There have been many discussions taking place on the timing to meet the forthcoming Meaningful Use regulations and incentives. As a reminder, below is a summary view of the three stages for achieving Meaningful Use.
What these stages directly relate to is gaining access to the incentive dollars. Below is a chart highlighting the overlay of the stages with the timelines for proving Meaningful Use. Included in this view are suggested project implementation approaches based on when organizations will pursue achieving the regulated guidelines.
Timing, as in most things, is critical. Depending on when your organization really begins to pursue the Meaningful Use criteria will drive which project implementation approach is optimal. In this case, optimal is based on two key elements:
Enhancing the ability to meet the stage 1, 2, and 3 criteria in the defined schedule
Gaining the maximum incentive payment in a target year
With this as background, let’s highlight the five different project implementation approaches outlined in the chart above and provide some insights on what each approach may mean to your organization.
Agile. Agile project management encompasses a tight collaborative approach with very short cycle times between projects. Individuals across functions work very closely together within rapid delivery time schedules. The project deliverables are well-defined and manageable, to a certain degree. Agile project teams stay together through all of the project cycles.
One of the key objectives is to put boundaries around project scope in order to go through the complete project cycle within a 4 week or so time schedule. Information flow between the team members is open and honest. A potential challenge with this approach is that it may not work as effectively with larger project scopes. Breaking the project into smaller “chunks” may not be an efficient way to implement larger projects in a productive manner. However, by starting in 2010 to meet Meaningful Use requirements in 2011 and 2012, the project deliverables initially undertaken can be defined around those specific year requirements.
Iterative. As the name suggests, this approach is a cyclical one. It is similar to the agile methodology. This implementation approach usually leverages cross-functional teams who have the responsibility and authority to quickly gather information, implement, and solicit immediate feedback until the requirements are met. It is an active approach in which there is a current iteration plan being worked while the next iteration plan is coming together. The second iteration plan is ready right after the current iteration is completed.
The number of iterations will be determine by the overall time schedule as well as the number of projects being pursued. There may be multiple iterative projects happening at the same time, which feed an overall iterative project plan. If you are getting dizzy from all the iterations, think of this approach as bees buzzing around furiously filling the honeycomb with their hard work.
The advantage to this approach is that you may discover issues earlier in the process and multiple projects can be more effectively handled at the same time. Additional coordination may be required to keep the iterations aligned and moving forward.
Waterfall. Using the waterfall project implementation approach is a sequential completion of various activities. Methodically, each phase –Requirements, Design, Implement, Test, and Production – is very structured, and it is completed prior to moving on to the next phase. It is a more cautious approach and requires more time to complete. The argument for using this approach is that by fully completing each phase, you will save time later in the cycle.
Using this approach involves identifying the various requirements now, and then lining the projects up in the right order to move through complete Meaningful Use achievement. A longer runway of time is needed to deliver effectively. Consequently, if you know that your organization will not be able to implement Stage 1 requirements until 2013, intense planning will be a prerequisite to meet all the requirements during that 3-year window. The project will need to be well defined and mapped out which aligns more appropriately with the waterfall approach.
Big Bang. Big bang approaches to implementation were more popular in Y2K projects. During this time, process re-engineering combined with major systems implementations all happened within one enormous project and within one project schedule. Taking this approach requires many resources – many people and big budgets. Much can be accomplished within a year or two, but multiple elements are crucial, including tight coordination between various teams, well-documented project plans and connection points, and a well-focused – single-focused – team. In this approach, details can be lost in the push to get the overall project completed, and fatigue can set in with the various team members.
Big Bang2. Take everything above, divide the time in half, square the team size, square the risks, and hope it works! The reality is, by this time, unless the scope of what needs to be completed is small, it is better to plan a reasonable implementation and not worry about the incentives. The central point is, if you waited this long to meet the requirements, your concern should be more on avoiding the penalties than realizing the incentives.
Implementing full scale projects on any of these timelines will create many obstacles and challenges. Having a well-thought out implementation approach along with talented people and flexible, adaptable supporting technology will reduce the risk and facilitate your efforts to meet regulation bars set.
Since February 2009, there has been uncertainty on the exact regulations extending from the passage of HITECH and the implementation of Meaningful Use. This uncertainty may have seeped into many healthcare workplaces through projects being placed on hold, changing project directions, or strategic plans being re-written. The outcome may be to keep your heads down and manage what you know and leave the rest until everything shakes out.
That is not the way to manage an operation, however.
Alaina Love may have gotten it right in a recent BusinessWeek article entitled You Can Lead. But Can You Inspire? As she states in the leadership article:
“…they do one thing particularly well: They give employees roles consistent with their unique skills, core values, and primary passions. Inspirational leaders focus unrelentingly on tapping the right people for each job and helping others determine where they can be their best; then they create that opportunity inside the organization. Given the economy-driven seismic shift that has occurred in most companies, leaders who can inspire others to achieve more than they believed possible have never been as essential for survival as they are today.”
With the work to be done to meet the Meaningful Use and HITECH objectives in 2011 and subsequent years, it is essential to understand each team member’s strengths and passions and tap into that stream of creativity, diligence and innovation. Being cynical about what needs to be done or some of the uncertainty that still lies ahead will not produce as much in the end. Inspired productivity is a must.
Take a few minutes to read this article, and rate your own leadership style – inspired or cynical – using the ten highlighted areas.
Although there has been concern expressed over which healthcare standards were going to be required in the Meaningful Use regulations, the Interim Final Rule (IFR) does not make any drastic changes, at least for Stage 1. The key healthcare standards outlined for Stage 1 include (taken from the Standards & Certification IFR):
Purpose
Adopted Standard(s) to Support Meaningful Use Stage 1
Category
Patient Summary Record
HL7 CCD R2 CCD Level 2 or ASTM CCR
Content Exchange
Problem List
Applicable HIPAA code set required by law (i.e., ICD-9-CM) or SNOMED CT®
Vocabulary
Medication List
Any code set by an RxNorm drug data source provider that is identified by the US National Library of Medicine as being a complete data set integrated within RXNorm
Vocabulary
Procedures
Applicable HIPAA code set required by law (i.e., ICD-9-CM or cpt-4®)
Vocabulary
Lab Orders and Results
LOINC® when LOINC codes have been received from a laboratory
Vocabulary
Drug Formulary Check
Applicable Part D standard required by law (i.e., NCPDP Formulary & Benefits Standard 1.0)
Content Exchange
Electronic Prescribing
Applicable Part D standard required by law (i.e., NCPDP SCRIPT 8.1) or NCPDP SCRIPT 8.1 and NCPDP SCRIPT 10.6
Content Exchange
Any code set by an RxNorm drug data source provider that is identified by the US National Library of Medicine as being a complete data set integrated within RXNorm
Vocabulary
Administrative Transactions
Applicable HIPAA transaction standards required by law
Content Exchange
Quality Reporting
CMS PQRI 2008 registry XML Specification
Content Exchange
Submission of Lab Results to Public Health Agencies
HL7 2.5.1
Content Exchange
LOINC® when LOINC codes have been received from a laboratory
Vocabulary
Submission to Public Health Agencies for Surveillance or Reporting
HL7 2.3.1 or HL7 2.5.1
Content Exchange
According to Applicable Public Health Agency Requirements
Vocabulary
Submission to Immunization Registries
HL7 2.3.1 or HL7 2.5.1
Content Exchange
HL7 2.3.1 or HL7 2.5.1 with CVX vocabulary
Vocabulary
What is Stage 1? There are three stages for Meaningful Use criteria, as defined by the Centers for Medicare & Medicaid Services (CMS). Outlined below are the three stages and their criteria (bold emphasis added to highlight key points).
Stage
Timing
Criteria
1
Beginning in 2011
"focuses on electronically capturing health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); consistent with other provisions of Medicare and Medicaid law, implementing clinical decision support tools to facilitate disease and medication management; and reporting clinical quality measures and public health information."
2
Beginning in 2013
"consistent with other provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results (such as blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac imaging, nuclear medicine tests, pulmonary function tests and other such data needed to diagnose and treat disease). Additionally we may consider applying the criteria more broadly to both the inpatient and outpatient hospital settings."
3
Beginning in 2015
"consistent with other provisions of Medicare and Medicaid law, to focus on promoting improvements in quality, safety and efficiency, focusing on decision support for national high priority conditions, patient access to self management tools, access to comprehensive patient data and improving population health."
Stage 1 is more clearly defined, with Stages 2 and 3 open for public comment and guidance. Within the IFR, public comment is encouraged throughout the document especially as it relates to the later stages. The focus in Stages 2 and 3 is to narrow the healthcare standards required so, in other words, fewer standards choices as Meaningful Use criteria unfolds in 2013 and beyond.
Although this article is a little tedious, the point is to highlight the healthcare standards being pulled forward for Stage 1 and draw attention to the direction in the subsequent years. More articles will be offered to add to the understanding and insight on the real impacts to healthcare IT's role in supporting these new goals and regulations.
"Nearly two-thirds of all respondents said they were at least somewhat worried about their ability to implement standards-based applications and how that would affect meaningful use determinations for their organizations." (Survey finds Healthcare CIOs Concerned about Proposed Meaningful Use Standards, December 3, 2009)
The statement above is a result of a recent healthcare CIO survey conducted by CHIME (College of Healthcare Information Management Executives). Primary reasons for the concern about implementing standards-based applications include:
21.6 percent of all respondents listed vendor readiness
14.8 percent of all respondents listed the need to implement upgraded or new systems
15.3 percent mentioned insufficient capital
10.2 percent were lacking staff with needed skill sets
8.5 percent indicated insufficient staff
In a previous article, the anxiousness over Meaningful Use and its impact on health IT operations and projects has grown. The CHIME survey reflects the concern about how it is all going to come together.
The concerns can be summarized in two primary points:
There are many systems to implement and tie together. Will there be enough internal budget and people with the right skills to make it happen within the defined milestones?
On the vendor readiness with healthcare standards point, it is important that vendors implement the healthcare standards in a cohesive, manageable manner. Today, the healthcare standards are very flexible, and there are numerous versions. The Health IT Standards Committee is adding to the mix of uncertainty by entertaining discussion on using the Internet as an example for the effective use of data standards. Add to this a recent statement by the HL7 CEO urging that the discussion remain focused on utilizing the existing standards rather than creating new ones.
The readiness concern, consequently, is valid since there isn't a clear direction on implementing healthcare standards. Essentially, it comes down to this: There are multiple healthcare standards available today which have extreme flexibility in the way they are used and implemented. Combine this with calls for revisiting the existing healthcare standards and adopting a new model or approach to defining healthcare data exchanges. What do you healthcare software application vendors to be ready for?
In the middle of this, literally, are healthcare integration platform vendors. They are ready to support the healthcare standards maze... and options. Hospital CIOs need to take this into account as they approach their software and process implementation initiatives. Software readiness to support standards cannot be viewed in separate application silos, but rather what technology can connect them together no matter what the standard or version of the standard.
Regarding the second point, proper funding may always be a challenge. In the HITECH case, hospitals and other providers must spend money to meet the requirements with the hope that all projects will align and they will be eligible for the incentive funds. In other words, it is taking limited financial resources and placing calculated bets on getting a return on the dollars spent. The return is both financial rewards from the Federal government and higher quality, more efficient patient care. Again, although the current debate is centered on health care reform, healthcare IT reform is already well underway with many risks of its own.
With HITECH passage, ensuring the right people skills are available was addressed through grant programs. There are two grant programs available:
Community College Consortia to Educate Health Information Technology Professionals in Health Care Program: This program is focused on quickly developing health IT academic programs at community colleges. The program is focused on the following roles: practice workflow and information management redesign specialists, clinician/practitioner consultants,implementation support specialists, implementation managers, technical/software support staff, and trainers.
Curriculum Development Centers Program: This program offers grants to colleges to develop curriculum healthcare information technology programs. The curriculum will be available to community colleges.
These programs are designed to develop the people through educational programs so there an adequate, qualified talent pool available. Unfortunately, this will take some time to develop and then began enrollment in the programs.
The CHIME survey confirms what is obvious and raises a rightful concern that there are many puzzle pieces which need to fall into place almost flawlessly to ensure the HITECH goals are accomplished. This is not to say it can't be done; it is saying - understand the current environment, the risks, the opportunities, and the goals, and develop a reasonable, practical, and thoughtful approach to implementing the plans.
On February 17, 2009, ARRA (America Recovery and Reinvestment Act of 2009) was signed into law, which included the passage of the HITECH provisions. Significant time has passed since then. Although some directional work has been done by the various ONC committees, the regulations governing the incentives are planned for initial publication prior to the end of December. CMS (Centers for Medicare & Medicaid Services) is responsible for publishing the regulations.
When it comes to governmental processes, time passes slowly. Unfortunately, the anxiousness of health IT executives rises rapidly as many key elements remain undefined.
Quote 1: "'I think there is a fair amount of anxiety about the work to be done and the challenges ahead at the provider level, and yet there's also an excitement about the opportunity to enable improved healthcare,' said Mike Smith, CIO at Lee Memorial Health System in Florida. He added, 'My sense is that the readiness level varies by area, provider organization and vendor.'"
Quote 2: "'I have been at the CIO level in the industry for 14 years, and we are being asked to do much more in the next six than I have seen happen in the past 14,' McCleese said, noting that Blumenthal agreed with his assessment. 'He understands the question, but [said] the law has been passed by Congress with good reason and we need to adhere to it.'"
Health IT reform has happened, but the devil is in the details. There is much work to be done to gain access to the HITECH incentives.
The reason behind the anxiety may be summarized around three areas:
HITECH Anxiety Reason #1: When to start which health IT projects? It is clear that a certified EHR must be used in order to gain access to the incentives. There is also clear directions outline on what Meaningful Use. To enable the health information exchanges, provide clinical summaries, and provide reasonable electronic access to a person's health record are all challenging projects. What will be required when is still unknown, including what the ramp in requirements will actually look like from 2011 to 2015.
Balancing competing and unknown health IT projects is disconcerting and may stall some initiatives until clear direction is delivered.
HITECH Anxiety Reason #2: Will there be a health IT resource shortage? There are funds available for Regional Extension Centers to provide information and best practices on implementing health IT solutions, including EHRs. Additionally, HHS recently announced $80 million in grants "to help address an estimated shortage of 50,000 health IT workers." (iHealthBeat, November 24, 2009) Through community colleges and other non-degree programs, the goal is to train and develop 10,000 new health IT workers on an annual basis.
Nevertheless, with quick timelines, multiple projects, and all providers on the same implementation path, the resource concern is justified. An article in Hospitals & Health Networks highlights this concern in an article entitled Triple Whammy Hits IT Departments. Sense the anxiety in the following quote from the article:
"Compounding the issue further is a triple whammy of major IT projects facing every health care organization. Not only is there the HITECH-fueled push for electronic health records, the stimulus law also tightens HIPAA privacy and security requirements, something American Health Information Management Association CEO Linda Kloss calls a 'very big challenge.' And already in the works is the transition to ICD-10 coding and the related ANSI X12 5010 electronic transactions."
Many projects, little time and, potentially, too few resources. Have a defined strategy and approach will be critical to meeting the new health IT demands ahead.
HITECH Anxiety Reason #3: How will the race for incentive funds impact the quality of patient care? Dr. Blumenthal has stated: "The meaningful use framework will be about the goals of care, not the technology." However, getting the dollars is dependent upon implementing certain technology enablers. In the initial incentive years, it seems that proving enhanced quality of patient care is nominal, but the continued receipt of incentive funds is likely headed toward showing meaningful performance improvements.
With the amount of money about to be spent, there will be scrutiny in the press on the results being achieved. The focus on results, even from the start, will put pressure (i.e., anxiety) on health IT professionals and healthcare operations executives to prove the value of the investments being made, especially since it is coming directly from taxpayers.
A balanced approach is needed when approaching the various health IT projects. There is time to realize the full value of the incentive funds; having everything ready in 2011 is not required. Full value still can be realized if a provider begins to meet the requirements in 2012. It is important to be methodical in the implementation approach and to be positioned to show enhanced patient quality of care or improvement in key performance metrics in the later years.
A well thought out plan is a necessity. More details will come soon. Have adaptable planning processes to adjust to the changes. Remember the old adage - Plan ahead, or Plan early and often.
02.10.2010
