CCHIT Submits Comments on Interim Final Rule on Standards, Implementation Specifications, and Certification Criteria for EHRs

The Certification Commission for Health Information Technology (CCHIT®) today submitted its public comments on the Interim Final Rule (IFR) entitled “Health Information Technology: Initial Set of Standards, Implementation Specifics, and Certification Criteria for Electronic Health Record Technology” to the Office of the National Coordinator (ONC).

“We congratulate ONC on development of the IFR, but we believe the criteria and standards need refinement in order to drive an achievable step forward in the meaningful use of EHRs,” said Mark Leavitt, M.D., Ph.D., chair of the Certification Commission, adding that the Commission is “concerned about the possibility of an unintended deceleration in the pace of EHR adoption.”

The comments highlight three broad concerns about the IFR requirements:

• Under the IFR, the scope of a ‘Complete EHR’ inappropriately includes administrative and billing functions, diverting funds and effort into unnecessary certifications of already-installed billing systems for every doctor and hospital seeking the EHR incentives.
• Certain criteria and standards in the IFR may represent a step backwards in progress toward EHR interoperability, by dropping standards that were already federally-recognized and widely adopted, while other criteria demand an unrealistic leap forward.
• Some IFR criteria define required functions of an EHR too microscopically, adding unnecessary costs and complexity, and creating barriers to innovation.

The Commission also commented on the regulatory impact analysis required as part of the rule making process. While the IFR concludes that the new rules would not impact a significant number of small businesses, the Commission supplied data and analysis indicating the impact would be very substantial.

A copy of the comments, including a more detailed analysis is below:

The Certification Commission for Health Information Technology (CCHIT) respectfully submits these comments on the Interim Final Rule (45 CFR Part 170, RIN 0991-AB58), published in the Federal Register of Jan 13, 2010, “Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology.”

Evidence Base

CCHIT has the most extensive experience in this country developing voluntary, consensus-based EHR certification criteria and test processes, and inspecting and certifying EHRs against Federally-recognized standards.[1] The Commission’s comments draw upon this deep base of practical experience.

Overview

The Certification Commission congratulates HHS and ONC on producing the Interim Final Rule within the statutory deadline. CCHIT is well aware of the challenges faced and the balances that had to be struck in a time-constrained environment. After careful review, however, the Commission believes that the certification criteria and standards in the IFR -- while an admirable first draft effort – need improvement and refinement to drive an achievable step forward in the meaningful use of EHRs, and to avoid an unintended deceleration in the pace of EHR adoption.

Before offering detailed suggestions, the Commission wishes to highlight three overarching concerns with the IFR as written:

• Scope. While “Complete EHR”sounds like a desirable certification, the package of requirements in the IFR may not match the needs and expectations of doctors and hospitals, nor the realities of the marketplace, for EHRs. By including two functions of an administrative/billing system in the scope of EHR certification, ONC may exclude one third or more of the offerings in the current EHR marketplace, while suddenly forcing hundreds of billing products to undergo unnecessary certifications. In other areas, the scope falls short of being complete: for example, an EHR that does not offer competent electronic management of progress notes would be unusable and medico-legally unsound, and an EHR that fails to prominently display patient advance directives in an emergency could compromise patients’ rights at their time of greatest vulnerability.
• Interoperability. The Commission and its expert volunteer panels believe that certain criteria and standards in the IFR represent a step backwards in progress toward EHR interoperability. For example, well-defined standards for receiving electronic laboratory results in the doctor’s office and for exchanging clinical summaries had already been recognized by the Federal government and widely supported by industry – as evidenced by the certification of over 80 EHR products to those standards in 2008. Yet under the IFR, that standard for receiving laboratory results, and the specific implementation guidance for exchanging clinical data, have been dropped. Where one standard was previously recognized for clinical data exchange, the IFR offers two different, incompatible standards. Conversely, other interoperability criteria in the IFR, such as the requirement that EHRs be capable of transmitting biosurveillance data to public health authorities, could immediately increase EHR cost and complexity while benefits remain years away because public health authorities lack standards-compliant infrastructure and systems for receiving that data.
• Functionality. Some of the IFR criteria define required functionalities of an EHR too microscopically, adding unnecessary complexity and creating barriers to innovation. Other criteria are too vague to be reliably verified in a testing process, creating a risk that the expectations of providers, payers, and the public regarding the performance, safety, and benefits of Certified EHRs will not be met. A particular concern surrounds the reporting of quality measures, with the IFR calling for standards and measures that are yet to be defined or that require significant revision to make them computable from EHR-based data.

These issues, however, can be resolved through refinements to the criteria and standards in the IFR, suggested in detail below.  With appreciation for the task ONC faces in reviewing an anticipated large volume of comments, the Commission offers these comments in order of priority, with the most critical issues first.

Specific Comments on Criteria and Standards in the Interim Final Rule

§170.302(j) and 170.302(k) General Certification Criteria for Complete EHRs or EHR Modules; Check insurance eligibility; Submit claims

Issues: The Commission wishes to emphasize that this issue, of all the others, has the greatest potential for an unintended consequence that runs counter to the goals of HITECH.

1. In the health IT marketplace, electronic eligibility and claim submission are functions of office billing and hospital financial systems. While some of the largest vendors offer both of these applications, many innovative EHR products have emerged from companies focusing on the challenging task of clinical information management, rather than competing in the mature marketplace for financial systems. Defining these administrative functions as part of a Complete EHR for certification purposes would create a major barrier to entry for EHR innovators.
2. The adoption of computerized billing and financial applications is already near 100%, and there is a natural incentive (more efficient revenue collection) for their usage. There is no justification for diverting HITECH incentives toward this area and away from the real challenge of EHR adoption and use by clinicians.
3. While increasing the utilization of electronic claims submission is a desirable goal, CMS and State Medicaid programs have more direct legal and regulatory mechanisms at their disposal to accomplish this.  

Recommendation: Drop criteria 170.302(j) and (k) from the Final Rule. If that is not possible, revise the definition of “Complete EHR” to make inclusion of these two modules optional, but with clear labeling required. While electronic claims submission could be retained as a Meaningful Use goal, the Commission recommends that this form of compliance it should instead be driven through existing Medicare and Medicaid regulatory mechanisms.

§170.302(i)(1) and 170.302(i)(2) General Certification Criteria for Complete EHRs or EHR Modules; Report quality measures; Display; Submission 

Issue: Item (1) requires calculation and display of “quality measures as specified by CMS or states”. This statement is too vague to be reliably tested. Most of the measures proposed in the NPRM still require significant revision to make them computable from EHR-based data; the denominators of many of these measures would require manual audits. Furthermore, the standard adopted for submission in (2) is not appropriate (see comment on §170.205(e) below).

Recommendation: These criteria should be dropped from Stage 1. A concise set of measures and an accompanying standard for data submission should be developed and defined in time for Stage 2 of Meaningful Use requirements.

§170.205(e) Content exchange and vocabulary standards for exchanging electronic health information; Electronically exchange quality reporting information 

Issue: The standard adopted, the CMS PQRI 2008 Registry XML Specification, was designed for ambulatory data reporting, not hospital data reporting. The standard is incomplete without an accompanying “XSD style sheet,” which does not exist. 

Recommendation: This standard requirement should be dropped from Stage 1. Standards for eligible provider and hospital quality data submission should be developed and defined in time for Stage 2 of Meaningful Use requirements.

§170.205(a) Content exchange and vocabulary standards for exchanging electronic health information; Patient summary record

Issue: This IFR criterion allows two different, incompatible content exchange standards for a patient summary record. Although requiring EHRs to be able to display the ‘alternate’ standard in a human readable format partially mitigates the issue, this results in the loss of structured data and an increase in the possibility of human error. Safety-focused EHR functionalities such as clinical decision support and medication reconciliation are significantly compromised by this loss of structured data.

Recommendations:  

1. Demonstrate year-to-year consistency in Federal health IT standards leadership by making the Federally-recognized CCD standard and associated implementation guides the required, or at least clearly preferred, format for HITECH certification.
2. If the above is not possible, clarify the transactions for which each standard applies (e.g., CCD for exchanges between professionals, and CCR for transmission to PHRs and consumer platforms). This approach would reduce the incidence of lost data structure in provider EHRs where critical clinical decision support takes place.

§170.302(g)(1) General Certification Criteria for Complete EHRs or EHR Modules; Incorporate laboratory test results; Receive results 

Issue: The IFR appropriately requires the ability to receive clinical laboratory results in a structured format. However, it inexplicably fails to specify a standard format for the laboratory results that the EHR must be capable of accepting. Receiving external laboratory results is the first and most important form of interoperability for EHRs in ambulatory care. The HL7 v2.5.1 format has been Federally recognized since 2006 for the purpose of receiving laboratory results in ambulatory settings, and CCHIT has tested and certified 142 ambulatory EHR products for compliance with that standard since 2007.

Recommendation: The certification criterion for receiving laboratory test results should be split into different versions for ambulatory settings and for hospitals. For ambulatory settings, the EHR requirement should include compliance with the HL7 2.5.1 standard. Note that this particular standard is already included in the IFR, but currently only applies when submitting lab results to public health agencies. It should be extended to apply to the laboratory results receiving transaction as well.

§170.202 Transport Standards for exchanging electronic health information

Issue: This IFR criterion allows two different, incompatible methods for transport of information, neither of which is sufficiently specified to ensure interoperability, and neither of which will deliver real-world data exchange until additional layers of standards and infrastructure are developed and widely adopted and deployed. The credibility of HITECH certification of EHRs could be seriously damaged by providing a false sense of assurance that EHRs offer “plug and play” readiness to  exchange data with other HITECH-certified EHRs.

Recommendations:

1. Inclusion of these as “Transport Standards” when they do not yet, in fact, assure end users of an ability to exchange data is deceptive. The item should be converted from a Standard to a point of guidance or roadmap regarding standards under development for future use.
2. In lieu of removing this item, if two alternative standards must be retained in the Final Rule, clearly specify the transactions for which each applies (e.g. SOAP for data exchange within enterprises or established networks, REST for communications with external entities such as providers outside the network or PHR platforms).

§170.302(a) General Certification Criteria for Complete EHRs or EHR Modules; Drug-drug, drug-allergy, drug-formulary checks

Issues: This criterion delves into an inappropriate level of design detail within EHRs, including features which are inappropriate or potentially harmful to adoption of EHRs and advancement of the technology.

1. §170.302(a)(1) Alerts would require real-time alerts, with the example of a “pop-up message or sound” in Table 1. Some usability experts would point out that pop-up alerts and sounds are a major source of user distraction and rejection of EHRs; better designs guide users toward making safe choices rather than interrupting them repeatedly. Such innovation is unlikely to emerge with a rigid standard constraining the design.
2. 170.302(a)(2) Formulary Checks requires formulary / preferred drug list checking as a general specification for all EHRs, yet this functionality is only appropriate for office-based providers. In hospitals, this function is accomplished before drugs ever appear in the EHR ordering lists.
3. §170.302(a)(3) Customization requires certain users have rights to deactivate, modify, and add rules for drug-drug and drug-allergy checking. Most organizations do not maintain this list themselves, and instead subscribe to an external knowledge source. Forcing the provision of abilities to make local modifications compromises the integrity of the knowledge base, breaks the chain of accountability, and puts patient safety at risk.
4. §170.302(a)(4) Alert Statistics requires tracking and reporting on “the number of alerts responded to by a user.” The language does not define what is meant by “responded to by a user”: Changed the order as a result of the alert? Entered a reason for overriding the alert? Dismissed the alert without changing the order? Requiring this tracking also further serves to force the EHR designer to use interruptive alerts and to “count mistakes caught” rather than designing prospective guidance to prevent the mistakes in the first place.

Recommendations:  

1. §170.302(a)(1) Delete “pop-up message or sound” from the appropriate row in Table 1.
2. §170.302(a)(2) Remove item from §170.302 General Certification Criteria, and move to §170.304 Specific Certification Criteria for Ambulatory Settings.
3. §170.302(a)(3) This item has greater risk of harm than benefit and should be removed.
4. §170.302(a)(4) Unless more clearly specified, this item has greater risk of harm than benefit and should be removed.

§170.302(e)(3) General Certification Criteria for Complete EHRs or EHR Modules; Record and chart vital signs; Plot and display growth charts

Issues:

1. The Commission and its Child Health work group recognize the importance of including growth chart functionality in every EHR used in the care of children, and has since 2008 required that capability – and others – for optional certification of EHRs as having Child Health capabilities. However, a significant number of vendors develop EHRs that focus on specialties and settings that do not serve children or adolescents. Forcing this capability into all EHRs adds unnecessary cost and complexity and diverts development effort away from other specialized clinical needs.
2. The IFR requires height and weight growth charts from age 2 to 20, but omits any requirement for charting weight, length, and head circumference from age 0 to 36 months. HITECH-certified EHRs would not be assured to include functionalities for safe care of the youngest children.
3. The IFR fails to require display of normative data alongside the measured patient data, greatly reducing the clinical usefulness of growth charts. 

Recommendations: 

In the absence of a structure for certifying specialty-specific EHRs, ONC should drop the requirement for growth charts and rely on EHR purchasers to check for this functionality.

Alternatively, ONC might retain the requirement for growth charts, but add requirements to display normative data and to capture and chart weight, length, and head circumference for children aged 0 to 36 months. This would ensure adequate functionality for all children, but would also likely result in a significant reduction in the number of certified EHRs immediately available as well as an increase in their cost.

§170.302(f) General Certification Criteria for Complete EHRs or EHR Modules; Smoking status 

Issue: While recording smoking status is crucial to health improvement efforts, the IFR oversteps by mandating that the smoking status field must include values of: “current smoker, former smoker, or never smoked.” These values may be used in health insurance underwriting, but they are not a standard accepted by clinicians. In the absence of a vocabulary standard being available from an accredited standards body, it is not appropriate to compose an ad hoc vocabulary as part of a rule making process.

Recommendation: The second sentence of the item, specifying smoking status types, should be dropped.

§170.302(l) Medication reconciliation

Issue: The criterion in the IFR is too vague to be reliably tested, and medication lists are not sufficiently standardized to be directly merged electronically. Although the IFR includes a vocabulary standard for medications, it does not define a standard for the meaning of items on a medication list Careful human review and interpretation are essential to medication reconciliation, and pushbutton automation can create a patient safety hazard.  Neither the most popular electronic prescribing network (Surescripts), nor one of the arguably most advanced EHR implementations (Kaiser Permanente), have found electronic merging of medication lists from different sources to be safe or workable. 

Recommendation: The criterion should be changed to:  Electronically display patient medication information from two or more sources, and allow the user to create or update the patient’s medication list based on a review and reconciliation of that information.

§170.304(e) Specific Certification Criteria for Complete EHRs or EHR Modules designed for an ambulatory setting; Clinical Decision Support

Issues: Please refer to our comments on 170.302(a) on the topics of Alerts and Alert Statistics for drug-drug, drug-allergy, and drug-formulary checks. 

Recommendations:

1. §170.304(e)(2) Delete “pop-up message or sound” from the appropriate row in Table 1.
2. §170.304(e)(3) Unless more clearly specified, this item has greater risk of harm than benefit and should be removed. 

§170.306(a) Specific certification criteria for Complete EHRs or EHR Modules designed for an inpatient setting; Computerized provider order entry

Issue: The IFR criterion specifies a long list of order types. While it is reasonable to require functionality for ordering medications, laboratory, and radiology/imaging, the criteria should not attempt an exhaustive list of other order types. No information is given as to what constitutes adequate functionality for any of these other orders, and some, such as “dialysis” may not be appropriate order functionality for a general EHR system for hospitals.

Recommendation: Items (4) through (10) should be dropped and replaced with a single item “Other order types”.

§170.306(c) Specific Certification Criteria for Complete EHRs or EHR Modules designed for an inpatient setting; Clinical Decision Support

Issues: Please refer to our comments on 170.302(a) on the topics of Alerts and Alert Statistics for drug-drug, drug-allergy, and drug-formulary checks. 

Recommendations:

1. §170.306(c)(2) Delete “pop-up message or sound” from the appropriate row in Table 1.
2. §170.306(c)(3) Unless more clearly specified, this item has greater risk of harm than benefit and should be removed.

§170.302(m)(2) Submission to immunization registries; State-designated standards format 

Issue: Specifying use of “the applicable state designated standard format” does not offer a defined and testable certification criterion. The 50 states may each have a different format, or no format, and vendors may serve customers in all states, a multi-state region, or a single state. Resolving State-to-State standards variations is an appropriate task for other ONC health IT programs. It is an impossible task for EHR vendors and developers and should not be required in EHR certification.

Recommendation: Item (2) should be dropped. It should be sufficient that EHRs demonstrate compliance with the national standard specified in item (1).

§170.302(n) Public health surveillance

Issue: Requiring EHRs to “electronically record, retrieve, and transmit syndrome-based public health surveillance information to public health agencies” is a worthwhile future goal, but very unlikely to be possible during the 2011-2012 time frame of Stage I certification. The criterion fails to specify which agencies (local, state, Federal) are included, and most of those agencies are not prepared to receive biosurveillance data electronically in the format specified. It would be difficult for any EHR to prove compliance with the criterion as written.

Recommendation:

The criterion should be dropped as a Stage I certification criterion and deferred until Stage II.

If the criterion is not dropped, it should be changed to “Electronically record, retrieve, and be capable of producing an electronic message containing syndrome-based public health surveillance information in accordance with one of the standards specified in §170.205(g).”

§170.306(g) Reportable lab results

Issue: Requiring EHRs to “electronically record, retrieve, and transmit reportable clinical lab results to public health agencies” is a worthwhile future goal, but very unlikely to be possible during the 2011-2012 time frame of Stage I certification. The criterion fails to specify which agencies (local, state, Federal) are included, and many of those agencies are not prepared to receive reportable lab results data electronically in the format specified. It would be difficult for any EHR to prove compliance with the criterion as written.

Recommendation:

The criterion should be dropped as a Stage I certification criterion and deferred until Stage II.

If the criterion is not dropped, it should be changed to “Electronically record, retrieve, and be capable of producing an electronic message containing reportable lab results in accordance with the standards specified in 170.205(f)”

§170.210(d) Standards for health information technology to protect electronic health information created, maintained, and exchanged; cross-enterprise authentication

Issue: The text of the IFR does not specify any standards for this requirement, but Table 2B Row 5 offers the example of “IHE Cross Enterprise User Assertion (XUA) with SAML identity assertions)”. The inclusion of this example can be interpreted in different ways, making it difficult to reliably test compliance with the corresponding criterion. 

Recommendation: The example provided in parentheses in Table 2B Row 5 should be dropped.

Comments on Section V – Regulatory Impact Analysis

The IFR invites comment on the economic impact analysis and the Commission is pleased to offer feedback based on in-depth experience with certification in the EHR marketplace. There are two serious concerns regarding the impact analysis:

• The IFR’s model for costs to EHR vendors and developers is overly simplistic, significantly underestimating regulatory economic impact
• The impact analysis does not take into account readily available data pointing toward a disproportionate impact on small businesses

An overly simplistic economic model underestimates regulatory impact

The IFR model estimates that EHR vendors will each bear a cost “somewhere between $10,000 and $250,000 per certification criterion to prepare a Complete EHR or EHR Module for testing and certification,” then multiplies by the number of new criteria (which the IFR estimates as 25% of those previously required for CCHIT certification) and finally multiplies by an estimated number of vendors to be certified (which the IFR estimates as 90% of the currently certified cohort). 

This overly simplistic, linear model fails to include a discontinuity: any vendor that lacks the immediately available capital and development resources to add the new features required will no longer be competitive in the marketplace. Even vendors with adequate resources may not be able to modify their software, have it certified, and roll it out to the marketplace in time for the incentive windows which begin in just a few months. Outright business failures are likely. The economic impact includes the loss of a company’s net worth and a dislocation of its jobs. Even if only 10% of vendors fail in this manner (based on the IFR’s optimistic estimate that 90% will succeed in being HITECH certified), and even if these are assumed to all be small businesses with annual revenues of $10M and private market capitalizations of $30M-$50M, the aggregate economic waste would be in the hundreds of millions of dollars, with potential dislocation of thousands of jobs. 

The model also fails to consider secondary impacts extending beyond the Medicare and Medicaid provider universe. Customers of failed vendors will bear costs to replace unsupported, “orphaned” EHRs. Many of the practices affected, based on their patient populations, would not even qualify for ARRA Medicare or Medicaid EHR incentives so they have no funding source to these costs. The economic impact on such “innocent bystanders,” many of whom would be small physician offices and community hospitals, should be of great concern to this rulemaking process. 

A disproportionate impact on small businesses

The IFR states, “Based on our analysis, we believe that a handful of multinational corporations and many national or regional businesses represent a significant majority of the potential Complete EHR and EHR Module developers and that many, if not all, exceed the specified SBA size standard…[and]...it is difficult at the present time to locate empirical data related to many of the commercial vendors and open source developers of Complete EHRs and EHR Modules to correlate to the SBA size standard.”

Data useful for estimating the regulatory impact on small businesses has been published by CCHIT on several occasions. The latest statistics are available in a presentation slide set that accompanied testimony by Dr Mark Leavitt to the National Committee on Vital and Health Statistics on April 28-29, 2009. [2] 

With regard to the Ambulatory EHR marketplace as of March 2009, vendors with annual revenue under $20M -- the SBA size standard for small software businesses -- represented 75% (25%+37%+13%) of certified vendors as of March 2009.   Based on this data, the assumption in the IFR that “many, if not all” vendors are large businesses is incorrect, and the HHS Secretary’s certification statement that “…this interim final rule will not have a significant impact on a substantial number of small entities” should be revisited.

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[1] Since 2005, the Commission has been developing and updating certification criteria annually using a voluntary, consensus-based process, and has inspected and certified over 250 EHR products to qualify them for various Federal, State, and private sector incentive and regulatory relief programs. www.cchit.org/about

[2] Accessible at http://www.ncvhs.hhs.gov/090428ag.htm

Implementation Starter Kit: Lessons & Resources to Accelerate Adoption

Audio is now available:

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Implementation Starter Kit: Lessons & Resources to Accelerate Adoption

• Agenda
• Presenter Biographical Sketches
• Public Sector Panel
  • Doug Fridsma, NHIN, Office of the National Coordinator, HHS
  • Hunt Blair, Deputy Director, Health Care Reform, Office of Vermont Health Access
  • Jessica Kahn, Centers for Medicare & Medicaid Services, HHS
  • Kim Davis-Allen, Alabama Medicaid
  • Ken Buetow, National Cancer Institute, HHS
  • Kathleen M. Roberts, National Institute of Standards and Technology
• Implementation Experiences Panel
  • David Muntz, Baylor
    
    • Muntz Questions and Answers
  • Jay Colfer, Eclipsys (Baylor vendor)
  • Charles Christian, Good Samaritan
  • Michelle Freed, McKesson (Good Samaritan)
  • Mitzi Cardenas, Truman Medical
  • Mike Valentine, Cerner (Truman Medical)
  • Michael Sauk, University of Wisconsin
  • Sumit Rana, Epic (University of Wisconsin)
• Implementation Experiences Panel, con’t
  • Amanda Parsons, New York City Primary Care Information Project (NYC PCIP)
    • Parsons Commentary
  • Sidd Shah, eClinical Works (NYC PCIP)
  • Dick Thompson, Quality Health Network
    • Thompson, About Axolotl
    • Thompson, Quality Health Network Overview
  • Ray Scott, Axolotl (Quality Health Network)
  • John Blair, Taconic, IPA
  • Jennifer Brull, Solo Family Physician, Plainville, KS
  • Maria Rudolph, eMDs (Dr. Brull’s vendor)
• Innovation Panel
  • David Stuart Buck, Healthcare for the Homeless – Houston & Baylor College of Medicine
    • Buck, Healthcare for the Homeless
  • Paul Uhrig, SureScripts
    • Uhrig, Buyer's Guide
  • Tom Morrison, NaviNet
  • Sherry Reynolds, Group Health
    • Reynolds, Article
  • Will Ross, Redwood MedNet
  • Peter Levin, Veterans Administration

via healthit.hhs.gov

NPRM on Certification Programs

The Office of the Nation Coordinator has published a corrected version of the NPRM on Certification Programs. The corrected version has been put into bureaucratic language and had typos, etc. fixed. It is substantially the same document as the draft version previously posted. After the proposed rule is published the comment period will begin.

Certification of Health IT will provide assurance to purchasers and other users that an EHR system, or other relevant technology, offers the necessary technological capability, functionality, and security to help them meet the meaningful use criteria established for a given phase. Providers and patients must also be confident that the electronic health IT products and systems they use are secure, can maintain data confidentially, and can work with other systems to share information. Confidence in health IT systems is an important part of advancing health IT system adoption and allowing for the realization of the benefits of improved patient care.

Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology. Once certified, Complete EHRs and EHR Modules would be able to be used by eligible professionals and eligible hospitals, or be combined, to meet the statutory requirement for Certified EHR Technology.

To this end, an NPRM proposing the establishment of certification programs for purposes of testing and certifying health information technology was issued in March 2010 with a request for comments. The NPRM proposes:

A temporary certification program to assure the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments would begin to report demonstrable meaningful use of Certified EHR Technology.

A permanent certification program to replace the temporary certification program.

The corrected proposed rule to be published in the Federal Register March 10, 2010 is here:

http://www.federalregister.gov/OFRUpload/OFRData/2010-04991_PI.pdf

Evolution of Transparency

The full post appears on O'Reilly Radar

With the sea change caused by the Open Government Directive I know that many federal agencies might be struggling with how to actually implement this new policy. This is a major cultural shift in government and there are always challenges when trying to bring such broad changes to any large organization. Government bureaucracy is certainly no exception. But this last week I was encouraged by one agency's office, which has shown a great start-up mentality in not only moving toward government 2.0 principles, but also achieving some pretty significant accomplishments along the way.

The Healthcare Information and Management Systems Society (HIMSS) hosts an annual event focused around health IT professionals and health IT vendors (Andy Oram has been covering HIMSS). I was fortunate at this year's HIMSS conference to have conversations with staff from the Office of the National Coordinator. Much of the discussion revolved around the rules for meaningful use of electronic health records, the creation of a Nationwide Health Information Network (NHIN), and standards and certification. But of course, I couldn't have access to federal officials without bringing transparency and open government into the conversation.

CMS on "Meaningful Use"

CMS hosted a Feb. 23 teleconference on its proposed rule defining "meaningful use" of electronic health records. Released in late December, the rule specifies proposed requirements to qualify for EHR incentive payments from Medicare and Medicaid beginning in fiscal year 2011 and avoid significant payment penalties in FY 2015. Among other topics, CMS representatives reviewed who would be eligible for incentive payments, and what constitutes meaningful use and how to demonstrate it.

Audio:

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Meaningful Certification

Open Source included in proposed rule on certification

The proposed rule announced today at HIMSS breathes new life into the movement towards open source solutions for electronic health records. On page 24 of the document it states::

HIT Policy Committee made five recommendations to the National Coordinator on August 14, 2009, which support the approach proposed in this rule. The recommendations addressed the scope of the certification process in general and the approach the National Coordinator should take to establish certification programs. The HIT Policy Committee recommended “that in defining the certification process…the following objectives are pursued:

1) Focus certification on Meaningful Use.

2) Leverage the certification process to improve progress on privacy, security, and interoperability.

3) Improve the objectivity and transparency of the certification process.

4) Expand certification to include a range of software sources, e.g., open source, self-developed, etc.

5) Develop a short-term certification transition plan.”

The National Coordinator reviewed and considered the recommendations made by the HIT Policy Committee and concluded that they should be used to provide direction for the proposals included in this rule. We believe that the proposals in this rule reflect the overall intent of the HIT Policy Committee’s recommendations.

So there is obviously going to be some focus and energy that will be voted towards open source solutions for electronic health records and I applaud this expansion of the certification process. The proposal would set up a two stage process to allow temporary certification in time for providers to meet deadlines for qualifying for the first stage meaningful use requirements. The rule states the must be "available before fall 2010." The eventual permanent program would transfer testing and certification to private sector organizations.

NRPM on Certification

Today the Department of Health and Human Services published a Notice of Proposed Rulemaking for the Establishment of Certification Programs for Health Information Technology (Health IT). The rule first proposes the creation of a temporary certification program for Electronic Health Records (EHRs) and EHR modules. This serves as a bridge to the second, permanent certification proposal, which establishes detailed guidelines to support an ongoing program of testing and certification of health IT. The meaningful use of certified EHR technology is a requirement for qualifying for incentive payments under the Medicare and Medicaid EHR Incentives program.  The temporary program therefore is critical as it assures the availability of Certified EHR Technology prior to the date on which health care providers may begin demonstrating meaningful use.

While we are making significant strides toward modernizing our health care system, these efforts will only succeed if providers and patients are confident that their health information systems are safe, secure, and meet standard functionality requirements.  Certification isn’t just about meaningful use; at its core, it is about providing assurances to patients and providers that EHR technology can deliver the benefits of improved quality of care and protect personal health information.

Significant stakeholder feedback was taken into account as we developed these rules, including formal recommendations from the HIT Policy Committee (a Federal Advisory Committee), but your input on the proposed rule is critical to this process. I hope that you will provide formal feedback at http://www.regulations.gov during the public comment period.

Certification of HIT programs is another critical step in the path to achieving the vision of the HITECH Act and we appreciate your engagement in the process.  In addition to your formal comments, we hope you will use this blog as a forum for a lively discussion about certification and its role in achieving meaningful use.

– David Blumenthal, M.D., M.P.P. – National Coordinator for Health Information Technology

via hhs.gov

Government Invasion of Health IT Vendor Show

The Office of the National Coordinator and other Federal and State officials make a strong showing at HIMSS

This year's HIMSS is very heavy on government officials as both attendees and presenters. This is not surprising due to the billions of ARRA funds devoted to health IT. Vendors are of course very interested in meeting with decision makers in state and federal government, and states in particular have a very keen interest in health information exchange and electronic health record vendors as they develop plans for implementation.

Some of the highlights of the ONC presentations are:

• Dr. David Blumenthal, the National Coordinator for Health Information Technology, will share his thoughts about ONC’s priorities for 2010 during the Keynote Address(March 3, 8:30 a.m.).
• The U.S. CTO Aneesh Chopra will also be at HIMSS to discuss “The Role of Healthcare IT in Building a 21^st Century Technology Ecosystem” (March 3, 2:15 p.m.)  HHS CTO Todd Park will join him immediately afterward in a dialog with participants on innovation and the future direction of health IT.
• ONC will be hosting a series of Pre-Conference Symposium Events (February 28) including: a Physician Symposium Keynote Address and a State HIE Symposium.
• During the Town Hall Session (March 2, 2:15 p.m.), ONC will host an interactive session, Implementing HITECH, which will bring together key players within ONC leadership to discuss current and upcoming programs to advance the national health IT agenda.
• ONC will host a series of Education Sessions including: The Costs and Benefits of Health IT (March 1, 9:45 a.m.) ,  Health IT Regulatory Review (March 2, 9:45 a.m.), and  Nationwide Health Information Network (NHIN) – 2010 (March 3, 1 p.m.) .
• ONC and the Federal Health Architecture (FHA) will participate in the State CIO Panel (March 3, 2:15 p.m.) and theClinical Decision Support Panel (March 3, 2:15 p.m.).
• At the Interoperability Showcase Theater, ONC and the FHA are hosting 25 presentations by organizations that illustrate how the Nationwide Health Information Network (NHIN) is enabling secure, electronic health information exchange across diverse providers and jurisdictions.

I'll be attending many of these sessions and will write about some of them that I find especially interesting.

HIT Standards Committee - December 18

The ONC has promised to make efforts to post the complete presentation in a more timely manner. I'm looking forward to having podcasts available the day after each meeting.
Below is the bookmarked presentation, transcript and audio from the December 18, 2009 HIT Standards Committee meeting:

NHIN Workgroup 12/16

Below is the bookmarked presentation, transcript and audio from the December 16, 2009 HIT Policy Committee NHIN Workgroup meeting:

HIE: Privacy & Security

This video from Oregon HISPC is pretty interesting:

HISPC Reports on State Law, Business Practices, and Policy Variations

Conducted during 2009 as part of the Health Information Security and Privacy Collaboration (HISPC), the following compendium of 5 reports detail variations in state law, business practices and policy related to privacy and security and the electronic exchange of health information. For quick reference, several reports contain aggregate findings tables in their appendices. Summaries of each report are below.

• Report on State Medical Record Access Laws [PDF - 308 KB]
  
  • Appendix A-1 [PDF - 130 KB]
    
  • Appendix A-2 [PDF - 205 KB]
    
  • Appendix A-3 [PDF - 117 KB]
    
  • Appendix A-4 [PDF - 265 KB]
  • Appendix A-5 [PDF - 528 KB]
  • Appendix A-6 [PDF - 304 KB]
  • Appendix A-7 [PDF - 166 KB]
  • Appendix A-8 [PDF - 457 KB]
  • Appendix A-9 [PDF - 613 KB]
  • Appendix B-1 [PDF - 441 KB]

This report analyzes state laws that are intended to require health care providers (specifically, medical doctors and hospitals) to afford individuals access to their own health information and to identify potential barriers to the electronic exchange of health information. Specific state law provisions examined: scope of medical records to which patients are afforded access, format of information furnished, deadlines for responding to requests, fees for furnishing copies, record retention laws and access to records of minors.

• Report on State Law Requirements for Patient Permission to Disclose Health Information [PDF - 2.25 MB]
  In Phase I of the HISPC project a majority of participants reported significant variation in the business practices and policies surrounding the need for and process of obtaining patient permission to use and disclose personal health information for a variety of purposes, including for treatment. This report furthers the initial work of this project by collating and analyzing state laws that govern the disclosure of identifiable health information for treatment purposes to identify commonalities and differences.
  
• Releasing Clinical Laboratory Test Results: Report on Survey of State Laws [PDF - 1.38 MB]
  For this report, state statutes and regulations were analyzed to determine to whom clinical laboratories may release test results. This report focused on clinical laboratory and hospital licensing laws (that contain standards for hospital laboratories). It also examined general state medical record access laws to determine whether they provided an avenue for patients to access their clinical laboratory results directly.
  
  
• Report on State Prescribing Laws: Implications for e-Prescribing [PDF - 331 KB]
  
  • Appendix A [PDF - 514 KB]
  • Appendix B [PDF - 60.5 KB]
  • Appendix C [PDF - 173 KB]
  • Appendix D [PDF - 125 KB]

This report identifies and analyzes the impact and variation of state laws related to e-prescribing. The report addresses state laws related to the e-prescribing of controlled and non-controlled substances as well as topics such as record keeping and content requirements, out-of-state prescriptions, and generic substitution laws.

• Perspectives on Patient Matching: Approaches, Findings, and Challenges [PDF - 629 KB]
  This report analyzes various approaches to matching patients to their health information in the context of electronic health information exchange. Current and potential methods for matching patients to their health records are discussed, challenges to performing patient matching such as scalability and ease of use are analyzed, and the types of information some HIOs use to match patients to their health records is described.

ONC Report Card

Now that their work is done for 2009 I thought it would be fun to grade the Office of the National Coordinator. It has been a very exciting year in health IT, with a cliff hanger right down to the wire on meeting the statutory requirement for publishing a proposed rule to define Meaningful Use criteria and and an interim final rule on Standards, Implementation Specifications, and Certification Criteria. For getting these rules out for comment before the years end, I give the ONC a solid B- overall (I consider myself a reasonably hard grader). I have some categories below, but would be very interested in any feedback you might have.

• Privacy and Security -
  
  The HIT Standard Committee made some excellent recommendations in September on privacy and security. Also in December the ONC announced the creation of a new Chief Privacy Office and the Office of Economic Modeling and Analysis (among three others including the Office of Chief Scientist, Deputy National Coordinator for Programs & Policy, and Deputy National Coordinator for Operations). This reorganization and good recommendations give a strong B in this area. This is only a a start and they have been at it for less than a year, so I am being generous.

• Meaningful Use -
  
  Since the rule has been posted before the end of the year, and considering all the hard work this has taken this is definitely an A for effort. Unfortunately, the 60 day comment period begins January 13, 2010 (after Federal Register publication) and there still appears to be a long way to go. However, I would give an overall B+ for the work so far, with a big question mark as to what will happen in the our years with a phased approach to defining the criteria.

• Transparency -
  
  This is an area that I am keenly interested in. I am very pleased that the ONC has made a strong commitment to transparency for 2010, but I will need to see results before giving a much higher grade. For now: a D!

• Standards and Certification -
  
  The HIT Standards Committee has done outstanding work in 2009! Reading this transmittal letter of their recommendations will give an inkling of the incredible work this body has accomplished. There is still a lot do in the coming year, but I would give an A- in this area...

• National Health Information Network (Health Internet) -
  
  This is an area that has not had much in the way of tangible results yet, and will be critical to succeed if we are to see the goals of health IT come to fruition. The NHIN Work Group of the HIT Policy Committee has made some progress charting a way forward, and the Federal Health Architecture e-government line of business initiative has been working for years towards an interoperable future, I can not grade on hopes for future success. So far, based on the framework being developed I feel comfortable giving a C.

Taking all of these in consideration, and weighting them based on my feelings at the moment (plus the feeling that grades C-level or below are unacceptable), I feel that a B- is really the best I can give right now. Being the eternal optimist I am hoping that things will improve significantly in 2010.

Cost of Healthcare

America spends more on healthcare than any other country in the world and gets less bang for the buck. As the graphic below from National Geographic shows, spending more does not necessarily guarantee better results. But the problem may really be that Americans expect to be able to live the way they want, and have the money to pay for the health consequences of their bad choices. Most of the health problems in America come from lifestyle choices...

The United States spends more on medical care per person than any country, yet life expectancy is shorter than in most other developed nations and many developing ones. Lack of health insurance is a factor in life span and contributes to an estimated 45,000 deaths a year. Why the high cost? The U.S. has a fee-for-service system—paying medical providers piecemeal for appointments, surgery, and the like. That can lead to unneeded treatment that doesn’t reliably improve a patient’s health. Says Gerard Anderson, a professor at Johns Hopkins Bloomberg School of Public Health who studies health insurance worldwide, “More care does not necessarily mean better care.” —Michelle Andrews

via blogs.ngm.com

Rules for Health IT

"Meaningful Use of Electronic Health Records"

The Medicare and Medicaid Health IT provisions in the American Recovery and Reinvestment Act of 2009 promote the adoption and meaningful use of certified electronic health records (EHRs). The Recovery Act authorized incentive payments for eligible professionals (EPS) and hospitals participating in Medicare and Medicaid for becoming meaningful users of certified EHRs. The law established maximum annual incentive amounts and includes Medicare penalties for failing to meaningfully use EHRs beginning in 2015 for professionals and hospitals that fail to adopt certified EHRs.

The Centers for Medicare & Medicaid Services (CMS) has published the proposed rule defining 'meaningful use.' This rule would implement provisions of the American Recovery and Reinvestment Act of 2009 (Recovery Act) that authorizes incentive payments to EPS and eligible hospitals participating in the Medicare and Medicaid programs for adopting and becoming meaningful users of certified EHR technology. Recommendations from the HIT Policy and Standards Committees (see below) have been used by CMS to inform the rule-making process. Much of the heavy lifting to develop this criteria has been done by these committees and their workgroups and many of their recommendations are incorporated into the proposed rule:



Here is the Interim Final Rule from ONC:

Both the HIT Policy Committee and the HIT Standards Committee provided recommendations to the National Coordinator for Health Information to help CMS develop the initial criteria for meaningful use and assist in planning for any criteria expansion for the future incentive programs. More than 800 public comments were also received on the HIT Policy Committee’s initial recommendations.

HIT Policy Committee Recommendations:

HIT Standards Committee Recommendations:

CONNECT Seminar

The CONNECT Seminar, held June 29-30 2009 in Washington, DC, was organized by the Office of the National Coordinator for Health Information Technology (ONC). The CONNECT Seminar showcased open source solutions built by federal agencies to enable secure, standards-based exchange of patient information between organizations and the National Health Information Network (NHIN). NHIN (or the Health Internet as it is now also known) will enable a secure, nationwide, interoperable health information infrastructure to make health information available and accessible to providers and consumers of healthcare across communities.
CONNECT is an on-ramp to the Nationwide Health Information Network (NHIN), a network of networks for health information exchanges, providers, payers, and other stakeholders enabling standards-based connectivity and information sharing.

CONNECT is an open source connectivity solution built for use by 20 federal agencies to securely link their systems to the NHIN. Earlier this year, CONNECT was released to the public including:

• The NHIN Gateway is used to locate patients at other health organizations within the NHIN, request and receive documents associated with the patient, create audit logs of these transactions, authenticate network participants, formulate and evaluate authorizations for the release of medical information, and honor consumer preferences for sharing their information.
• The Enterprise Service Component includes a Master Patient Index (MPI), Document Registry and Repository, Authorization Policy Engine, Consumer Preferences Manager, HIPAA-compliant Audit Log and a software development kit for developing adapters to plug in existing systems such as electronic health record solutions to support the secure exchange of health information across the NHIN.
• The Universal Client Framework is used to develop applications using the Enterprise Service Component.

Speakers at the CONNECT Seminar '09 include keynoters ONC head David Blumenthal and CTO Aneesh Chopra.




Dr. David Blumenthal, National Coordinator for Health Information Technology, Department of Health and Human Services





Aneesh Chopra, Chief Technology Officer and Associate Director for Technology, Office of Science and Technology Policy, Executive Office fo the President

Health IT Leadership

The Information Technology and Innovation Foundation (ITIF) released a report providing a detailed analysis of the countries that are leading in the use of information technology (IT) in health care, the factors that have led to their success, and the lessons that can be learned by other nations, including the United States, to drive health IT adoption. The report identifies elements contributing to success with health IT, including strong national-level leadership, the use of incentives and mandates, and the deployment of shared IT infrastructure in the health-care sector, and recommends strategies for policymakers to jumpstart progress on health IT adoption.

Better utilization of IT is one area of healthcare reform that has bipartisan support. Yet, although some countries have made dramatic progress in developing and implementing advanced health IT systems, the United States has struggled to make progress and is far behind international best practices. The United States has issued mandates for health IT only in a few cases for limited technical changes rather than as a push for broad reform, according to the report.

Daniel Castro, author of the report, said he viewed adoption of e-prescribing in this country as one of the core technologies of a national health IT system. He also stressed the need for adoption of Electronic Health Record (EHR) systems. "Countries like Denmark, Finland and Sweden demonstrate that widespread use of mature technologies like electronic health records improve the efficiency and effectiveness of health care," Castro, ITIF senior analyst said. "Policymakers in the United States should heed the lessons learned by the leaders. This isn't high school -- it's okay to copy from your neighbors."

For example, all primary care physicians in Sweden use electronic health records, while the rate is 99 percent in Finland and 95 percent in Denmark. Only 28 percent of primary care physicians in the United States use EHRs.

Although the United States is following a decentralized approach to the adoption of health IT, the foundation recommended policymakers support the development of a common infrastructure for routine tasks, such as a system for electronic patient authentications.

The key factors that have led to success in other countries discussed in this report are:

• National leadership to promote health IT
• Health care system organization and financing
• Financial incentives for health IT
• Government mandates to spur health IT
• Size of a country’s population
• Structural issues in the health care sector
• Societal and cultural factors related to health IT
• Privacy issues related to health IT systems
• Policies to support telehealth
• Common health IT infrastructure
• Robust standards to support health IT
• Use of unique patient identifiers

Further actions for policymakers to spur use and maximize benefits of health IT include the following:

• Provide strong national-level leadership on health IT
• Provide sufficient funding for health IT adoption
• Build and share tools for health IT
• Encourage the creation of health record data banks
• Encourage personal health records with data sharing
• Address legitimate privacy concerns
• Eliminate barriers to health IT adoption
• Leverage federal resources to support health IT initiatives
• Encourage "in silico" health research
• Collaborate and partner with all stakeholders

It is well worth the time to review the entire report.



The Information Technology and Innovation Foundation is a non-profit, 501(c)(3), non-partisan public policy think tank committed to articulating and advancing a pro-productivity, pro-innovation and pro-technology public policy agenda internationally, in Washington and in the states.