Health Insurance Reform: Standards for Electronic Transactions. IV. Summary of Changes to the Regulations


Listed below is a summary of changes made to 45 CFR.

  • Added Part 160 and moved proposed §§ 142.101, 142.103, and 142.106 to Part 160.
  • Added definitions for the following terms in §160.103: “business associate,” “compliance date,” “covered entity,” “implementation specification,” “modify,” “standard setting organization,” “state,” “trading partner agreement,” and “workforce.”
  • Added definitions for the following terms in §162.103: “code set maintaining organization,” “data condition,” “data content,” “data element,” “data set,” “descriptor,” “designated standard maintenance organization,” “direct data entry,” “electronic media,” “format,” “maintenance,” “maximum defined data set,” “segment,” “standard transaction.”
  • Deleted definitions for “ASC X12,” ASC X12N,” “medical care,” and “participant.”
  • Added §160.104 to describe the effective date and compliance date of a modification to an established standard.
  • Included the word “retail” when referring to the NCPDP standard.
  • Included language in §162.923 (formerly 142.102) to include the requirements for the use of direct data entry and to clarify requirements for covered entities.
  • Added §162.910 to address the process for maintenance of the standards.
  • Added section §162.915 to include the requirements of trading partner agreements.
  • Removed the words “at no cost” in §162.920(a) when referring to the acquisition of implementation specifications.
  • Revised language in §162.925 (formerly §142.104) to state that a health plan may not delay the transaction or attempt to adversely affect the entity or the transaction on the basis that the transaction is a standard transaction. Added COB and code set requirements.
  • Included language in §162.930 to clarify compliance of health care clearinghouses.
  • Added §162.940 to include the process for requesting an exception to test proposed modifications to standards.
  • Revised language in §162.1000 to include the requirement for the use of applicable medical code sets and, in §162.1002, we listed the name of all the standard medical code sets.
  • Added §162.1011 to address compliance dates for maintenance changes to code sets.
  • Corrected language in §162.1102 to reflect the correct version of the NCPDP Batch Standard, Version 1 Release 0.
  • Added language in §162.1602 to include the NCPDP standard for health care payment and remittance advice within the retail pharmacy sector.
  • Added language in §162.1202 to include the NCPDP standard for patient eligibility and coverage information within the retail pharmacy sector.
  • Included the description of each transaction in subparts K through R, §§162.1101, 162.1201, 162.1301, 162.1401, 162.1501, 162.1601, 162.1701, and 162.1801.