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Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse [email protected] @ToEllen LegalAspectsofIntegrativeMedicin e.com Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

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Page 1: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Legal Aspects of Integrative Medicine

Ellen Stiefler, J.D.

Stiefler Law Group

Transmedia Multiverse

[email protected]

@ToEllen

LegalAspectsofIntegrativeMedicine.com

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 2: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Magnifying Reputation & Impact

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 3: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 4: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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, Email New Technologies & Telemedicine

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 5: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 6: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

& moreLegal Aspects of Integrative Medicine

Copyright © 2013 Stiefler Law

Page 7: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Top Issues

1. Licensure2. Professional discipline by medical board3. Exceeding Scope of Practice4. Civil actions for medical malpractice

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 8: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 9: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 10: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Crackdown on Medical Spas

New CA law increasing penalties (to $50K or double amount of fraud + 2-5 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 2417.5 to the Business and Professions Code,

Page 11: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 12: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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?

Page 13: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 14: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Licensure in CAM

1904: Chiropractic 1910’s: Naturopathy 1960’s: Massage Therapy 1970’s: Acupuncture

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 15: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 16: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

# of States Licensing CAM Providers

Chiropractic

Massage

Acupuncture

Midwifery

Naturopathy

Homeopathy

0 5 10 15 20 25 30 35 40 45 50Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Source: http://nccam.nih.gov/health/decisions/credentialing.htm

Page 17: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

# of Licensed Practitioners

Naturopathic Doctors

MD Acupuncturists

Acupuncturists

Chiropractors

Massage Therapists

Medical Doctors

Registered Nurses

0 1000000 2000000 3000000Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 18: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Importance of Licensure under Affordable Care Act

2013    ► Health insurance plans must cover more preventive services► Medicare covers more wellness and preventive care

2014   ► 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

2020     ► 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

Page 19: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 20: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 21: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 22: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 23: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

States with Safe Harbor Health Freedom Laws

Arizona 32-2911 amended 2008 California SB 577 Colorado 2013, SB13-215 Idaho 54-1804 in 1976 Louisiana 20-37 VI-B in 2005 Minnesota 1999-Safe Harbor Exemption 146A New Mexico Unlicensed Health Care Practice

Act 2009 Oklahoma 59-480 1994 Rhode Island – 23-75 in 2003Source: http://www.nationalhealthfreedom.org/InfoCenter/laws_passed.html

Page 24: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Health Freedom Laws

http://www.nationalhealthfreedom.org/

Page 25: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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. 2053.

Page 26: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Nutrition Advice, VitaminsWhat 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

Page 27: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 28: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 29: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Nutritional Supplements Legal and Regulatory Update Copyright © 2013

Stiefler Law

Page 30: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

State Regulation for CliniciansSelling 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 tooNutritional Supplements Legal and

Regulatory Update Copyright © 2013 Stiefler Law

Page 31: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 32: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Ethical Issues – Conflict of Interest

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

Page 33: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 34: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 35: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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, andDisplay prominent notices about your

practices

Nutritional Supplements Legal and Regulatory Update Copyright © 2013

Stiefler Law

Page 36: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 37: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 38: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Malpractice

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 39: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 40: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Has the PractitionerBreached 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

Page 41: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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)

Page 42: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

What is the Standard of Care for Integrative Medicine?

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 43: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 44: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

What Standard of Care?

Page 45: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

professionsReasonable Doctor Standard (majority)Reasonable Patient (minority view)

Page 46: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Provide AdequateInformed Consent

Informed consent requires disclosure of:

Material (significant) risksBenefitsReasonable alternatives

Page 47: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 48: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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)

Page 49: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 50: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 51: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Risk Management Tool #5:Document the literature

supporting the therapeutic choice.

►Poor documentation often compounds disciplinary and malpractice problems.

Page 52: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 53: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 54: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Risk Management Tool #1:Determine the clinical risk level.

►Safe and effective – recommend.►Safe and possibly effective – monitor.►Effective but possible unsafe – caution.►Unsafe and ineffective – avoid/discourage

Legal Aspects of Integrative Medicine Copyright © 2013 Stiefler Law

Page 55: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Managing Decision-Making To Avoid Malpractice

Imagine 4 scenarios for treatmentNeitherSafeNor

Effective

EffectivebutnotSafe

Safe but not

Effective

Safeand

Effective

LESS SAFE

LESS --------------- EFFICACY ------------ MORE

MORE SAFE

SAFETY

Page 56: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Fee-Splitting, Anti-Kickback,

Stark (Self-Referral) Laws

Legal Issues Integrative Medicine Copyright © 2012 Stiefler Law

Page 57: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 58: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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).

Page 59: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 60: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 61: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 62: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Fee-Splitting, Kickbacks

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

Page 63: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 64: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Conflicts of Interest—Fee-Splitting

Mich. Cons. L., s. 16221:“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.......

Page 65: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 66: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 67: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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, 2013. 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, 2013.

California Law Requires pharmaceutical companies to adopt compliance programs that

include limits on gifts or incentives to physicians (Health and Safety Code

section 119402) Other similar legislative initiatives are foreseeable

Page 68: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Conflicts of InterestBottom 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, orClinician splits profits of dietary supplement

sales with integrative care center.

Page 69: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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). 

Page 70: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 71: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Corporate Practice of Medicine

Legal Issues Integrative Medicine Copyright © 2012 Stiefler Law

Page 72: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 73: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 74: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 75: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 76: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 77: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 78: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

New Technologies and HealthMobile Medical Apps

Online Medicine Telemedicine

Legal Issues Integrative Medicine Copyright © 2012 Stiefler Law

Page 79: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Telemedicine – What it is

Telemedicine is telephone & Internet therapy, videoconferencing

California Law (CA Bus & Prof Code § 2290.5)

• 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.

Page 80: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

Telemedicine – What it’s Not

Telemedicine is not a telephone conversation, e-mail/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

Page 81: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

TelemedicineTelemedicine 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

Page 82: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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.

Page 83: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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

Page 84: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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)

Page 85: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

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 43689

FDA – when cellphones are used as medical devices, they are subject to rules & regs governing medical devices.

Page 86: Legal Aspects of Integrative Medicine Ellen Stiefler, J.D. Stiefler Law Group Transmedia Multiverse Ellen@StieflerLaw.com @ToEllen LegalAspectsofIntegrativeMedicine.com

DisclaimerThese 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.