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§170.205 Content exchange and vocabulary standards for exchanging electronic health information.

(a) Patient summary record.

(1) The Secretary adopts the following content exchange standards for the purposes of electronically exchanging a patient summary record or to use in creating an electronic copy of a patient summary record:

(i) Standard. Health Level Seven Clinical Document Architecture (CDA) Release 2, Level 2 Continuity of Care Document (CCD) (incorporated by reference in §170.299).

(ii) Alternative standard. ASTM E2369 Standard Specification for Continuity of Care Record and Adjunct to ASTM E2369 (incorporated by reference in §170.299).

(2) The Secretary adopts the following vocabulary standards for the purposes of specifying the code set, terminology, or nomenclature to use to represent health information included in a patient summary record:

(i) Problem list.

(A) Standard. The code set specified for the conditions specified at 45 CFR 162.1002(a)(1).

(B) Alternative standard. International Health Terminology Standards Development Organization (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) July 2009 version (incorporated by reference in §170.299).

(ii) Procedures.

(A) Standard. The code set specified at 45 CFR 162.1002(a)(2).

(B) Alternative standard. The code set specified at 45 CFR 162.1002(a)(5).

(iii) Laboratory orders and results.

(A) Standard. Logical Observation Identifiers Names and Codes (LOINC®) version 2.27, when such codes were received within an electronic transaction from a laboratory (incorporated by reference in §170.299).

(B) [Reserved]

(iv) Medication list.

(A) Standard. Any code set by an RxNorm drug data source provider that is identified by the United States National Library of Medicine as being a complete data set integrated within RxNorm.

(B) [Reserved]

(b) Drug formulary check. The Secretary adopts the following content exchange standard for transmitting formulary and benefits information between prescribers and Medicare Part D sponsors.

(1) Standard. Drug formulary and benefits information must be transmitted in accordance with 42 CFR 423.160(b)(5).

(2) [Reserved]

(c) Electronically transmitting prescription information.

(1) The Secretary adopts the following content exchange standard to provide for the transmission of a prescription or prescription-related information.

(i) Standard. An electronic prescription for a Medicare Part D covered drug that is prescribed for a Medicare Part D eligible individual must be transmitted in accordance with 42 CFR 423.160(b)(2)(ii), in all other circumstances, if consistent with applicable state and other Federal law, electronic prescriptions may be transmitted in accordance with 42 CFR 423.160(b)(2)(ii) or using the NCPDP SCRIPT Standard, Implementation Guide, Version 10.6 (incorporated by reference in §170.299).

(ii) [Reserved]

(2) The Secretary adopts the following vocabulary standard for the purposes of specifying the code set to use to represent health information included in electronic prescriptions.

(i) Standard. Any code set by an RxNorm drug data source provider that is identified by the United States National Library of Medicine as being a complete data set integrated within RxNorm.

(ii) [Reserved]

(d) Electronically exchange administrative transactions. The Secretary adopts the following content exchange standards and associated implementation specifications for the following electronic transactions.

(1) Standard and implementation specifications. An eligibility for a health plan transaction as defined at 45 CFR 162.1201 must be conducted in accordance with:

(i) 45 CFR 162.1202(b) or for the period on and after January 1, 2012, in accordance with 45 CFR 162.1202(c); and

(ii) the operating rules specified in Phase 1 of the Council for Affordable Quality Healthcare (CAQH) Committee on Operating Rules for Information Exchange (CORE) (incorporated by reference in §170.299).

(2) Standard and implementation specifications. Eligibility inquiry and response transactions between dispensers and Part D sponsors for Part D prescription drugs must be conducted in accordance with 42 CFR 423.160(b)(3)(ii). (3) Standard and implementation specifications. A health care claims or equivalent encounter information transaction as defined at 45 CFR 162.1101 must be conducted in accordance with 45 CFR 162.1102(b) or for the period on and after January 1, 2012, in accordance with 45 CFR 162.1102(c).

(e) Electronically exchange quality reporting information. The Secretary adopts the following content exchange standard and implementation specification for quality reporting.

(1) Standard. The CMS Physician Quality Reporting Initiative (PQRI) 2008 Registry XML Specification (incorporated by reference in §170.299).

(2) Implementation specification. Physician Quality Reporting Initiative Measure Specifications Manual for Claims and Registry (incorporated by reference in §170.299).

(f) Electronic submission of lab results to public health agencies.

(1) The Secretary adopts the following content exchange standard for the electronic submission of lab results to public health agencies.

(i) Standard. HL7 2.5.1(incorporated by reference in §170.299).

(ii) [Reserved]

(2) The Secretary adopts the following vocabulary standard for the purposes of representing lab results in an electronic submission to public health authorities.

(i) Standard. Logical Observation Identifiers Names and Codes (LOINC®), version 2.27, when such codes were received within an electronic transaction from a laboratory (incorporated by reference in §170.299).

(ii) [Reserved]

(g) Electronic submission to public health agencies for surveillance or reporting. The Secretary adopts the following content exchange standards for electronic submission to public health agencies for surveillance or reporting:

(1) Standard. HL7 2.3.1(incorporated by reference in §170.299).

(2) Alternative standard. HL7 2.5.1(incorporated by reference in §170.299).

(h) Electronic submission to immunization registries.

(1) The Secretary adopts the following content exchange standards for electronic submission to immunization registries:

(i) Standard. HL7 2.3.1 (incorporated by reference in §170.299).

(ii) Alternative Standard. HL7 2.5.1 (incorporated by reference in §170.299).

(2) The Secretary adopts the following vocabulary standard for electronic submissions to immunization registries.

(i) Standard. HL7 Standard Code Set CVX - Vaccines Administered, July 30, 2009 version (incorporated by reference in §170.299).

(ii) [Reserved]

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