Transcript michaelhcohen.com

Telemedicine & Mobile Health
Compliance Concerns
Michael H. Cohen, Esq.
Robert A. Polisky, Esq.
www.michaelHcohen.com
www.rphealthlaw.com
Annual Healthcare Law Compliance Symposium
Los Angeles County Bar Association
October 9, 2014
Case Study: App Developer
• BACKGROUND
• Treats skin conditions
• Patient takes picture with mobile phone – sends to Company
• Company uses outsourced Consultants to diagnose
• Product roll-out:
• Phase 1 – Consultants make recommendations
• Phase 2 – App’s algorithm gives treatment advice
Overview
1.
Who are our Clients:
•
2.
Telemedicine & Mobile Health
Compliance Concerns
•
•
•
•
Licensing Issues
HIPAA Compliance
FDA Concerns
Reimbursement
3.
Takeaways
4.
Q&A
Telemedicine & Mobile Health
Clients
•
Individual physician
•
Multi-state telemedicine venture
•
Mobile Medical App developer
•
Wearable tech manufacturer
•
“Business associate”
Telemedicine & Mobile Health
Clients
Telemedicine & Mobile Health
Clients
Telemedicine & Mobile Health
Clients
http://www.curely.co/
Compliance Concerns
Licensing
•
Licensure:
•
State law issue
•
“Remote State” vs. “Home State”
•
Hagseth v. Superior Court
• Review by Colorado MD of an online questionnaire
from a California resident
• Prescription
• Patient died
• Colorado MD “prescribed” in CA
• Unlawful practice of medicine by CO doc in CA
• Criminal
Clinical Advice vs. Information
•
Definition of “practicing medicine:”
• Diagnosis
• Treatment
• Operation
• Prescription
•
Licensing required for clinical (medical) practice
•
Information / education as “free speech”
CA Medical Board (Telehealth)
• Video-conferencing and store-andforward (asynchronous)
• Telephone, email, IM and fax are not
telehealth
• Standard of care same as in-person
• Verbal and written informed consent
• Same privacy/security requirements
• Need “appropriate prior exam to diagnose
and/or treat the patient.”
Appropriate Prior Exam
•
•
Diagnosis
•
Usually can be virtual if:
•
Equivalent to in-person exam under the same standard of
care
Prescription
•
Usually an in-person exam is required, either because:
• Rules require it, or
• Standard of care requires it.
• “where the threshold information to obtain any
accurate diagnosis has been obtained.” (NC
proposed)
•
Controlled substances—Ryan Haight Online Pharmacy
Consumer Protection Act of 2008
Strategic advice to clients
•
Options:
1.
Avoid telemedicine in states with tough laws (e.g., NYS)
2.
Limit telemedicine to “State MD consultation with
patient’s Home State doc”
3.
Provide only “limited and occasional patient care” in
Remote State
4.
Obtain a “special purpose telemedicine” license
5.
Limit advice to “information/education” and use
disclaimers in the terms of use
Strategy – Sample Disclaimer
The contents of this website are for informational purposes only
and do not render medical, psychiatric, or psychological advice,
opinion, diagnosis, prescription, or treatment. Use of this website
does not create a doctor-patient relationship. The Company does
not practice medicine and does not employ or retain any health
care providers to practice medicine or any other health care
profession.
Federation of State Medical
Boards
•
Interstate Medical Licensure Compact (September 5, 2014)
•
Practice of medicine occurs where Patient is.
•
Remote State’s board can discipline MD/DO.
•
“Expedited license”
• Vetting process by Remote State
• Fee
• Coordinated database for complaints
• Joint investigations, sanctions
Licensing
Much legislative activity (ATA Report)
· Reimbursement of telemedicine by naturopathic providers (AZ)
· Inclusion of telemedicine in scope of practice for psychologists
(AZ)
· Telemedicine for physical therapy and athletic training (DE)
· Telepharmacy (NE)
· Inclusion of telemedicine in scope of practice for dental therapy
hygienist (NM)
· Telepractice for speech-language pathologists and audiologists
(SC)
· Telemental health (WI)
Tele-Shrink
FDA
•
Mobile Medical App Guidance
•
Medical device
•
Intended Use
•
Enforcement Discretion
FDA
•
Not an MMA
•
Providing general information about disease
• Organize and track health information (log blood pressure
measurements)
• Help patients document, show or communicate (e.g., videoconferencing)
•
Automate simple tasks for providers (like calculating BMI)
•
Enable patients or providers to interact with EHR
FDA
•
Probably an MMA
• Transform the mobile platform into a device, because they use
the built-in feature (such as camera) to diagnose or treat
disease. Example: app uses an attachment to measure blood
glucose levels.
• App controls the operation or function of a medical device.
Example: app controls the inflation or deflation of a blood
pressure cuff.
• App displays, transfers, stores, or converts patient-specific
medical device data from a connected medical device.
Example: app connects to bedside monitor and transfers the
patient’s data to a central viewing station.)
FDA
• Maybe an MMA
• Provide behavioral tips (example: for smokers to quit)
• Provide patient-specific recommendations once patients input
their characteristics such as age, sex, and behavioral risk factors
• Record a clinical conversation and send it to the patient after
• Keep track of medications and provide reminders, or compare
vital signs
• Allow individuals to log, record, track, evaluate, or make
behavioral decisions relating to general fitness, health or
wellness, such as those that provide meal planners or recipes,
calculate calories burned in a workout, help people track sleep.
HIPAA
Applicability for m-health?
• Covered entity?
• Business Associate?
HIPAA
Security Rule requirements include:
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Security management process
•
Workstation security
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Security incident procedures
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Contingency plan
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Access controls
•
Workstation use
HIPAA
Security Rule requirements include:
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Workstation security
•
Device and media controls
•
Audit controls
•
Person or entity authentication
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Transmission security
HIPAA
•
Encryption? Addressable implementation specification.
•
Covered entity / business associate must take into account the
following factors in deciding which security measures to adopt:
•
Its size, complexity, and capabilities;
•
Its technical infrastructure, hardware, and software security
capabilities;
•
The costs of security measures; and
•
The probability and criticality of potential risks to ePHI.
HIPAA
Miscellaneous issues:
•
Compliance with state privacy laws
•
Business Associate Agreements with subcontractors
•
Distribution and acknowledgement of Notice of Privacy
Practices
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Training
•
Breach notification
Reimbursement - Medicare
• Telehealth services covered by Medicare include consultations,
office visits, psychotherapy, and pharmacologic management.
• See CMS’s website.
• Proposed 2015 Medicare Physician Fee Schedule: CMS proposes
adding initial and subsequent annual wellness visits via telehealth
if they include a personalized prevention plan of service.
Reimbursement - Medicare
• Telehealth services need to be delivered via interactive audio and
video telecommunications system.
• Needs to permit two-way, real-time interactive communication
between the beneficiary and practitioner.
• Telephones, fax machines, and email systems do not qualify.
Reimbursement - Medicare
• Telehealth services need to be furnished to a beneficiary located at
“originating site”:
• Office of a physician/practitioner
• Hospital, including CAH
• Rural health clinic
• FQHC
• Hospital-based dialysis center
• SNF
• Community mental health center
Reimbursement - Medicare
• Originating site must be:
• Located in a rural HPSA;
• Located in a rural county outside of an MSA; or
• An entity participating in a federal telemedicine demonstration
project, regardless of geographic location.
Reimbursement - Medicare
• Eligible distant site practitioners:
• Physician
• PA
• NP
• Clinical nurse specialist
• Nurse midwife
• Clinical psychologist
• Clinical social worker
• Registered dietician / nutrition professional
Reimbursement - Medicare
• The service must be within a practitioner’s scope of practice under
state law.
• The beneficiary’s exam needs to be under the control of the distant
site practitioner.
Reimbursement - Medicare
•
A medical professional is not required to present the beneficiary
to the distant site unless medically necessary.
•
Medicare pays an originating site fee to the originating site and
provides separate payment to the distant site practitioner for
furnishing the service.
•
See 42 CFR § 410.78; Medicare Benefit Policy Manual, Ch. 15,
§ 270; Medicare Claims Processing Manual, Ch. 12, § 190.
Reimbursement – Medicaid
•
State Medicaid programs have flexibility to determine whether
and to what extent they cover telehealth services.
•
47 state Medicaid programs, including California’s, provide
some type of coverage for telehealth. (American Telemedicine
Association, Sept. 2014)
Reimbursement – Medi-Cal
•
California law: appropriate telehealth services must be covered
and reimbursed under the Medi-Cal program. (CA Welfare and
Institutions Code § 14173.72)
•
Setting not limited for the originating site.
•
Except for teleophthalmology and teledermatology, telehealth
needs to be delivered via a real-time interactive communications
system.
Reimbursement – Medi-Cal
•
Medi-Cal will reimburse for store-and-forward services for
teleophthalmology and teledermatology. (CA Welfare and
Institutions Code § 14173.725)
•
Medi-Cal reimburses originating site and practitioner.
Reimbursement – Commercial
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21 states (including California) and D.C. have parity laws
requiring that commercial payors cover telehealth services the
same as they cover in-person services (American Telemedicine
Association, Sept. 2014)
•
Commercial payors in many other states cover at least some
telehealth service, and have expressed interest in expanding their
telehealth coverage. (American Telemedicine Association)
Reimbursement – Commercial
•
California parity law prohibits health insurers and health care
service plans from doing either of the following with respect to
covered services appropriately provided through telehealth:
•
Requiring in-person contact between patient and provider; or
•
Limiting setting for originating site or practitioner.
(CA Insurance Code § 10123.85; CA Health & Safety Code §
1374.13)
Case Study – HIPAA &
Reimbursement
• HIPAA
• Applicability
• Privacy and Security Rules
• Business associates
• Reimbursement
• Medicare
• Medi-Cal
Case Study – Licensing & FDA
• Licensing issues
• Use of Consultants
• Mobile medical app issues
• Smart App Dilemma
The Future
• Blurring of lines of between medical advice (regulated) vs.
general wellness (education/information)
• Overlap between state-law regulation of physical providers
(licensing laws) and federal regulation of healthcare
products (FDA rules)
• Trends
• More ease of licensing and greater reimbursement
• Technology continually outpacing regulation
• Edgy clients pushing technological & regulatory
boundaries
Telemedicine & Mobile Health
Compliance Concerns
Michael H. Cohen, Esq.
Robert A. Polisky, Esq.
www.michaelHcohen.com
www.rphealthlaw.com
Annual Healthcare Law Compliance Symposium
Los Angeles County Bar Association
October 9, 2014