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Health Data Standards
and Health Information Privacy
The Health Insurance Portability and Accountability Act of 1996
Title II - Subtitle F
Administrative Simplification
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Improve the efficiency and effectiveness of the health care system, by standardizing the electronic transmission of certain administrative and financial transactions
Protect the security and privacy of health information
Purpose of Provisions
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Overview of Provisions Secretary of HHS must adopt standards for
electronic health care transactions, unique health identifiers, code sets, security, and privacy
All health plans, clearinghouses, and those providers who choose to conduct these transactions electronically are required to implement these standards
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Overview of Provisions Supersedes most contrary provisions of
state laws
Expands the scope and membership of the National Committee on Vital and Health Statistics
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Overview of Provisions Civil and criminal penalties are prescribed for
failure to use standards or for wrongful disclosure of confidential information
– Penalties of $100 per violation of standards (up to $25,000 total per year per standard)
– Penalties of $50,000 to $250,000 and 1 to 10 years in jail for wrongful disclosure of individually identifiable health information
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Transaction Standards Claims or equivalent encounter information
Coordination of benefits information
Referral certification and authorization
Enrollment & disenrollment in a health plan
Eligibility for a health plan
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Transaction Standards Health care payment & remittance advice
Health plan premium payments
First report of injury
Health claims status
Health claims attachments
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Supporting Standards Unique identifiers (including allowed uses) for:
– Individuals– Employers– Health Plans– Health Care Providers
Code sets (including issues of maintenance)
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Supporting Standards Security (including electronic signatures),
confidentiality, and privacy
Low cost distribution mechanism
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Implementation Timeline
HHS adoptstransaction stds.(excl. claims)
HHS adoptsclaims stds.
HHS reviews/modifies first stds.
Plans, clearinghousesand providers adoptstds.
NCVHS recommendsstds. and legislation forelectronic exchange ofmedical records
Small plansadopt stds.
August February February August February August February1997 1998 1999 2000 2001
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Standards Adoption Process In general, any standard adopted shall be a
standard that has been developed, adopted or modified by an ANSI accredited standards setting organization (SDO)
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Standards Adoption Process The Secretary may adopt a different
standard if:
– it will significantly reduce administrative costs compared to alternatives, and it is promulgated in accordance with “negotiated rulemaking” procedures, or
– No SDO has developed, adopted or modified a standard in that area
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Standards Adoption Process A standard may not be adopted unless the SDO has consulted
with:– NUBC– NUCC– WEDI– ADA
In adopting standards, the Secretary will rely upon the recommendations of the NCVHS and the HHS Data Council
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Implementation Strategy HHS will utilize a three tier approach to
implementation
– HHS Data Council will provide senior level policy guidance and decision making and will serve as the contact point for the NCVHS
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Implementation Strategy– The Data Council’s Health Data Standards
Committee will be responsible for the daily operation and management of the standards activities
– Implementation Teams will be responsible for the research, analysis, and development of mandated national standards
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Implementation Teams HHS has established six internal
interdepartmental implementation teams to identify and assess potential standards
– Infrastructure and cross-cutting issues
– Health insurance claims and encounters
– Health insurance enrollment and eligibility
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Implementation Teams
– Health identifiers for providers, health plans, employers and individuals
– Code sets and classification systems
– Security and safeguards
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Team Approach Identify existing candidate standards for
each area, identify gaps and conflicts, and present findings to NCVHS and HHS
Develop recommendations for standards to be adopted and present to NCVHS & HHS
Submit draft regulations to the Secretary and to OMB for initial review
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Team Approach Publish proposed rules in Federal Register for
public comment
Analyze comments and prepare and publish Final Rules
Distribute adopted standards and implementation guides
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Privacy Goals Provide patient rights
– Informed consent to release information
– Access to own health information
– Ability to correct erroreous entries Establish process for exceptions
– Research, Law Enforcement, Public Health Limit amount of information and access Establish deterrents and penalties
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Privacy Timeline
HHS privacyrecommendations
Privacy legislation
If no privacy legislation,HHS privacy regulations
August February February August February August February1997 1998 1999 2000 2001
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Opportunities for Input Participate with standards development
organizations
Provide testimony at NCVHS public hearings
Provide written input to NCVHS
Provide written input to the Secretary of HHS
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Opportunities for Input Comment on the Federal Register
publications for each proposed standard
Invite Implementation Teams staff to meetings with public and private sector organizations
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National Committee on Vital
and Health Statistics
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New NCVHS Responsibilities Membership increased from 16 to 18 with
two members appointed by Congress
Annual report to Congress on HIPAA implementation status
Serve as a public forum for all interested parties and provide mechanisms for public input through hearings and meetings
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New NCVHS Responsibilities Assistance to Secretary:
– Standards - Secretary to rely on the recommendations of NCVHS and publish recommendations in Federal Register
– Privacy & Confidentiality - Secretary to consult with NCVHS on legislative privacy recommendations
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New NCVHS Responsibilities– Report to Secretary within 4 years with
recommendations and legislative proposals on standards for computerized patient record
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Current NCVHS Activities Full Committee meetings quarterly
Subcommittee on Privacy and Confidentiality
Subcommittee on Health Data Needs, Standards and Security
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Sources of Information HHS Data Council Web Site
– http://aspe.hhs.gov/datacncl/
NCVHS Web Site
– http://aspe.hhs.gov/ncvhs/
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Cross-Cutting Implementation Issues
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Charge
Purpose– Provide overall guidance and coordination to the
HIPAA EDI standards Implementation Teams– Track progress of the HIPAA EDI standards
project– Serve as the information point for overall HIPAA
EDI standards implementation information.
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Charge Responsibilities
– Develop and maintain master data dictionary and data structures list for all standards
– Develop a timeline for the entire project– Provide periodic progress reports on the project to
HHS and the NCVHS– Monitor progress of individual implementation
teams
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Charge
Responsibilities cont.– Provide guidance and coordination on common
issues (e.g. regulation development)– Facilitate communciation among implementation
teams– Serve as communication point between
implementation teams and HHS Data Council.– Assure all implementation teams have common
understanding of issues
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Guiding PrinciplesImprove efficiency and effectiveness of
systemMeet the needs of usersBe consistent with other administrative
simplification standardsHave low implementation costsBe supported by a SDO
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Guiding PrinciplesHave timely adoption proceduresBe technologically independent of platformsBe precise & unambiguous, but as simple as
possibleKeep data & paperwork burdens lowHave flexibility to adopt to health system
changes
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Barriers Barriers to adopting national uniform standards:
– Conflicting standards; e.g., ANSI vs. industry vs. government
– Conflicting implementations; e.g., proprietary collection of unique or differently defined data
– Incomplete standards; e.g., no implementation guide
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Barriers More barriers:
– Proprietary code sets; e.g., professional associations make $ selling code sets
– Cost of change; e.g., cost of changing length of ID– Privacy; e.g., potential use of SSN as unique ID
raises fear of easier access and linkage of confidential information
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Frequently Asked Questions
Is Big Brother forcing this on the industry? Will only providers benefit from HIPAA
standards? Is DHHS doing this alone? Will DHHS merely adopt Medicare
standards? Will all HIPAA standards be adopted in 18
months?
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Frequently Asked Questions
Will private sector standards be adopted with no change?
Which HIPAA standards will be adopted first?
Will HIPAA standards be tested?
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Issues
Conformance testing– Who does it– Who pays for it– Who monitors the testers
Data dictionary/Implementation guides– Who maintains them– Who pays for them
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Issues
Timely updates to “Final Rule”– How do we keep standards up with
developments How do we draw the lines between
employers, plans, and providers Timing
– Is 2 years enough time– Is February, 2000 the safest time to comply
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Issues
Are the teeth big enough– Some have indicated it would be cheaper to pay
the fines initially– If Medicare/Medicaid implements it, is that
enough to move industry
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Current Activities
Master data dictionary– over 4700 elements included to date
Draft ‘boilerplate’ regulation language Cross-cutting implementation issues
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Claims and Encounters Implementation Team
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Charter
Adopt formats and data content for:
– Health insurance claims, encounters, COB
– Remittance advice
– Claim status inquiry
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Charter
Facilitate identical implementations through:
– Implementation guides
– With precise instructions on data content
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Process
Created information structure Solicited formal advice
– National Uniform Billing Committee– National Uniform Claim Committee– Workgroup for Electronic Data Interchange– American Dental Association
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Principles
Data Content Management Structural Stability Reliability Documentation
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Principles
Data Content Management – Data update timeliness– Implementation guide update
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Principles
Structural Stability– 3 years– One structure– Annual data updates
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Principles
Reliability
– Testing part of the process– Results made public– For claims, encounter, COB - pilot
production required
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Principles Documentation
Complete and unambiguous– Implementation guide– Data dictionary– Data conditions
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Principles
Each transparent to the other, i.e., common/like data will be found in the same location
– Claim
– Encounter
– Coordination of Benefits
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Recommendations
Retail Pharmacy Claim - NCPDP v. 3.2 Remittance Advice - X12.835 v. 3070 Claims Status - X12.277 v. 3070 Dental Claims - X12.837 v. 3070 Physician/Supplier Claims - X12.837 v.
3070 Institutional Claims - X12.837 v. 3070
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Data Content
Working with base sets Working with organizations Superset concept
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Issues
Divided opinions– Institutional and physician/supplier
claims/encounters/coordination of benefits
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Unique Health Identifiers Implementation Team
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Charge
Recommend Standard Unique Health Identifiers (including allowed uses)
– Individual
– Employer
– Health plan
– Health Care Provider
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Individual Identifier
Current Activities– Analysis of proposals in ANSI/HISB inventory– Use of criteria from American Society for Testing
and Materials Standard Guide for Properties of a Universal Health Care Identifier
– Evaluation of SSN by SSA– Evaluation of Postal Service as Trusted Authority
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Individual Identifier
Current Thinking--Eliminate consideration of– Unenhanced, unverified SSN– Biometric identifier proposals– Identifier based on existing medical record
number plus practitioner prefix
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Individual Identifier
Current Thinking--Continue consideration as identifiers– Enhanced SSN, as proposed by the Computer-
based Patient Record Institute– Identifier based on personal immutable properties– Universal Health Care Identifier (UHID), as
described in ASTM Guide
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Individual Identifier
Current Thinking--Continue consideration as supporting technologies– Directory service, or master patient index– Public/private key encryption
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Individual Identifier
Issues– Risks, limitations of SSN as a health identifier– Insufficient documentation of infrastructure for
other proposals– Adequacy of current technology to support
national master patient index (MPI) or public/private encryption
– Acceptance by public of a national MPI or national health identifier
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Individual Identifier
Issues– Method to positively link individual to his/her
identifier– Method to prevent issuance of duplicate
identifiers – Medical record linkage vs right to anonymous
care– Costly infrastructure investment likely– Controversy with any recommendation
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Employer Identifier
Current Activities– Coordination with Enrollment/Disenrollment,
First Report of Injury, Premium Payment transactions
Current Thinking– Recommendation of Employer Identification
Number (EIN)
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Employer Identifier
Issues– EIN is not unique to the employer--Is this a
problem for health transactions?– Some sole proprietors do not have an EIN--
Would they be required to obtain an EIN for health transactions?
– Would health transaction uses of EIN require legislative or regulatory change?
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Health Plan Identifier
Current Activities--PAYERID to be proposed– 9-position numeric, including 1 check digit– No intelligence in number– Can enumerate 100 million health plans and
employers that offer funded and unfunded health benefits
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Health Plan Identifier
PAYERID System Features– Registry of business information about the
entity– Electronic “phone book” containing names of
entities and their PAYERIDs– Data base of information needed to route health
care transactions electronically Issue--High-level vs detailed enumeration
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Provider Identifier
Current Activities--National Provider Identifier (NPI) to be proposed– 8-position alphanumeric, including 1 check
digit– No intelligence in number– Can enumerate 20+ billion providers
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Provider Identifier
System Features– Data validation (SSN, address,etc.)– Search/match for duplicate providers– Query/report generation--national data base
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Provider Identifier
Issues
– Enumeration options
– Provider practice addresses and location codes
– DHHS OIG Sanction Data
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Enrollment and Eligibility Implementation Team
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7
Charge
Standards and implementation guides for the following transactions
– Enrollment
– Eligibility
– First Report of Injury
– Health Plan Premium Payments
– Referral Certification and Authorization
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Recommendations
Enrollment - X12.834 1st Report of Injury - X12.148 Premium Billing and Payment -
X12.811/820 Health Care Services Review - X12.278 Eligibility - X12.270/271
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Enrollment
Current Implementation Guide Covers Forms of Benefits
Narrower scope for a health care-specific guide Policy: Are standards imposed by OMB
Directive 15 applicable to HIPAA? Are performance measurement and outcome
research needs covered by HIPAA?
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1st Report of Injury
No Current Implementation Guide Not health care-specific transaction guide:
outside HHS purview DoL - OSHA, BLS, OWCP Policy: Expand to allow physician first
report? May have to engage private sector “workers
comp” community
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Premium Billing & Payment Used in Industry as ANSI finance function No Implementation Guide HIPAA Use Not Very Complicated
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Health Care Services Review
Multiple Implementation Guides Possible Limited, If Any, Actual Use Pilot Project Underway May be a late deliverable for 2/98
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Eligibility
Mapping Government data element Requirements
All necessary components in place to produce the regulation
Not doing interactive Eligibility Transactions
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Data Dictionary
Includes
– Listing of names, definitions, transactions and locations
– Organized by individual transactions Does NOT include
– Code values
– Implementation instructions
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Coding and Classification Implementation Team
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Charge
Codes and classification– Diseases, injuries, impairments, other health
problems– Causes of these conditions– Actions taken to prevent, diagnose, treat or
manage these conditions» including substances, equipment, and supplies
used
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Charge
Responsibilities– Select standards for codes/classifications for
administrative transactions and ensure appropriate mechanisms for distribution and maintenance
– Recommend set of health vocabularies for full electronic health records and ensure appropriate mechanisms for distribution and maintenance
– Map vocabularies to administrative codes/classifications
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Recommendations - 2000
Diseases, injuries, impairments, etc.– ICD-9-CM
Procedures– ICD-9-CM– CPT– CDT– HCPCS (encompasses CPT and CDT)
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Recommendations - 2000
Drugs– For most administrative transactions
» HCPCS– For pharmacy transactions
» NDC Devices
– HCPCS
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Issues
Use of official implementation guidelines Likelihood of changes in some standards
for 2001 and beyond– e.g., move to ICD-10-CM
Need to have ability to accept codes and identifiers > 5 characters in 2001 and beyond
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Issues
Openess of update process for privately owned and maintained systems
Cost and use restrictions for privately owned and maintained systems
Availability of electronic formats suitable for full range of users
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Security Standards Implementation Team
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Charge Security of Healthcare Systems/Transactions Electronic Signatures
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Objectives
Establish a Healthcare Data/Systems Security Framework
– e.g., NRC Report Identify Requirements “Baseline” Technology Neutral -- if possible
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Scope of Work Defined Transactions Only, however ... Key Considerations (in act)
– tech cap of rec systems– costs– training, personnel issues– value of audit trails– needs and capabilities of small hc providers and rural
hc providers Security, not Privacy
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Definitions Privacy vs.Confidentiality vs Security Security
– Confidentiality– Integrity– Availability
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Definitions Security Mechanisms
– Identification– Authentication– Authorization– Access Controls– Audit/Accountabilty
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Requirements Analysis Underlying Requirements
– Interoperability System Model / Matrix Baseline Security Requirements Potentially Conflicting Requirements
– Other Groups’ Work (e.g., Privacy, Transaction Sets, etc.)
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Issues Level of detail/specificity of published
“standards” Determining needs/constraints of “Small”
players