The document announces a webinar on regulatory requirements for diabetic retinopathy screening in community clinics, including topics like HIPAA, credentialing, scope of service guidelines, procedures and protocols, telemedicine consent forms, and other issues. Attendees will learn about compliance with these requirements from experts at Northeast Valley Corp and Clinica Sierra Vista. Questions are welcome during the webinar.

1. SUMMERTIME LEARNING COMMUNITY - THE
HEAT IS ON:
REGULATORY REQUIREMENTS FOR
DIABETIC RETINOPATHY SCREENING
IN COMMUNITY CLINICS.
August 22, 12:30 PM Pacific Daylight Time
Call In Number: 800.747.5150
Access Code: 9438735
Jorge Cuadros, OD, PhD
University of California, Berkeley
Digital Health

2. QUESTIONS?
 Please select the “Raise Hand” button on your
control panel, or send an instant message,
email, or chat message during the conference
 We will un-mute your line & your question will
be heard by the presenters & the group

3. TOPICS:
 HIPAA Requirements
 Credentialing Requirements **
 FQHC’s and Scope of Service **
 Procedures, Processes, and Protocols **
 Telemedicine Consent Forms
 Other Regulatory Requirements: Please let us
know your thoughts, advice, and questions!
 **Thanks to Missy Nitescu, COO, Northeast Valley Corp. and
 Karen McNerny, COO, Clinica Sierra Vista

4. HIPAA BUSINESS AGREEMENTS
 Rationale: to protect the privacy and integrity of
confidential patient information (PHI).
 Who needs to do it? Clinics, UCB, and EyePACS may wish
to include with service contracts.
 Features:
 Non-disclosure
 Mitigation
 Make information available to authorized requesters
 Make PHI policies available to authorized requesters
 Sample available at:
http://www.hhs.gov/ocr/privacy/hipaa/understanding/c
overedentities/contractprov.html

5. CREDENTIALING READERS
 Rationale: Credentialing readers – security,
liability, consistency
 Who gets credentialed?
 UCB and EyePACS credentials readers:
 Certification test
 Quality assurance
 Proof of liability insurance and licensure for panel
readers
 JCAHO-certifiedhealth centers (20% of clinics)
must use their own credentialing process to
credential EyePACS readers who view their
encounters.

6. SCOPE OF SERVICE RECOMMENDATIONS FOR
RETINOPATHY SCREENING (DRS) IN CLINICS:
 Addition of DRS qualifies for a scope of service (aka
scope of project) change if it directly impacts the
type, intensity, duration and amount of FQHC/RHC
services.
 Costs for conducting DRS can be included in scope
of service change not related to DRS (allowable
under Medicare Reasonable Cost Principles).
 When adding a non-mandated service (eye care), it is
required to justify how the additional service will
result in improved health status for all patients.
 Imaging service vs. eye care service – guidelines are
unclear.

7. PROCEDURES, PROCESSES, AND PROTOCOLS
 Rationale –
 Regulatory consistency,
 Guide for case managers,
 Consistent patient care.
 Committee initiates and develops protocols.
 Validation and use of data for research
 IRB
 Disclosures
 Prohibitions

8. TELEMEDICINE CONSENT FORM
 Patient Rights. It is understood that the patient participating in a telemedicine
consultation may:
 Request that the participating doctor omit specific details of the history or
examination that are personally sensitive.
 Limit any physical examination proposed during the telemedicine consultation.
 Request that nonmedical personnel leave the consultant’s location at any time.
 Request that all personnel leave the consultation site in order to have a private
consultation with the off-site provider.
 Withhold or withdraw consent to this procedure without affecting rights to future
care or treatment.
 Access all medical information transmitted during this telemedicine
consultation,
 and obtain copies of this information for a reasonable fee.
 Is this really necessary? – Not Necessary as of May 1, 2011.

9. OTHER REGULATORY ISSUES:
 Data Backups
 Information systems:
 CCHIT guidelines
 FDA requirements
 510 K
 Title 21 CFR Part 11 (electronic signatures and official
copies)
 Validation
 Your Thoughts??