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Background

The Secretary adopted version 5010 to replace the current version of the X12 standard that covered entities (health plans, health care clearinghouses, and certain health care providers)  must use when conducting electronic transactions including:  claims (professional, institutional and dental), claims status requests and responses, payment to providers, eligibility requests and responses, referral requests and responses, enrollment and disenrollment in a health plan, Coordination of Benefits and premium payments. 

The Secretary also adopted version D.0 to replace the current version of the NCPDP standard covered entities must use for pharmacy and supplier transactions including:  claims, eligibility requests and responses, referral certification and authorization and Coordination of Benefits. 

The current versions of the standards (the Accredited Standards Committee X12 Version 4010/4010A1 for health care transactions and the NCPDP Version 5.1 for pharmacy and supplier transactions) are widely recognized as lacking certain functionality that the health care industry needs. 

Implementation Timeline

For all covered entities:

  • Effective Date of the regulation:  March 17, 2009
  • Level I* compliance to begin by:  December 31, 2010
  • Level II** Compliance by:  December 31, 2011
  • All covered entities have to be fully compliant on: January 1, 2012

Level I compliance means "that a covered entity can demonstrably create and receive compliant transactions, resulting from the compliance of all design/build activities and internal testing."  We expect covered entities to be testing throughout calendar year 2011, and to schedule testing as early as possible, to ensure sufficient time for corrective actions and re-testing.

Level II compliance means "that a covered entity 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."

Medicaid agencies sometimes pay pharmacy claims for which another payer is liable for payment.  A new standard for Medicaid subrogation for pharmacy claims, known as NCPDP Version 3.0, was adopted in the Modifications rule, along with Version 5010, D.0 and ICD-10.   Medicaid agencies will use the subrogation standard to pursue reimbursement from other payers. The compliance date for the Medicaid subrogation standard is also January 1, 2012, except for small health plans, which will have until January 1, 2013 to come into compliance.

The requirement to adopt transaction standards originated from the 1996 Health Insurance Portability and Accountability Act (HIPAA).  The Transactions and Code Sets final rule published on Aug. 17, 2000, adopted standards for the statutorily identified transactions, some of which were modified in a subsequent final rule published on Feb. 20, 2003. On January 16, 2009, HHS published a final rule that replaces the current Version 4010/4010A and NCPDP Version 5.1 with Version 5010 and Version D.0, respectively, and adopted NCPDP Version 3.0 as well.

Learn more about Transactions and Code Sets Standards.