Transcript World of Change - Legal Aspects of Integrative Medicine

Legal Aspects of Integrative Medicine
Ellen Stiefler, J.D.
Stiefler Law Group
Transmedia Multiverse
[email protected]
@ToEllen
LegalAspectsofIntegrativeMedicine.com
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Magnifying Reputation & Impact
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Risk Management
Chart a course to avoid the risks and pitfalls
in an integrative medicine clinical practice
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What Does a Legal Audit
of the Risks in an
Integrative Medicine Practice Cover?
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Licensing
Scope of Practice
Standard of Care
Informed Consent
Advertising, Website, Online Use, Email
New Technologies & Telemedicine
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More Legal Aspects of
Integrative Medicine Practices
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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
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Still More Legal Issues of
Integrative Medicine Practices
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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
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Top Issues
1. Licensure
2. Professional discipline by medical board
3. Exceeding Scope of Practice
4. Civil actions for medical malpractice
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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
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Licensure – Don’t Mess Around
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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
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Crackdown on Medical Spas
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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,
Licensure v. Scope of Practice
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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
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How to Analyze Licensing Issue
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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?
Licensure:
Practicing Medicine (MD & DO only)
Diagnosis
Treatment
Prevention
Cure
Prescribe
Disease
Injury
Physical
Mental
Condition
Practice
of
Medicine
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Licensure in CAM
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1904: Chiropractic
1910’s: Naturopathy
1960’s: Massage Therapy
1970’s: Acupuncture
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State by State License Laws
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Every state restricts scope of practice for nonmedical 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
# of States Licensing CAM Providers
Homeopathy
Naturopathy
Midwifery
Acupuncture
Massage
Chiropractic
0
10
20
30
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Source: http://nccam.nih.gov/health/decisions/credentialing.htm
40
50
# of Licensed Practitioners
Registered Nurses
Medical Doctors
Massage Therapists
Chiropractors
Acupuncturists
MD Acupuncturists
Naturopathic Doctors
0
1000000
2000000
L
3000000
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 staterecognized license & shall reimburse licensed health care
providers in health insurance plan
Legal Aspects of Integrative sMedicine
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CAM Licensure After Affordable Care Act
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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
Scope of Practice (Boundaries)
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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
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What Can you be Disciplined For?
“Unprofessional Conduct” defined as:
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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
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CAM & Allied Health
Health Freedom Laws
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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
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States with Safe Harbor
Health Freedom Laws
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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 2003
Source:
http://www.nationalhealthfreedom.org/InfoCenter/laws_passed.html
Health Freedom Laws
http://www.nationalhealthfreedom.org/
California’s Health Freedom Law
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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.
Nutrition Advice, Vitamins
What are the Legal Issues?
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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
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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
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
Nutritional Supplements Legal and Regulatory
Update Copyright © 2013 Stiefler Law
State Regulation for Clinicians
Selling Dietary Supplements
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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
Ethical Issues
Conflicts of Interest
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“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
Ethical Issues – Conflict of Interest
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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
Ethical Issues – Scientific Validity
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"Physicians who choose to sell healthrelated 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
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.”
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Nutritional Supplements Legal and Regulatory
Update Copyright © 2013 Stiefler Law
Dietary Supplements
Bottom Line
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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
Malpractice Risk for a Clinician
Selling Dietary Supplements
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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
Liability in Multidisciplinary Practice
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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
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Kickbacks, fee-splitting
Corporate Practice of Medicine
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Malpractice
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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
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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
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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)
What is the Standard of Care for
Integrative Medicine?
Legal Aspects of Integrative Medicine Copyright
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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 ‘nonconventional’ may well necessitate a finding
that the doctor who practices such medicine
deviates from ‘accepted’ medical standards.”
Charell v. Gonzales
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What Standard of Care?
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)
Provide Adequate
Informed Consent
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Informed consent requires disclosure of:
Material (significant) risks
Benefits
Reasonable alternatives
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
Malpractice & Duty to Refer
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Duty for ND, CAM to refer to MD, not other way
around.
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MD’s risk of liability for malpractice of ND or
CAM practitioner.
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MD malpractice much higher than for CAM
providers (source: JAMA article)
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
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.
Risk Management Tool #5:
Document the literature supporting the
therapeutic choice.
► Poor
documentation often compounds
disciplinary and malpractice problems.
Defenses to Malpractice?
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Informed Consent
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Assumption of the Risk (express
assumption of risk is complete defense
to negligence)
Legal Aspects of Integrative Medicine Copyright
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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
Risk Management Tool #1:
Determine the clinical risk level.
and effective – recommend.
► Safe and possibly effective – monitor.
► Effective but possible unsafe – caution.
► Unsafe and ineffective – avoid/discourage
► Safe
Legal Aspects of Integrative Medicine Copyright
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Managing Decision-Making
To Avoid Malpractice
Imagine 4 scenarios for treatment
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Fee-Splitting,
Anti-Kickback,
Stark (Self-Referral)
Laws
Legal Issues Integrative Medicine
Copyright © 2012 Stiefler Law
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.
Fee-Splitting, Kickbacks
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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).
Safe Harbors
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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
Fee-Splitting, Kickbacks
 Examples of potential kickback problems:
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Hospital demanding that MDs pay over FMV (over
what Medicare reimburses under Part B service copayments)
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
Fee-Splitting, Kickbacks
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“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
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Even the Government can’t figure it out.
Fee-Splitting, Kickbacks
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Federal Anti-Kickback Laws
 Federal “Stark” Laws (self-referral)
 State AKS/Fee-Splitting
 State Self-Referral Laws
Conflicts of Interest - Fee-Splitting
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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.
Conflicts of Interest—Fee-Splitting
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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.......
Conflicts of Interest—Fee-Splitting
Corporate Practice of Medicine
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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
Conflicts of Interest—Fee-Splitting
Corporate Practice of Medicine
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Center Model (Medical Services Organization
Model)
 Layperson owns an LLC (MSO)
 MSO renders services to the practice at Fair
Market Value:
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Bookkeeping, front desk
Billings, collections
Marketing and advertising
Increased Scrutiny of Physician
Relationships with Industry
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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
Conflicts of Interest
Bottom Line
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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.
The Stark Law
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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.
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“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).
The Stark Law
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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.
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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.
Corporate Practice of Medicine
Legal Issues Integrative Medicine
Copyright © 2012 Stiefler Law
What Type of Corporate Entity to Create?
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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
Exceptions to Corporate Practice of Medicine
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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, speechlanguage pathology and audiology services.
What is Corporate Practice of Medicine
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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
Can Corporations Hire or contract with
CAM or Allied Health Professionals ?
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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.
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Michigan Attorney General Opinion 7151, 2004
See LegalIssuesinIntegrativeMedicine.com for opinion
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.
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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.
New Technologies and Health
Mobile Medical Apps
Online Medicine
Telemedicine
Legal Issues Integrative Medicine
Copyright © 2012 Stiefler Law
Telemedicine – What it is
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Telemedicine is telephone & Internet therapy,
videoconferencing
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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 storeand-forward-technology to provide or support
health care delivery.
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
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
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.
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
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)
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.
Disclaimer
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