Heavily based on a presentation I gave for the CMS 2020 National Quality Forum. Emphasis is on dialysis (particularly home dialysis). Discusses regulatory framework, medical devices used to render the services and outcomes of studies performed to day

1. TELENEPHROLOGY
CHRISTOS ARGYROPOULOS MD, PHD, FASN
DIVISION CHIEF
DEPARTMENT OF INTERNAL MEDICINE, DIVISION OF NEPHROLOGY

2. Public Service Announcement

3. Disclosures
Consulting fees from Baxter, Research Support from DCI, Inc

4. Overview
Components of a telehealth program
Current regulatory framework
TeleNephrology Component Outcomes
Future Considerations

5. Components of a
Telehealth Program

6. What is telehealth?
Teheleath is the delivery of health care services, where
distance is a critical factor, by all health care professionals
using information and communication technologies for the
exchange of valid information for diagnosis, treatment and
prevention of disease and injuries, research and evaluation,
and for the continuing education of health care providers, all
in the interests of advancing the health of individuals and their
communities.
World Health Organization. Telemedicine: Opportunities and Developments in Member States. 2010:1–92.

7. Non-Local Communication + Exchange of
Info = Health Applications
METHOD AND MODALITIES
Web based applications
“store and forward”
Portals
Education interventions
Videoconferencing
Remote Monitoring Devices
GOALS OF TELEHEALTH
Reduce distance between patients and
health care professionals
Improve patient access
Reduce operational costs and overhead
(Hopefully) improves outcomes

8. The early history of telehealth
Smoke signals and light reflection used to communicate outbreaks
Symptoms were communicated to ancient Greek doctors via relatives who communicated back diagnosis and
treatment
Alexander Graham Bell’s seeking of assistance for a work-related injury
Telepediatrics : case report in Lancet 1879
American Civil War battlefield consultations
 Radio News Magazine formalized the concept in 1924!
Interactive video link to support telepsychiatry in Nebraska (1964)
Logan Airport and MGH partnership (1967)
Federal Research – Demonstration Programs: rural health programs in New Hampshire, Maine, Puerto Rico,
Minnesota, Washington
STARPAHC (Space Technology Applied to Rural Papago Advanced Health Care) : NASA + Lockheed + IHS
History of Telemedicine: Evolution, Context, and Transformation. ISBN 9781934854112
Bull Med Libr Assoc. 1996 Jan; 84(1): 71–79

9. Back to the
Future !

10. Basic Setup of a Telehealth Program
Kidney International (2017) 92, 1328–1333

11. Telehealth Facilities and Peripherals
MOST TELEMEDICINE ENCOUNTERS
ORIGINATE IN DUAL PURPOSE
DIRECT CONTACT, EXISTING
FACILITIES
FACILITATED BY STANDARD
VIDEOCONFERENCING OVER A
MOBILE CART
CART SUPPORTS AND HOUSES
TELEHEALTH PERIPHERALS THAT
TRANSMIT BIOMEDICAL DATA
Med Clin N Am 102 (2018) 533–54

13. Telemedicine Medical Examination
Devices
Tools that are used to carry out physical examination
Electronic + web enabled versions of devices used in conventional physical exam
Regulated by the FDA as Medical Devices (this also includes the apps that control
them/transmit data)
Telemedicine carts : Class I
Stethoscopes / ultrasound probes / otoscopes / opthalmoscopes / scales: Class II
Home Dialysis Machines : Class III
Electronic Health Records : not currently regulated by the FDA
Performance equivalent to traditional medical exam tools (and often better due to digital
signal processing capabilities)
Most components of physical exam (except palpation) may be undertaken remotely

14. Regulatory
Framework

15. Definitions
Originating Site: the location of the beneficiary when the telehealth service happens
Distant Site Practitioner: providers who may furnish and receive payment for covered
telehealth services
Physicians
Advance Practice Providers
Nurse – midwives
Clinical Nurse Specialists
Nurse Anesthetists
Clinical Social Workers
Dieticians
Telehealth Services: interactive, bidirectional, real time audio and visual
communication between beneficiary and the person at the distant site

16. What is (NOT) a telehealth service?
TELEHEALTH NOT TELEHEALTH
Patient EHR Portals
Electronic Consults
Remote Monitoring in the absence of the patient
Project ECHO
Sanjeev Arora’s (UNM) pioneer model of
videoconferencing between hepatologists and
PCPs discussing de-identified cases AND a
didactic patient focused curriculum to enable PCPs
to deliver specialty care for Hepatitis C during the
interferon era
Med Clin N Am 102 (2018) 533–544

17. Compliance Considerations
HIPAA privacy rule must be adhered to
during face to face and tele interactions
Implications for videoconferencing
Encrypted internet connection
Video Transmissions are not stored unless requested (another
difference from ECHO which records its didactic focused case
discussions)
Authentication and access controls
Vendors of such videoconferencing must sign a business associate
agreement with the provider of the service
Many popular commercial platforms (Skype/Facetime) are not
encrypted and thus cannot be used
Others (e.g. Zoom) are HIPAA compliant and thus can be used as the
videoconferencing platform

18. Regulation Relevant to Dialysis
SITUATION IN 2018
Originating Site:
•County outside MSA OR a Health Professional
Shortage Area in a rural census tract
•Physician offices, federally qualified health centers,
Critical Access Hospitals, Skilled Nursing Facilities,
community mental health centers
•Excluded most free standing dialysis facilities
•CMMI granted waivers to ESCOs which were
participating in the CEC model
HR 1892 – BIPARTISAN BUDGET ACT
OF 2019
Did not remove types of originating sites Expanded
access for home dialysis patients
 Patient’s home
 A dialysis unit that partner’s with the patient’s own home
unit
 Hospital or CAH unit
 Home patients in non rural areas
Patients NOT Providers opt in telehealth
Initial 3 visits must be face to face
At least one out every 3 subsequent visits must be
face to face
A facility fee may not be collected if the originating site
is the patient’s home

19. Facilitating the telehealth dialysis visit
AJKD Vol 74 | Iss 1 | July 2019

20. Risk and Benefits of
Telehealth

21. TeleNephrology
Outcomes
OUTCOMES OF COMPONENTS OF TELEHEALTH OF
RELEVANCE TO NEPHROLOGY

22. Reviewing the evidence for
telehealth components
VIDEOCONFERENCING REMOTE MONITORING
APPLICATIONS FOR HOME
DIALYSIS
PATIENT PORTALS (NOT
EXAMINED HERE)

23. Which evidence is relevant ?
DISEASE STATES
In-center dialysis
Home dialysis
CKD
Conditions in which fluid excess leads to
trouble (heart failure)
WHAT TO LOOK FOR
Is it feasible to provide care remotely?
Is it acceptable to do so?
Is there any evidence for inferior
outcomes ?

24. Queen
Elizabeth
Hospital to its
satellite units in
South Australia
J Telemed Telecare. 1997;3(3):158-62.

25. How was telenephrology used?
HCP Clinical Use
Surgeons Vascular access
Nephrologists & fellows Vascular access, dialysis
complications, transplant
eval
Pharmacist Explanations of drug
treatment and side effects
Assessment of compliance
Dietician Diet education
Social Worker Social service, housing,
transporation
Nursing Education/access and PD
exit sites
Use Cases of Telemedicine
Dialysis complications
(dyspnea/hypotension)
Management of Skin infections
Monitoring of cannulation access
problems
Monitoring of fluid status
Acute psychosocial interventions
Assessment of drug compliance
Non-nephrological specialist care
J Telemed Telecare. 1997;3(3):158-62.

26. /
What did this study actually show?
J Telemed Telecare. 1997;3(3):158-62.
“ I think the real
challenge for us was
to show that there
was clinical purpose,
a clinical usage for
telemedicine “
01
“show that it had
some place in the
management of
patients, that we
could assess
patients”
02
“that we
couldestablish an
acceptable human
link with them”
03
“that we could get a
quality of picture that
was regarded as
adequate for most
daily purposes”
04

27. The known unknowns
Usage was so tightly integrated with day to day activities that
no record keeping of time spent in telehealth was kept
Lack of cost-effectiveness data
Was quality actually improved?
Impact on efficiency of practice
J Telemed Telecare. 1997;3(3):158-62.

28. A randomized controlled trial in CKD
PARTICIPANTS AND SETTINGS
Minneapolis VA and affiliated clinics
Randomized participants from the CKD
registry
Treatment group received care by a
nephrologist at home
Control group may or may follow with a
nephrologist (no data were collected about it)
Assignment was random
Education module incorporated for both
arms
TELEHEALTH INTERVENTIONS
Multidisciplinary team: nephrologist, APP. nurses,
psychologist, CSW, pharmacy tech, dietician
Team conducted remote monitoring, videocalls
when vitals were out of range and weekly huddles
Peripherals:
Bidirectional camera
Blood pressure cuff
Scale
Glucometer
Stethoscope
Pulse Ox
Am J Kidney Dis. 2016;68(1):41-49

29. The study at a glance
Am J Kidney Dis. 2016;68(1):41-49

30. Outcomes
Time to death/hospitalization/ED
visit/admission to SNF
Am J Kidney Dis. 2016;68(1):41-49

31. How should this study be
interpreted?
Trial period coincided with the PACT (Patient
Aligned Care Team) implementation across
the VA
PACT AND Telehealth have independently
associated with improved outcomes
A patient centered, multidisciplinary approach
can be equivalently delivered either remotely
or through face to face encounters
https://www.patientcare.va.gov/primarycare/PACT.asp

32. Lessons from the Heart Failure Space
Mortality: Low Quality Evidence for benefits Hospitalizations: Moderate Quality Evidence for
lack of benefit
Cochrane Database Syst Rev. 2015 Oct 31;(10):CD007228.

33.  Improved travel
time
 Improved waiting
time
 Improved quality of
life
 Improved kidney
function
 Improved
proteinuria
 Improved blood
pressure
 No effect on rate of
loss of kidney
function
Decreased provider
costs
Decreased patient
and provider time
Decreased
Hospitalizations
Decreased Costs
CKD
Dialysis
Canadian Journal of Kidney Health and Disease Volume 6:
1–13

34. Remote Monitoring (RM) in Home
Dialysis
WHAT IS IT?
Remote monitoring systems interfacing with the
home hemodialysis machines and cycles
Allow the real time monitoring of prescription
delivery, vitals, weight
Patients do not have to manually record
treatment parameters
Data stream available for remote viewing by the
multidisciplinary team
Formally NOT a telehealth service because of the
lack of a audiovisual encounter
May trigger telephone, face to face or telehealth
encounters
POTENTIAL BENEFITS
Increase confidence and satisfaction
Early flagging of problems
Avoidance of hospitalizations
Technique survival (“keeping the patient at
home”)
Bending the cost curve
Safer treatments
Higher quality treatments

35. Remote Monitoring in Home
Hemodialysis
DESIGN
Retrospective case control design of
users of the Nx2me platform
Users of the platform were matched to
non-users
Examined Hospitalizations, Technique
Survival , Dialysis Cessation, training
graduation
Formally not a telehealth service
application
Connected Health Application
PATIENTS
606 users identified
49.5% initiated in the first 3 months
2000 controls identified
Hemodialysis International 2018; 22:318–327
Hemodialysis International 2018; 22:318–327

36. Graduation from training
61% higher rate of training graduation
(10% - 36%, p =0.02)
Hemodialysis International 2018; 22:318–327

37. Patient and Technique outcomes of
Remote Monitoring in HHD
Hemodialysis International 2018; 22:318–327

38. Remote Patient Monitoring in PD
OVERVIEW OF STUDIES
Retrospective pre and post designs
looking at clinical outcomes and processes
Statistical matching techniques used to
address confounding
Few prospective studies looking into
acceptability of monitoring by patients, and
workflow patterns
Data available from both US and exUS
sources
OVERVIEW OF OUTCOMES
Acceptability by patients
Cost of care
Hospitalizations
Prescription changes
Blood pressure
Workflows

39. What about costs?
PD units in the mid-atlantic area
Telehealth kit: real time biometric of BP and
body weight
Encrypted secure videoconferencing
system
Full access to patient data
Pre and post non-randomized design
CMS claims data for costs
Dialysis EMR for labs / hospitalizations
Highly acceptable (used > 95% of time)
J Telemed Telecare. 2019 Dec;25(10):581-586

40. Associations of Remote Monitoring
of BP/Weight in PD
21.5% (BP) & 29.5% (Wt) generated an
alert
Breached range followed by nursing
intervention in 20% of the alerts
Having any review of a breach was
associated with reduced odds of another
breach (> 70% reduction in subsequent
alerts)
Overall unadjusted cost was lower by
US$ -734.51 (p<0.05) but the result
dissipated after multivariate adjustment
Remote monitoring of weight
Fewer hospitalizations (adjusted OR) 0.54
, 95% CI (0.33 -0.89)
Fewer days hospitalized (adjusted OR)
0.46 95% CI (0.26 – 0.81)
Remote monitoring of BP:
More hospitalizations (adjusted OR) 1.95
, 95% CI (1.10 – 3.46)
More days hospitalized (adjusted OR)
1.65 95% CI (1.02 – 2.65)
J Telemed Telecare. 2019 Dec;25(10):581-586 Perit Dial Int 2017; 37(5):576–578

41. Remote Patient Monitoring in PD:
hospitalizations
SETTINGS AND PARTICIPANTS
BRCS Colombia Network (n=126)
RP used the capabilities of the cycler and
the Sharesource platform
PD nurse (1 for each patient) reviewed
data daily: 1 hr/day
Flagged patients who missed treatments,
had deviations from treatment, lost
connectivity
Non-randomized study, used propensity
score adjustments to reduce confounding
OUTCOMES
Peritoneal Dialysis International, Vol. 39, pp. 472–478

42. Remote Patient Monitoring in PD:
prescription handling
SETTINGS AND PARTICIPANTS
BRCS Colombia Network (n=49)
RP used the capabilities of the cycler and
the Sharesource platform
PD nurse (1 for each patient) reviewed
data daily: 1 hr/day
Flagged patients who missed treatments,
had deviations from treatment, lost
connectivity
Pre – post design with each patient
serving as their own control
PRESCRIPTION CHARACTERISTICS
Kidney International Reports (2019) 4, 873–876

43. Remote Patient
Monitoring in PD:
multiple
prescription
changes and
improved volume
management
Kidney International Reports (2019) 4, 873–876

44. RM and Nursing Workflows in PD
ERA EDTA 2017 SP508

45. Future Considerations

46. How to measure quality in
TeleNeph?
Structure
Originating Site
Process
How frequently telehealth was
selected by patients
Route and frequency of
medications
Transportation costs
Workflow characteristics (e.g.
direct/direct)
Outcome
Mortality
ED Visits
Hospitalization rate & length of stay
Technique survival
Education graduation
Antecedents of Care
(Coyle and Battle model)
Age
Rurality
Access to broadband
Affordability to devices
International Journal for Quality in Health Care, 2019, 00(00), 1–4

47. Where do we go from here?
Patient Clinical Teams
Connected Health
and Telehealth
Platforms
Adding More Sensors:
Low Hanging Fruit
“Hype-able”
Presenting data/Analytics:
Half Way up the Tree
“Hype-able”
Analysis + Inference + Action:
Large volume, high dimensional, high
variability data: high hanging fruit

48. Audiovisual
Communication
Self-
examination
E-prescribing
Remote Vital
Sign Monitoring

49. Can we envision a telehealth service in
which patients own their diagnosis?

50. Best Practices 2020: Remote
Monitoring
Data to date from multiple medical systems around the globe provides encouraging evidence that remote
monitoring:
 Increases graduation rates from home therapy programs
 Decreases attrition to incenter dialysis
 Optimizes prescription to avoid volume overload
 Decreases hospitalizations
 Proactive rather than reactive model of care delivery
 No evidence of harm
 Highly acceptable by patients
Implications for practice: Remote Monitoring should be used wherever available, and should be instituted if
not available

51. Best Practices 2020: Remote
Monitoring
Evidence for telehealth visits is not as clear as RM, but:
 Acceptable by patients and providers
 No evidence of harm
 Potentially beneficial effects on hospitalization/cost
Further real world data to come from:
 ESCOs for in-center dialysis
 Outcomes of telehealth for home dialysis: pre-post analyses
Implications for practice: Telehealth should be discussed with patients and offered if found
acceptable by patients in a regulatory compliant manner

52. Summary and remaining questions
Favorable regulatory framework to
expand telehealth services to
(home) dialysis
Initial experience suggests high
patient engagement, and
potentially improved outcomes
(mainly hospitalizations)
Data very similar to the heart
failure field, in which management
of volume is paramount
Quality metrics probably need to
be adapted to the field
Technological improvements imply
that the definition of “service” has
to change (e.g. if a patient self
diagnoses volume overload and
the team responds via a connected
health domain, why should one
even require a videconference?)
How can telehealth be made
affordable to socieconomically
vulnerable populations who may
not be able to afford broadband
and/or the telehealth peripherals?

53. Thank
you for
your
attention