your state, and ways to help manage risk of professional liability by creating a proper legal structure for the business.

58 Fee-Splitting, Kickbacks   Fee-splitting & kickback issues arise when medical clinics include non-physician providers and they share fees.   Law is a broad prohibition of offer, solicitation, payment of receipt of anything of value, direct or indirect, overt or covert, in cash or in kind, intended to induce referral of patient for items or services reimbursed by all federal programs including Medicare, Medicaid and Veterans’ Benefit programs.   Must have intent to violate anti-kickback statute (not strict liability).

59 Safe Harbors   26 business relationships for which there are safe harbors:   Discounts, bona fide employment, space rentals, personal service and management contracts, co-insurance and deductible waiver, price reductions for eligible managed care organizations, and much more.   You can mitigate risk by requesting Advisory Opinion from Office of Inspector General of US Dept of Health & Human Services

60 Fee-Splitting, Kickbacks   Examples of potential kickback problems:   Hospital demanding that MDs pay over FMV (over what Medicare reimburses under Part B service co- payments)   Hospital MD group coerced to join clinic that refers patients to hospital. Professional revenues to clinic MDs induce them to refer patients to hospital   Non-MD products purchased by MDs for below FMV Medicare fee schedule.   Sub-FMV, or a payment for each MD/RN/ND/DC/LacC… services sold to patient of other docs who refer patients   Professional courtesy discount to other MDs

61 Fee-Splitting, Kickbacks   “It’s complicated.”   We must begin with an explicit acknowledgment of the limits of this opinion. In general, we will decline to state firm conclusions. Our reticence derives from several factors: the highly uncertain state of the law; the necessity to write an opinion based on a set of complicated facts as given, when additional facts might change the analysis; our inability to make judgments about financial matters, like the ‘fair market value’ of certain services, that are inextricably linked to legal conclusions; and, finally, the reality that abstract conclusions in an opinion cannot substitute for the judgment of those who enforce these laws in particular cases, who are able to develop a fuller factual record, and who therefore may have a different perspective on the situation than we do.” Hon. Paula Hollinger, MD Senate   Even the Government can’t figure it out.

62 Fee-Splitting, Kickbacks   Federal Anti-Kickback Laws   Federal “Stark” Laws (self-referral)   State AKS/Fee-Splitting   State Self-Referral Laws

63 Conflicts of Interest - Fee-Splitting   CA Business & Professions Code, 650:   The offer, delivery, receipt, or acceptance by any person licensed under this division or the Chiropractic Initiative Act   of any rebate, refund, commission, preference, patronage dividend, discount, or other consideration,   whether in the form of money or otherwise, as compensation or inducement for referring patients, clients, or customers to any person,   irrespective of any membership, proprietary interest, or co-ownership in or with any person to whom these patients, clients, or customers are referred is unlawful.

64 Conflicts of Interest—Fee-Splitting   Mich. Cons. L., s :   “The disciplinary subcommittee shall proceed.. if it finds:   (d) Unethical business practices, consisting of …:   (i) False or misleading advertising.   (ii) Dividing fees for referral of patients or accepting kickbacks on medical or surgical services, appliances, or medications purchased by or in behalf of patients

65 Conflicts of Interest—Fee-Splitting Corporate Practice of Medicine   Mall Model   Just a rental   Lease must be a Fair Market Value   Additional considerations if Medicare involved   Separate and independent practices   Patient pays practitioner/practice

66 Conflicts of Interest—Fee-Splitting Corporate Practice of Medicine   Center Model (Medical Services Organization Model)   Layperson owns an LLC (MSO)   MSO renders services to the practice at Fair Market Value:   Bookkeeping, front desk   Billings, collections   Marketing and advertising

67 Increased Scrutiny of Physician Relationships with Industry   Mandatory Reporting and Public Disclosure Under Federal Law   The Physician Payments Sunshine Act is designed to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP.   The Act requires companies to begin recording any physician payments that are worth more than $10 in 2012 and to report them on March 31,   Reportable payments include stock options, research grants, consulting fees and travel to medical conferences. The details will be posted in a searchable database starting Sept. 30, California Law   Requires pharmaceutical companies to adopt compliance programs that include limits on gifts or incentives to physicians (Health and Safety Code section )   Other similar legislative initiatives are foreseeable

68 Conflicts of Interest Bottom Line   Have Legal Counsel review arrangements for unlawful fee-splitting or heightened liability.   In some states, it could be considered fee-splitting or an unlawful kickback if:   Clinicians profits from in-office sales of dietary supplements, or   Clinician splits profits of dietary supplement sales with integrative care center.

69 The Stark Law   The Stark Law ("Physician Self-Referral Statute"), prohibits referral of Medicare and Medicaid beneficiaries by a physician to an entity for the provision of "designated health services" if the physician, or the physician's immediate family member, has a financial relationship with the entity, unless a statutory exception applies to that financial relationship.   “Financial relationship" can include an ownership or investment interest in, or a compensation arrangement with, an entity that provides designated health services (which includes inpatient and outpatient hospital services).

70 The Stark Law   Unlike the Anti-Kickback Statute, the Stark Law is a strict liability statute and thus, no proof of bad intent is required. As a result, any arrangement that does not satisfy all of the criteria of a statutorily-defined Stark Law exception is illegal.   The Stark law provides for significant civil sanctions for violations including, but not limited to: the denial of payment of a claim; refunds of amounts collected in violation of the statute; and civil monetary penalties.

71 Legal Issues Integrative Medicine Copyright © 2012 Stiefler Law

72 What Type of Corporate Entity to Create?   C, S, Limited Liability Company or a Professional Corporation   Some states require that all owners of an entity that will provide professional services, such as physician services, hold the same professional license – Professional Medical Service Corps.   “Corporate Practice of Medicine” – to prohibit a business corporation or lay person from controlling medical decisions

73 Exceptions to Corporate Practice of Medicine   Again, depends on State law   Health maintenance organizations.   Hospitals authorized to provide health service   Professional Service Corporations   Entities to offer optometry, ophthalmic dispensing, massage therapy, pharmacy, speech- language pathology and audiology services.

74 What is Corporate Practice of Medicine   Laws vary by state.   “Weak” statutes precludes non-physicians from owning or controlling a professional medical services corporation.   “Strong” (e.g. NY) prohibition typically says that MDs who want to utilize a corporation must practice medicine through a professional service corporation

75 Can Corporations Hire or contract with CAM or Allied Health Professionals ?   Answer depends on State & health occupation.   Sometimes corporation doesn’t need to hold license if individuals providing services are licensed.   Unlicensed corporate practice includes unlicensed practice of professions beyond medicine.   A general business corporation cannot offer CAM, Allied Health or Medical services.   Example of Osteopath & Chiropractor not allowed to share professional service corporation together.   Michigan Attorney General Opinion 7151, 2004   See LegalIssuesinIntegrativeMedicine.com for opinion

76 Can Corporations Hire or contract with CAM or Allied Health Professionals ?   Professional Service Corporation – all shareholders must be licensees of one profession   Professional service limited liability company may provide services in more than one profession (does not apply in the professions of medicine, dentistry, veterinary medicine, licensed clinical social work, mental health counseling, psychoanalysis, creative arts therapy, or marriage and family therapy) provided the company includes an owner licensed in each of professions in which company will offer services.

77 California Corporate Practice of Medicine "Corporations and other artificial entities shall have no professional rights, privileges, or powers.” Business and Professions Code section 2400 These "business" or "management" decisions and activities, resulting in control over the physician's practice of medicine, should be made by a licensed California physician and not by an unlicensed person or entity:   Ownership is an indicator of control of a patient's medical records, including determining the contents thereof, and should be retained by a California-licensed physician.   Selection, hiring/firing (as it relates to clinical competency or proficiency) of physicians, allied health staff and medical assistants.   Setting the parameters under which the physician will enter into contractual relationships with third-party payers.   Decisions regarding coding and billing procedures for patient care services.   Approving of the selection of medical equipment and medical supplies for the medical practice.

78 Legal Issues Integrative Medicine Copyright © 2012 Stiefler Law

79 Telemedicine – What it is   Telemedicine is telephone & Internet therapy, videoconferencing   California Law (CA Bus & Prof Code § ) Telemedicine is practice of health care using “interactive” audio, video or data communications involving a real-time or near real-time 2-way transfer of medical info.   Telemedicine typically involves the application of videoconferencing or store- and-forward-technology to provide or support health care delivery.

80 Telemedicine – What it’s Not   Telemedicine is not a telephone conversation, /instant messaging, conversation, or fax.   It’s not technology-devices and their laws   Telemedicine is not Telemedicine. It’s now to be known as “telehealth” at least in California Telehealth Advancement Act AB 415 Oct 2011

81 Telemedicine Telemedicine Development Act of 1996 Pros:   Reaching underserved populations   Reduce barriers by connecting over great distances   More accessibility Cons:   Possibility of missing cues from patients   Security of Technology   Emergencies become more complicated

82 What Laws Govern Telemedicine?   Telemedicine laws are handled (for now) at a State level with great variability. Some apply it to mental health counseling, some tuck provisions into licensure   Rule that doctors be licensed in state where patients are treated.

83 No prescribing via Telemedicine  California aggressively disciplines physicians who prescribe medications online: (a) No person or entity may prescribe, dispense, or furnish … dangerous drugs … on the Internet for delivery to any person in CA, without an appropriate prior examination and medical indication … (b) … A violation … may subject the person or entity … to … a fine of up to twenty-five thousand dollars ($25,000) per occurrence … CA Busn & Prof Code §2242.1

84 Telemedicine Affirmative Obligations   Before a health care provider delivers health care through telemedicine, the treating health care provider shall obtain verbal or written informed consent from the patient or the patient's health care decision maker;   The patient is entitled to all existing confidentiality protections;   All medical reports resulting from a telemedicine consultation are part of a patient's medical record;   Dissemination of any images or information identifiable to a specific patient for research or educational purposes shall not occur without the patient's consent, unless authorized by state or federal law. (Arizona Law example)

85 Mobile Medical Apps & Smartphones   Mobile Medical Apps are: used as an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.   FDA – preliminary guidance – they intend to regulate apps that create great risk when they do not work as intended. i.e. Smartheart - smart phone converted to an ECG heart monitor FDA FR   FDA – when cellphones are used as medical devices, they are subject to rules & regs governing medical devices.

86 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 Bar in New York and does not practice law in any other state.


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