TELEMEDICINE AND TELEHEALTH –
COMPLIANCE CHALLENGES©
Deborah A. Randall, JD & Consultant
202-257-7073
[email protected]
www.deborahrandallconsulting.com
Electronically Enabled Care
Delivery in 2012
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HIT = Health Information Technology
HIE = Health Information Exchange
EHR = Electronic Health Record
EMR = Electronic Medical Record
PHR = Personal Health Record
ONC = Office of the National
Coordinator for HIT [DHHS]
American Telemedicine Assn
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Extensive materials on-line and
training. Creating standards for
practice in telemedicine and
telehealth. Lobbying for expansion.
Working groups in new areas. I chair
palliative care and end-of-life.
www.americantelemed.org
Survey 2010: eHealth Initiative
61% of respondents agree or strongly
agree that significant progress has
been made in the successful adoption
and use of HIT since 2007.
BUT 54.9% disagree or strongly disagree
the value of HIE is clearly understood &
66.6% disagree or strongly disagree
outreach on value of EHR/HIE is effective
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eHealth Survey, cont.
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55.5% of respondents disagree or
strongly disagree that differences
between federal and state privacy laws
are not a barrier to consumer’s rights
to healthcare privacy.
56% agree or strongly agree that HIT
and HIE have had a positive effects on
care delivery.
Evolving Definitions
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Telemedicine vs. telehealth
Doctor to doctor d2d
Doctor to patient d2p
Distance learning
Remote monitoring
eCare eHealth mHealth
“Smart” homes
Developments & Trends
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New Medicare Reimbursement
Possibilities: Reviewed annually;
patient must be in a rural or
underserved area.
Devices as diagnosis-enhancers
Infrastructure for Telemedicine and
Telehealth
Legislation
“Originating Sites”
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office of a physician or practitioner
Hospitals; Critical Access Hospitals
Hospital or CAH-based Renal Dialysis
Centers (including satellites)
Community Mental Health Centers
Rural Health Clinics;
Skilled Nursing Facilities ;Federally
Qualified Health Centers (FQHC);
Medicare Coverage Expansion
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In 2011 HCPCS codes added for:
Individual and group Kidney Disease
Education (KDE) services;
Individual and group Diabetes SelfManagement Training (DSMT)
services;
Group Medical Nutrition Therapy
(MNT) services;
Medicare Coverage Expansion
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Group Health and Behavior
Assessment and Intervention (HBAI)
services; and
Subsequent hospital care and nursing
facility care services.
LEGISLATION 2009-2010
HITECH ACT 2009- Stimulus Bill
HIT Policy Committee of ONC
Infrastructure got first funding
Aging Services Technology Study
PPACA – Health Reform Act 2010
[email protected]; Medicaid Medical
Home; Chronic Care; Innovation Cntr
HighTech Telehealth Impact
A. $2 billion Office of the National Coordinator
– Regional health information exchange
efforts and state-based “extension centers"
– Health information enterprise integration
- Big grants
B.Medicare and Medicaid provider and
hospital incentive to adopt and use health
IT through “meaningful use”
HIGHTECH, cont.
– Indian Health Service health IT
– Community health centers for health IT
acquisition
– Social Security
– $1.1 billion for comparative
effectiveness research
BEACON: $16+Million Buffalo
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Western NY Info.Exchange
clinical decision support –registries +
point-of-care alerts/reminders
innovative telemedicine =improve
primary/specialty care for diabetics, ↓
preventable ER visits, hospitalizations
re-admissions for diabetes, CHF,
pneumonia; ↑immunization of diabetics
Patient Protection and
Accountable Care Act of 2010
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“PPACA” --This is where the
expansion will continue to be.
PPACA drives the process towards
management of chronic disease.
Health information technology is finally
showing, with reliable data, that
telehealth can integrate with traditional
care and use staffing innovations.
PPACA
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Post-hospitalization bundling pilot
Independence at Home
demonstration
Innovation Center at DHHS; policy
includes strong telehealth focus
ACOs
Medical Home-Medicaid and Pilots
Blue Cross/Blue Shield WNY
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Blue Cross/Blue Shield Western New
York in May 2010 initiated online
physician-patient communication as a
compensated service; encouraging
telehealth communications and
webcam visits; measuring quality of
care and patient compliance factors
Hawai’I HMO doing major telehealth
Scope and Payers
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Home-based telehealth mostly chronic
care management => avoid ER & rehospitalizations. Provider funded;
grants.
Medicaid pays some telehealth visits.
Home as “originating site” NOT
reimbursed by Medicare. Skilled
nursing home= live consultations in
rural or medically underserved area
Technology-enabled
Community Care
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Satellite health facilities
In situ care w medical devices
Remote monitoring and sensors
Awareness and acceptance
European efforts in ambient care
The VA system –the Vanguard
Telehealth Expansion
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Care coordination and Chronic
Disease
Patient self-management
Ambulatory care and safety
Palliative care
Rehabilitative services
Behavioral & mental health services
VA Chronic Care Coordination
Telehealth Report 12/08
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% DECREASE UTILIZATION
Diabetes
8,954
20.4
Hypertension 7,447
30.3
CHF
4,089
25.9
[congestive heart failure]
COPD
1,963
20.7
[chronic pulmonary obstruction]
CONDITION
VA Chronic Care Coordination
via Telehealth Study, cont.
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Posttraumatic stress disorder 45.1%
Depression 56.4%
Other mental health condition 40.9%
Single condition 10,885 patients;24.8%
Multiple “ “
6,140 patients;26.0%
Interventions “just in time”; “air traffic
control”
VA Chronic Care Coordination
via Telehealth Study
The cost ($1,600.24 pp/yr compares favorably)
 direct cost of VHA’s home-based primary
care services of $13,121.25 per annum and
 market nursing home care rates that
average $77,745.26 per patient per annum”.
Conclusion: a flexible and cost-effective
adjunct to VHA’s existing services. Darkins
et al., Telemedicine & EHealth, 12/2008.
Telehealth: Dementia Patients
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Residential facilities designed to allow
movement of individuals through
facility and grounds; Families can track
on computer/internet based systems
Sensoring systems; Intel research;
TRILL; diagnostic sensoring for fall
prevention yielding data on Alzheimer
specific movement differentials
Telehealth:Dementia Patients
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AlarmTouch GPS is a personal safety phone
with GPS location in Europe. The telecare
device includes a ‘Geofencing’ feature,
enabling accurate location of users in need.
When the wearer wanders outside a
specified zone – such as home or school
area - the system can send a short message
(SMS) alert to a monitoring centre or to a
relative or caregiver.
Ambient Assisted Living
Programme - EU
23 EU member states with support of European
Community [EC]
-Enhance quality of life of older people
-Strengthen industrial base by use of Information and
Communication Technologies [ICT]
-Aging well at home, community and work
-Coherent framework for research into solutions which
are compatible with varying social preferences
www.aal-europe.eu
What are the New Directions?
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Tele-rehabilitation; Falls prevention
Tele-mental and behavioral health
Continuous monitoring: diabetes;
cardiac
Impaired; Alzheimer’s & dementias
“Wellness”
Telehealth and Rehabilitation
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Distanced assessments
Robots in SNFs
Telestroke => telerehab
Wii units in senior living facilities
Remote monitoring for falls anticipation
Traumatic brain injury;wounded warrior
Behavioral & Mental telehealth
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On-going research
Post traumatic stress disorder
Tele-psychiatry
Distanced mental health services
under new Medicare reimbursement
provisions for community mental
health centers
VA Rapidly Expanding
Behavioral Health Outreach
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Major projects to help with PTSD and
other mental and behavioral concerns
of wounded warriors
Use of local centers and distanced
mental health specialists
Use of internet-based programs along
with Skype-type live sessions
Palliative Care
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Pain and symptom management
Outreach and crisis management
Triage without transporting to facility
Psychological pain and suffering
Diagnostic opportunities; family
interactions
Ethical principles= autonomy enhanced
Advanced Illness –Is there a
Role for Telehealth
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Using an existing model. Kaiser’s
Advanced Illness Coordinated Care
Program (AICCP) included health
counseling
developed for patients with advanced
illness (congestive heart failure, endstage pulmonary disease, end-stage
renal disease, and cancer) in 3
settings of a multistate health plan.
Expanding a model, cont’d.
Improved communication about
discomfort, support for decision
making;
Advance directives (5.5 mo.);problem
resolution; attention to caregiver needs.
 more agreement to do-not-resuscitate
or intubate orders; <inpatient admits
with no difference in survival.
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Opportunities and Challenges
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Medical Director and other physicians
Demonstrating cost savings, &/or
quality of care/life improvements- to
justify expense of equipment and staff
Training and staffing. Maintenance of
depth of field/bench so turnover is not a
problem. Need for a "champion".
Leading nurses to embrace technology
Telehealth: Impediments
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Medicare Reimbursement and Coding
Medicaid
Grants
Outcomes, cost savings and Disease
Management concerns
Licensure and interstate barriers
Standards; Interoperability among
devices/software/infrastructure
Compliance Concerns
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Licensure and Credentialing
Under-serving patients; Liability
Consent
Reimbursement and Documentation
Management of the Case
Privacy and confidentiality
Security of Communication
Fraud and Abuse
Licensure
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Many states –New York is one--bar
physicians from practicing via
telehealth without a full or partial new
license => quality; control as issues
Some states now licensing the entity
which arranges for and participates in
telehealth services
Nurses more sane but States [NY] not
Credentialing
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HHS concessions on no need for
physicians and other health
professionals to have admitting
privileges at “receiving” institution
where patient is located who gets
telehealth.
Next steps for Compliance Officer
HHS Concessions in Rules
76 Fed Reg 65891,65893 (10/24/11) c
HHS wants to “provide hospitals the
clarity and flexibility they need under
federal law to maximize their staffing
opportunities for all practitioners,..
particularly for non-physician [s]..
under ..States’ laws.”
Final Rule due soon.
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Liability-Consent-Management
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Medical device or simply a conduit of
information
Manufacturer; Software vendors will
seek total immunity from exposure
Patients need to hear from physicians
and health entity about conditions,
errors and backup response
Malpractice Insurers reluctant or
ignorant
“Under-Serving” Patient
Need? Not likely but.....
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Civil Money Penalties Act concerns
Loss of Provider Arrangement
If telehealth is not covered by
Medicare in the home, is it a “visit”, an
“encounter”, a service or an
accessory? Is it a patient inducement?
–OIG Advisory Opinion from 2000
suggests not (when not advertised.....)
Impediments to Data Exchange
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State privacy laws
HIPAA
Congressional focus HITECH and other HIT
bills resulted in Strong language extending
privacy protections including business
associates.
Telemedicine and telehealth raise HIPAA
issues on transmission, storage, security,
“use” and authorizations grounds, at least
Meaningful Use Regulations
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The developments around electronic
health records have concentrated on
privacy and encryption.
First stages will be ePharmacy
transmissions; see MLN Matters
Number: SE1107 and version 5010
coding [began Jan 2012, with
enforcement delay.]
Texting? mHealth?
The UK’s NHS on tablet/iPad security:
“We have developed interim guidance
these devices are currently not as
secure as more traditional IT
equipment. They should therefore not
be used to store sensitive patient data
and should, as with all mobile devices,
be encrypted as necessary.”
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Texting? Joint Commission:
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Not acceptable for physicians or
licensed independent practitioners to
text orders for patients to the hospital
or other healthcare setting. ..provides
no ability to verify the identity of the
person sending the text .. no way to
keep the original message as
validation of what is entered into the
medical record.
Contracting Issues
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When private pay, family members are
the contracting parties
When you are subcontracted to
another organization
When the HIT vendor writes the
contract….Indemnification concerns
and insurance issues
When the State intervenes
Fraud and Abuse
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Coordination of telehealth services vs.
Impermissible incentive to referral
source, including patient herself.
-Limited OIG safe harbor
-OIG advisory opinions
-Stark law :physician financial
interests
- ACO guidances HHS and FTC
RESOURCES
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Final ACO regulations 76 Federal
Register 67802 November 2, 2011
Final OIG waivers for ACOs, same
Fed Reg, at page 67992.
OIG Advisory Opn 11-12,
oig.hhs.gov/compliance/advisoryopinion and OIG e-prescribing safe
harbor oig.hhs.gov/authorities/docs/06
OIG Advisory Opinion 11-12
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Advisory opinion regarding a health
system’s proposal to enter into
arrangements to provide neuro
emergency clinical protocols and
immediate consultations with stroke
neurologists via telemedicine
technology to certain community
hospitals --Approved with caveats
Discussion – Are you involved
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Audience experience in telehealth
Reluctance….and reasons
Board reactions…have they been
educated about telemedicine and
telehealth?
Can our society afford not to bring
telehealth into our healthcare
management situations?
Thank You!
Deborah Randall, JD
Health Law Attorney
Telehealth Consultant
202-257-7073
[email protected]
www.deborahrandallconsulting.com
©2012 deborahrandall
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Telemedicine and Telehealth