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Standards for Electronic Healthcare
Claims Attachments

For the reasons set forth in the preamble, the Department of Health and Human Services proposes to amend 45 CFR subtitle A, subchapter C, part 162 to read as follows:

PART 162—ADMINISTRATIVE REQUIREMENTS

1. The authority citation for part 162 is revised to read as follows:

Authority: 42 U.S.C. 1320d–1320d–8, as amended, and sec. 264 of Pub. L. 104–191, 110 Stat. 2033–2034 (42 U.S.C. 1320d–2 (note)).

2. In §162.103, the introductory text to the section is republished, and a definition for ‘‘LOINC’’ is added in
alphabetical order to read as follows:

§ 162.103 Definitions. For purposes of this part, the following definitions apply:

* * * * *

LOINC stands for Logical Observation Identifiers Names and Codes.

* * * * *

3. In §162.920, the following changes are made:

A. The section heading is revised.

B. The introductory text is revised.

C. New paragraph (a)(10) is added.

D. New paragraph (a)(11) is added.

E. New paragraph (c) is added.

The changes read as follows:

§ 162.920 Availability of implementation specifications and guides.

A person or an organization may directly request copies of the implementation standards described in subparts I through S of this part, from the publishers listed in this section. The Director of the Office of the Federal Register approves the implementation specifications and guides described in this section for incorporation by reference in subparts I through S of this part in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The implementation specifications and guides described in this paragraph are also available for inspection by the public at the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Copy requests must be accompanied by the name of the standard, number, if applicable, and version number. Implementation
specifications and guides are available for the following transactions:

(a) ASC X12N specifications. * * *

(10) The ASC X12N 277—Health Care Claim Request for Additional Information, Version 4050 (004050X150), May 2004, Washington Publishing Company as referenced in §162.1915.

(11) The ASC X12N 275—Additional Information to Support a Health Care Claim or Encounter, Version 4050
(004050X151), May 2004, Washington Publishing Company as referenced in §162.1925.

* * * * *

(c) HL7 specifications. (1) The HL7 CDAR1AIS0000R021 Additional Information Specification Implementation Guide, Release 2.1 (based on HL7 CDA Release 1.0), May 2004, Health Level Seven, Inc. The AIS Implementation Guide for the HL7 standard may be obtained from Health Level Seven, Inc., 3300 Washtenaw Avenue, Suite 227, Ann Arbor, MI 48104–4250, or via the Internet at http://www.hl7.org; or from the Washington Publishing Company, PMB 161, 5284 Randolph Road, Rockville, MD 20852, or via the Internet at http://www.wpcedi.com/.

(2) The HL7 Additional Information Specifications for each of the six attachments listed in §162.1915 and §162.1925 may be obtained from Health Level Seven, Inc., 3300 Washtenaw Avenue, Suite 227, Ann Arbor, MI 48104–4250, or via the Internet at http://www.hl7.org; or from Washington Publishing Company, PMB 161, 5284 Randolph Road, Rockville, MD 20852, or via the Internet at http://www.wpc-edi.com/. The six HL7 AIS documents are:

(i) Ambulance services information: The CDAR1AIS0001R021 Additional Information Specification 0001, Ambulance Service Attachment, Release 2.1, based on HL7 CDA Release 1.0, May 2004, as referenced in §162.1915(b)(1) and §162.1925(c)(1).

(ii) Emergency department information: The CDAR1AIS0002R021 Additional Information Specification 0002: Emergency Department Attachment, Release 2.1, based on HL7 CDA Release 1.0, May 2004, as referenced in §162.1915(b)(2) and §162.1925(c)(2).

(iii) Rehabilitation services information: The CDAR1AIS0003R021. Additional Information Specification 0003: Rehabilitation Services Attachment, Release 2.1, based on HL7 CDA Release 1.0, May 2004, as referenced in §162.1915(b)(3) and §162.1925(c)(3).

(iv) Clinical reports information: The CDAR1AIS0004R021 Additional Information Specification 0004: Clinical Reports Attachment, Release 2.1, based on HL7 CDA Release 1.0, May 2004, as referenced in §162.1915(b)(4) and §162.1925(c)(4).

(v) Laboratory results information: The CDAR1AIS0005R021 Additional Information Specification 0005: Laboratory Results Attachment, Release 2.1, based on HL7 CDA Release 1.0, May 2004, as referenced in §162.1915(b)(5) and §162.1925(c)(5).

(vi) Medications information: The CDAR1AIS0006R021 Additional Information Specification 0006: Medications Attachment, Release 2.1, based on HL7 CDA Release 1.0, May 2004, as referenced in §162.1915(b)(6) and §162.1925(c)(6).

(3) The LOINC Modifier Codes booklet "for use with ASC X12N 277 Implementation Guides when requesting Additional Information," is available from Washington Publishing Company, PMB 161, 5284 Randolph Road, Rockville, MD 20852, or via the Internet at http://www.wpc-edi.com/.

4. In §162.1002, paragraph (c) is added to read as follows:

§ 162.1002 Medical data code sets.

* * * * *

(c) For the period beginning [24 months after the effective date of the final rule published in the Federal Register]: Logical Observation Identifiers Names and Codes (LOINC), as maintained and distributed by the Regenstrief Institute and the LOINC Committee. The LOINC database may be obtained from the Regenstrief Institute Web site at the following Internet address: http://www.regenstrief.org/loinc/loinc.htm. Users without access to the Internet may obtain the LOINC database from the Regenstrief Institute, c/o LOINC, 1050
West Wishard Blvd., Indianapolis, IN 46202.

5. A new subpart S is added to part 162 to read as follows:

Subpart S—Electronic Health Care Claims Attachments

Sec.
162.1900 Definitions.
162.1905 Requirements for covered entities.
162.1910 Electronic health care claims attachment request transaction.
162.1915 Standards and implementation specifications for the electronic health care claims attachment request transaction.
162.1920 Electronic health care claims attachment response transaction.
162.1925 Standards and implementation specifications for the electronic health care claims attachment response transaction.
162.1930 Initial compliance dates for the electronic health care claims attachment response and electronic health care claims attachment request transaction standards.

Subpart S—Electronic Health Care Claims Attachments

§ 162.1900 Definitions.

Ambulance services means health care services provided by land, water, or air transport and the procedures and supplies used during the trip by the transport personnel to assess, treat or monitor the individual until arrival at the hospital, emergency department, home or other destination. Ambulance documentation may also include nonclinical information such as the destination justification and ordering practitioner.

Attachment information means the supplemental health information needed to support a specific health care claim.

Clinical reports means reports, studies, or notes, including tests, procedures, and other clinical results, used to analyze and/or document an individual’s medical condition.

Emergency department means a health care facility or department of a hospital that provides acute medical and surgical care and services on an ambulatory basis to individuals who require immediate care primarily in critical or life-threatening situations.

Laboratory results means the clinical information resulting from tests conducted by entities furnishing biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathology, or other examinations of materials from the human body.

Medications means those drugs and biologics that the individual is already taking, that are ordered for the individual during the course of treatment, or that are ordered for an individual after treatment has been furnished.

Rehabilitation services means those therapy services provided for the primary purpose of assisting in an individual’s rehabilitation program of evaluation and services. These services are: Cardiac rehabilitation, medical social services, occupational therapy, physical therapy, respiratory therapy, skilled nursing, speech therapy, psychiatric rehabilitation, and alcohol and substance abuse rehabilitation.

§ 162.1905 Requirements for covered entities.

When using electronic media to conduct a health care claims attachment request transaction or a health care claims attachment response transaction, a covered entity must comply with the applicable standards of this subpart if:

(a) Information not contained in a health care claim is needed for the adjudication of that health care claim; and

(b) The health care claim is for one or more of the following types of services:

(1) Ambulance services;

(2) Emergency department services;

(3) Rehabilitation services; or

(c)The additional information requested is for one or more of the following types of information:

(1) Clinical reports;

(2) Laboratory results; or

(3) Medications.

§ 162.1910 Electronic health care claims attachment request transaction.

(a) The health care claims attachment request transaction is the transmission, from a health plan to a health care provider, of a request for attachment information to support the adjudication of a specific health care claim. A health plan may make such a request—

(1) Upon receipt of the health care claim;

(2) In advance of submission of the health care claim; or

(3) Through instructions for a specific type of health care claim which permit a health care provider to submit attachment information on an unsolicited basis each time such type of claim is submitted.

(b) If a health plan conducts a health care claims attachment request transaction using electronic media and the attachment information requested is of a type described at §162.1905, the plan must conduct the transaction in accordance with the appropriate provisions of §162.1915.

(c) A health plan that conducts a health care claims attachment request transaction using electronic media, must submit complete requests and identify in the transaction, all of the attachment information needed to adjudicate the claim, which can be requested by means of the transaction.

(d) The health care claims attachment request transaction sent using electronic media, is comprised of two component parts:

(1) The general request structure that identifies the related claim; and

(2) The LOINC codes and LOINC modifiers identifying the attachment information being requested.

§ 162.1915 Standards and implementation specifications for the electronic health care claims attachment request transaction.

The Secretary adopts the following standards and implementation specifications for the electronic health care claims attachment request transaction:

(a) The ASC X12N 277—Health Care Claim Request for Additional Information, Version 4050, May 2004,
Washington Publishing Company, 004050X150 (incorporated by reference in §162.920).

(b) The following HL7 AIS documents to convey the LOINC codes that identify the attachment type and specific information being requested—(1) Ambulance services information: The CDAR1AIS0001R021 Additional Information Specification 0001, Ambulance Service Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

(2) Emergency department information: The CDAR1AIS0002R021 Additional Information Specification 0002: Emergency Department Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

(3) Rehabilitation services information: The CDAR1AIS0003R021. Additional Information Specification 0003: Rehabilitation Services Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

(4) Clinical reports information: The CDAR1AIS0004R021 Additional Information Specification 0004: Clinical
Reports Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

(5) Laboratory results information: The CDAR1AIS0005R021 Additional Information Specification 0005: Laboratory Results Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920).

(6) Medications information: The CDAR1AIS0006R021 Additional Information Specification 0006: Medications Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920).

§ 162.1920 Electronic health care claims attachment response transaction.

(a) The health care claims attachment response transaction is the transmission of attachment information, from a health care provider to a health plan, in response to a request from the health plan for the information.

(b) If a health care provider conducts a health care claims attachment transaction using electronic media, and the attachment information is of the type described at §162.1905, the health care provider must conduct the transaction in accordance with the appropriate provisions of §162.1925.

(c) A health care provider that conducts a health care claims attachment response transaction using electronic media must submit a complete response by providing, to the extent available, all of the requested attachment information or other appropriate response in the transaction.

(d) A health care provider that sends scanned images and text documents in the attachment transaction, for the human decision variants, is not required to use the LOINC codes as the response, other than to repeat the LOINC codes used in the request. Response information may be free text, scanned documents, or an embedded document within the BIN segment of the response transaction.

(e) A health care provider may submit an unsolicited response transaction only upon advance instructions by a health plan.

§ 162.1925 Standards and implementation specifications for the electronic health care claims attachment response transaction.

The Secretary adopts the following standards and implementation specifications for the electronic health care claims attachment response transaction:

(a) The ASC X12N 275—Additional Information to Support a Health Care Claim or Encounter, Version 4050, May 2004, Washington Publishing Company, 004050X151 (incorporated by reference in §162.920).

(b) The HL7 Additional Information Specification Implementation Guide Release 2.1 (incorporated by reference in §162.920) for implementing the HL7 Additional Information Specifications to convey attachment information within the Binary Data segment of the ASC X12N 275 (004050x151).

(c) The following HL7 AIS documents to convey the LOINC codes that identify the attachment type and specific attachment information being sent—

(1) Ambulance Services information: The CDAR1AIS0001R021 Additional Information Specification 0001: Ambulance Service Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

(2) Emergency Department information: The CDAR1AIS0002R021 Additional Information Specification 0002: Emergency Department Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

(3) Rehabilitation services information: The CDAR1AIS0003R021 Additional Information Specification 0003: Rehabilitation Services Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

(4) Clinical reports information: The CDAR1AIS0004R021 Additional Information Specification 0004: Clinical Reports Attachment, Release 2.1, based on HL7 CDA Release 1.0 (incorporated by reference in §162.920);

§ 162.1930 Initial compliance dates for the electronic health care claims attachment response and electronic health care claims attachment request transaction standards.

(a) Health care providers. A covered health care provider must comply with the applicable requirements of this subpart S no later than [24 months after the effective date of the final rule published in the Federal Register].

(b) Health plans. A health plan must comply with the applicable requirements of this subpart S no later than one of the following dates:

(1) Health plans other than small health plans—[24 months after the effective date of the final rule published in the Federal Register].

(2) Small health plans—[36 months after the effective date of the final rule published in the Federal Register].

(c) Health care clearinghouses. A health care clearinghouse must comply with the applicable requirements of this subpart S no later than [24 months after the effective date of the final rule published in the Federal Register].

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

Dated: May 27, 2005.

Michael O. Leavitt, Secretary.

[FR Doc. 05–18927 Filed 9–22–05; 8:45 am]

BILLING CODE 4120–01–P

Standards for Electronic Healthcare Claims Attachments

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Standards for Electronic Healthcare
Claims Attachments