Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

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###### Department of Health and Human Services

###### Office of the Secretary 

          - 45 CFR Part 162 
          - [CMS-0050-N] 
          - RIN 0938-AK62 

# ACTION:

Notice of extension of comment period for proposed rule. 

# SUMMARY:

                        This notice extends the comment period for a proposed rule published in the                         **Federal Register**                         on September 23, 2005 (70 FR 55990) that would recommend the adoption of a set of standards to facilitate the electronic exchange of clinical and administrative data to further improve the claims adjudication process when additional documentation is required. Due to the very technical nature of this rule, the industry is asking for additional time to conduct a more comprehensive and thorough review in order to provide comments to the Standards Development Organizations as well as to CMS. The comment period is extended for 60 days.                     

# DATES:

The comment period is extended to 5 p.m. on January 23, 2006. 

# ADDRESSES:

In commenting, please refer to file code CMS-0050-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. 

You may submit comments in one of four ways (no duplicates, please):

                        1.                         *Electronically.*                         You may submit electronic comments on specific issues in the September 23, 2005 proposed rule to                         *http://www.cms.hhs.gov/​regulations/​ecomments*. (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.)                     

                        2.                         *By regular mail.*                         You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-0050-P, P.O. Box 8014, Baltimore, MD 21244-8014.                     

Please allow sufficient time for mailed comments to be received before the close of the comment period. 

                        3.                         *By express or overnight mail.*                         You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-0050-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.                     

                        4.                         *By hand or courier.*                         If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or, 7500 Security Boulevard, Baltimore, MD 21244-1850.                     

(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) 

Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. 

                        For information on viewing public comments, see the beginning of the                         **SUPPLEMENTARY INFORMATION**                         section.                     

# FOR FURTHER INFORMATION CONTACT:

Lorraine Doo, 410-786-6597. 

*Submitting Comments:*                         We welcome comments from the public on all issues set forth in the September 23, 2005 proposed rule to assist us in fully considering issues, developing policies and adopting standards. You can assist us by referencing the file code CMS-0050-P and the specific “issue identifier” that precedes the section on which you choose to comment.                     

*Inspection of Public Comments:*                         All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. CMS posts all comments received before the close of the comment period on its public Web site as soon as possible after they have been received. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.                     

# SUPPLEMENTARY INFORMATION:

                    On September 23, 2005, we published a proposed rule in the                     **Federal Register**                     (70 FR 55990) that would recommend the adoption of a set of standards to facilitate the electronic exchange of clinical and administrative data to further improve the claims adjudication process when additional documentation is required. This rule proposes two X12N transaction standards: One to request the information, and one to respond to that request with the answer or additional information. This rule also proposes the use of Health Level 7 (HL7) specifications for the content and format of communicating the actual clinical information. Finally, this rule proposes the adoption of the Logical Observation Identifiers, Names and Codes or LOINC® for specific identification of the additional information being requested, and the coded answers that respond to the requests. Due to the highly technical nature of the materials, and the size (length) of the technical documents being reviewed, we want to provide additional time for the industry to review and comment upon all of the technical documents (implementation guides, specifications, code sets, modifiers), and the policies proposed in the September 23, 2005 proposed rule.                 

                    Due to the complexity of this proposed rule, the length of time                           ( print page 70575)                        between the development of the proposed standards and the publication of this proposed rule, the potential need to upgrade the data content of the specifications or the use of Release 2 of the Clinical Document Architecture (CDA), numerous members of the industry and professional associations have requested more time to analyze the potential impact and consequences of the proposed rule. Thus, we have decided to extend the comment period for an additional 60 days. This document announces the extension of the public comment period to January 23, 2006.                 

Authority:Secs. 1173 and 1175 of the Social Security Act (42 U.S.C. 1302d-2 and 1320d-4). 

Dated: November 9, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & Medicaid Services. 

Dated: November 17, 2005. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 05-23077 Filed 11-21-05; 8:45 am] 

BILLING CODE 4120-01-P