Thursday, March 29, 2012

Our Cancer Journey Week 15

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Kathy can no longer feel her hands and feet.   The good, good, good days have become challenging days.    Kathy would normally push through it, but her oncologist advised us that being stoic increases the risk of permanent nerve damage.

Based on the advice of her care team, Kathy is taking a break from chemotherapy this week to enable her body to recover.

She's also taking Vitamin B6 (100mg daily) based on anecdotal evidence that B6 reduces numbness and tingling in patients receiving Taxol.

Together, we continue to pack up our house for the April 27th move to our farm.   We make a great team with Kathy doing logistics/operations planning and with me doing heavy lifting.    It's quite a "spa treatment" - I've lost 6 pounds in the past few weeks and gained significant upper body strength.   However, I do not recommend moving as a long term fitness strategy since the mental cost of displacing your entire household is high.

Although our move is proceeding on schedule, the sale of our existing home is on hold.  The bidders negotiated the final price and paid a $1000 deposit.   Our final contract was to be signed on March 26.   On March 23 they notified us that they were bidding on two houses and elected to forfeit their deposit.   Our house goes on the market today and our first open house is Sunday.   Hopefully we'll have a quick sale since the process of keeping a house in perfect showing condition is anxiety provoking.

Thus no chemotherapy, B6, a focus on moving to our farm and a wrap up of 16 years in our existing home is the plan for this week.   We remain optimistic, energetic, and ready for whatever the future will bring.

Wednesday, March 28, 2012

The Salesman End Run Around IT

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In my 15 years as CIO, I've experienced a gamut of sales techniques - the "end of quarter deal never to be repeated", the "we're your partner and you always get our best price", and the selling of products that don't yet exist.

However, today I experienced one of the most reprehensible - The Salesman End Run Around IT.

Don't like the answer IT is giving you?  Go to the CFO and try to convince financial leadership that IT leadership is squandering budgets.

Here's the redacted email that the salesman sent the CFO.

"From: Storage Sales Specialist at a large company
Sent: Wednesday, March 28, 2012 9:00 AM
To:  BIDMC Chief Financial Officer
Subject: Lower Storage Costs

I am the Storage Sales rep for the Caregroup hospitals.  We have been working with healthcare organizations that are typically XXX shops and saving them $500,000+ in storage cost and associated resources. We will guarantee that we migrate your current environment to 50% or less storage.  The industry leading analyst group Gartner has named our storage as the leader.

Why am I reaching out to you?  I met with IT a few weeks ago and they told me they didn’t have the time or the resources to evaluate new technology and they were happy with XXX.  I know healthcare organization have to think smarter and get more value out of the IT dollar.  Our storage is easier to manage (we have customers who reduce admin by 90%+ with our storage), our storage is faster, highly available (ability to have five 9’s reliability for critical applications) and has superior service/support.

Can I schedule some time with you next week to go into detail on how our storage can make your IT budget go further and give your stakeholders the best experience they deserve?  Please let me know a time that fits your calendar.

Best Regards,

Storage Sales Specialist at a large company"

I completely respect the challenges of commissioned salespeople and the difficulty that large companies face in a lackluster economy.   However, there is no better way to sour a long term relationship than to bypass the usual lines of hierarchy in an organization via an end run.

This salesperson works at a company I respect a great deal, so I believe this is an example of rogue behavior.  However, I welcome your comments and feedback - have you experienced the end run and how have you responded to it?

Tuesday, March 27, 2012

The March HIT Standards Committee Meeting

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The March HIT Standards Committee meeting focused on a review of the Standards and Certification NPRM, as well as planning for our upcoming second quarter work on the NwHIN portfolio, QueryHealth, Radiology image exchange standards, and governance.

Doug Fridsma began with an ONC update.  He described S&I Framework activities in 2011 that resulted in a single lab results implementation guide, merging the work of HITSP and CHCF/ELINCS.   This same approach will be used to create a single lab ordering implementing guide, including a standardized compendium of the most commonly ordered tests.   He described the plans for S&I Framework efforts on Clinical Decision Support standards.    He noted that ONC is looking at RESTful transport standards and the use of TLS for consumer mediated exchange.  He described further refinements to the NPRM that are needed to constrain Consolidated CDA (CCDA) in sufficient detail to ensure interoperability, such as the requirement to have specific templates for transitions of care.  Finally he described the future work needed on Health Insurance Exchanges and NIEM.

A robust discussion followed including the role of CCDA for longitudinal summaries verses episode of care summaries, the use of CCDA for  submission to registries/quality measurement entities,  and the possible use of CCDA for submission of data about multiple individuals in batch.

Next, Liz Johnson and Cris Ross described the Implementation Workgroup evaluation of certification criteria and testing procedures.   Here's a summary and here's the detail.

Highlights include a focus on workflows and testing procedures that are relevant to clinical environments in the domains of CPOE, e-Prescribing, Clinical Decision Support.  – The workgroup offered to develop clinical scenarios for use in testing such as ensuring EMAR implementations support the five rights - Right Medication, Right Dose, Right Patient, Right Time, Right Administration Method.

Jamie Ferguson provided an update on the Clinical Operations Workgroup and Vocabulary task force.    Issues include:
*The use of SNOMED-CT instead of ICD-10 for diagnosis.  If the intent is to gather clinical data, SNOMED-CT is best.    If billing classification is needed ICD-10 can be used.  There needs to be some criteria of usability for data entry of diagnosis.
*When e-Prescribing discharge medications, HL7 is often used inside an organization.  The NPRM does not include an HL7 option.  This may or may not be an issue because the NPRM does not describe workflows within an organization.
*The NPRM should include structured allergy vocabularies such as RxNorm for medications, UNII for individual ingredients, NDF-RT for categories, and SNOMED-CT for non-medications.   Since RxNorm includes UNII and NDF-IT, RxNorm CUI codes may work for all.
*Transmission - the Workgroup recommended both SMIME/SMTP and SOAP be required
*For patient access to view/download/transport, the Workgroup recommended TLS for transport and CCDA for download.
*For Family history, the Workgroup highlighted the adoption of the Surgeon General's Family History XML Format and tools, even though it is incomplete

Jim Walker provided update on the work of the Clinical Quality Workgroup, highlighting the work ahead on the journey to making quality measures easier to compute from existing EHR data.

Leslie Kelly Hall described the charter and work ahead for the Consumer Engagement Power Team.

Dixie Baker provided an update from the Privacy & Security Workgroup.   Highlights include the need to clarify the role of SOAP as an optional transport standards in the transitions of care as described in my recent post about transport.  She also discussed suggested improvements to patient audit log access, record download, and correction to records.

Finally, we emphasized the need for ongoing communication among ONC, workgroup chairs, and members to consolidate and coordinate all the NPRM input over the next month.  Liz Johnson was nominated as a person to serve as the HITSC representative to the HITPC Certification/Adoption Work Group, ensuring cross FACA coordination.

A great discussion and I'm very pleased with the progress we're making on the 2012 HITSC work plan.

Monday, March 26, 2012

The State HIE Privacy and Security Program Information Notice

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On March 22, ONC issued important privacy and security guidance to State Designated Entities.  It addresses concerns from State leaders and other stakeholders that health information exchange efforts have been hampered and slowed by the lack of consistent approaches to core privacy and security issues.  The Program Information Notice (PIN) provides clear national guidance.

It covers eight Core Domains
1. Individual access
2. Correction
3. Openness and transparency
4. Individual choice
5. Collection, use and disclosure limitation
6. Data quality and integrity
7. Safeguards
8. Accountability

Here's a summary of the highlights:

Access and Correction
Where HIE entities store, assemble or aggregate individually identifiable health information (IIHI), such as longitudinal patient records with data from multiple providers, HIE entities should make concrete plans to give patients electronic access to their compiled IIHI and develop clearly defined processes (1) for individuals to request corrections to their IIHI and (2) to resolve disputes about information accuracy and document when requests are denied.

Openness and transparency
Where HIE entities store, assemble or aggregate IIHI, individuals should have the ability to request and review documentation to determine who has accessed their information or to whom it has been disclosed.

Individual Choice
Push Model
Where HIE entities serve solely as information conduits for directed exchange of IIHI and do not access IIHI or use IIHI beyond what is required to encrypt and route it, patient choice is not required beyond existing law. Such sharing of IIHI from one health care provider directly to another is currently within patient expectations.

Pull Model
Where HIE entities store, assemble or aggregate IIHI beyond what is required for an initial directed transaction, HIE entities should ensure individuals have meaningful choice regarding whether their IIHI may be exchanged through the HIE entity.   Both opt-in and opt-out models can be acceptable means of obtaining patient choice provided that choice is meaningful

Use and Disclosure Limitation
In principle, a health care provider should only access the minimum amount of information needed for treatment of the patient.

Data quality and integrity
Where HIE entities store, assemble or aggregate IIHI, they should implement strategies and approaches to ensure the data exchanged are complete and accurate and that patients are correctly matched with their data.

Safeguards
HIE entities should conduct a thorough assessment of risks and vulnerabilities.

Accountability
HIE entities should ensure appropriate monitoring mechanisms are in place to report and mitigate non-adherence to policies and breaches.

In my view, these are very reasonable principles.   The use of "shall" and "should" in these guidelines is important to note.   Shall means your must and should means it's a good idea to try.   Should is used for more aspirational goals that need additional technology, standards, and policies.

Massachusetts goes live with its statewide HIE this Fall, so it was very helpful that no new regulations are required by the PIN for Push transport models.    The new guidance is completely aligned with the Strategic and Operating Plan we already have in process to replace existing paper-based workflows with electronic workflows leveraging current consent models.

Friday, March 23, 2012

Cool Technology of the Week

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I've often posted about transport standards and the need to accelerate interoperability by mandating a  method for EHRs to send/receive data from each other.

The Meaningful Use Stage 2 NPRM includes such a requirement for transport standards, making healthcare information exchange real.  Here's a capsule summary of what it says:

The NPRM proposes that EHR technology be required to implement the Direct specifications  - §170.202(a)(1) Applicability Statement for Secure Health Transport - SMTP/SMIME and §170.202(a)(2) XDR/XDM for Direct Messaging.  Products cannot be certified unless they support these transport standards.

Transport is also referenced in the Transitions of Care Meaningful Use objective.  To support this objective, ONC’s 2014 Edition standards and certification criteria proposed rule includes a certification criterion at § 170.314(b)(2) which would require EHR technology to be certified to the Direct specifications (mentioned above).  However, for this certification criterion, EHR technology is also able to be certified to the standard proposed for adoption at §170.202(a)(3) “SOAP-based Secure Transport Requirements Traceability Matrix 1.0” in order to accomplish the cross organizational transport among different vendor applications proposed by CMS as part of Stage 2.

As new transport implementation guides, such as REST, become available,  ONC will consider adding them as transport options.  The Direct specification certification will be required but others will be listed as viable optional alternatives.

Just as CCR and CCD were offered in Stage 1, then reduced to a single standard in Stage 2, Consolidated CDA, I believe that by Stage 3 a single transport standard will be chosen by the community as the harmonized approach for healthcare information exchange.

With Stage 2, we finally have a parsimonious set of required transport options that will break down data silos in healthcare.   That's cool!

Thursday, March 22, 2012

Our Cancer Journey Week 14

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Taxol's major side effect is peripheral neuropathy.    Kathy will receive the 4th cycle of Taxol this week.  At this point, she can no longer feel her fingers and toes.

As an artist, she depends on a fine sense of touch.   The peripheral neuropathy was the side effect we dreaded most.   She'll meet with her doctors on Friday to discuss next steps - possible change in medications and addition of other medications to reduce the intensity of numbness/pain.

She's tolerated the Taxol well, keeping up with her daily activities with the usual verve.  One other complication is that her nails are black and brittle.  The slightest impact causes extreme pain - imagine that brushing your nails against a counter feels like slamming your hand in car door.

As we continue with treatment, we're planning ahead for the end of chemotherapy in May, the imaging studies to evaluate the results of chemotherapy and the surgery to come.     I've cancelled all my international travel for the rest of the year and have minimized domestic travel to a single day trip to Washington or Chicago each month.    Whatever the future brings, we'll be ready for it.

My colleagues at BIDMC have been incredibly supportive, giving me the flexibility to join Kathy at chemotherapy appointments, to be available for heavy lifting when she needs help at home with activities that are too painful or awkward for her to complete on her own, and to relax my meeting schedule enough to bring better balance between my work and personal lives at a time when my family needs extra attention.

I know that it may seem ill advised to plan changes in our lives like purchasing a farm (closes April 27), selling our old home (closes May 2), and moving during cancer treatment.  In general, the consents for chemotherapy emphasize that major life decisions should be avoided.   However, as I've written about in other blog postings, part of winning the battle against cancer is taking control.    We've long wanted to live more rurally, and now that we're empty nesters and I've focused my job responsibilities on BIDMC and the State HIE, we're ready for a new beginning.    Sometimes a change in home with corresponding reduction of the stuff you own and refinement of the lifestyle you lead can be transformative.   What better way to plan for the completion of chemotherapy and surgery, than emerging from the cocoon of your old life as the butterfly in a new life.

Wednesday, March 21, 2012

Clinical IT Governance Update

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I've written many posts about the importance of IT governance to set priorities, align stakeholders, and allocate budgets.

Today, I will meet with the Clinical IT Governance Committee to discuss the 5 major IS projects in the BIDMC Annual Operating Plan, brief them about the Meaningful Use Stage 2 NPRM, and discuss 2012 State HIE initiatives.

Here's an overview of what I'll say

*Electronic Medication Administration Records - at BIDMC, we wanted to eliminate all handwritten orders in every care setting, so we aggressively implemented CPOE before automating Medication Administration Records.   Now that we have 100% electronic ordering, we're implementing projects that close the loop - checking patients, medications, staff ID, and active orders when medications are given to the patient.   We've developed a scope, a timeline, and a workflow that embraces both fixed bedside devices and mobile technology to document when, where, and how medications are administered, reconciling orders and doses given.   We buy technology when it is mature and robust.   In this case, we'll need highly innovative, integrated technology supporting a unique workflow, so we're building it.

*Clinical Documentation - at BIDMC, our ambulatory documentation is entirely electronic.   In our monitored units, all flowsheets are electronic.  On our wards, progress notes are still written on paper.   In 2012, we're designing inpatient clinical documentation to align with the needs of our ICD10 project.  We'll use templates, macros, and free text input to support computer assisted coding, reducing the burden on clinicians and coders who need to pick the right code from 68,000 diagnosis and 87,000 procedure choices.  

*ICD10 - Although Secretary Sebelius has announced an intent to delay ICD10 enforcement dates, the project is such an enormous undertaking requiring policy change, workflow change and technology change that we're continuing full steam ahead.   We're executing a multi-phase project that includes current state documentation, a gap analysis, and a remediation plan.

*Personal Health Records - Patientsite, our PHR, is used by over 60,000 people every month.   Since its inception in 2000, Patientsite has not had a major upgrade.   This year, we're enhancing the look and feel, adding Open Notes (patients viewing all notes written about that), and creating a mobile friendly version.

*Standardized project management including a single intake process - among the many departments of BIDMC, different techniques are used for project charters, Gantt charts, issue logs, status reports, and project intake.  This year, we plan to create a single set of uniform project management artifacts that can be used by all business owners on IS related and other projects.

In addition to ICD-10, future stages of Meaningful Use Stage 2 will require multiple years of technology and policy work.   I'll present a summary of the challenges ahead based on the Stage 2 NPRM requirements .

Finally, in October of 2012, the Massachusetts Statewide HIE will go live and we'll use the infrastructure to enhance data sharing with payers, providers and patients.   At the same time we'll want to share more, compliance requirements will suggest further restrictions on data flows.   It will be a delicate balance.

I look forward to the meeting tomorrow.  Being a CIO means there's always new challenges and life will never be boring!

Tuesday, March 20, 2012

Provider Directory Strategies

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The Office of the National Coordinator asked me to present the Massachusetts Provider Directory approach to the Provider Directory Community of Practice (CoP) on March 21.

Here's the powerpoint that I'll present tomorrow.

It highlights the decisions we had to make (Entity v. Individual, Central v. Federated, web API verses LDAP, etc)

Issue: Should we include organizations, individuals or both in the provider directory?
Answer: The directory should have a schema that enables lookup of entities (e.g., Organizations, Departments, State Agencies, Payer Organizations, Patient Health Record services) AND an individual's affiliation with an entity trusted by the HIE.  You can lookup John Halamka to discover that I'm affiliated with BIDMC, then lookup BIDMC to determine how to exchange data with my organization.

Issue: Should the Provider Directory be centralized or federated?
Answer:  The Provider Directory should be centralized at the State level, given lack of proven scalable approaches to federated provider directories standards and architecture.  However, Public Key Infrastructure can be federated based on the Direct DNS specification for certificate exchange.

Issue: How should we expose Provider Directory services to the Internet?
Answer: A SOAP-based web services API will support query/response, add/change,  and delete operations over the Internet.  An LDAP approach will support directory access for applications behind the MassHealth firewall.

Issue: How should we populate the provider directory?
Answer:  Commercial databases often lack timely updates.   In Massachusetts, we have several existing data sources to leverage including those used by payers for quality reporting, those used by provider organizations, and those used by the regional extension center.

Issue: How will we integrate this service into EHRs?
Answer: We will work with EHR vendors via a centralized program management office to procure software components that integrate provider directory and HIE transport services into the workflow of the EHR itself.  We will not force clinicians with certified EHRs to use a disconnected portal outside of their the EHR.

I look forward to speaking with the Provider Directory Community of Practice (CoP) to hear about approaches in other states and share lessons learned.

Monday, March 19, 2012

popHealth

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While in Chicago last Thursday, I was asked how we validated our quality measures when we moved from chart abstraction to automated computation of PRQS, Meaningful Use, Pioneer ACO, and Alternative Quality Contract measures via the Massachusetts eHealth Collaborative Quality Data Center (QDC).   This is an important question because Meaningful Use Stage 2 enables easy use of modular components outside the EHR such that data can be captured in the EHR and sent to a cloud based analytics engine via standards such as CCD/C32 for content and Direct for transport.

Initially we did spot checks to validate the integrity of the Continuity of Care Document data flows from electronic health records to the normalized QDC schema.

When Mitre Corporation offered to test their popHealth tool against 2 million BIDMC patient records to validate the Meaningful Use quality measures computed by our QDC, we jumped at the opportunity.

First, we ensured appropriate business associate agreements were in place to protect the privacy of patient data.   Next, we required all work to be done on site in the Quality Data Center to protect the security and integrity of clinical summary data.

Mitre ran the tool against 2 million BIDMC Continuity of Care Documents and compared the results to the reports generated by the QDC.

The results were enlightening.

The computations aligned well for most quality measures, justifying our early manual validation.

However, Mitre discovered ambiguities in the CCD specification itself that led to some differences in the calculations.     This was despite our use of this CCD implementation guide  which provides even greater specificity than the HL7 standard.

For example, the CCD does not specify an allergy vocabulary.   At BIDMC we use First Data Bank to codify medication allergies.   PopHealth expects RxNorm, the vocabulary standard required for exchanging medication history.   Even the Stage 2 NPRM does not specify an allergy vocabulary and we recognized the need to enhance the Stage 2 to include RxNorm for medication allergies (Penicillin VK),  NDF-RT for categories of medication allergies (all Penicillins and Cephalosporins) and SNOMED-CT for non-medication allergies (food and environmental agents).

I'll post other pertinent findings from the Mitre analysis after next week's debrief meeting.

Mitre demonstrated their work at HIMSS in the interoperability showcase as illustrated in the photograph above.

BIDMC and MAeHC were proud to participate in this event, which we hope provided lessons learned for other provider, payer, and government stakeholders wanting to compute quality measures in the cloud using popHealth.

Friday, March 16, 2012

The Chicago Healthcare Information Exchange

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On Thursday, I met with the Chief Medical Officers working group of the Metro Chicago Healthcare Council to discuss Healthcare Information Exchange strategy in a world rapidly moving toward accountable care organizations, patient centered medical homes, and global capitation.

Chicago has created a consolidated summary record for patients using technologies from Microsoft (aggregation and analytics) and HealthUnity (master patient index services).   CSC provides Systems Integration and Program Management.

Importantly, they've built governance, trust, a policy framework, engagement, and commitment from stakeholders in the greater Chicago metro area.

Their architecture is a bit different from the Massachusetts approach and it will be very interesting to compare lessons learned over the next year.   They are receiving HL7 feeds from participating hospitals, matching identical patient records together, and  aggregating the data using the kind of data-atomic attribute-value pairs suggested by the President's Council of Advisors on Science and Technology Healthcare IT report.

The centralized/consolidated summary record can then be accessed by authorized clinical users such as primary care physicians, hospitalists, and emergency departments.

The Chicago HIE will also offer secure messaging to support the kinds of push use cases we've discussed in Massachusetts i.e.

Referral/Consult
Admission notification
Post-encounter summary
Discharge Summary/Instructions
Lab Order/Results
Public health (SS, Imm., ELR)

They've worked hard to engage the Chief Medical Officers of the region's hospitals and to create patient demand for HIE services via consumer education.

A great group of people and definitely an HIE to watch!

Thursday, March 15, 2012

Our Cancer Journey Week 13

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It's week 13 since diagnosis and Kathy's will receive the 7th cycle of chemotherapy tomorrow. (3rd cycle of Taxol)

Kathy's hematocrit continues to trend downward (from 42 at diagnosis to 29 last week), her nails have turned black/brittle, and her eyelashes have disappeared, but the worst is over.   She's feeling fine, the tumor is undetectable, and she's tolerating Taxol very well.

Taxol typically does not cause a drop in hematocrit, so why the gradual downward trend over the past few weeks?  

Kathy received Neulasta as part of her 4 cycles of Adriamycin/Cytoxan.  Neulasta is a colony-stimulating factor  that encourages hemopoietic stem cells to produce white blood cells, avoiding the neutropenia and susceptibility to infection that was previously a serious problem with chemotherapy.   One issue with Neulasta is that it may encourage so many stem cells to differentiate into white blood cells that fewer red blood cells are produced, leading to a mild anemia.    Over the next few weeks, her bone marrow should return to normal and her hematocrit should rise.   The only consequence of a low hematocrit for Kathy has waning energy mid-day that necessitates a 15 minute nap.   Otherwise, her activities of daily living (including packing the house for our upcoming move) remain unchanged.

Her hair is beginning to grow back.  She wears head wraps for warmth around the house and while sleeping.   When we go out to dinner, she wears a wig (interestedly termed a "hair protheses" for reimbursement purposes) that is so attractive, her friends and family have grown accustomed to the style.  When her hair grows back, she'll likely get the same cut.

One unexpected consequence of having breast cancer is that Kathy has stopped eating Tofu and soy products that are estrogenic, given that her tumor is Estrogen Receptor positive and is "fueled" by estrogen.   Minimizing estrogenic foods seems reasonable.   She continues to get her protein from vegetable sources, but has also added eggs - remaining vegetarian but not vegan.    Given that we'll soon have a coop of chickens on our new farm property, having at least one person in the family who eats eggs makes sense.

Thus, her trajectory is positive, her clinicians are optimistic, and we're pressing forward with life, balancing the needs of our personal lives, family lives, and work lives.   We're in control, not the cancer.

Wednesday, March 14, 2012

Will Payers be the Business Intelligence Services of the Future?

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What is a payer/insurer?

Typically, payer organizations collect premiums from employers and individuals, process claims, and engage in a variety of case management/disease management activities to encourage the appropriate use of medical resources.   If they collect more premiums than claims paid,  their medical loss ratio is less than 100% and they earn a profit.

In a world of accountable care organizations and healthcare reform, new reimbursement methods will include global payments to providers, which implies the risk of loss will shift from the payer to hospitals and clinicians.   Payers will no longer need their large claims processing staff, nor create complex actuarial models.   They'll become very different organizations.

How different?

My prediction is that payers will become the health information exchange and analytics organizations that help hospitals and clinicians manage risk in a world of capitation.

I've said before that ACO=HIE+Analytics.

The payers are already making strategic acquisitions to build these new business models

Aetna acquired Medicity to gain expertise in healthcare information exchange.  Aetna had already acquired Active Health to gain access to its CareEngine analytics platform.

United acquired Axolotol to gain expertise in healthcare information .   United already had a comprehensive suite of analytic capabilities via its Ingenix subsidiary.   United rebranded the combination of HIE plus analytics as OptumInsight

Three of the nation's largest Blue Cross plans acquired Navinet for its real-time communication network that links physicians, hospitals, and health insurers.

Humana acquired AnvitaHealth for its real time analytics and decision support capabilities.

The next several years will be interesting to watch as the country gains experience from Pioneer ACOs (7 of the 32 are in New England and 5 in Massachusetts).

Watch the payers carefully.   As they acquire more HIE and Analytics businesses, I believe you'll see a shift from claims processing to wellness management and cloud-based provider services.

Tuesday, March 13, 2012

Surescripts Clinical Data Exchange

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Yesterday, Surescripts announced a national approach to sharing clinical summaries and public health data via its Clinical Interoperability Network:

"WALGREENS AND SURESCRIPTS IMPROVE COORDINATION OF CARE BY ELECTRONICALLY DELIVERING IMMUNIZATION AND PATIENT SUMMARY RECORDS TO PRIMARY CARE PROVIDERS

Surescripts Network Accelerates Interoperability Between Physicians, Pharmacists and Take Care Health Providers by Making It Easier to Supply Information Often Missing During Patient Visits"

According to the release, the Surescripts Clinical Interoperability Network supports all federal and state policies and standards for health information exchange, including privacy and security standards (such as HIPAA and state law), technology interoperability standards (such as Direct) and various message types.   The service is being rolled out to 500 hospital labs to connect to public health under a grant from the Centers for Disease Control and Prevention, and is also being used by physicians for physician-to-physician communication and care coordination.

I asked for further details about the transport, content, and vocabulary standards they plan to use.   Here's their response:

"Currently, we’re delivering PDFs over a REST-based protocol or Direct - whatever manner we have connectivity. We’re also faxing and mailing while vendors work on their connectivity modules. We’re in the process of determining which profile in terms of CCD/CDA will be the easiest for most vendors to receive. We’re targeting implementation later this summer.

When we start reporting to state registries, we’ll be sending the records in the most modern standard the states are ready to implement. We hope to see the majority of registries stepped up to HL7 2.5.1, Release 1.3 and August 2011 CVX code sets. But if a state isn’t quite ready, we’ll connect to what they have and upgrade the transport/content when they’re ready."

Massachusetts and other HIEs are implementing Direct for the summary and public health transactions.   With State HIE and national Healthcare Information Service Providers like Surescripts, we'll connect every payer, provider, and patient in time for Meaningful Use Stage 2 requirements.

Monday, March 12, 2012

Leadership lessons learned from James T. Kirk

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Recently, Alex Knapp wrote a brilliant article entitled "Five Leadership Lessons From James T. Kirk" in Forbes.  For those of us who have watched every episode and can recite every line of dialog from memory, these 5 lessons are a great distillation of the series.

On April 29, I'm speaking at the American College of Physician Executives about Leading Innovation.   These same 5 points are a great framework for that event.

1. Never Stop Learning

30 years ago I befriended one of the great thinkers from the vacuum tube era.  I showed him the miracle of a modern integrated circuit - one of his most complex tube designs fit into a dime sized chip.   He told me that he was not interested because he could not comprehend the silicon-based technology.

As I've told my staff, if I ever become an impediment to innovation because I'm stuck in a technology era of the past, it's time for me to move on.

2. Have Advisors With Different Worldviews

I try very hard not be dogmatic.   I use open source and proprietary software.  I use Macs and Windows devices.   I run Java and .NET applications.    Surrounding yourself with with smart people (smarter than yourself), who may have contrary opinions, improves your own decision making .   I've always felt that "B" leaders surround themselves with "C" employees who simply reinforce status quo leadership thinking.   "A" leaders surround themselves with "A" employees who constantly challenge the status quo.

3. Be Part Of The Away Team

It's truly hard for healthcare CIOs to understand the needs of their customers.  It helps to be a clinician or partner with a CMIO.   The best way to truly understand the strengths and weaknesses of your IT organization is to use the applications you purchase or create, "Eating your own dog food".  This requires leaving the comfort of your office and spending your day in the field.   I spend less than an hour a day sitting at my desk - my office is wherever my laptop and iPhone reside.

4. Play Poker, Not Chess

It's important to take educated risks.   I bet on the web for healthcare in 1996.   Transforming organizations with healthcare information exchange in support evolving accountable care organizations, patient centered medical homes, and global payment is the right thing to do.

5. Blow up the Enterprise

Every organization has peaks and valleys.    Goliaths fall and Davids rise.   In my own career, I've experienced the perfect storm of innovation that results in revolutionary rather than evolutionary change.   Sometimes its clear that an organization should exit certain businesses, downsize and divest to ready itself for the next phase of growth.  Being the best "buggy whip" manufacturer is not a sustainable strategy.

Thanks Alex for a great article.   In the early days of Meaningful Use work a graphic appeared labeling Dr. David Blumenthal as Kirk, Dr. John Glaser as Spock and me as Bones (thanks to Brian Ahier for this).  It's an honor to be considered part of that crew!

Friday, March 9, 2012

Cool Technology of the Week

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As readers of my blog may know, I'm a consulting mycologist, treating over 600 patients who ingest toxic mushrooms every year.

Now there's a novel way to use mushrooms to create custom packing materials.

Imagine choosing your packaging based on its absorptive, cushioning, and strength criteria, then just growing the package you need.

It seems like science fiction but a  New York company is doing this.

Ecovative Design  "grows"  packaging components for Dell Inc. servers and Crate and Barrel furniture, among others.

Mushroom-based packaging you can custom grow for each customer.  That's cool!

Thursday, March 8, 2012

Our Cancer Journey Week 12

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Last week Kathy started Taxol.   She's tolerated it well and did not have any of the fatigue, appetite changes, or anemia that came with Adriamycin/Cytoxan.

The short term challenge with Taxol is not the medication, but the solvent (called Cremophor) used to create an injectable solution.   Solvent-related hypersensitivity reactions are relatively common, so Kathy's pre-chemotherapy medications included:

*Dexamethasone 20 mg IV 30 minutes prior to chemotherapy.
*Diphenhydramine (Benadryl) 25-50 mg IV 30 - 60 minutes prior to chemotherapy. 50 mg for first dose. May reduce dose to 25 mg on subsequent doses if tolerated
*Famotidine (Pepcid) 20 mg IV infuse over 15 minutes. 30 minutes prior to chemotherapy.

She had no reaction of any kind, so tomorrow's Taxol dose will include 25mg of Diphenhydramine, yielding less Benadryl-induced sleepiness.

Her usual pattern of chemotherapy, one good day, one moderate day, two bad days, then back to good days has been replaced with chemotherapy followed by good, good, and good days.   Since we're preparing our Wellesley house for sale (goes on the market April 1) as part of our move to a farm property in Sherborn, Massachusetts, she needs all the energy she can get.   Our nights and weekends are filled with painting, cleaning, and boxing.

Her mood is good, our hope for cure is strong, and our optimism for an American Gothic future keeps us going every day.

Wednesday, March 7, 2012

Early NPRM Questions

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As HIT stakeholders review the Meaningful Use Stage 2 NPRMs in detail, questions about the intent of the language are circulating throughout the industry.

The two most common questions I've heard are related to image display (is it viewing via an EHR, through an EHR, DICOM required etc.) and Healthcare Information Exchange transport standards.

Here's a very thoughtful blog post from David Clunie that summarizes the issues of image viewing in the Stage 2 NPRMs.

Healthcare Information Exchange transport is now required per this provision in the CMS NPRM:

"The EP, eligible hospital, or CAH that transitions or refers their patient to another setting of care or provider of care electronically transmits a summary of care record using certified EHR technology to a recipient with no organizational affiliation and using a different Certified EHR Technology vendor than the sender for more than 10 percent of transitions of care and referrals."

Many are asking what standards and what architecture will be required, since the Standards and Certification NPRM offers a few options.

The HITSC NwHIN Power Team will continue to make recommendations to ONC, but here's my suggestion:

1.  For Push transactions, use SMTP/SMIME between Health Information Services Providers (HISPs) with the option of SOAP for "on ramps" and "off ramps" to EHRs (and PHRs).   For point to point transport between EHRs without a HISP use SOAP.
2.  For Pull transactions, use SOAP per a rewritten NwHIN Exchange implementation guide (eliminate the layering of specifications that refer to standards within standards within standards).   For point to point Pull, consider the kind of simplified Exchange-like SOAP transaction we've implemented between BIDMC and Atrius that does not require a master patient index, record locator service, or  document registry.
3.  If a RESTful implementation guide becomes available for Push or Pull,  consider it.

Over the next 60 days, HITPC and HITSC experts will examine all the ambiguities in both NPRMs.   I'm confident that with public comment and expert review, CMS and ONC will polish the NPRMs into Final Rules that are pure poetry.

Tuesday, March 6, 2012

The Bookmarked CMS and ONC rules

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Thanks for Robin Raiford of the Advisory Board for these resources

She's created a poster comparing Meaningful Use Stage 1 to Stage 2 as currently proposed. This is a 48” x 66” wall poster if you want to render it at a commercial printing service, or zoom to 75% to see it on your screen.

Here's the bookmarked CMS Notice of Proposed Rule Making Stage 2 EHR Incentive Program

Here's the bookmarked ONC Notice of Proposed Rule Making Standards and Certification Criteria

I hope you find these useful.

Monday, March 5, 2012

Data Segmentation

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In my recent post about consent policy for HIEs, I reflected that opt in consent to disclose at each institution generating data is patient centric and implementable.    One challenge with trying to implement a special "consent to view data at each encounter" workflow for HIV is the difficulty of segmenting the medical record to isolate HIV data.   Here's a sample record that illustrates the problem:

Medications
1.  Tylenol
2.  Sudafed
3.  AZT
4.  Bactrim

Problem List
1.  Headache
2.  Sinus Infection
3.  HIV positive
4.  UTI

Letter
I hope you and your partner had a great weekend in Provincetown and that the thrush has improved with the mouthwash sample I gave you

We can create filters for medications that are related to HIV treatment such as AZT.   However, some medications are ambiguous.  Is the Bactrim being used as prophylaxis against an HIV-related respiratory illness or something else?   We see from the problem list that the patient has a UTI, so likely the Bactrim is not HIV related and should be listed as a non-HIV medication.   The Letter does not include the words HIV, AIDS, or any medication name.  However, it lists Provincetown, which has the highest concentration of same-sex couple households of any zip code in the United States.   It mentions thrush which occurs in immunocompromised patients.   The Letter could imply HIV positivity.

ONC has launched the data segmentation initiative with the goal of tagging portions of the medical record with enough metadata to separate data into categories that better allow control of information exchange in accordance with patient privacy preferences.

For example, a sample medical record might contain

*Standard care information - problem list, medications, allergies, labs, notes, and immunizations that are not specific to the categories listed below
*Mental Health
*Sexually transmitted diseases
*Substance abuse
*Domestic Violence history
*HIV status

A person's preference may be to share Standard care information with any care provider, but only share STDs and HIV status with a primary care provider, and only share mental health, substance abuse, and domestic violence history with a mental health provider.

The current state of EHRs and HIEs is that data segmentation is very hard because of ambiguity in categorizing data elements, per the example I gave above.   With the ONC data segmentation initiative, implementers will receive guidance so that providers and automated decision support tools can tag data as it is entered, enabling segmentation.

Once data is segmented, we can then record patient privacy preferences for each segment.   How do we do that?

Mitre has created an open source patient consent policy management tool called Kairon Consents that is available for use now.

It enables the patient to designate who they want to share data with (e.g., by name, institution, referral relationship to PCP, etc.) and what data they wish to share (e.g. allergies) and for what purposes (treatment, research, etc.).

When a request for data is received, there is a policy reasoner that examines the request and presents the record holder with the relevant patient policies for that request (e.g., "The request is from an allowed physician but only allergy data is allowed to be communicated".

Clearly this is just the beginning of national-scale consent management tool development, but it is a reasonable platform for initial capabilities and can be scaled for institutional use.

In 2008, I proposed a "Consent Assertion Markup Language" (CAML).   With the Data Segmentation initiative and Kairon Consents, a mechanism for gathering and enforcing more granular patient privacy preferences will soon become a reality.

Friday, March 2, 2012

Cool Technology of the Week

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 Although I did not attend HIMSS this year because of my wife's chemotherapy timing, I did send several of my staff.    I asked them to summarize the cool technologies, most frequently heard buzzwords, and the overall conference trends.

Just as "Plastics" was the catchword from The Graduate, this year's HIMSS Conference theme was a combination "Cloud-based EHRs" and "HIE".

Cloud-based EHRs which follow the model pioneered by AthenaHeath for minimal hardware and minimal configuration in the office now include a number of new entrants including CareCloud and iPatientCare.   It will be interesting to see how these companies address the issue of integration with hardware in the office, the desire for customization, and the need for unique interfacing/integration with third party products.

HIE companies are appearing on the landscape faster than ever before.   Companies such as Orion, Intersystems, RelayHealth, United/OptumInsight, Aenta/Medicity, DBmotion, Axway, and Certify are increasingly visible in the industry.

With the Stage 2 NPRMs and increased HIMSS emphasis on interoperability, the industry is fast moving toward the Learning Healthcare System we've all envisioned.   That's cool!

Thursday, March 1, 2012

Our Cancer Journey - Week 11

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Tomorrow, Kathy starts her next round of chemotherapy - 12 weeks of Taxol administered every Friday at noon.

As with Adriamycin/Cytoxan (AC), we fear the unknown - what symptoms will it bring, how will it affect day to day and long term physical well being (since Taxol causes numbness that can be permanent).      Kathy reacted very well to AC so we're hopeful that she'll tolerate Taxol.

The process of treating breast cancer - 20 weeks of chemotherapy followed by surgery and radiation, can be wearing.   Of course, we are focused on optimizing the therapy, but at the same time we've needed a long term goal that brings joy and passion for the future, minimizing the day to day challenges of treatment.

Together we've been looking for a farm property, discussing the plans/projects ahead, and preparing for our next stage of life.   We moved to Massachusetts 16 years ago and raised our daughter in a family neighborhood, nearby to great public schools and a local library.   We believe that we have at least 2 more phases in our lives.  Phase 1 - 15 years as empty nesters at the peak of our mental and physical capabilities, ensuring the health of our parents, and supporting our daughter's early career.   Phase 2 - 15 years as retirees (and possible grandparents), continuing to write, lecture, and consult but without a "9 to 5" office schedule.

In Phase 1,  we're eager to take on the physical labor and mental creativity needed to expand our production of organic vegetables and raise a few chickens/alpaca/llama/goats/sheep.

The quest for a farm property has provided us with enough positive activity to energize our nights and weekends.

Plans and projects for the future are important to sustain optimism, but they're also essential to grow and develop our 30+ year relationship.

As noted in the recent New York Times article Love and Death, having plans and projects for the future is what sustains love beyond the physical attraction, infatuation, and novelty of the initial relationship.

Our farm vision has provided that.   To keep patients and families psychologically healthy during cancer treatment it's really important to focus on life after cancer and not let the cancer rule your life.    As you'll hear in the new few weeks, we found our farm and now we're planning our move there by May, ensuring that the end of chemotherapy marks the beginning of our new life chapter together.