MEMORANDUM OF
UNDERSTANDING
AMONG
THE
ORGANIZATIONS DESIGNATED TO MANAGE THE MAINTENANCE OF
THE ELECTRONIC DATA INTERCHANGE STANDARDS
ADOPTED UNDER THE
HEALTH INSURANCE PORTABILITY
AND ACCOUNTABILITY
ACT OF 1996
Preface
On
The purpose of this MOU is to outline a framework of
cooperation between and among HHS and the Standards Development Organizations
(SDOs) and Data Content Committees (DCCs) designated by the Secretary of HHS
(the Secretary) to play an active role in
the HIPAA AdministrativeSimplification
transactions maintenance process. These organizations agree to work together to
manage the change request process affecting thetransaction
standards adopted by HHS under HIPAA. This includes all necessary and
appropriate modifications to the standard implementation guidelines/manuals and
documentation as well as the related data dictionaries. It also includes review of requests to add
new functionality or new transactions to the HIPAA standards. This MOU documents the
overall process for coordinating the review of HIPAA standard change requests
among these organizations. More detail
of the coordination process can be found in Annex 1. Specific information on how each SDO and DCC
will handle its review can be found on each organization's Web site. The URLs
for those Web sites are listed in Annex 2.
The signatory organizations agree to the following guiding
principles for managing HIPAA Standard Change Requests:
2.1 Allow open
public access. Any person or
organization shall have the opportunity to submit a HIPAA Standard Change
Request.
2.2 Provide for
timely review. The organizations agree
to establish or maintain a methodology or process that ensures timely reviews
and responses to all HIPAA Standard 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.
2.3 Cooperate and
communicate. 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.
2.4 Consider all
viewpoints. 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.
2.5 Evaluate the
impact of each change request. The
organizations agree to consider the overall impact of the HIPAA Standard 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.
2.6 Maintain a
national perspective. The organizations
agree to maintain a national perspective in satisfying the business needs of
the health care industry while fostering administrative simplification.
2.7 Conform to
law. All changes
recommended shall be consistent with HIPAA statutory and regulatory provisions.
The parties to this MOU are HHS and the DCCs and SDOs as
designated by the Secretary. The DCC and SDO designees currently include the
following six organizations, but may in the future include other organizations:
Accredited
Standards Committee X12
The Dental
Content Committee
Health Level
Seven
National
Council for Prescription Drug Programs
National
Uniform Billing Committee
National
Uniform Claim Committee
In general, DCCs are committees that provide a national
forum for discussion, review and action regarding change requests to the data
sets associated with health care financial and administrative
transactions. The DCCs assess the global
business needs and impacts of potential changes on the health care
industry. The committees are comprised
of a balanced representation of key national organizations that are affected by
health care transactions. Their
operating protocols vary, but all are open to input from the public and include
a formal appeal process. Their voting
structures provide balanced, proportional and accountable representation of the
end users of those transactions and data sets, e.g., payors, health care
professionals, institutional providers, standards development organizations,
public health and research communities, etc.
In general, SDOs are organizations that develop and maintain
the models, data dictionaries, structure, syntax and implementation materials
for electronic transaction standards.
Their operating protocols vary, but all maintain policies that meet the
requirements of the American National Standards Institute for open
participation and assurance of due process.
Their voting structures can vary, both between organizations and at
different levels within the same organization, but final voting is generally on
the basis of one vote per member-in-good-standing.
To
facilitate the implementation of this MOU, the signatories to this MOU agree to
designate a steering committee. Each
signatory shall have a representative to the Steering Committee. Each
organization shall have one vote, except HHS, which shall have a non-voting
liaison role. The steering committee will communicate monthly unless there is
no business to discuss.
The
duties of the steering committee shall include general oversight as well as the
specific duties specified in sections 5, 7, 8 and elsewhere in this MOU, which
include conducting an appeals process and assessing the effectiveness of the
MOU and the process it implements.
In the May 7, 1998 Federal Register, (Volume 63, Number 88) a Notice of Proposed Rule Making identified the initial standards
for electronic transactions to fulfill
the requirements of the administrative simplification provisions of HIPAA. A final rule will mandate these
standards. According to HIPAA,
modification to these initial standards, or adoption of additional standard electronic
transactions can occur. The HIPAA
Standard Change Request process outlined below is further detailed in Annex 1
of this document.
5.1 HIPAA Standard Change
Requests can be submitted by anyone at any time via a designated Web site that
will be available to the public. The Web site will have the forms and
instructions for the public to submit a HIPAA Standard Change Request. The Web site will also contain instructions
for paper submission of HIPAA Standard Change Request forms. The Web site administrator will ensure the
completeness of each HIPAA Standard Change Request. The Web site administrator will batch all HIPAA
Standard Change Requests monthly and ensure that all HIPAA Standard Change
Request are forwarded to HHS and each of the maintaining organizations (DCCs
& SDOs).
5.2 Once notified by
the Web administrator, each maintaining organization will have ten business
days to decide whether or not it will collaborate in the analysis and
development of the HIPAA Standard Change Request.
5.3 The organizations
collaborating in the analysis will have 90 days to complete a business analysis
and develop a preliminary recommendation for the disposition of the HIPAA
Standard Change Request. If necessary,
there can be one 45-day extension.
5.4 Within 15 days
after the business analysis is completed, all the collaborating organizations
will review and compare their recommendations in an informal consensus process.
If all the collaborating organizations agree on a single recommendation for
disposition of the HIPAA Standard Change Request, then that recommendation is
forwarded to the appropriate SDO to make the appropriate changes to its
implementation guide(s), data dictionaries, etc. In case of disagreement, the collaborating
organizations shall, to the greatest extent possible, resolve those
disagreements by consultation among themselves
or by development of data conditions that isolate a data change to one or more
specified industry segments or circumstances.
Nonetheless, if the collaborating organizations cannot reach a consensus on a solution, any collaborating
organization may invoke the appeal process.
5.5 The formal appeal
process requires convening the steering committee within 30 calendar days of
the appeal. The steering committee will review each of the proposed solutions
for the HIPAA Standard Change Request and work toward a common solution. Each organization will have one vote. A two-thirds majority of the Steering
Committee will be required to move a proposed disposition forward, as described
in the following section.
.
5.6 Once the
collaborating organizations or the steering committee agree on a single
disposition for the HIPAA Standard Change Request, the appropriate SDO will
proceed with development of the changes necessary to implement the disposition
identified by the foregoing process.
(See Section 6 of Annex 1 for
details.) The resulting proposed changes
to the transaction, implementation guide or other documentation will be
communicated to each of the collaborating organizations for them to review and
confirm that the solution satisfies the disposition recommendation. SDO proposed changes confirmed to satisfy the
recommendation will then be incorporated into the appropriate documentation;
SDO proposed changes not satisfying the recommendation will be referred back to
the SDO for further development.
5.7 On a cycle to be
determined, all the approved HIPAA Standard Change Requests will be presented
to the National Committee on Vital and Health Statistics (NCVHS). (NCVHS is designated by HIPAA as an advisor
to the Secretary of HHS. NCVHS may
review the approved changes and may issue its own recommendations to HHS.)
5.8 HHS will assess the
recommendations and initiate the HIPAA rule modifications accordingly,
including the rulemaking process if required.
HHS will analyze public comments received during the rulemaking process
and will utilize the steering committee to solicit the consultations of the
appropriate SDOs and DCCs on technical or business issues.
All
signatory organizations shall establish and maintain appropriate liaisons with
all other signatory organizations, either voting or non-voting.
The
steering committee shall review and evaluate the performance of the HIPAA
Standard Change Request management system annually. Among other things, the report will indicate
the number of denied requests and appeals as well as the basis for denial.
The initial term of
this MOU shall be three years. Unless otherwise agreed by the signatories, this
MOU shall automatically renew for subsequent one-year periods.
Changes
to this MOU, including additional signatories, must be approved by three-fourths
majority of the Steering Committee, and by HHS. Modifications
can be made to this MOU to keep the HIPAA Standard Change Request management
system aligned with industry and regulatory needs. As
appropriate, the Committee will address urgent issues.
Any party to the MOU may withdraw from the MOU upon six (6)
months notice to HHS and the other signatories.
The steering committee shall make recommendations to the Secretary for
assignment of any unmet responsibilities to other parties.
.
This MOU may be
signed in one or more parts. The effective date of this MOU shall be the
effective date of the HIPAA transaction set final rule. The HIPAA Standard Change Request
management system shall go into effect for all Change Requests received after
the effective date of this MOU. For
changes initiated by any of the parties prior to the effective date, those
parties shall make reasonable efforts to advise all the other parties about
those changes.
The undersigned organizations agree to this
Memorandum of Understanding:
Accredited Standards Committee X12
By:
_________________________________
Date: __________
Dental Content Committee
By:
_________________________________
Date: __________
Health Level Seven
By:
_________________________________
Date: __________
National Council for Prescription Drug Programs
By:
_________________________________
Date: __________
National Uniform Billing Committee
By:
_________________________________
Date: __________
National Uniform Claim Committee
By:
_________________________________
Date: __________
List of Attachments
Annex 1: Details of
the HIPAA Standard Change Request Management Process.
Annex 2: Web information. Annex 2 lists the URL of the Web site for the change request
system. It includes the URLs for the Web
sites of all signatories. Those sites contain additional information such as
specific reference to operating protocols, membership, meeting agendas and
other information that the general public would need or find useful in
connection with this HIPAA Standard Change Request management system. These URLs may be changed by the
organizations that control them after approval by a majority of the steering
committee.
Annex 1
HIPAA Administrative
Simplification Change Request Management Process
There
will be a designated Web site open to the general public that has the forms and
instructions for HIPAA Standard Change Requests, including access to the
industry implementation guides, HIPAA data dictionaries, booklets, etc. HIPAA
Standard Change Requests can be submitted by anyone at any time. While most HIPAA Standard Change Requests
will be completed and submitted on-line, the Web site will also contain
instructions for how to submit paper HIPAA Standard Change Requests. Throughout the process, the Web site will
track each HIPAA Standard Change Request and its current status so that anyone
(e.g., requestor, DCC, SDO, general public, etc.) will be able to track its
progress.
The industry implementation guides, data dictionaries, booklets, etc., will be
available on the designated Web site or via links to the SDO Web sites.
The
designated web site administrator will review each HIPAA Standard Change
Request for completeness. Incomplete HIPAA
Standard Change Requests will be returned to the requestor. Properly completed HIPAA
Standard Change Requests will be acknowledged and then batched at the end of
the month. No later than the fifth business
day of each month, the Web administrator will post the batch of HIPAA Standard
Change Requests to the Web site. At the same time it will automatically notify
all signatories to this MOU. Each DCC and SDO will submit to the Web site no
later than the fifteenth day of the month their interest in each HIPAA Standard
Change Request. They will either state
that they wish to actively collaborate in addressing the HIPAA Standard Change
Request or that they have no interest in the HIPAA Standard Change Request. The Web administrator will work with the
steering committee (see below) to ensure that at least one organization
addresses each of the HIPAA Standard Change Requests.
All
collaborating organizations will have up to 90 days in which to do their
analysis and develop their organization's business recommendation(s). Each collaborating organization shall post to
the Web site pertinent information about its plans for handling the HIPAA
Standard Change Request, including at least the date, place and time that the HIPAA
Standard Change Request will be addressed and information on how public
comments should be submitted. Each
organization will allow open public input into its review and analysis of the HIPAA
Standard Change Request. Meetings on the
HIPAA Standard Change Request are not necessarily restricted to face-to-face
meetings.
For a more complex HIPAA Standard Change Request, the collaborating
organization can ask the steering committee for one 45-day extension, which is
permissible. Additional extensions may
only be granted by the steering committee upon presentation of compelling
justification. The Web site will track
the status, including all extensions and the anticipated resolution date by the
organization.
At the end of the analysis period, the recommendations of the collaborating
organizations will be posted to the designated Web site and the requestor will
be notified.
Within
fifteen business days after posting the recommendations, representatives from
all of the collaborating organizations will compare and discuss the
recommendations.
If all collaborating organizations agree on a single disposition for the HIPAA
Standard Change Request, then they will document that recommended disposition
and post it to the Web site as the consensus recommendation. The recommended disposition can be as simple
as a yes or a no, or it can be something more complex. If all of the collaborating organizations
cannot agree on a single disposition, then any dissenting collaborating
organization may request a formal appeal to the steering committee.
Alternatively, the dissenting collaborating organization, at its sole
discretion and based on its analysis of the impact on the industry, may simply
record its opposition and not request a formal appeal. If there is no appeal,
the consensus recommendation will proceed to the appropriate SDO(s) for
development of the changes necessary to implement the disposition identified by
the foregoing process. Otherwise, the
formal appeal will proceed to the steering committee. In either case, the status will be posted to
the designated Web site.
If the requestor of the HIPAA Standard Change Request disagrees with the
recommended solution either at the end of this informal consensus step or at
the end of the formal appeal step, the requestor may invoke an appeal to the
steering committee. (Requesters may also appeal at the DCC or SDO level in
accordance with the protocols of those organizations.) Persons other than the requestor would not be
allowed to appeal to the steering committee at these steps. They would have an
opportunity to present their appeals either during NCVHS hearings or through
the public comment period of the rulemaking process.
To
the greatest extent possible, disagreements between collaborating organizations
should be resolved by consultation between the pertinent DCCs or SDOs or by
development of data conditions that isolate a data change to one or more
specified industry segments or circumstances.
At
the DCC or SDO level, any person or entity shall have the right to appeal the
outcome of a HIPAA Standard Change Request or a contrary decision made by the
DCC or SDO. All such appeals must follow
the procedures specified in the respective protocols of the DCC or SDO.
In
case of disagreement, the collaborating organizations shall, to the greatest
extent possible, resolve those disagreements by consultation among themselves
or by development of data conditions that isolate a data change to one or more
specified industry segments or circumstances.
Nonetheless, if the collaborating organizations cannot reach a consensus
on a solution, any collaborating organization may invoke the appeal process.
Appeals
beyond the DCC or SDO level are restricted to only the collaborating
organizations under this MOU and to the requester of the HIPAA Standard Change
Request. Other parties would not be
allowed to appeal to the steering committee at these steps. They would have an
opportunity to present their appeals either during NCVHS hearings or through
the public comment period of the rulemaking process.
If
a requestor or a collaborating organization makes a formal appeal, that person
or collaborating organization will have fifteen calendar days from the date the
recommended disposition is posted to the Web to submit notice of intent to
appeal, and an additional fifteen calendar days to submit documentation to the
steering committee to substantiate the appeal.
Within thirty calendar days of receipt of the appeals documentation, the
steering committee will convene to address the appeal. The steering committee will be comprised of
all the organizations that are signatories to this MOU. Each organization shall have one voting
representative, except HHS, which shall have a non-voting liaison role. A two-thirds majority of the voting
organizations shall be required in order to allow a HIPAA Standard Change
Request disposition to proceed. The steering committee shall establish standing
monthly meetings that would be canceled if there are no agenda items.
The requestor's appeal can be upheld, denied or remanded to
the collaborating organizations for reconsideration. If the appeal is upheld, the original
consensus disposition recommendation will be modified, posted to the Web site
and forwarded to the appropriate SDO(s).
If the appeal is denied, the original consensus disposition
recommendation will be posted to the Web site and forwarded to the appropriate
SDO(s). If the decision is to remand to
the collaborating organizations, that decision will be posted to the Web and
the 90-day clock for the collaborating organizations starts anew. HIPAA
Standard Change Request disposition recommendations that have been entered into
an appeal process will not become part of an implementation guide unless and
until the disposition recommendation is overturned on appeal.
Once
the disposition recommendation is cleared through the collaborating
organizations, whether through the informal consensus process or the formal
appeal process, the appropriate SDO or SDOs will proceed with development of a
technical solution. The SDO will identify
and propose changes to its transaction sets, data dictionaries, implementation
guides, booklets, etc. to incorporate the recommended disposition. When completed, the SDO will post its
technical solution to the designated Web site and all collaborating
organizations will be notified. From the
date of the posting, all collaborating organizations will have thirty calendar
days to review the proposed technical solution and to render an opinion as to
whether the technical solution meets the intent of the disposition
recommendation. If any collaborating
organization believes the SDO technical solutions do not adequately implement
the disposition recommendation, it shall have 15 days to come to an informal
consensus with the SDO. If consensus is not reached, the dissenting
collaborating organization may invoke the formal appeal process with the
steering committee, as previously described.
HIPAA
requires that the National Committee on Vital and Health Statistics (NCVHS)
advise the Secretary of HHS on all changes proposed to the HIPAA administrative
simplification rules. Therefore, on a
cycle to be determined, all of the HIPAA Standard Change Requests approved since
the previous cycle shall be presented to NCVHS.
HIPAA requires that
the Secretary of HHS adopt changes to the Administrative Simplification rules
no more frequently than once a year.
Therefore, on a cycle to be determined, all of the proposed transaction
rule changes approved by the DCCs and SDOs since the previous cycle shall be
submitted to HHS.
HHS will process the proposed changes including, if required, publishing a
Notice of Proposed Rule Making (NPRM).
The NPRM process includes consulting with the organizations named in the
Act, drafting of the rule and clearance by the Health Care Financing
Administration (HCFA), clearance by HHS and the Office of Management and Budget
(OMB), publication of the NPRM in the Federal
Register, a public comment period, analysis of the public comments, then
drafting of the final rule, clearance and publication. It is anticipated that the non-policy issues
HHS receives during the public comment period to the NPRM will be referred to
the steering committee. The steering
committee would then review the issues with its member organizations and
coordinate the responses back to HHS.
Annex 2
Web site information
HIPAA administrative
simplification electronic standards change requests: www.changeHIPAA.com
Accredited Standards Committee X12: http://www.x12.org
Dental Content Committee:
(tbd)
Health Level 7: http://www.hl7.org
National Council for Prescription Drug Programs:
http://www.ncpdp.org
National Uniform Billing Committee: http://www.nubc.org
National Uniform Claim Committee: http://www.nucc.org
US Department of Health and Human Services: http://aspe.hhs.gov/admnsimp/
National Committee on Vital and Health Statistics: http://ncvhs.hhs.gov