MU Stage1 Final Rule - Capability To Exchange Key Clinical Information (EP)

SECTION #  Section 170.304(i)—Exchange Clinical Information and Patient Summary Record

MU OBJECTIVE Capability to exchange key clinical information (for example, problem list, medication list, medication allergies, diagnostic test results), among providers of care and patient authorized entities electronically.

MU STAGE 1 MEASURE Performed at least one test of certified EHR technology's capacity to electronically exchange key clinical information.

CERTIFICATION CRITERION Final Rule Text: §170.304(i) (1) Electronically receive and display. Electronically receive and display a patient’s summary Record, from other providers and organizations including, at a minimum, diagnostic tests results, problem list, medication list, and medication allergy list in accordance with the standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2). Upon receipt of a patient summary Record formatted according to the alternative standard, display it in human readable format. (2) Electronically transmit. Enable a user to electronically transmit a patient summary Record to other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list in accordance with: (i) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (ii) For the following data elements the applicable standard must be used: (A) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in §170.207(a)(2); (B) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and (C) Medications. The standard specified in §170.207(d).

STANDARDS(See below) §170.205(a)(1) §170.205(a)(2) §170.205(a)(2) §170.207(a)(1) §170.207(a)(2) §170.207(c) §170.207(d)

§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]

§170.207 Vocabulary standards for representing electronic health information. The Secretary adopts the following code sets, terminology, and nomenclature as the vocabulary standards for the purpose of representing electronic health information.

(a) Problems.

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

(2) 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).

(b) Procedures. (1) Standard. The code set specified at 45 CFR 162.1002(a)(2).

(2) Standard. The code set specified at 45 CFR 162.1002(a)(5).

(c) Laboratory test results. 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).

(d) Medications. Standard. Any source vocabulary that is included in RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine.

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

(f) Race and Ethnicity. Standard. The Office of Management and Budget Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, October 30, 1997 (available at http://www.whitehouse.gov/omb/rewrite/fedreg/ombdir15.html). [The hyperlink returns a message "404 Page Not Found". This problem was reported to ONC.Certification@hhs.gov on 08/23/2010.]

TEST CRITERIA # §170.304(i) http://healthcare.nist.gov/docs/170.304.i_ExchangeClinicalinforPatientSummaryRecordAmb_v1.1.pdf

SOLUTION DESIGN / TECHNOLOGY (Add details here)

SOLUTION COMPONENTS (Add details here - Ex. KIDS patch, Delphi code, User guide, Web resources, Manual test script, etc)

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COMMENTS / NOTES (Add details here)

PREVIOUS NOTES

(1) This capability will be provided by the code coming from the CCR-CCD project. The latest project code can be found on http://trac.opensourcevista.net and there are calls almost every Tuesday night at 9 PM Eastern to work on the project. You can sign up to receive notices of the meetings at http://groups.google.com/group/ccd-ccr-project?hl=en. Both a CCR and CCD level 2 are being produced at this time and we are hoping that there will be the capability of transmitting a CCD level 3 in the future as that work is underway. WorldVistA will be submitting a recommendation to the ONCHIT to use both the CCR and CCD as standards for transmission of these health summaries. The production of an XSLT transform to create a CCD level 3 from a CCR, which is the current goal of some work being done by Ken Miller of Solventus as an open source project funded by Oroville Hopital in California, should make this easily possible for healthcare providers.

(2)This will also be covered by the CCR-CCD project. Either a CCR or CCD level 2 is something that can be extracted at this time. (see above) This particular standard does not specify how the transmission must be done. It is clear that it must be encrypted but it is not clear how it may be transmitted. Then NHIN is mentioned but there it is not clear that other methods of transport are not allowed such as email with an encrypted attachment. (There is mention that if it is physically transported outside of a healthcare facility, it should be encrypted.)

DEVELOPMENT STATUS As Above. The production of a level 3 CCD from a CCR is coming along nicely within the CCR-CCD project and an additional new volunteer who is very knowledgeable has just joined, but more would be welcome. XSLT experience is needed.

The CCD is being produced for lab results but more domains of results need to be added. Help with that would be appreciated.

The work is being done as part of the CCD-CCR project. We do not know if the CCD or the CCR will be the ultimate medium of exchange but for the moment, we need to be able to store and display either one.

Some additional work is needed to make that seamless.

Largely, the document received in XML format needs to be displayed in a browser along with the file that "translates" it into a human readable format. This involves putting the document as received in the same directory as the file that allows it to be displayed and opening it in a browser.

Documents received are not yet able to be absorbed to populate other files such as the lab file and it is clear that not all physicians what that. Portions of CCR can be parsed into XPath elements (I have to check if the CCD can be as well)   However, the EHR will eventually most likely be required to be capable of absorbing the data out of the CCR or CCD and putting it into existing files in VistA other than these new files storing the XPath and variables. We will need to be able to indicate that that data is from another source. Problems, Allergies, Medications are top priorities from this.

The best we can recommend to help with this is to help out in the CCR-CCD project and make yourself know to George Lilly, Dave Whitten or Nancy Anthracite as someone who can help. Action ITEMS / NEXT STEPS (Add details here)

OPEN ISSUES / QUESTIONS (Add details here)