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??