Antonyms and Meaningful Use

Andrew asks: "What is the difference in the content to be included in the 'clinical summary' for each visit, in contrast to the 'Electronic Copy of Health Information'?  And goes on to suggest that: "Both of these items require either the CCR or HITSP/C32. Some of us agree they are to contain the same data as it is a summary of that point in time and the phrase 'for each visit' is not relevant."

There are two places to look for details on this information:

1. 45 CFR Part 170 Meaningful Use Standards Final Rule
2. 42 CFR Parts 412, 413, 422, and 495 Meaningful Use Incentives Final Rule  

The Standards Final Rule will tell you what a Certified EHR Product must do.  The Incentives Final Rule wil;l tell you what an EP or Hospital must do when exchanging information.

To keep your customers happy, an EHR product needs to be able to support what is required for certification, as well as what is required for a provider to obtain incentive payments.

Page 158 of the Incentives Final Rule describes what is meant by "Electronic Copy of Health Information".  The following is taken from the PDF of the display text for that rule [emphasis mine].

Comment: Commenters requested clarification of the term “health information” or alternatively a list of elements required to satisfy the objective.


Response: Subject to the withholding described above, an EP, eligible hospital, or CAH should provide a patient with all of the health information they have available electronically. At a minimum, this would include the elements listed in the ONC final rule at 45 CFR 170.304(f) for EPs and 45 CFR 170.306 (d) for eligible hospitals and CAHs as required for EHR technology to become certified.

Just for reference I'll include the referenced sections from 45 CFR 170.304(f) and 170.306(d) from the Standards final Rule below [emphasis mine]:

§170.304(f) Electronic copy of health information. Enable a user to create an electronic copy of a patient’s clinical information, including, at a minimum, diagnostic test results, problem list, medication list, and medication allergy list in:


(1) Human readable format; and
(2) On electronic media or through some other electronic means 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).

§170.306(d)

(1) Enable a user to create an electronic copy of a patient’s clinical information, including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, and procedures:
(i) In human readable format; and
(ii) On electronic media or through some other electronic means in accordance with:

(A) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and
(B) For the following data elements the applicable standard must be used: (1) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in §170.207(a)(2); (2) Procedures. The standard specified in §170.207(b)(1) or §170.207(b)(2); (3) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and (4) Medications. The standard specified in §170.207(d).


(2) Enable a user to create an electronic copy of a patient’s discharge summary in human readable format and on electronic media or through some other electronic means.

And just in case you were wondering, §170.205(a)(1) references CCD and HITSP C32 and §170.205(a)(2) references CCR.  §170.207 contains the vocabulary standards and is not relevant to THIS discussion.

Looking closely at the objectives being referenced for Eligible Providers [emphasis mine]:

[pp 769] (d) Stage 1 core criteria for EPs. An EP must satisfy the following objectives and associated measures, except those objectives and associated measures for which an EP qualifies for an exclusion under paragraph (a)(2) of this section specified in this paragraph :

           ...
[pp 772] (12)(i) Objective. Provide patients with an electronic copy of their health information (including diagnostics test results, problem list, medication lists, medication allergies) upon request.
(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all patients who request an electronic copy of their health information are provided it within 3 business days.
(iii) Exclusion in accordance with paragraph (a)(2) of this section. Any EP that has no requests from patients or their agents for an electronic copy of patient health information during the EHR reporting period.

And for Eligible Hospitals or CAHs [emphasis mine]:

[pp 777] (f) Stage 1 core criteria for eligible hospitals or CAHs. An eligible hospital or CAH must meet the following objectives and associated measures except those objectives and associated measures for which an eligible hospital or CAH qualifies for a paragraph (b)(2) of this section exclusion specified in this paragraph:
      ...
[pp 780] (11)(i) Objective. Provide patients with an electronic copy of their health information (including diagnostic test results, problem list, medication lists, medication allergies, discharge summary, procedures), upon request.
(ii) Measure. Subject to paragraph (c) of this section, more than 50 percent of all patients of the inpatient or emergency departments of the eligible hospital or CAH (POS 21 or 23) who request an electronic copy of their health information are provided it within 3 business days.
(iii) Exclusion in accordance with paragraph (b)(2) of this section. Any eligible hospital or CAH that has no requests from patients or their agents for an electronic copy of patient health information during the EHR reporting period.

Problem, medication and allergy lists can certainly be provided in the HITSP C32 (or the CCR), as can summary information on test results and procedures.  Discharge summaries are another story, which long-time readers of this blog already understand.  ONC did finally get the memo (I was one of the "few commenters"), because the Standards Final Rule has this commentary starting on page 167:

Comments. A few commenters noted that neither the CCD nor CCR contain an applicable section for discharge summary. One commenter recommended that because the provision of an electronic copy of discharge instructions was required by another certification criterion, that discharge instructions should be removed as an element in this electronic copy.


Response. We reviewed commenters’ concerns and agree that there is no applicable section for a discharge summary. Therefore, we have revised this certification criterion to reflect that while the other data elements can be conveyed using the patient summary record standards (CCR or CCD), we are not requiring the use of any standards for the discharge summary section. In order to support the meaningful use objective and measure, however, we note that we do expect Certified EHR Technology to be capable of providing a electronic copy of a discharge summary like a patient summary record, in human readable format and on electronic media or through some other electronic means.


Other electronic means could include, for example, the discharge summary represented as a CCD plus the "Hospital Course" CDA section or provided as a PDF. We have revised the certification criterion accordingly.

So, how does this help answer Andrew's question?

To be certified for an inpatient setting, you need to be able to support the rule under §170.306(d)(2) as well §170.306(d)(1), which means that you need to be able to support exchange of Discharge Summaries.  You probably know my views on that, but if you don't read If I had a Hammer and the Redux which report them.

That means that the difference between a "Clinical Summary" and "Health Information" includes at least the Discharge Summary for EHRs in an inpatient setting.  For ambulatory settings, the difference is still vague.  It seems as if you could use the Clinincal Summary to support the requirements for certification for both Clinical Summaries and Health Information.  BUT:  From my perspective, I'd also expect to get the rest of the ORIGINAL test reports in human readable form, which would include Imaging or other study reports, and lab test results.

Why?  Because summaries are just that, and for my PERSONAL health records, I want not just summaries, but also DETAILS.  I suspect that other patients will feel the same way, and that Eligible Providers will want to provide their patients with details.  The details of an ECG report, lab report, or other test result or procedure just don't belong in a summary document.  

From my viewpoint, the antonym of summary is detail, and visa versa.

So, if you want to get away with the minimum for meaningful use for ambulatory care, you can probably just send the summary.  But to be really meaningful to your customers and their patients, you'll have to do better than that.

    Keith

DISCLAIMER: I am neither a lawyer, nor a representative of CMS or ONC.  These are my personal opinions about the wording in these regulations.  I would advise you to obtain your own expert legal advice before acting on the information reported above.  You assume any of the risks in using these opinions for decision making.