Summary of Meaningful Use Stage 2 Certification

Updated 6/12 to provide links to text in the Federal Register.

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Before I get into details, here's a quick overview of what's new and interesting:

• Direct and Exchange
• The HL7 CDA Consolidation guide replaces CCD 1.0 for most uses of summary information as expected.
• InfoButtons are required to support access to reference information by providers
• HL7 2.3.1 is no longer an option for reporting to public health, and the expected guides have been included.
• The CDC Cancer Registry reporting guide (using CDA) has been incorporated into the requirements for ambulatory reporting to cancer registries.
• RxNORM, LOINC, SNOMED and ICD-10 are the vocabularies to use for medications, labs, and problems

If you want a bookmarked copy of the rule, thank Corey Spears of McKesson for providing one.  Thanks Corey!

If you want the crosswalks, see Certification to Standards, and Objectives to Certification just posted. 

Stage 2 Standards §170.200-299
Transport (§170.202)

1. The DIRECT Protocol
   No big surprise here
2. External Data Representation and Cross-Enterprise Document Media Interchange for Direct Messaging
   IHE XDM!
3. Simple Object Access Protocol (SOAP)-Based Secure Transport Requirements Traceability Matrix (RTM) version 1.0
   the title is VERY misleading, what I think it really means is the Exchange specifications, but I cannot find any link.

 Functional Standards (§170.204)

1. Web Content Accessibility Guidelines
   Basically used for patient engagement view access of records
2. Health Level Seven Context-Aware Knowledge Retrieval (Infobutton)
   A surprise in some ways, but a welcome one.
3. National Quality Forum (NQF) Quality Data Model (QDM)
   Used in section 314(c) for quality measures, probably "overused" a bit, and will likely be misunderstood.

Content (§170.205)

1. Summaries §170.205(a)(3): HL7 Implementation Guide for Clinical Document Architecture, Release 2.0 Consolidated CDA
   W00T!
4. Syndromic Surveillance §170.205(d)(3): PHIN Messaging Guide for Syndromic Surveillance: Emergency Department and Urgent Care Data HL7 Version 2.5.1
   No surprises here, this was what replaced the broken guide originally issued in Stage 1 and was then withdrawn.  See my comments on it here  
5. Immunization Reporting §170.205(e)(3):  HL7 2.5.1 Implementation Guide for Immunization Messaging Release 1.3
7. Lab Reporting to Public Health §170.205(g):  HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1
9. Cancer Information §170.205(i):  Implementation Guide for Healthcare Provider Reporting to Central Cancer Registries
   A surprise entry from Cancer Registries, using not HL7 2.5.1, but CDA.  A welcome change, but it isn't clear whether folks are ready for it yet.
10. Imaging §170.205(j): Digital Imaging and Communications in Medicine (DICOM) PS 3—2011.
    Is there something else you would use for imaging?
11. Electronic incorporation and transmission of lab results §170.205(k):  HL7 Version 2.5.1 Implementation Guide: Standards and Interoperability Framework Lab Results Interface, Release 1
    Another win for S&I Framework.

Vocabulary (§170.207)

1. Problems §170.207(a)(3): SNOMED CT 2012 Edition
   They basically updated the version of SNOMED
2. Procedures §170.207(b)(3): HIPAA Code Sets at 42 CFR 162.1002(c)(3)
   And added a new line for ICD-10-PCS
6. Race and Ethnicity §170.207(f):  The OMB Directive on Race and Ethnicity
   I don't see any real change here, I'm not sure why it's there.
7. Laboratory Tests  §170.207(g):  LOINC
   Added version 2.38, otherwise, no real change from 207(c)
8. Medications §170.207(h):  RxNORM
   As you might recall, Stage 1 said "any standard that was an RxNORM data source". Stage 2 says to USE RxNORM
9. Immunizations §170.207(i):  HL7 Standard Code Set CVX - Vaccines Administered, August 15, 2011
   This also seems to just be a version update.
10. Preferred language §170.207(j):  ISO 639-1:2002
    Another DUH, but necessary I would guess.
11. Preliminary determination of cause of death §170.207(k):  The code set specified at 45 CFR 162.1002(c)(2)
    ICD-10-CM for cause of death
12. Smoking status §170.207(l):  Smoking status types must include: current every day smoker; current some day smoker; former smoker; never smoker; smoker, current status unknown; and unknown if ever smoked.
13. Encounter diagnoses §170.207(m):  The code set specified at 45 CFR 162.1002(c)(2) for the indicated conditions.
    Again, ICD-10-CM

Security (§170.210)

5. §170.210(e) (Audit) Record actions updated to reflect additional auditing for enabling/disabling audit or encryption of external devices, and incorporation of time synchronization standards
   IHE ATNA is a great resources for auditing.
6. §170.210(f) (Encryption and Hashing) FIPS 140-2 Annex A
   Consolidates Encryption/Decryption/Hashing to use appropriate algorithms in Annex A, and doesn't call out SHA version specifically.
7. §170.210(g) (Time) Synchronize your clocks using NTP (RFC 1305) or NTPv4 (RFC 5905)
   Anyone heard of the IHE CT Profile?  And BTW, they should have named SNTP, not NTP, because NTP isn't always needed.

Stage 2 Certification Criteria (§170.314)

The numbers in the list below are lined up with 42 CFR Part 170 Section 314:

1. §170.314(a) Clinical Requirements
1. §170.314(a)(1) †  Record, Change and Access Medication, Laboratory and Imaging orders
   no major change from Stage 1
2. §170.314(a)(2) † Enable med/med and med/allergy interaction checks before an order is placed, and adjust severity of messages by appropriate users.
   Again, no major changes here.
3. §170.314(a)(3) Enable capture of demograpics, including preferred language (ISO 639-1), gender, race & ethnicity (OMB Race and Ethnicity), and date of birth, and preliminary cause of death in inpatient settings.
   Language is in ISO 639-1, preliminary cause of death is in ICD-10-CM, and Race and Ethnicity must follow OMB Guidelines.  Nothing major here.
4. §170.314(a)(4) Capture vital signs: Height, Weight, BP, calculate BMI, and optionally plot growth charts
   Plot and display growth charts seems to have become optional now.
5. §170.314(a)(5) Capture problem list using SNOMED CT 2012 edition
   The shift to SNOMED CT is not a big surprise, but only if you've been paying attention.
6. §170.314(a)(6) † Record, change, and access medication list.
   I don't see any vocabulary mentioned here, but there wasn't any in Stage 1 either
7. §170.314(a)(7) † Record, change, and access allergy list.
   I don't see any vocabulary mentioned here, but there wasn't any in Stage 1 either
8. §170.314(a)(8) † Provide Clinical Decision Support based on (some combination of) problems, medications, allergies, demographics, lab results, and vital signs.
   Lots of clarification in this section, needs a deeper read
1. Enable a user to access reference information on  problems, medications, allergies, demographics, lab results, and vital signs using InfoButton (not clear whether one category or all are required to be supported).
9. §170.314(a)(9) Record, change, access and search electronic notes.
   No big changes from Stage 1
10. §170.314(a)(10) Drug formulary checks.
    No big changes from Stage 1
11. §170.314(a)(11) Record, change and access smoking status.
    No big changes from Stage 1
12. §170.314(a)(12) Enable electronic access to imaging results and status
    New criteria!  See IHE Cardiology's Image Enable Office profile.
13. §170.314(a)(13) Record, change and access family history.
    New criteria!
14. §170.314(a)(14) Select, sort, access and create patient lists based on problems, medications, demographics and lab results.
    No big changes from Stage 1
15. §170.314(a)(15) (Ambulatory only) Create patient reminder lists based on problems, medications, allergies, demographics and lab results.
    No big changes from Stage 1
16. §170.314(a)(16) Provide patient specific resources on each of problems, medications, and laboratory results using InfoButton.
    New criteria!
17. §170.314(a)(17) † (Inpatient only) Allow user to verify right patient, medication, dose and route and record time synchronized with NTP
    New criteria
18. §170.314(a)(18) (Inpatient only) Record whether patient has an advanced directive
    No big changes from Stage 1
2. §170.314(b) Care Coordination
1. §170.314(b)(1) Incorporate data received from a Consolidated CDA Document into the EHR upon receipt, including: demographics; smoking status; vital signs; medications; medication allergies; problems; procedures; laboratory tests and values/results; provider information, hospital admission and discharge dates and locations; discharge instructions; reason(s) for hospitalization; care plan, including goals and instructions;
   Replaces CCD with Consolidated CDA, and adds requirements for provider information, hospitalization data, and care plans.
2. §170.314(b)(2) Generate a summary of care record using a Consolidated CDA document, including patient demographics, provider information, care plan, and all the stuff above (hospitalization details are inpatient only) and Transmit it using Direct (required) or via Exchange (optional)
3. §170.314(b)(3) † ePrescribe
   Using NCPDP and RxNORM
4. §170.314(b)(4) † Reconcile meds, problems and allergies
   Reconciliation is not just for medications any more!  See the IHE Reconciliation of Diagnoses, Allergies and Medications profile.
5. §170.314(b)(5) Incorporate lab results using LRI and LOINC (ambulatory setting only), or as structured data (inpatient setting only), display in human readable format, and show CLIA required data, 
6. §170.314(b)(6) (Inpatient only) Transmit lab tests/results to ambulatory providers using LRI and LOINC.
   This one is a bit bogus.  They keep conflating a hospital-based lab and their information systems with a hospital.  They aren't the same system.
3. §170.314(c) Quality Measures
1. §170.314(c)(1) Electronically record and export all data elements present in the NQF QDM Standard.
   OK, I really need to spend some time with QDM.  I think the data element list is probably too big
2. §170.314(c)(2) Incorporate and calculate measures in the EHR technology, and
   See my posts on Query Health for some help on calculating measures. 
3. §170.314(c)(3) Export a data file using a CMS specified data file format
   CMS has to specify it, but they haven't yet, or there'd be a reference to it.  This is underspecified for a requirement.
4. §170.314(d) Privacy and Security
   I'll leave it to John Moehrke to provide comments on this section.
1. Authenticate users and establish appropriate access controls for them
2. Enable audit events by default, protect the audit log from alteration, and detect alterations
3. Generate an audit report
4. Support amendment of the health record, preserving original content, via user or using patient supplied information
5. Terminate login session after a predetermined time-out.
6. Permit emergency access
7. Encrypt data at rest on "end-user" devices.
8. Create a message digest
9. Optionally record an accounting of disclosures
5. §170.314(e) Patient Engagement
1. §170.314(e)(1) Enable a patient to view (via the web in an accessible fashion), download (in a human readable format, or using Consolidated CDA), or images using DICOM, and transmit using Direct and Exchange standards.
   The AND is emphasized for a reason.  Apparently you have to support BOTH.  Fortunately, you can do so using IHE XDS messages and a HISP that accepts XDR.
2. §170.314(e)(2) (Ambulatory setting only) Enable a user to provide patient summaries using Consolidated CDA to the patient
   OK, if I go to the hospital, I want my summaries from there also.
3. §170.314(e)(3) (Ambulatory setting only) Enable a user to send and receive messages from a patient using a secure channel
   And it sure would help if my hospital based provider could receive information from my patient advocate.  Also, this needs to include "authorized representative"
6. §170.314(f) Public Health
1. §170.314(f)(1) Enable a user to record, change and access immunization information
2. §170.314(f)(2) And transmit it to Public Health using the HL7 2.5.1 Immuniziation Guide from the CDC.
3. §170.314(f)(3) Enable a user to record, change and access syndromic surveillance information, 
4. §170.314(f)(4) And transmit it to public health using HL7 2.5.1, and if in an inpatient setting, using Syndromic Surveillance guide (also allowed in ambulatory settings, but not required).
5. §170.314(f)(5) (Inpatient setting only) Enable a user to record, change and access laboratory information, 
6. §170.314(f)(6) (Inpatient setting only) And transmit it to public health using the HL7 2.5.1 ELR Guide
7. §170.314(f)(7) (Ambulatory setting only)  Enable a user to record, change and access cancer information, 
8. §170.314(f)(8) (Ambulatory setting only)  And transmit it to public health using the CDC Cancer Registry Reporting Guide (CDA)
7. §170.314(g) Utilization
1. §170.314(g)(1) Automate numerator recording for each percentage-based MU objective
2. §170.314(g)(2) Automate measure calculation for each  percentage-based MU objective
3. §170.314(g)(3) Record date and time of use for each non-percentage-based MU objective where the capability was enabled, disabled or executed and provide a report of it.
4. §170.314(g)(4) Ensure that user-centered design processes are applied to capabilities described in §170.314(a)(1); §170.314(a)(2); §170.314(a)(6); §170.314(a)(7); §170.314(a)(8); §170.314(a)(17); §170.314(b)(3); and §170.314(b)(4).

† Requires use of User Centered Design principals (see g.4 above)

An Exhausting Week

And exasperating, and exhilarating. I am so ready to get home and get some sleep. I spent the last four days getting up at 5:30, only to be frustrated 15 minutes later when the regs weren't there. This was exasperating. Having 2 hours of unsused time, it was too late to go back to sleep. Following that was an exhausting day running from one hotel to another, then to the booth, then upstairs, downstairs, and all around the square. There were as many or more important hallway (or ailse-way) conversations as there were pre-planned meetings, and the former were often the most important. My last customer contact of the day promised to call me later with her MU questions, and the one just before that had some excellent questions about whether you had to use the required certification criteria [direct], or could use the optional method [exchange] to support transfers of summary data. I'll talk about that next week after I've had a chance to read the Standards and Certification rule (the short answer is either).

We (ONC S&I Query Health Implementation workgroup members) presented on our current progress implementing the Query Health specifications, and drew very large crowds at both the ONC and Interoperability Showcase booths. I also presented along with colleages and partners on important work moving forward on Clinical Decision support using the HL7 InfoButton standards. I spend hours meeting with policy makers and influencers at numerous opportunities presented by the EHRA and through other opportunities just because it was HIMSS12.

As I sit now, recovering from the show in DC, waiting to get to Boston, I'm missing all the people that I got to spend time with last week. HIMSS is, as I've said previously, the culmination of one year, and the start of the next. As with any such marker, I am relieved by what is behind me (e.g., the Query Health demo), and anticipating the future (e.g., Stage 2 standards).

HITsm Meetup at HIMSS12 at 4:15 today

Last year IHE hosted a meetup for HITsm in the Interoperability Showcase, and we are doing it again this year.  The meetup is at 4:15 in the Interoperability Showcase, at the rightmost Information desk.  To find it, head to Hall G and follow the signs on the floor to the showcase.  We're in the very back.  Once you get there, you'll likely be near one of two theaters.  If you find yourself near the welcome theater, head towards the theater at the other end, and keep going until you see the Information desk on the other side.  If you wind up at the Education theater, head towards the closest corner until you get to the Information desk on that side.  If it looks like the picture to the right, you are in the right place.

After we all gather, we'll head over the the "Interop Cafe", which is simply a collection of tables where we can sit and chat for a while, take a few pictures, et cetera.  I've arranged a tour for us as well, so we can all see what is happening in the Interop Showcase.  I hope to see you there today.

Crowd Sourcing Comments on MeaningfulUse on Twitter at HIMSS12

My reading for this morning again failed to arrive when I expected it.  ONC and CMS still have a few hours before it has to show up before another PR fail.  When it arrives, you can bet many will be focused on that instead of the reason that they came to #HIMSS12.

To simplify matters, I'm proposing we crowd-source our initial reviews on Twitter using the Hash Tags #MU2S for the Standards and Certification Rule, and #MU2I for the Incentive rule.

The format to use for commenting is:

#hashtag [page ### | section #.#.# ] ["quote" | comment[?] | "quote" comment[?]]  

I'll mine the tags and post all the feedback, along with my own summary later.

Please try to stick with the syntax so that I can easily parse and sort the comments.  Anything quoted from the reg's verbatim should appear in quotation marks first (single or double is fine), followed by your comments (if you have any), or you can just supply your comments.  If you have a question rather than a comment, put a ? at the end of it.  If you see a question, just reply to it if you have the answer, using the same format.

I will start with the standards and certification rule, and I hope others start with the incentives rule.  If we each pick our favorite parts to review first, we could have a twitter assessment before ONC and CMS get off the stage.  Of course there's always the chance we'll have nothing to talk about, but I live in hope.

Query Health and Quality Measurement

Query Health has a great deal of promise to improve the ability of public health and clinical research to access clinical data.  And of course, being based on HQMF, the big promotion for it is what it will do for quality measures.  As Dr. Michael Buck and Rich Elmore pen in their announcement (see the bottom half) with regard to quality measures:

 "... the cycle time [for quality measure development] could go from years to days"

Whoa, Nelly.  Days? 

From a technical perspective, I'd say months, but it is still a dramatic improvement.  What Query Health will do is enable providers to access their data to measure performance quite easily.  But delivering a quality measure is much more than being able to access the data and computing a score.  Query Health may deliver vast improvements there, but it still won't address the non-IT issues.

One of the major challenges in Quality Measurement is in how to deal with "exceptions" and "exclusions".  Exclusions are cases where the measure doesn't apply to a situation where it might otherwise be relevant (e.g., patients with certain types of conditions that don't really fit into the measure criteria).  Exceptions are cases where even though everything else fits, there is a good reason not to count that situation as being detrimental to quality (e.g., patient refused treatment) because it is not something that the provider can control.

The collection of situations which may need to be excluded varies depending on the measure.  And to be able to apply these to the measure means that providers will likely need to change their workflow to capture the reason why the measure may not apply.  To compute the measure means that the data has to be there.

You can still compute the measure without exception or exclusion data.  It just results in a different value.  Failures to accurately capture the necessary data won't neccessarily be apparent in the computed result.  This isn't really a technical problem.  Give the computer the data, and it can compute the result.  Give it inaccurate data, and it will compute an innacurate result.  Query Health doesn't have any special protections against GIGO.

When you implement a measure, you need to avoid GIGO.  Doing so may require changes in workflow to capture the neccesary information.  Changes in workflow don't happen in days, and that is why I say months.

The Clinical Quality Measure workgroup is looking at improving the overall process for measure development.  Exceptions and exclusions are a critical part of that process, because of the challenges they provide for implementation.  I don't think the solution here is a technical one.  Query Health will help, but it isn't a silver bullet.
  -- Keith

Unanticipated Concequences, Process and Predictability

Meaningful Use has been all the buzz at HIMSS, but not in the way that HHS would have desired this week. Someone yesterday suggested that since we are in Vegas, we should start a betting pool on when it would drop.

I was talking to my 13-year old on Sunday about it, and the challenges that we faced at HIMSS. She knows how frustrated I've been. "Why can't they talk about it?" She asked me. "There's a process they have to go through, " I explained "and until it is released, they cannot say anything about what will be in it because it could provide unfair advantage to anyone who wasn't there when they did discuss it before it became publicly available. And, that's the law, and there really is a good reason for it."

I think the one lesson learned here is that the unintended consequence of having a process, is that sometimes it can get in the way of other objectives. Where it produces predictability in terms of quality, it can have undesirable impacts on time, and vice versa.

From the perspective of a standards developer who has been observing ONC impatience with standards development, I now get to see how the shoe fits when it is placed on their feet. In standards development, there are consensus-based processes, and those processes require the right amount of time to be beneficial. It doesn't matter that you wanted this yesterday, it's going to take as long as it takes to get it done right, and those needing the results will have to wait if they want a quality product.

While process does provide for predictability, it doesn't do address all factors equally. There are always trade-offs. Maybe this will be a lesson that can be learned from on all sides.

2011: A Year in Review at HIMSS12

HIMSS is always a bit like New Year's Day for me.  It provides a pretty clear dividing line between what I did last year, and what I'm doing in the year to come.   Quite a bit of what I worked on for the last year shows up in the Interoperability Showcase at HIMSS, or as presentations in the HL7 Booth, or even presentations in our own booth.

Some of the stuff I worked on over the last year includes:

• CDA Consolidation Guide - This HL7 Implementation guide takes work that I've been involved with in three different organizations over a five year period spread across dozens of documents and puts it all together in one place, and starts to make it computable.  You can get the HL7 Trifolia Workbench with the Consolidation Project data entered from HL7 here.
• Much of the work I did in the ONC S&I Framework project for Transitions of Care earlier this year revolved around the CDA Consolidation guide, and the previous HITSP C83 and IHE PCC Technical Framework efforts. 
• The IHE PCC Reconciliation profile, while not on display here, addresses issues about how to record reconciliation of problems, medications and allergies.
• The IHE ITI XDS Document Workflow profile which will be discussed at the showcase.  This promises to simplify the automation and tracking of the various workflows that providers implement across multiple organizations to provide patient-centered, accountable care.

At the same time, many new things that I'm also working on this year will be discussed, and even shown at the show:

• The most obvious of these are the Query Health Demonstrations on Wednesday and Thursday.  We get to compete with CMS and ONC discussing (we hope) Meaningful Use Stage 2 on Wednesday morning, but I hope some of you will show up anyway, and if you miss it then, come see us at the Interoperability Showcase on Thursday morning.  Query Health marks a pretty significant transition point for me, as my focus on standards moves away from CDA and towards HQMF.  I suspect that I'll be spending significant amounts of my time in standards focusing on quality measurement and clinical decision support as a result of it.
• As I said, HQMF is going to be important, and I'll be spending a good deal of time in the coming months working on that, and also on QRDA.  I've written so much lately on HQMF that I suspect you are probably tired of hearing about it.  QRDA is another third of that picture (and it would take a whole blog post to explain about the missing third, which I'll likely write AFTER HIMSS).
• The IHE Request for Clinical Knowledge profile takes over where HITSP left off with T81.  IT's essentially a new revision of the HITSP work.  One of my colleagues will be showing what we've done with T81 with the CDC at a customer site Tuesday afternoon in the Interoperability Showcase, and I'll be talking ever so briefly about how this is influencing the work on this new IHE Profile that takes advantage of the HL7 InfoButton standard.
• Workflow, Workflow, Workflow.  That pretty much describes the rest of IHE PCC's work for the year, with new profiles on Referral, Remote Monitoring and Tumor Boards being developed over the course of this year.  Our transition into workflow has expanded the reach of the IHE PCC domain into Italy, the Netherlands and other parts of Europe, with much of the work being driven in these areas from outside the US.  It only makes sense, because these countries have a much longer history with Health Information Exchange, and are more ready for this logical next step.
• CDA Release 3 continues to grab some of my attention, and I expect that I'll be more involved as it get's closer to being ready for it's first ballot, which will almost certainly happen this year

And of course, there's the ever looming Meaningful Use rules, which we hear should be available Tuesday (hopefully in the morning).  While I haven't been responsible for either the legislation or the regulation, clearly the work that I've been involved with in HL7, IHE and the ONC S&I Framework has had some small influence in the Standards and Certification rule.  I look forward (along with all the rest of you) to see how they turn out.