On Friday, January 16, 2009, the Office of the Secretary of the Department of Health and Human Services published in the Federal Register final rules pertaining to: Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards (74 Federal Register 3295-3328); and, HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards to Adopt ICD-10-CM and ICD-10-PCS (74 Federal Register 3328-3362).
Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards
Standards. This final rule adopts Accredited Standards Committee (ASC) X12 Version 5010 and National Council for Prescription Drug Programs (NCPDP) Versions D.0, 3.0, and 5.1 standards for electronic transactions, as reproduced from Table 1 in the final rule pp. (3296-3297):
| ASC X12 837D | Health care claims—Dental |
| ASC X12 837P | Health care claims—Professional |
| ASC X12 837I | Health care claims—Institutional |
| NCPDP D.0 | Health care claims—Retail pharmacy drug |
| ASC X12 837P and NCPDP D.0 | Health care claims—Retail pharmacy supplies and professional services |
| NCPDP D.0 | Coordination of Benefits—Retail pharmacy drug |
| ASC X12 837D | Coordination of benefits—Dental |
| ASC X12 837P | Coordination of benefits—Professional |
| ASC X12 837I | Coordination of benefits—Institutional |
| ASC X12 270/271 | Eligibility for a health plan (request and response)—Dental, professional, and institutional |
| NCPDP D.0 | Eligibility for a health plan (request and response)—Retail pharmacy drugs |
| ASC X12 276/277 | Health care claim status (request and response) |
| ASC X12 834 | Enrollment and dis-enrollment in a health plan |
| ASC X12 835 | Health care payment and remittance advice |
| ASC X12 820 | Health plan premium payment |
| ASC X12 278 | Referral certification and authorization (request and response)—Dental, professional, and institutional |
| NCPDP D.0 | Referral certification and authorization (request and response)—Retail pharmacy drugs |
| NCPDP 5.1 and NCPDP D.0: | Retail pharmacy drug claims (telecommunication and batch standards) |
| NCPDP 3.0 | Medicaid pharmacy subrogation (batch standard |
Most of the standards reflect updates. The Medicaid pharmacy subrogation standard is newly adopted, and two standards are adopted for retail pharmacy supplies and professional services.
Effective Dates. There are two effective dates for this final rule. For all of the standards except the Medicaid pharmacy subrogation transaction, the effective date is March 17, 2009. For the Medicaid pharmacy subrogation transaction standard, the effective date is January 1, 2010. What is an effective date? “[T]he effective date is the date that the policies set forth in this final rule take effect, and new policies are considered to be officially adopted (p.3302).”
Compliance Dates. With one exception, all covered entities must comply with the standards in the final rule by January 1, 2012. The exception is that small health plans have an additional year to January 1, 2013 to comply with the Medicaid pharmacy subrogation standard. Please note the following discussion in the preamble to the final rule on page 3303:
“Covered entities are urged to begin preparations now, to incorporate effective planning, collaboration and testing in their implementation strategies, and to identity and mitigate any barriers long before the deadline. While we have authorized contingency plans in the past, we do not intend to do so in this case, as such an action would likely adversely impact ICD-10 implementation activities. HIPAA gives us [HHS] authority to invoke civil money penalties against covered entities who do not comply with the standards, and we have been encouraged by industry to use our authority on a wider scale.” [emphasis added]
Testing Dates. Again, referring to the preamble of this final rule (pp.3302-3303), HHS outlines expectations for covered entities to conduct two levels of testing of the standard transactions. To facilitate testing from the effective date of the final rule (March 17, 2009) until the compliance date (January 1, 2012), HHS permits, subject to trading partner agreement, “dual use of standards during that timeframe, so that either Version 4010/4010A1 or Version 5010, and either Version 5.1 or D.0, may be used.”
Level 1 Testing: “The level 1 testing period is the period during which covered entities perform all of their internal readiness activities in preparation for testing the new versions of the standards with their trading partners. When we refer to compliance with Level 1, we mean that a covered entity can demonstrably create and receive compliant transactions, resulting from the completion of all design/build activities and internal testing.”
» January 2009: Begin Level 1 testing period activities (gap analysis, design, development, internal testing) for Versions 5010 and D.0.
» January 2010: Begin internal testing for Versions 5010 and D.0.
» December 31, 2010: Achieve Level 1 compliance (Covered entities have completed internal testing and can send and receive compliant transactions) for Versions 5010 and D.0.
Level 2 Testing: “The Level 2 testing period is the period during which covered entities are preparing to reach full production readiness with all trading partners. When a covered entity is in compliance with Level 2, it has completed end-to-end testing with each of its trading partners, and is able to operate in production mode with the new versions of the standards by the end of that period. By ‘production mode,’ we mean that covered entities can successfully exchange (accept and/or send) standard transactions and as appropriate, be able to process them successfully.”
» January 2011: Begin Level 2 testing period activities (end-to-end testing with trading partners, achieve production mode exchange of appropriate standard transactions with trading partners).
» January 1, 2012: “[A]ll covered entities will have reached Level 2 compliance, and must be fully compliant in using Versions 5010 and D.0 exclusively.
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