ICD-10 Regulatory Process

The Health Insurance Portability and Accountability Act (HIPAA) defined the authority for approval and the process by which ICD-10-CM and ICD-10-PCS can become a standard code set used in healthcare transactions.

HIPAA requires the secretary of Health and Human Services (HHS) to approve any code set used in a HIPAA transaction. But before the secretary can make this decision, NCVHS provides advice. The NCVHS serves as the statutory public advisory body to HHS in the area of health data and statistics.

In November 2003, the NCVHS sent a letter to HHS recommending:

• Adoption of ICD-10-CM and ICD-10-PCS as HIPAA standards for national implementation as replacements for current uses of ICD-9-CM volumes 1, 2, and
• Initiation by HHS of the regulatory process for the concurrent adoption of ICD-10-CM and ICD-10-PCS
• An implementation period of at least two years following issuance of a final rule

The adoption of ICD-10 now rests in the hands of the secretary of HHS. There are essentially five steps in the regulatory process:

1. The secretary accepts the NCVHS recommendation
2. The federal government publishes a notice of proposed rule making (NPRM) calling for public comments on its policy, plus the published ICD-10-CM and ICD-10-PCS materials incorporated in the Federal Register
3. The public at large has at least 30, but more likely 60, days to submit comments on the NPRM and its incorporated materials
4. The federal government analyzes the public comments. Based on this analysis, any necessary changes are made
5. The federal government publishes a final rule containing its updated policy, an explanation of it, and the implementation date in the Federal Register

There would likely be at least a two-year implementation window after the effective date of the final rule announcing adoption of ICD-10-CM and ICD-10-PCS. The effective date is usually 60 days after publication in the Federal Register.

A correction notice may be published after the final rule if modifications to an already published rule are necessary.

For more information about the regulatory process, read:

"The Regulatory Journey to Destination 10: Understanding the Process for Adoption of ICD-10-CM and ICD-10-PCS" (May 2004)

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