Monday, July 19, 2010

A Meaningful Use and Standards Rule FAQ

Since the Final Meaningful Use and Standards Rules were released last week, many people have emailed me questions, which I'd like to share generally. My blog is not reviewed by ONC or CMS, so these answers are my own opinion.

1. The Meaningful Use Rule identifies 15 Core Set required criteria and 10 Menu Set optional criteria (from which eligible professionals and hospitals must choose 5). Can they choose any 5?

You cannot choose any 5. Page 59 of the Meaningful Use final rule notes "all EPs and hospitals must choose at least one of the population and public health measures to demonstrate as part of the menu set. This is the only limitation placed on which five objectives can be deferred from the menu set."

This means that eligible professionals (EPs) must submit data to immunization registries or syndromic surveillance registries. Hospitals must submit data to immunization, syndromic surveillance or reportable lab registries. If such registries do not exist in your state/city (i.e. there is no repository to receive the data), CMS will not penalize the EP or Hospital.

2. The patient engagement aspects of the Meaningful Use Rule seem challenging to operationalize. Can I provide a paper copy of the visit summary or discharge summary to the patient? If not, how do I deliver a summary to the patient electronically? Can it be a PDF?

Patient engagement is probably the most complex area of the Meaningful Use and Standards Rule. Here's my understanding:

a. EHRs and Hospital Information Systems must have the capability of producing a human readable summary AND a computable summary that adheres to the Standards Final Rule (CCR or CCD). For some organizations, that would be two documents (a human readable PDF and a computable CCD, for example), or they could produce one electronic copy with an XSL style sheet that makes the CCD human readable. Thus, the Standards Rule requires a CCR/CCD at a minimum plus optional human readable PDF, Text, DOC etc. Here's the Standards Rule text:

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)."

b. To achieve Meaningful Use, you must give an encounter summary to 50% of outpatients and 50% of ED/Inpatients who ask �and that summary can be electronic or printed. Even though the EHR must be certified to produce a CCR or CCD, meaningful use does not require that the patient actually receive their information in these formats. Paper is fine. In fact, even if you were to provide a CCR or CCD, the patient still has the option of requesting paper and you must provide paper if asked.

c. If you do want to deliver summaries to the patient electronically. how can you do it? The answer - anyway you want per Page 179 of the Meaningful Use Final Rule:
"Comment: Several commenters requested changes to the media through which this information could be provided. Differing commenters recommended eliminating the paper option, while others recommended only the paper option.

Response: We believe that more options give the EP needed flexibility. The EP could choose any of the listed means from the proposed rule of PHR, patient portal on a web site, secure email, electronic media such as CD or USB fob, or printed copy. If the EP chooses an electronic media, they would be required to provide the patient a paper copy upon request. Both forms can be and should be produced by certified EHR technology."

3. Do Emergency Department Systems need to be certified?

The Final Meaningful Use Rule clarifies that Emergency Department professionals are part of hospital staff and hospital meaningful use. Specifically, the Emergency Department is mentioned as part of the patient summary and CPOE requirements. For example:

"* More than 50% of all patients who are discharged from an inpatient or ED of a hospital who request an electronic copy of their discharge instructions must be provided with it."

Thus, ED information systems are likely going to be certified as to their ability to export an electronic copy of discharge instructions/clinical summaries. I suspect that ordering and medication management will also be included in certification of ED systems. We'll know more over the next few months at the Authorized Testing and Certification Bodies begin their work.

4. At what points in care does Medication Reconciliation have to be done?

If patient is transitioned from the ED to the ICU to the inpatient ward of the same hospital, does medication reconciliation have to be done 3 times per the Meaningful Use Rule?

At BIDMC, our Joint Commission mandate for medication reconciliation has led us to verify medications at every external and internal care transition. However, Meaningful Use does not. Per Page 193:
"Comment: Commenters requested additional clarity of the term �transition of care.� A few suggestions were provided by commenters including expanding the description to include all transfers to different settings within a hospital or revising the definition to �the movement of a patient from one setting of care (hospital, ambulatory primary care practice, ambulatory, specialty care practice, long-term care, home health, rehabilitation facility) to another�.
Response: In the proposed rule we clarified �transition of care� as the transfer of a patient from one clinical setting (inpatient, outpatient, physician office, home health, rehab, longterm care facility, etc) to another or from one EP, eligible hospital, or CAH (as defined by CCN) to another. We believe that different settings within one hospital using certified EHR technology would have access to the same information so reconciliation would not be necessary. We modify our clarification to account for some of the revisions provided. We clarify 'transition of care' as the movement of a patient from one setting of care (hospital, ambulatory primary care practice, ambulatory, specialty care practice, long-term care, home health, rehabilitation facility) to another. We also clarify that the receiving eligible hospital or EP would conduct the medication reconciliation."

5. Can I use multiple software applications to achieve Meaningful Use?

Meaningful Use can be achieved using any combination of systems. However, every application and module used to achieve meaningful use must be certified (or the combination of systems in use at the site must achieve site certification).

At BIDMC, we're doing a site certification of our EHR, CPOE, Lab/Pharmacy/Radiology, decision support and data warehousing systems, since all will be used to achieve Meaningful Use.

Commercial vendors will certify their products, but in my opinion, many hospitals will end up doing site certification because they have numerous built and bought applications that will be used to achieve Meaningful Use.

I hope these answers are useful. I also hope they are correct. Each time I'm asked a question, I forward it to CMS and ONC to include in their internal FAQ database, so there will eventually be official answers!
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