1. Implementation Guide Change Process (DSMO)
The Fifth National HIPAA Summit
Implementation Guide Change Process (DSMO)
Session 5.02
Friday, November 1, 2002
Gary Beatty
Chair: X12N Insurance Subcommittee

2. HIPAA Implementation Guides
Implementation Guides Cannot change more frequently than once per year
X12 Standards change 3 times per year
Any healthcare stakeholder can request changes including:
Providers
Payers
Clearinghouses
Healthcare Industry Representatives
Federal / State Government
HIPAA is adopting and mandating X12N Implementation Guides NOT X12 Standards!
Anyone or organization can request changes to the HIPAA Implementation Guides.

3. HIPAA Implementation Guides
National Committee on Vital and Health Statistics
Public advisory body to the Secretary HHS
Composed of 18 individuals from the private sector
Public meetings and hearings
National Committee on Vital and Health Statistics (NCVHS)
Charged with advising the Secretary of HHS
Composed of 18 PHD, MD, Federal Agency Representatives, and other industry representatives
Public hearings – broadcast over the web
NCVHS is listening closely to the needs of the industry – Good Job!

4. Change Request Coordination ?
3 ANSI Standards Organizations
3 Data Content Committees
DHHS / NCVHS
Memorandum of Understanding
X12
HL7
NCPDP
NUCC
NUBC
DeCC
Organizations mentioned in the legislation:
3 Standard Setting Organizations (SSO)
3 Data Content Committees (DCC)
DHHS / NCVHS
Concern over coordination, consistency, confusion to the industry
MOU to define process for IG changes
DHHS
NCVHS

5. Implementation Guide / Data Content Change Request
Web
Request
Form
Work Request
Tracking System
X12
HL7
NCPDP
Approved
Changes
X12
HL7
NCPDP
NUBC
NUCC
DeCC
90 Days to develop organizational Recommendation (45 Day Extension If Needed)
X12
HL7
NCPDP
NUBC
NUCC
DeCC
10 Business Days to Express Interest
MOU established
Change Request System (CRS)
Frequently Asked Questions (FAQ) data base
Change Request (CR) Process
Complete CR online or via paper (which you must download from the web)
No later than 5th business day CR are sent to DSMO
10 Business days to express interest in change request (at least 1 organization must express interest)
Organizations that express interest are called Collaborating Organizations – CO)
The CO has 90 days to develop their Recommendation (+45 days if extension is needed)
2/3 vote of the CO needed to approve CR
CO or Requestor can appeal decision of the CO (no one else can appeal)
If approved CR is passed to the SSO to incorporate change into IG

6. Requesting A Change Choose the Implementation Guide
State the Business Case for Change Request
Provide a suggested change to meet Business Case
External Code List
Changes
IG Appendix C – Code List Maintainers
Changes are linked to a specific Implementation Guide
Business case for change must be completed
Provide a suggested change (technical or not) to meet the business case
DO NOT REQUEST CHANGES TO EXTERNAL CODES referenced within the IG
Request these changes of the organizations mentioned in Appendix C who maintains the code list

7. MOU Guiding Principals
Public Access – Single Point of Entry
Timely Review of Change Requests
Cooperation and Communications
Consider All Viewpoints
Evaluate Impact of Change Requests
Maintain a National Perspective
Conform to Legislation and Regulatroy Process
Any person or organization shall have the opportunity to submit a HIPAA Change Request and that there be a single consistent point of entry or process to request a change.
The organizations agree to establish or maintain a methodology or process that ensures timely reviews and responses to all HIPAA Change Requests. Since the Secretary can promulgate new or revised HIPAA rules no more frequently than once a year, each organization's process should be designed to work within that time frame.
The organizations agree to cooperate and communicate with one another as each organization looks at new transactions, changes in technology, or changes in the health care industry.
The process allows for input and consideration of various viewpoints from health plans, providers and other entities involved in, or affected by, the HIPAA transaction rules.
The organizations agree to consider the overall impact of the HIPAA Change Request on all the HIPAA transactions. While a request may seek a change to one transaction, it is possible that the change could have an effect on other transactions.
The organizations agree to maintain a national perspective in satisfying the business needs of the health care industry while fostering administrative simplification.
All changes recommended shall be consistent with HIPAA statutory and regulatory provisions.  

8. Next Steps… Annual DSMO Report to NCVHS - Recommendations
NCVHS Review & Recommendations to HHS
HHS
Initiate the Federal Regulatory Process
Draft NPRM
NPRM Internal Clearance
Publish NPRM – Federal Register
Public Comment Period (30 – 60 days)
Response to Comments
Draft Final Rule
Final Rule Internal Clearance
Publish Final Rule – Federal Register
30-60 day Congressional Review Period
Final Rule Includes the compliance date
Cannot be less than 180 days
Review the steps and the fact this alone will guarantee changes will not occur more frequently than once per year.

9. SUMMARY Process and timeline for IG Changes Frequently Asked Data Base
Participate!
Questions
Gary Beatty
Chair: X12N Insurance Subcommittee