The February HIT Standards Committee Meeting

The February meeting of the HIT Standards Committee included an in depth discussion of the Stage 2 Standards and Certification NPRM, updates from the projects in our 2012 HITSC work plan, and an overview of HITPC plans for 2012.   It was one of the highest energy, most optimistic meetings we've had.

We began the meeting with a review of the Standards and Certification NPRM by Steve Posnack and Doug Fridsma.  As I noted in my recent post about the NPRM, most of the HITSC "Summer Camp" recommendations were accepted.   Highlights from their presentation:

*In Stage 2, Certified Electronic Health Record Technology (CEHRT) will be "just enough" to support the functions documented during attestation.     In Stage 1, certified technology  was required for menu set items that were not part of an organization's attestation i.e. even if you did not plan to submit syndromic surveillance data, you needed to buy that technology anyway.  
*Every eligible professional/eligible hospital/critical access hospital (EP/EH/CAH)  must have a "base EHR"  that includes the ability to capture demographic data/patient history/problem lists, provide decision support, support provider order entry, record data needed to report quality, exchange electronic information, and protect confidentiality
*In addition to this base EHR, every EP/EH/CAH should have the EHR technology with capabilities for the MU core and menu set objectives they seek to achieve.  These can be a collection of modules or a complete EHR.
*Clinical Quality certification includes the ability to capture, calculate, and report clinical quality measures.   It's completely fine to use certified EHR technology to capture the data, then export it to another certified technology for calculation and reporting.   This is what BIDMC does today and to achieve it we had to do self-certification.   Now, anyone can use this approach, assembling certified components from vendors.
*The Standards specified in the 2014 Criteria include
  Content - Consolidated CDA for summaries, NCPDP for eRx, HL7 2.5.1 for public health
  Vocabulary - CVX for immunizations, SNOMED-CT for problem lists, ICD10-CM for diagnoses, LOINC for labs, RxNorm for meds, OMB, ISO639-1 for spoken language, CDA for cancer submissions 
  Transport - Direct Specifications and NwHIN Exchange
  Security - FIPS for encryption, NTP for time
*The MU Stage 2 Menu set includes  several functions with evolving standards such as Imaging display in EHRs, transmission to clinical registries, cancer case information, and family health history.  That's why they are menu set

Initial reactions from the HIT Standards Committee included

   TLS should be listed as an acceptable transmission standard for data exchange with patients
   Organizations with internal pharmacies should be allowed to use HL7 for eRx of discharge meds
   Quality reporting XML needs additional work on content, vocabularies, data model
   Imaging in MU should be clarified (view/access/transmit in an EHR or via an EHR)
   Allergy terminology should be included in the Standards Final Rule - RxNorm for meds, NDF-RT for drug classes, SNOMED-CT for non-meds
   Our focus should be the adoption of SNOMED-CT as the clinician facing vocabulary, not ICD-10
   XDR as a transport standard should be optional, as was defined in the Direct Project
   Patient Portals - Direct should be used with patients i.e. EHRs should be able to "cc the patient"
 
Next, Betsy Humphreys presented the Vocabulary and Code Sets update  focusing on SNOMED0CT, LOINC and RxNorm tools.  A new API to access cloud hosted SNOMED-CT resources from NLM will be available in March 2012.

Next, Dixie Baker presented the NwHIN Power Team review of NwHIN Exchange implementers comments.   Major themes included
*Complexity seems to be related to the specifications themselves which include optionality and layers of references to other specifications (indirection).  There was no specific complaint about SOAP or the need for REST
*No current Exchange implementation is being used for large scale production except the SSA's disability determination project
*The Exchange Patient Discovery architecdture lacks scalability

Next, Paul Tang presented the 2012 HITPC work plan.  He reviewed the 5 year vision with 2011being capture of structured data, 2013 being HIE/Care Coordination, and  2015 being outcomes measurement and improvement.   The 2012 work plan includes
*Q1 discussion of MU Stage 3 principles, review of the MU Stage 2 NPRM, governance, next generation quality measures
*Q2  Quality measure lifecycle, patent generated data, information exchange, EHR safety
*Q3  Stage 3 draft recommendations, long term and post-acute care, governance NPRM
*Q4   Reconcile MU3 Recs with Stage 2 Final rule,  HITSC feedback on stage 3 , Consumer eHealth, Strategic plan revisions

Next, Jim Walker presented the work plan for the Clinical Quality Workgroup.

Finally, Doug Fridsma presented the S&I Framework update identifying the levels of support currently available - Self Service, Limited Service, Strategic Support and Full support.  S&I portfolio of new work includes longitudinal coordination of care, electronic submission of medical documentation signatures and content, query health, and data segmentation for privacy.

Thus, the HIT Standards Committee is on track for our 2012 work plan, the first quarter of which includes 4 projects

a.   NPRM review
b.  Quality measurement
c.  NwHIN Exchange refinement
d.  Value sets/vocabulary mapping

At the next meeting, we'll review our collective comments on the NPRM (gathered from each of our workgroups) and ensure we're on the right trajectory for our next quarter's work on standards governance, Query Health, Radiology Standards and NwHIN supporting components (Provider Directories, PKI).

S&I Framework Implementation Guides

Now that the Stage 2 Standards and Certification NPRM has been released, many people are asking me for the detailed implementation guides that will support it.

The S&I Framework website is being enhanced to make their work products easier to find.

In the meantime, here are some of the major S&I Framework resources

Final DNS/LDAP Hybrid Specification for Direct Project Certificate Discovery

Final Data Model for Query/Response to the Provider Directory for electronic service information (implementation guidance forthcoming):

Latest Laboratory Reporting Implementation Guide (will be balloted a second time at HL7 this spring)

Final Consolidated CDA Implementation Guide

We're getting closer to our goal of one stop shopping - a single website with all the content, vocabulary, and transport standards needed for certification.

The Stage 2 Standards and Certification NPRM

On Friday, ONC released the Standards and Certification NPRM, the companion to the the CMS Meaningful Use Stage 2 NPRM.

Here's a bookmarked PDF  - thanks to Tony Panjamapirom of the Advisory Board.

In my view, the NPRM is a work of art, reflecting the work of the HIT Standards Committee, the S&I Framework, and  the multi-stakeholder consensus that fewer, more complete standards with less optionality will lead to greater interoperability.

I've always thought of healthcare standards as having three components -  content, vocabulary, and transport.

For content, the NPRM specifies HL7 2.51 for lab results, syndromic surveillance, reportable lab, and immunizations (HL7 2.31 is not longer an option).   For summary transactions, the Consolidated CDA is the only recommended standard.   (CCR and CCD/C32 are no longer specified).    NCPDP is specified as standard for the exchange of prescription information between entities, including for discharge medications.

For vocabularies, the NPRM specifies a single vocabulary per domain, just as HITSC recommended
Lab - LOINC
Medications - RXnorm
Problem Lists - SNOMED-CT
Discharge Diagnosis - ICD10-CM
Immunizations - CVX
Demographics preferred language - ISO 639-1
Demographics preliminary cause of death ICD10-CM

For transport, two standards are available, consistent with the Direct Project - SMTP/SMIME and SOAP.   A RESTful option is not specified, but ONC recognizes that a RESTful implementation guide may be available in the future.

The 2014 edition of the Standards and Certification NPRM eliminates the "OR", since this standard OR that standard implies that vendors need to support both, creating an "AND" for implementers.  

The ONC NPRM is clear, unambiguous, forward looking and reasonable.   Congrats to the team who wrote it.

A First Look at Meaningful Use Stage 2

The Meaningful Use Stage 2 Notice of Proposed Rulemaking was released today at 4:15pm.  It represents the work of hundreds of people from every healthcare stakeholder group.   I'll summarize all 455 pages this weekend and give two webinars next week (Greater New York Hospital Association and a special session for the Harvard School of Public Health).  

For now, I recommend you read this summary on pages 156-163 to understand that EPs must meet or qualify for an exclusion to 17 core objectives and 3 of 5 menu objectives.   Also that eligible hospitals and Critical Access Hospitals must meet or qualify for an exclusion to 16 core objectives and 2 of 4 menu objectives.

Other key points from the executive summary:

*For EPs, we propose a set of clinical quality measures beginning in 2014 that align with existing quality programs such as measures used for the Physician Quality Reporting System (PQRS), CMS Shared Savings Program, and National Council for Quality Assurance (NCQA) for medical home accreditation, as well as those proposed under Children's Health Insurance Program Reauthorization Act CMS-0044-P 18 (CHIPRA) and under ACA Section 2701.

*For eligible hospitals and CAHs, the set of CQMs we propose beginning in 2014 would align with the Hospital Inpatient Quality Reporting (HIQR) and the Joint Commission's hospital quality measures.

*This proposed rule also outlines a process by which EPs, eligible hospitals, and CAHs would submit CQM data electronically, reducing the associated burden of reporting on quality measures for providers. We are soliciting public feedback on several mechanisms for electronic CQM reporting, including aggregate-level electronic reporting group reporting options; and through existing quality reporting systems. Within these mechanisms of reporting, we outline different approaches to CQM reporting that would require EPs to report 12 CQMs and eligible hospitals and CAHs to report 24 CQMs in total.

*Stage 2 meaningful use requirements include rigorous expectations for health information exchange including: more demanding requirements for e-prescribing; incorporating structured laboratory results; and the expectation that providers will electronically transmit patient care summaries to support transitions in care across unaffiliated providers, settings and EHR systems.

To understand the themes underlying Meaningful Use Stage 2, here's a great blog post from Health Affairs.

Finally, here's a powerpoint summary you can reuse for your own presentations - no attribution needed.  I've compared each criteria to its Stage 1 equivalent.

Our Cancer Journey (Week 10)

Kathy is now finished with the hardest part of her chemotherapy regimen, Adriamycin/Cytoxan.   Next week, she begins Taxol every week for the next 12 weeks.    Taxol is typically far less fatiguing than AC.    It does have a problem that it is suspended in an solvent that can cause allergic reactions.   Her regimen will include supportive doses of diphenhydramine (benadryl) and dexamethasone (a steroid).

At last week's checkup, Kathy's oncologist could no longer locate the tumor.

Her breast surgeon will order an MRI at the completion of the Taxol cycles and if the tumor is undetectable, Kathy may be able to have to breast conserving surgery rather than a complete mastectomy.

On Taxol, her hair will begin to grow back and her energy is likely to rebound.   However, she is quite concerned about one side effect - a neuropathy causing numbness in her hands.    As an artist, she depends on a keen sense of touch to create her work.

She will no longer need Neulasta (a bone marrow stimulant).   She welcome the fact that Neulasta protected her from neutropenic nadirs/infections but really did not like the bone pain/total body aches that it caused.

So the journey continues and we feel that we've turned the corner.   It's too early to see the light at the end of the tunnel, but at least the tunnel will be easier to traverse for he next 12 weeks.

Lessons Learned from China

On Sunday I returned from a week in Shanghai and Hangzhou.   A remarkable trip that included daily meetings with government, academic, and clinical leaders.   What did I learn?

In China, about 5% of the GDP is spent on healthcare per year compared to 16% in the US.    Although there is wide variation in lifespan and other population health measures between rural and urban settings, there are few interesting observations about Chinese healthcare

*It's a single payer, publicly funded system that provides universal healthcare via a 14% payroll tax.
*There is a single national set of regulations and policies applied to all hospitals, clinics, and doctors
*There is a single set of national privacy laws
*Immunization is mandatory for the entire population
*There's a single national healthcare identifier

EHRs are widely used in China, however they are optimized for episodes of care, using templates for capture of selected data elements specific to a disease i.e. hypertension, hepatitis, diabetes.    The volume of patients is overwhelming - in one hospital I visited (Huashan), the  dermatology clinic sees 4000 patients per day.    The Chinese EHR enables clinics to document the basics of a problem specific encounter, facilitating extremely fast throughput.   The downside of this is that there is not a longitudinal problem list, medication reconciliation, or coordination of care to avoid repeat testing.

Health Information Exchanges are beginning and in Shanghai and there's a pilot in place which enables data sharing among the public hospitals.   The Chinese have designed an architecture to support HIE in cities, provinces, and across the country.   The idea is similar to the US NwHIN - a network of networks that shares detailed data on a local level and summary data on a national level.

The Standards for HIE are in the early stage and I have shared the US approach to the Consolidated CDA.   The Chinese believe that using building blocks of XML to specify aspects of the record for transition of care is exactly what they need.

I travel the world and over the past year I've worked on aspects of HIE in Japan, Scotland, New Zealand, Europe, and China.    The problems are the same all over - capturing the data, protecting privacy, creating standards-based summaries, embracing vocabularies, and providing decision support.   It's encouraging to see such progress.  In my lifetime, I believe we will achieve a level of healthcare data capture and sharing that enables us to improve healthcare quality, safety, and efficiency throughout the world.  We'll solve these problems, so that the next generation will reap the benefits.

HIE Consent Policy

I was recently asked how consent policy can evolve in Massachusetts to balance patient privacy preferences and the need to coordinate care/optimize population health.    Here's the letter I wrote to stakeholders about it:

"My name is John D. Halamka MD and I serve as chief information officer of Beth Israel Deaconess Medical Center, co-chair of the Massachusetts HIT/HIE Advisory Committee, and co-chair of the  HIT Standards Committee.

In my role as a CIO and clinician, I have been passionate about the need to electronically coordinate care to improve quality, safety, and efficiency.

My wife was recently diagnosed with Breast Cancer and her treatment has relied on the secure exchange of healthcare records with her consent.

The consent model that has worked best throughout the Commonwealth is 'Opt in consent to disclose at each institution'.    This means that no data is exchanged between organizations until the patient consents to the release of information from the sending institution (the place where the data was generated).   This consent stays in force until a patient revokes it.  

A separate consent to view the data at the receiving institution is not needed.   There is no need to re-consent the patient at each episode of care.

We've implemented this model in the New England Healthcare Exchange Network (NEHEN), in the Department of Public Health immunization registry, and in the design of the statewide healthcare data exchange that the MassHealth is building.

Opt in to disclose is straightforward to implement and support.  It's easy to enforce and audit.

The one complexity to this approach is the data sharing of records containing HIV information.    Current and proposed Massachusetts regulations require opt in consent to view at each episode of care in addition to opt in consent to disclose.

Consenting the patient at each release of information is challenging to implement, difficult to audit, and likely impossible to enforce.   Security experts agree that easy to implement, easy to audit, enforceable approaches are much more secure than complex, challenging and cumbersome approaches.

I believe that Massachusetts stakeholders will support opt in consent to disclose at each institution as the single best approach for the release of all healthcare data.   Implementing this uniformly across the Commonwealth will ensure respect for patient privacy is maintained, care delivery organizations can support healthcare data exchange processes, and IT departments can implement the necessary applications.

As a CIO, physician, and husband of a cancer patient, I highly recommend we consider this simplification of current regulation and legislation.

Sincerely,

John D. Halamka MD"

Privacy protection will always be a journey, but we need to start somewhere and I hope my comments above seem reasonable.