The October HIT Standards Committee Meeting

by John Halamka, Life as a Healthcare CIO


This month's meeting focused on the planning for standards which will support meaningful use stage 2 and 3, as well a review of NHIN Direct and its future plans to provide simple transmission of data among stakeholders.

We began the meeting with Jamie Ferguson's Vocabulary Workgroup report.   He highlighted the work that has been done to reduce the intellectual property barriers which have slowed the creation of centralized, web-based resources containing all vocabularies, codesets, and mappings needed by eligible providers and hospitals to achieve meaningful use.  Several financial models have been considered, including federal government funding of vocabulary licensing fees and the establishment of a single administrative group to centrally collect a single fee from providers in return for providing them all the meaningful use vocabulary resources they need.    We discussed two related issues 1) identifying who pays licensing fees and we determined it should be those who generate data not those who receive it or manipulate it as a business associate of the data generator.  2) identifying the need for proprietary code set vendors to create free mappings to federally mandated standards.   For example, RxNorm includes proprietary medication codesets and the vendors of these codesets should offer free mappings from ALL their proprietary codes to RxNorm codes.

Next, Liz Johnson updated the group on the Implementation Workgroup activities.   She highlighted the need for hearings, to be held in December or January, on five topics - the role of RECS in attaining meaningful use, certification experiences, lessons learned from early adopters seeking meaningful use attestation in 2011, experience with performance/quality measures, and the status of health information exchanges.   I discussed two barriers to certification - the fact that the syndromic surveillance implementation guide in the Final Standards Rule is incorrect.   It was updated via an interim final rule  so that has been addressed.   Also that the NIST testing tools for e-prescribing transactions did not include the XML forms of NCPDP standards.   On October 24, NIST issued version 1.1 of those tools, addressing the issue.

Paul Tang and George Hripcsak then presented the guiding principles behind Stage 2 and 3 meaningful use.   Summarizing the key points
*Some aspects of stage 2 will be incremental changes to stage 1 (i.e. raising the thresholds)
*Some will be a stepping stone on the way to stage 3
*Stage 3 will likely including outcomes measures as well as process measures. 
*Stage 2 and 3 will likely require analysis of data across a community and not just within an institution, increasing the amount of HIE enablement to be demonstrated.
*Patient engagement in future stages will clarify methods to share data with patients - "access/download" which is real time on demand, "copy" which is a point in time summary of available information including specific use documents/datasets. 

Our discussion included the need to clarify the term "document".  Most people concurred that "document" meant a collection of data elements, in electronic form, capable of many reuses.   Ideally, the standards committee will suggest a common container for assembly of structured and unstructured information that does not require creating numerous standards for individual document types.

Arien Malec then updated the group on NHIN Direct.   The consensus of the Direct collaborators is to require secure email (SMTP/TLS/certificates) as the backbone but allow SOAP (XDR) or SMTP at the edges.  This means that senders and receivers can decide how to transmit/receive data (SMTP or SOAP) as long as they have a way to communicate with the SMTP backbone.   Finally, an exception was made for those senders and receivers who agree to use SOAP from point to point by previous agreement.  This approach enables existing vendor products which already support SOAP to continue to do so, while enabling innovative approaches using secure email.   Specifications will be finalized by next month and live implementations will be evaluated by the Standards Committee in March.

Doug Fridsma reviewed the current state of the Standards and Interoperability framework, noting that it now has a set of tools and processes to support health information exchange project development including use case writing, harmonization, implementation guide writing, reference implementation and testing.   Priorities will focus on Meaningful Use data exchanges and the Virtual Lifetime Electronic Record (VLER) project.   Much discussion followed about the best way to incorporate the HIT Policy Committee, the HIT Standards Committee, NHIN, and the Standards and Interoperability Framework into a more coordinated set of activities.   The Concept of Operations document which guides the Standards and Interoperability Framework is being updated to knit all these activities together and we will discuss that at our November meeting.

Health Reform 101

In Health Reform Hits Main Street, the Kaiser Family Foundation delivers a cartoon video overview of the health reform law. Narrated by Cokie Roberts of National Public Radio.

Accountable Care Organizations - the week's top links

Accountable Care: The Top Five Things the Community Hospital Can Do Now by Luke Peterson

Report from the Accountable Care Organization Workshop by Bass Berry Sims

Accountable Care Organizations: The Gathering Storm? at Better Health

Accountable Care Organizations - Accountable for What, to Whom, and How by Elliott Fisher, Stephen Shortell

ACOs and the Looming Antitrust Crisis By David Dranove

2011 Draft Accountable Care Organizations (ACO) by NCQA

Hospital Strategies to Support Accountable Care by HFMA

Accountable Care Organizations Workshop by the Office of the Inspector General

10 Stories on How to Build an Accountable Care Organization by Becker's Hospital Review

The Health Reform (Almost) Everyone Loves by Michael Millenson

Shared Savings Program for Accountable Care Organizations: A Bridge to Nowhere? by Robert Berenson

Accountable Care Organizations - Top links

Accountable Care Organizations - "made simple" by David Harlow

Becoming Accountable — Opportunities and Obstacles for ACOs by Harold Luft

Creating Accountable Care Organizations panel with Thomas Lee, Lawrence Casalino, Elliott Fisher, and Gail R. Wilensky

The Achilles Heel of ACOs? Shared Savings Payment Model Unlikely to Motivate Hospitals by Vince Kuraitis

Accountable care organizations: How your practice can profit by Victoria Stagg Elliott

Why Hospitals Are Beating the Bushes for Primary-Care Doctors by Ken Terry

Controlling healthcare costs the old, new way by Richard Kipp and Lisa Mattie

Information Technology for Accountable Care Organizations by John Glaser and Claudia Salzberg

The Vermont Accountable Care Organization Pilot: A Community Health System to Control Total Medical Costs and Improve Population Health by Jim Hester, Julie Lewis and Aaron McKethan

Achieving Accountable Care by Mark McClellan

Why Accountable Care?  Core Principles Underlying ACOs by Elliott Fisher

Next Steps for ACO Implementation by Mark McClellan and Elliott Fisher

ACO success tied to EHR, HIE capabilities by Patty Enrado

10 People to Know in the World of ACOs by Leigh Pag

Accountable Care Organizations: A new model for sustainable innovation by Paul Keckley

Accountable Care Organizations - "made simple"

by David Harlow, Health Care Law Blog

Don Berwick kicked off the day-long Accountable Care Organization (ACO) Workshop and Listening Session, co-hosted by the FTC, CMS and the OIG, with a short, stirring speech that touched on his Triple Aim for health care: better care for individuals, better health for populations and reduced per-capita costs.  He committed the government to interpreting applicable statutes "wisely, so as not to impede the development of ACOs."  That sums up the reason this workshop was so eagerly anticipated.  Health care providers are extremely eager to become ACOs - though the term has yet to be fully defined - yet are extremely concerned about the potential to have specific ACO arrangements identified as illegal by the FTC, the OIG or CMS because the arrangements violate antitrust law, Stark, anti-kickback or anti-fraud and abuse laws, or may be subject to civil monetary penalties.  The health reform legislation authorized these agencies to develop waiver programs and safe harbors in order to implement the ACO concept, and proposed rules doing so will have to be issued this fall in order to have these systems up and running next year, as called for by the law.  Berwick's commitment to make this as pain-free as possible was echoed by FTC Chairman Jon Leibowitz and HHS Inspector General Dan Levinson.  Check out the live-tweeting transcriptof the day's events. (Audio of the day's proceedings should be posted in the near future.)

So, this leaves just a few questions:

• What is an ACO and why are they given special status under the law?
• Why are waivers or safe harbors needed if ACOs are authorized by the Federal health reform law?
• What waivers or safe harbors are likely to be proposed in the next month or so?
• Will these waivers and safe harbors protect ACO activity where the payor is a commercial payor, rather than a federal health care program payor?

What is an ACO and why are they given special status under the law?

The health reform law, now known by its acronym PPACA or ACA (Patient Protection and Affordable Care Act, or simply Affordable Care Act), authorizes (among many other demo and pilot programs) the establishment of a shared savings program known as the ACO program, in Section 3022 (codified as Title XVIII, Section 1899). See CMS Shared Savings (ACO) FAQ for details.  At its core, the law requires that an ACO must:

1) Have a formal legal structure to receive and distribute shared savings
2) Have a sufficient number of primary care professionals for the number of assigned beneficiaries (to be 5,000 at a minimum)
3) Agree to participate in the program for not less than a 3-year period
4) Have sufficient information regarding participating ACO health care professionals as the Secretary determines necessary to support beneficiary assignment and for the determination of payments for shared savings.
5) Have a leadership and management structure that includes clinical and administrative systems
6) Have defined processes to (a) promote evidenced-based medicine, (b) report the necessary data to evaluate quality and cost measures (this could incorporate requirements of other programs, such as the Physician Quality Reporting Initiative (PQRI), Electronic Prescribing (eRx), and Electronic Health Records (EHR), and (c) coordinate care
7) Demonstrate it meets patient-centeredness criteria, as determined by the Secretary. 

The ACO provision in the ACA has garnered a disproportionate amount of attention, likely because of the opportunity for shared savings and the opportunity for hospitals to more closely ally their affiliated physicians.  However, the point was made time and again at the workshop that the goal of the program is to improve patient care and the patient experience -- without that guidepost at the core, the exercise won't work.

Aside from large IDS's seeking to use the ACO program as a means to protect and potentially grow market share and margin (after all, "no margin, no mission"), why would hospitals want to get involved?  Hospital reimbursement is on the line here: about 70% of costs -- and potential savings -- are on the hospital side of the equation, and much of the control over those costs lies with physicians.  If they are not already employed physicians, the sharing of savings means the hospital will be sharing with the physicians, and not vice versa.  Despite this apparent disincentive, past experience has shown that strong physician-led initiatives can bring hospitals into the fold.  Two examples: the Medicare Physician Group Practice Demonstration Project (an ACO precursor) and the Grand Junction, Colorado experience: a physician-led arrangement initially targeted by the FTC as a price-fixing scheme, eventually resolved through a settlement agreement, and now seen as a national model of collaboration, aligned incentives, cost-effectiveness, and quality improvement.

Why are waivers or safe harbors needed if ACOs are authorized by the Federal health reform law?

The general idea is to get providers across the continuum of care to band together, work on reducing costs and improving quality, continue to be paid on a fee-for-service basis by CMS, and then retrospectively look at system-wide savings (e.g., avoided readmissions) and share those savings around.  Sharing those savings around outside of an integrated delivery system raises a host of potential antitrust, fraud and abuse (anti-kickback), Stark and CMP issues, and the statute authorizes the development of waiver programs and safe harbors in order to make it all work.  It's really a square peg-round hole problem, because the policy basis for making illegal this sort of sharing is grounded on fee-for-service, retrospective reimbursement systems.  Prospective payment, particularly bundled payments for episodes of care, eliminates the potential for the harm these rules protect against (over-provision of care due to financial incentives), yet they are still on the books.  For example, we want physicians to share in the hospital savings experienced as a result of an avoided readmission which would not be eligible for separate reimbursement; this opportunity will incentivize them to work harder to prevent the readmission.  Under current rules, however, a payment by the hospital, directly or indirectly, to the physician, tied to that savings, is impermissible.

What waivers or safe harbors are likely to be proposed in the next month or so?

Federal officials at listening sessions are notoriously tight-lipped, so not much was said about what to expect, other than proposed regulations are expected to come out this fall.  However, all were keen to emphasize that they want to eliminate the regulatory impediments to ACOs, and welcome further comments from the public.

As a whole, the regulated community is eager to have greater certainty, in the form of new regulated guidance; however, some would prefer to simply be guided by what's out there already: advisory opinions, guidelines, regulations, etc., that lay out safe harbors.  For example, the joint DOJ-FTC healthcare antitrust guidelines provide that clinical integration -- even in the absence of full merger or acquisition, or direct employment of physicians by a hospital -- will keep providers out of antitrust hot water even iof they are collaborating in ways otherwise prohibited.  At the other end of the spectrum, some folks would prefer to have the federales get broad authority to issue blanket waivers without establishing super-specific criteria.

Establishing criteria for waivers or safe harbors will be somewhat difficult, because the definition of an ACO is a little slippery. The financial arrangement at its core can be simply a shared savings arrangement, but it might also veer into other territory: underwriting patient expenses such as transportation costs or home monitoring device costs, or the payment of a physician group's up-front capital expenses by a hospital in order to kick-start the process (all potentially illegal inducements under current law).

Many of the comments were directed at ensuring that a particular type of arrangement or organization does not escape the feds' notice, so that they can all be written into waiver or safe harbor language.   

Will these waivers and safe harbors protect ACO activity where the payor is a commercial payor, rather than a federal health care program payor?

The rules at issue are all Federal health program rules -- except for the FTC antitrust rules, which apply across the board. 

A number of forum participants suggested that a rule of reason analysis under the antitrust laws (rather than "per se" analysis) would be needed in order to address market power issues in each unique ACO situation.  It seems to me that such an approach would be throwing away the current opportunity to craft a set of guidelines focused not only on ACOs but on other provider arrangements likely to come down the pike under other ACA demo and pilot authority.  This opportunity should be seized by the other agencies as well -- not just the FTC. 

Final thoughts

Will providers actually come together to form ACOs?  The jury is still out.  There is certainly a lot of noise being made, but the long-term key from both a policy and business perspective is that the efforts of the provider organizations must be to make themselves more patient-centered.  Berwick's emphasis on this point was striking, and he illustrated it with an anecdote from his days of practicing as a pediatrician at Harvard Community Health Plan, where systems were in place to support a patient-clinician partnership at a very high level, suggesting that HCHP was an ACO long ago.  In current-day Massachusetts, Blue Cross Blue Shield of MA has rolled out its Alternative Quality Contract to  a quarter of its provider network; half of the docs involved are in small practices.  While it has taken some years for the AQC program -- another proto-ACO program -- to get off the ground, it is significant because it has allowed for the agglomeration of small practices into a larger whole for purposes of the contract, thus perhaps lighting the way for ACO participation by organizations other than IDS's.

So is this deja vu all over again? Have we stepped back in time a couple of decades to re-experience managed care failures of an earlier era?  Certainly, some rpoviders see the ACO structure as a way to increase market share, margin and bargaining power -- and it's a no-downside financial deal.  As noted above, it cannot be only that.  There are significant costs and potentially difficult negotiations ahead as providers across the continuum work with the regulators to hash out the final status of the ACO landscape, and then deal with integrating themselves into one or more ACOs with a laser focus on patient-centered care.  That focus should yield benefits up and down the line: for patients, providers and ultimate payors in both the public and private sectors.

Chopra - Investing in Healthcare IT Summit

Aneesh Chopra DC2VC Oct 6, 2010

View more presentations from DC2VC.

Returning to the Source to Help Achieve Patient Safety Goals

by David Blumenthal, ONC 

Two landmark reports by the Institute of Medicine (IOM) changed Americans’ perception of their health care system and launched today’s drive to improve the quality and safety of medical care in America. The reports were To Err Is Human, published in 1999, and Crossing the Quality Chasm, released in 2001. 

Both these reports highlighted the important potential role that health information technology (HIT) could play in improving health care quality and reducing medical errors. In fact, Recommendation #9 in Crossing the Quality Chasm called for “renewed national commitment to building an information infrastructure” and said: “This commitment should lead to the elimination of most handwritten clinical data by the end of the decade.”

The end of that decade is now just three months away, and not to mince words, we’re behind the ambitious schedule that the IOM report envisioned. Nonetheless, we have at last made the substantial commitment that was called for in the report.  

Last year in the HITECH Act, Congress and the President authorized $27 billion in Medicare and Medicaid incentive payments for providers who adopt and make meaningful use of certified electronic health records (EHRs). At the same time, the Act created $2 billion in new programs to support the transition to HIT-assisted care. And this summer, the regulatory framework was completed for Stage 1 of the Meaningful Use path toward an EHR-based future in health care.

With the engines of change now in place, it is time to bring closer focus to other key issues for achieving the full potential benefits of HIT. One of these is the issue of improving patient safety. 

We know, both in theory and practice, that HIT-assisted care can reduce errors and improve patient safety. In particular:  

• Reliable access to complete personal health information is the foundation of safe and effective care. EHRs are inherently superior to paper in delivering such access.    
• Even more uniquely, EHRs can use their computing power to automatically cross-check personal information and other sources. With such backup, clinicians can be automatically alerted when drugs or other treatments may be contraindicated because of allergies, potential drug interactions, or other factors.

At the same time, however, it would be naïve to suppose that HIT-assisted care can deliver its full patient safety benefits in a single stroke – or that HIT will not present its own safety issues. Clinicians need to become familiar with new EHR systems, which will take time. EHR systems themselves need to evolve and improve. We need to ensure that the “decision support” information they provide is accurate and personalized. Their interfaces need to grow in user-friendliness. Even safety alerts need to find the right medium and avoid producing “alert fatigue.”

These challenges can be met – and indeed, the very “fix-ability” of HIT-based care can be one of its primary safety benefits. HIT systems tend to record and expose patient safety problems when they occur, while paper-based care too often hides them. And EHRs are amendable to rapid, systemic correction of problems – while corrections in a non-systemic, paper-based clinic can take years to accomplish, even when they are identified.

How can we maximize patient safety through HIT-based care? What roles and actions by government, the private sector, and health care providers themselves can help achieve the full potential benefits that were sought in those seminal IOM reports?

As we address these questions, there is no better source of guidance than the IOM itself, building on the same expertise and convening power that produced its initial reports 10 years ago. For that reason, the Office of the National Coordinator for Health Information Technology has contracted with IOM for a follow-up one-year study. In this study, IOM will:  

• Identify approaches to promote the safety-enhancing features of HIT while protecting patients from any safety problems associated with HIT and preventing HIT-related patient safety problems before they occur;
• Identify approaches for surveillance and reporting activities to bring about rapid detection and correction of patient safety problems;
• Address the potential roles of private sector entities such as accrediting and certification bodies as well as patient safety organizations and professional and trade associations; and
• Examine existing authorities and potential roles for key federal agencies, including the Food and Drug Administration, the Agency for Healthcare Research and Quality, and the Centers for Medicare & Medicaid Services.

As this study is carried out, we will move where appropriate to improve surveillance, reporting, product safety, and clinician performance. But at the same time, we will anticipate a “deep dive” in knowledge synthesizing and a new round of productive recommendations from the IOM.

There is every reason to believe that HIT-assisted care will be transformative for American medicine, but no reason to think the change will be easy or instantaneous. We are returning to the IOM as a key partner in helping to refine the course that it first helped to chart a decade ago.

The Social Network and Epidemics

Can the social network predict the spread of epidemics?  Nicholas Christakis presents his compelling research on the early detection of epidemics (as compared to the early warning of Google Flu Trends).

Clarifying Certification

by John Halamka, Life as a Healthcare CIO


On Friday, CCHIT announced certification of 33 complete and modular EHRs.  Drummond Group announced 3 certifications.

Many folks are asking about the difference between complete EHR certification and modular EHR certification.

A complete EHR must perform the functions necessary to support all 25 meaningful use criteria - 15 from the core set and all 10 from the menu set.   A complete EHR must support the 3 core quality measures, the 3 alternate quality measures and at least 3 of the menu set quality measures.

Modular EHR components are certified for the functions they perform.  The user then mixes and matches components as needed to meet the core set and the 5 menu set items they have chosen.   Each function included in meaningful use attestation must be certified.   Thus, in 2011, you only need to acquire the modular EHR components for the 20 criteria you are planning to include in your meaningful use attestation.

If your existing vendor-based hospital information does not provide all the functions you need for meaningful use, then acquire the modules needed to fill the gaps.   Alternatively, you can do what I am doing and seek a site certification of the hospital rather than assemble certifications for the products you are using.

It's likely that many existing EHRs will achieve modular certification - having most but not all needed functionality.   It's perfectly reasonable to use your existing EHR for the majority of the functionality you need, then supplement it with a data warehouse or health information exchange to achieve all the certifications necessary.

I hope this clarifies the certification process.

There will be many interesting lessons learned in this first round of certification.

1.  As I've reported previously, the Syndromic Surveillance implementation guide in the Standards Final rule is incorrect.   However, until it is fixed, vendors must implement the wrong data exchange in order to be certified because that is what the NIST testing site specifies.

2.  Some vendors may opt to be modular EHRs now and evolve to become complete EHRs as data exchange issues are clarified.   

3.  Testing procedures are going to evolve in these early days of certification and that is going to be challenging for vendors to support.   For example, NIST currently offers an e-prescribing validation procedure for NCPDP e-Prescribing formats using EDI but not XML implementations.  The HIT Standards Committee and the Standards Final Rule did not limit the transaction to just the EDI type.   Thus, it's likely NIST will change their testing criteria to support both EDI and XML.

  In the end, it will fall to the purchaser to ensure their goals are aligned with vendor plans.     If purchasers are seeking modules to expand the capabilities of an existing EHR, that should be clear.   If purchasers want a complete EHR and their preferred vendor is currently a module,  purchasers should request an agreement that the vendor will offer a complete EHR in a set period of time.

Health Wonk Review at Healthcare Talent Transformation

Peggy Salvatore posts the latest Health Wonk Review - the best of the healthcare policy blogosphere.

ONC releases FAQ on EHR Certification

Download all 20 Questions and Answers [PDF - 79 KB]

Question [9-10-001-1]: What certification criteria will ONC-ATCBs use to certify EHR technology for purposes of the “deeming” provision of the Physician Self-Referral Prohibition and Anti-Kickback Electronic Health Record (EHR) Exception and Safe Harbor Final Rules?
Question [9-10-002-1]: If my EHR technology is capable of submitting batch files to an immunization registry using the adopted standards (HL7 2.3.1 or 2.5.1 and CVX), is that sufficient for demonstrating compliance with the certification criterion specified at 45 CFR 170.302(k)?
Question [9-10-003-1]: In the “Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” Final Rule published on July 28, 2010, the Secretary adopted the following implementation specifications at 45 CFR 170.205(d)(2) for HL7 2.5.1 – Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting Final Version 1.0 and Errata and Clarifications National Notification Message Structural Specification. We believe that these implementation specifications may have been adopted in error because they only provide direction to public health agencies on how to report to the Centers for Disease Control and Prevention (CDC). Therefore, their adoption does not appear to either provide the appropriate or requisite implementation guidance for the adopted standard, HL7 2.5.1, or more importantly, to enable the user to “electronically record, modify, retrieve, and submit syndrome-based public health surveillance information…,” as required by the adopted certification criterion, 45 CFR 170.302(l). Please clarify whether these implementation specifications are appropriate for the intended capability specified by the public health surveillance certification criterion at 45 CFR 170.302(l)?
Question [9-10-004-1]: I currently use EHR version 1.3 which I purchased from EHR technology developer XYZ. EHR technology developer XYZ has informed me that it is not going to seek certification for EHR version 1.3. Can I seek certification for EHR version 1.3 or can I partner with a group of other health care providers that also use version 1.3 to split the cost of certification? Additionally, if EHR version 1.3 becomes certified can anyone else using EHR version 1.3 rely on the certification issued to EHR version 1.3?
Question [9-10-005-1]: I am an EHR technology developer. I have sought and achieved certification for the Complete EHR that I sell. The Complete EHR, however, is also designed to be sold in separate components so that I can offer my customers different prices based on the capabilities they seek to implement. Is it possible for me to sell components of my certified Complete EHR separately as certified EHR Modules, or do I need to seek testing and certification for each of the separate components that I plan to sell as certified EHR Modules?
Question [9-10-006-1]: I submitted a Complete EHR for certification, but it has not passed a test for one or more of the certification criteria. Can I request that the ONC-ATCB certify the EHR technology that I submitted as an EHR Module instead (i.e., certify only those capabilities that have been tested successfully)?
Question [9-10-007-1]: My hospital purchased a certified EHR Module that provides approximately 75% of the capabilities we need to meet the definition of Certified EHR Technology. The other 25% are provided by our own self-developed system(s). Can we have our self-developed system tested and certified as an EHR Module and then subsequently use the combination of our self-developed certified EHR Module with the certified EHR Module we purchased to meet the definition of Certified EHR Technology? As a follow up, do we need to have the combination of the purchased certified EHR Module and our self-developed certified EHR Module tested and certified together as a Complete EHR (above and beyond the certifications they have already been issued)?
Question [9-10-008-1]: If an EHR Module addresses multiple certification criteria (thus providing multiple capabilities), does it need to be tested and certified to the applicable privacy and security certification criteria as a whole or for each capability?
Question [9-10-009-1]: I'm an EHR technology developer and I've had my Complete EHR certified. I work with business partners/distributors and permit them to sell my (unmodified) certified Complete EHR under their own brand/name/label. Is this business practice permitted? Is there anything that I should do or be aware of?
Question [9-10-010-1]: My EHR technology is designed to receive demographic data from a registration system or a practice management system. The data from these other IT systems is then used by my EHR technology to demonstrate compliance with one or more certification criteria. Do these other IT systems that act as data sources to my EHR technology need to be certified?
Question [9-10-011-1]: I’ve identified that I am using two different EHR technologies to meet a single certification criterion (my document management system receives and displays summary records (45 CFR 306(f)(1)) and my EHR technology from EHR technology developer XYZ transmits summary records (45 CFR 306(f)(2)). Do both EHR technologies need to be certified?
Question [9-10-012-1]: How many clinical quality measures must EHR technology be capable of calculating in order to get certified?
Question [9-10-013-1]: I plan on sending/transferring meaningful use quality reporting data from my EHR technology to my “data warehouse” and have the data warehouse submit/report out the data to CMS. Does my data warehouse need to be certified?
Question [9-10-014-1]: I’ve selected a certified Complete EHR [or certified EHR Module] from EHR technology developer XYZ. That being said, I prefer the certified CPOE EHR Module designed by EHR technology developer ABC over the CPOE capability included in EHR technology developer XYZ’s Complete EHR. Can I use the certified CPOE EHR Module from EHR technology developer ABC instead of the CPOE capability included in EHR technology developer XYZ’s certified Complete EHR? Alternatively, can I use both of the certified CPOE capabilities included in EHR technology developer XYZ and ABC’s EHR technologies at the same time? In other words, can I use duplicative or overlapping certified capabilities of different certified EHR technologies without jeopardizing my ability to meaningfully use Certified EHR Technology?
Question [9-10-015-1]: I am an EHR technology developer preparing my EHR technology for certification. I am relying on a 3rd party software program to demonstrate my compliance with a specific certification criterion. Does this 3rd party software program need to be independently certified?
Question [9-10-016-1]: I’m in the process of implementing EHR technology developer XYZ’s certified Complete EHR [or certified EHR Module] “E-HealthSystem2010.” Scenario 1: I have determined that E-HealthSystem2010 needs to be reconfigured in order to connect with one of my patient registration systems. Can I reconfigure E-HealthSystem2010 without compromising the certified status of my implementation of E-HeatlhSystem2010? Scenario 2: EHR technology developer XYZ communicated to my organization that they relied upon a 3rd party software program “PatientInfoTracker 2.0” for the purposes of demonstrating compliance with the “generate patient lists” certification criterion specified at 45 CFR 170.302(i) in achieving E-HeatlhSystem2010’s certification. I have already implemented, use, and would like to continue using “SuperListGenerator 7.0.” I have determined that I can reconfigure SuperListGenerator 7.0 to work with E-HeatlhSystem2010. Can I use SuperListGenerator 7.0 in lieu of PatientInfoTracker 2.0 without compromising the certified status of my implementation of E-HeatlhSystem2010?
Question [9-10-017-1]: Under the Medicare and Medicaid EHR Incentive Programs Final Rule, eligible health care providers are permitted to defer certain meaningful use objectives and measures and still receive an EHR incentive payment. However, it is our understanding that in order for us to have our EHR technology certified, we must implement all of the applicable capabilities specified in the adopted certification criteria regardless of whether we intend to use all of those capabilities to qualify for our EHR incentive payment. Is our understanding correct?
Question [9-10-018-1]: I use or would like to use an “interface” to submit data to a public health agency/registry. Does this interface need to be certified?
Question [9-10-019-1]: The “electronic copy of health information” certification criteria (45 CFR 170.304(f) and 45 CFR 170.306(d)) each require that Certified EHR Technology “enable a user to create an electronic copy of a patient’s clinical information… in: (1) Human readable format; and (2) On electronic media or through some other electronic means….” Is there more than one way to demonstrate compliance with these certification criteria?
Question [9-10-020-1]: The certification criterion at 45 CFR 170.302(n) specifies that “[f]or each meaningful use objective with a percentage-based measure, electronically record the numerator and denominator and generate a report including the numerator, denominator, and resulting percentage associated with each applicable meaningful use measure.” Is it possible for the action of “record” in the certification criterion to be implemented in different ways and still remain in compliance with the certification criterion? For example, could “record” comprise the ability of a centralized analytics EHR Module to accept or retrieve raw data from another EHR Module or EHR Modules, and upon receipt of this raw data, the centralized analytics EHR Module would calculate the numerator, denominator, and the resulting percentage as specified by 45 CFR 170.302(n)?

Additional FAQs

• Standards and Certification Criteria Final Rule: Frequently Asked Questions
• Temporary Certification Program: Frequently Asked Questions

The September HIT Standards Committee

by John Halamka, Life as a Healthcare CIO

The September HIT Standards Committee included three major topics, all of which are important for "living the dream" of achieving meaningful use in the real world.

First, Jamie Ferguson and Betsy Humphreys briefed the committee on the recent Vocabulary Task Force Hearings which focused on reducing barriers and creating enablers to accelerate interoperability. One such enabler is creating a "one Stop shopping" resource for downloading the vocabularies and codesets required by the Standards Final Rule. Major themes included from the hearings included:

*Clarity about what is required, of whom, for what intended purpose and future vision is more important than simplicity

*A comprehensive plan does not mean it should be done all it once. Phased implementation of prioritized content sets and maps will ease adoption burdens

*A major issue reported by testifiers were intellectual property barriers to making these tools widely available. For examples, there are mappings that are only available to licensed users of proprietary vocabularies (i.e. RxNorm to First Data Bank mapping) and some code sets are embedded in HL7 and NCPDP standards which are only available via yearly membership in those organizations.

Vocabularies are increasingly important and Betsy Humphreys reported that licensure of UMLS for access to SNOMED-CT and RxNorm has grown tremendously - the final rule has accelerated adoption of controlled terminology. Thus, it is important that resources that facilitate the implementation and maintenance of meaningful use vocabularies are important.

Several ideas for addressing intellectual property issues were discussed including government licensure of vocabularies for general use and centralized procurement/license management for vocabularies needed for meaningful use that reduces the burden on hospitals and eligible professionals.

Judy Murphy and Liz Johnson presented the Implementation Workgroup's key priorities for the next year which include information sharing and communication to reduce the burden of achieving meaningful use. Hospitals and eligible professionals have similar questions, frustrations, and change management challenges. By leveraging the wisdom of the crowd via novel social networking approaches and education, we can accelerate the process for all.

Doug Fridsma presented the Standards and Interoperability Framework, the RFPs that have been awarded, and processes that will be defined to ensure that clear, easy to use implementation guides are available in the future.

Next month we'll hear from the HIT Policy Committee so that we can begin the standards selection effort in support of Meaningful Use Stage 2 and 3. The industry needs a phased implementation plan and thus my preference would be to declare what is needed for stage 3 and then define stage 2 as the incremental steps to get us on the right trajectory.