Note: This information outlines the regulatory process as defined by HIPAA for adoption of a new standard code set. Recently, legislation has been introduced in both Houses of Congress that address national health information issues. A few bills that have been introduced include provisions for the adoption of ICD-10. Both House and Senate must approve legislation before the bill advances to the President for signature. At this time no legislation has passed joint conference compromise. The inclusion of ICD-10 adoption provisions with in current legislation is separate from the process outlined in HIPAA. Should a bill pass both House and Senate and be signed by the President, the regulatory process outlined here must still take place. Please see the ICD-10 Corner Home page for an update on the status of ICD-10 implementation.

Background

On Wednesday, November 5, 2003, the National Committee on Vital and Health Statistics (NCVHS) voted to recommend that the Secretary of the Department of Health and Human Services (HHS) take steps toward adoption of ICD-10-CM and ICD-10-PCS as Health Insurance Portability and Accountability Act (HIPAA) standards for national implementation as replacements for the current uses of ICD-9-CM, Volumes 1, 2, and 3.

The committee formulated a letter of recommendation requesting that the Secretary of HHS initiate the regulatory process for the concurrent national adoption of the two classification systems with an implementation period of at least two years following issuance of a final rule. The recommendation by NCVHS was the first step of the regulatory process. The next step will be acceptance of the recommendation by the Secretary of Health and Human Services. AHIMA has also urged the Secretary of HHS to issue a Notice of Proposed Rule Making (NPRM) as quickly as possible, which will be the next step in the regulatory process. This NPRM is with CMS waiting for the election year to close (according to NCVHS members). The federal government will then publish a notice of proposed rule making which provides the public with an opportunity to submit comments, usually 30 to 50 days. An analysis of comments and revision period follows, after which the federal government publishes a final rule, an updated policy, and the implementation date in the Federal Register.

On August 22, 2008 the NPRM was published in the Federal Register with a proposed implementation date of October 1 of 2011. A two-year implementation period after establishment of the final rule is required under the HIPAA two-year "window" for compliance. This giving facilities two years to become compliant with the rule once it goes into effect. The effective date is usually 60 days after publication in the Federal Register. The comment period ends for the NPRM on October 21, 2008. A final rule must be published before October 1, 2009 in order to provide for the HIPAA two-year "window" for compliance.

History

In February 2007 we still remained at step 1 of the regulatory process for adopting ICD-10-CM/PCS. The Secretary of Health and Human Services, Mike Leavitt had yet to issue the NPRM. According to the regulatory process under HIPAA regulations, changes to the standard code sets must allow for a 24-month implementation period. Expectations still are that implementation will coincide with the update schedule of the major prospective payment systems on October 1 of a year. If an NPRM had been released by May 1, 2007, there would have been time for the publication of a final rule after the comment period ends for the proposed rule. The final rule was not published 60 days in advance of the effective date of the rule (August 1). This placed the next possible (and highly unlikely) implementation date that coincides with the October 1 schedule as October 1, 2009.

The letter of recommendation for adoption of ICD-10-CM and PCS (for inpatient only) was delivered to the Secretary of HHS in April 2004. Almost three year later, we still have not seen a Notice of Proposed Rule Making (NPRM) published in the Federal Register.

In the United States the clinical modification of the code set is maintained by the ICD-9-CM Coordination and Maintenance Committee (NCHS, CMS, AHA, and AHIMA). However, the code set standard is approved by legislative process. The Administrative Simplification provision of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) encourages the development of health care information systems through the establishment of standards. These standards include code sets for each data element for health care services. The Act requires the Secretary of Health and Human Services (HHS) to adopt the code set standards. The National Committee for Vital Health Statistics (NCVHS) was tasked by the Department of Health and Human Services (HHS) with studying and recommending the standard code sets. These impact studies have been completed and reports have been made to Congress and HHS.

These are the necessary steps to implementation:

Development of recommendations for standards to be adopted by HHS/NCVHS.

Publication of the Proposed Rule in the Federal Register with a 60-day public comment period.

Analysis of the public comments and publication of the Final Rule in the Federal Register with an effective date of the rule being 60 days after publication.

Distribute standards and coordinate preparation and distribution of implementation guidelines and crosswalks. Implementation is 24 months from effective date, excluding small health plans (fewer than 50 participants) which have 36 months to comply.

We remained at step 1 of this process until 2008. Cost/benefit analyses were performed. According to the regulatory process, implementation was no sooner than October 1, 2009. The NPRM was not released before May 1, 2007, that implementation date passed.