The August HIT Standards Committee Meeting

The agenda began with comments from Jon Perlin and me reflecting on the busy Summer, reacting to the final rules, and planning for the future of policies and technologies to support interoperability. I summarized my experience with questions and feedback on the Standards Final Rule. Thus far, questions about consistency of content, vocabulary, and standards named in quality measures have been clarified without requiring changes in the rule.

Sam Karp and Aneesh Chopra summarized the Enrollment Workgroup deliverables that satisfy the requirements of Section 1561 of Affordable Care Act. The recommend use of the NIEM framework to support standards and processes going forward. They recommend the creation of web services on top of existing legacy systems as well as create a reference implementation of running software that could be used by states and other stakeholders (note, this does not imply creating a single Federal hub for all transactions). They recommended use of the HIPAA Content standards (834, 270, 271) and codification of human readable business rules using tools such as OMG’s SBVR. Finally, they made a number of privacy/security recommendations that highlight consumer access to data and disclosure logging.

Deven McGraw and Paul Egerman summarized the Privacy & Security Tiger Team Recommendations. Most important are the consent recommendations that require the patient be provided with an opportunity to give meaningful consent before the provider releases control over exchange decisions. The trigger is when the decision to disclose or exchange the patient’s identifiable health information from the provider’s record is not in the control of the provider or that provider’s organized health care arrangement (“OHCA”), patients should be able to exercise meaningful consent to their participation.

Doug Fridsma provided an overview of Standards and Interoperability Framework and its associated RFPs.

The awardees thus far are:

Harmonization of Core Concepts (NIEM Framework) - Deloitte

Implementation Specifications - Deloitte

Pilot Demonstration Projects - Lockheed

Reference Implementation - Lockheed

Testing - Stanley

Tools and Services - Stanley

The role of the HIT Standards Committee will be to provide oversight, coordination and prioritization advice on the Standards and Interoperability Framework to ONC.

Jamie Ferguson presented the Vocabulary Task Force Update.

Judy Murphy and Liz Johnson presented the Implementation Workgroup Update.

The work ahead in September is defining the Standards requirements for Meaningful use Stage 2 and 3. It will be a busy Fall!

A Meaningful Use and Standards Rule FAQ Part II

As a followup to the HIMSS Webinar I gave last week, here's an FAQ in the spirit of last month's Meaningful Use and Standards Rule FAQ.

1.. The Emergency Department is mentioned in 9 Core Measures and 3 Menu Measures, yet industry discussions seem to focus on the ED for CPOE and Discharge instructions. What functions do ED Information Systems need to support? Are these functions for just admitted patients or all ED Patients?

In my conversations with CMS, I believe that CMS will be issuing a corrections notice to clarify the role of the ED in the rule.

2. There are 44 Quality measures for Eligible Professionals. Do EHRs need to support all 44 measures to be certified?

To achieve certification, EHRs must support the 3 Core Measures, the 3 Alternate Quality Measures and at least 3 others from the remaining 38 measures.

3. Can eligible professionals from ancillary service providers such as stand alone radiology imaging centers qualify for meaningful use?

Although it seems a bit of stretch, if these professionals can meet all the meaningful use measures, then can qualify. This implies that radiologists will have to chart weight/height, ask about smoking status, record race/ethnicity etc.

4. The original implementation guide for the CCD specified one preferred vocabulary for each data content type. The Final rule includes SNOMED-CT and ICD9 as problem list vocabularies. Is there an inconsistency?

No, the C32 2.5 implementation guide supports all the vocabularies specified in the final rule. See Keith Boone's blog for details.

The XML for CCD in the C32 v. 2.5 implementation can accept any vocabulary for structured data elements.

5. The Quality Measures in Meaningful use mention vocabularies like RxNorm and SNOMED-CT to compute numerators and denominators. The Standards Final Rule offers vocabulary options. Is this an inconsistency?

No. The Final Rule for certification indicates “Any source vocabulary that is included in RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine.” The Final Rule further difines the following source vocabularies as being included in RxNorm: GS – Gold Standard Alchemy, MDDB – Medi-Span Master Drug Data Base, MMSL – Multum MediSource Lexicon, MMX – Micromedex DRUGDEX, MSH – Medical Subject Headings (MeSH), MTHFDA – FDA National Drug Code Directory, MTHSPL – FDA Structured Product Labels, NDDF – First DataBank NDDF Plus Source Vocabulary, NDFRT – Veterans Health Administration National Drug File – Reference Terminology, SNOMED-CT – SNOMED Clinical Terms (drug information), and VANDF – Veterans Health Administration National Drug File. “Consequently, an one of these “source vocabularies” identified by NLM may be used, or any other source vocabulary successfully included within RxNorm.” (pages 132-133 of DHHS Final Rule 45 CFR Part 170, RIN 0991-AB58)

In creating value sets for the measures, providing 11 options (those listed in the Final Rule) was overly cumbersome, as was selecting NDC codes. By listing medications with RxNorm codes, the measures allow any user of an acceptable source vocabulary to map to the medications required by the measure. The measure criteria, therefore, can be used by any compliant EHR that uses a source vocabulary.

In general the measure specifications provide currently used terminologies as expected in the Final Rule. However, since there is a requirement for billing to use ICD-10 by 2013, the measures also provide, for those considering future implications, ICD-10 and SNOMED for appropriate concepts. While ICD-10 and SNOMED are not required, many have appreciated the ability to consider how to map their local term usage to these potential future options. Note, all measures provide “Groupings” (or nested) value sets which include a number of options. For example, all conditions (diagnoses) include ICD-9, OR ICD-10, OR SNOMED. There is one exception: persistent asthma is not an available concept in ICD-9. Therefore the measure provides an option of “persistent asthma” in ICD-10 OR SNOMED; it also provides the option of “asthma” using ICD-9 with a constraint that severity = persistent. The measures do not seek to require any terminology that is not specified in the Final Rule. The decision to include ICD-10 and SNOMED options was a conscious decision made in concert with CMS.

6. The Syndromic Surveillance implementation guide in the Final Rule seems to be the wrong document - it's the CDC's "Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting Final Version 1.0 and Errata and Clarifications National Notification Message Structural Specification" which is for disease reporting, not symptom reporting.

It's true that the wrong implementation guide is included in the final rule. ONC is hard at work correcting this. We'll discuss it today at the HIT Standards Committee August meeting.

Cool Technology of the Week

In my recent hiking trip on the John Muir trail, I limited my pack weight to 10 pounds so that I could cover 25 miles a day.

Some backpacks weigh 4-5 pounds when empty.

Mine weighed 13 ounces. It could have weighed 6 ounces if I gave up a bit of durability.

I used the Zpacks Dyneema X 26 holding 2,600 cubic inches.

Dyneema Gridstop is a heavy duty 4.2 oz/square yard. Each white Dyneema thread can hold over 150 lbs. A secondary ripstop grid is angled at 45 degrees.

I've successfully used Dyneema for my outdoor activities for years.

It's abrasion resistant, puncture resistant, and completely sufficient for supporting typical backpack gear weights.

As I hiked, I watched numerous people struggling with 35-50 pound packs.

My advice - start with an 13 ounce pack and only carry what you'll need. You'll enjoy the experience instead of struggling with every step.

A 13 ounce backpack that's stronger than steel - that's cool.

The Stages of Life

Recently my 17 year old daughter and I discussed my nearly 50 years of experience with life, the evolution of my mindset through time, and my thoughts about roles/responsibilities at each age. I summarized life as

0-10 A time to master the day to day activities of being human

11-20 A time to master the process of learning

21-30 A time to experience the world, take risks, establish relationships, and seek stable employment

31-40 A time to build a household, a family, and a career ladder

41-50 A time to build financial security, support growing children, think about wellness, and nurture your relationships

51-60 A time to fund college, assist adult children with their increasing responsibilities, and to support aging parents

61-70 A time to begin the transition to a different phase of life, pursing those activities that you did not have time or resources to do in the past. Note that this phase is getting later and later in life with many people working past 70. A time to start playing with grandchildren and assisting your children's growing families. Continuing to support aging parents, given increasingly long human lifespans.

71+ Exploring new ideas, new places, keeping your mind and body healthy, aging well.

To which my daughter responded - "How depressing...that you think of life as so linear"

I suggested that life is anything but linear. When I was 5, I wrote a first grade homework assignment declaring "I want to be a scientist". When I was 12, computer science seemed like the right direction. When I was 16, medicine and engineering seemed the right approach. Now nearly 50, I'm a CIO, married for 26 years, with a 17 year old daughter. Completely unpredictable and more of random walk than a linear progression.

Of course, my suggested life timeline is a bit traditional and stereotypical. There are hundreds of variations that may involve zero or multiple marriages, zero or many children, zero or dozen careers. I will not measure my daughter's life success by her adherence to my timeline.

Pondering my life experience, I realize that my current mindset in the 41-50 span includes a different set of challenges, goals, and dreams than in my 21-30 span. I'm continually changing. I remember the pride I felt when I exceeded some of my parents capabilities when I was in 11-20 span. I now feel great humility as my daughter begins to exceed some of my capabilities at the same time in her life.

When I'm asked what span is best, my answer will always be, wherever I am now. My current experiences, frustrations, and relationships always seem most appropriate to my current condition. I only look backwards to gather lessons learned, not to relive any previous events. I recently skipped my 30 year high school reunion because the joys and sorrows of my 11-20 span are no longer relevant after the experiences of three decades.

At times, I struggle with the politics, conflicts, and uncertainties of daily living. I think back on the challenges of my 20's and 30's and realize that any anxiety I felt earlier life was over minor and inconsequential events. In my 50's I'm sure I'll feel that same way about my 40's. Realizing that life is a continuous progression with different roles, responsibilities, and expectations at each stage enables us to look forward to the future, relish the present, and learn from the past.

Onward to the stages ahead!

Consent Recommendations from the Privacy Tiger Team

I've written several blog posts about the need for consent policy and technology.

For 2011, the Meaningful Use Stage 1 data exchanges are a "push" of data from provider to public health, quality registries, and other providers. Consent is obtained by the provider when the patient is present during an episode of care. The consent process will be driven by Federal/State policy and workflow rather than technology.

For 2013, the data exchanges are likely to be "pull" based on patient controlled consent for release of information from institutions. The consent process will be a marriage of policy and technology.

On August 19, the Privacy and Security Tiger Team released its recommendations for the consent policy to support Stage 1 data exchanges.

Here's a powerpoint summary.

Key points include:

When the decision to disclose or exchange the patient’s identifiable health information from the provider’s record is not in the control of the provider or that provider’s organized health care arrangement (“OHCA”), patients should be able to exercise meaningful consent to their participation.

where meaningful consent is defined by

Advanced knowledge/time

Not compelled, or used for discriminatory purposes

Full transparency and education.

Commensurate with Circumstances

Consistent with Patient Expectations

Revocable

Although granular consent is a desirable future goal (i.e. line item redaction of medications depending on the recipient of the data), technology has not yet evolved to the point where this is widely implementable. It is important that ONC find evidence (such as through pilots) for successful models and not rely on theoretical possibilities. In the interim, patient education is paramount. Realistic expectations about privacy need to be established.

State Health Information Exchanges are busy defining their own policies and technologies to support Meaningful Use Stage 1 Data Exchanges:

Core Set

1. Provide patients an electronic copy of their ambulatory, ED or inpatient summary of care record record

2. Transmit prescriptions

3. Capability to exchange key clinical information among care providers and patient authorized entities

4. Report clinical quality measures

Menu Set (must include at least one public health reporting transaction)

5. Incorporate clinical lab tests results into EHRs as structured data

6. Provide summary of care record for patients referred or transition to another provider or setting

7. Capability to submit data to immunization registries, provide syndromic surveillance and lab data to public health agencies

The guidance from Privacy and Security Tiger Team provides a valuable framework to inform state activities. In Massachusetts, we have Chapter 305, which requires opt-in consent for data sharing.

By adopting a national policy that ensures providers educate their patients about Meaningful Use data exchanges and obtain consent before sharing information with outside organizations, we will ensure that patient privacy is protected.

The Role of a Leader

I've written many blog posts about leadership and the challenges of running large complex organizations. Recently, I've thought about how I have personally changed during my 15 years in healthcare leadership positions.

In my early years, the initial challenges were to break through technical barriers by creating prototype applications and demonstrating the possibilities of the emerging web in the mid 1990's.

I then progressed to organization building, devising the strategy, structure and staffing of a growing IT organization.

From there I evolved to thinking about processes - how to ensure reliability, security, and performance of complex infrastructure and applications.

I then moved on to education - writing and speaking about our efforts inside and outside my organizations.

Where am I today as a leader? I believe I'm a convener.

Whether it's my Federal, State, hospital or medical school roles, my most important leadership task is assembling people with various opinions, some of them very vocal, and achieving a set of priorities, next steps, and policies.

In some ways, I'm becoming less technology focused and more business focused. Many of the technologies that were risky/bleeding edge a few years ago - the web, clouds, clusters, enterprise storage, and thin clients, are now mainstream. My day is less about getting the technology working right and more about ensuring we're using the right technology to meet the needs of business owners. Unfortunately, many business owners do not know what they need, although they have high expectations.

The theme of my next leadership year will be governance.

Of course there is meaningful use, EHR implementation, and privacy policy change - but convening stakeholders via a recognized governance model is a prerequisite to getting those done.

It's painful at times to gather everyone together and hear a multitude of diverse opinions, some of which may be factually incorrect and many of which can be critical. All of us are tempted to 'wait to speak' instead of listen. However, the best way I can serve my staff and ultimately all my stakeholders is to condense the messiness of contentious viewpoints and competition for resources into a well communicated list of priorities.

Now that Meaningful Use Stage 1 and the Standards Rules are final, the pace of my Federal responsibilities will be a bit less. This will give me a chance to focus on Massachusetts and hospital/medical school governance. The measure of my success should be the projects we decide NOT to do, since great governance will set priorities and align them with limited budgets and fixed timeframes. A sign of failed governance is saying yes to everything, flogging staff until they resign in fatigue, and creating general dissatisfaction throughout the organization because scope is too large and resources are too small.

Convening and governance will be my role as a leader over the next year. Only when I can master that can I progress to my next leadership stage.

Experiencing Healthcare with my Family

I've been lucky when it comes to health issues. In my 48 years of life, I've had Lyme disease twice (still not out of the woods), a corneal ulcer caused by windblown grit while kayaking across the Baltic Sea, a benign AV nodal reentry tachycardia, a kidney stone from dehydration, and elevated intraocular pressure (multiple generations of males in my family history had glaucoma). I've never broken a bone, had any GI/Neuro/Pulmonary/Rheumatological issues or taken any chronic medication, other than Xalatan for my intraocular pressure.

My family history is otherwise unremarkable.

Thus, it came as a complete surprise when the call came in at the end of last week that my father was having a posterior/inferior myocardial infarction and was on his way to the cath lab to be stented.

On Thursday night my wife and I flew to Los Angeles to be with him in the ICU.

The process of medical care is like any complex project - there's a technical part and there's a people part. The doctors and nurses did a remarkable job on the technical part. The role my wife and I played was to manage the people part - building confidence in my parents that everything would be okay, that the quality of life would be just fine, that returning home would be safe, and that the future would be bright.

We stocked the refrigerator with low fat vegan foods. We helped interpret patient education materials, discussed life style recommendations, and managed the process of transitioning from inpatient to outpatient.

Hospitals are a great place in a crisis, filled with professionals who can medicate, operate, and heal. But the larger social context of healthcare - the orchestration of emotions, calming of fears, and regaining the cadence of daily life requires a support system.

In the past, extended families lived together or at least clustered together in a community. With increasing specialization of employment, a challenging economy, and the ease of long distance travel, we've lost many of our family support systems. What I experienced was a remarkable coming together of a virtual extended family in support of my father. Colleagues, former employees, and friends gathered together to support my parents. My father was rarely alone during his ICU stay. In a world that can be filled with road rage, competition for resources, and a lack of civility, I was grateful to experience healthcare supported by the community around my family.

The circumstances, a heart attack, were bad, but the outcome was good. My father is back home, back to his usual routine, and the love and respect of his network of supporters will always be with him.