Health IT State of the Union

I appeared on the Fed Tech Talk radio program on Federal News Radio which aired on WFED 1500 AM in Washington, DC on January 28, 2014. It was a fun discussion with host John Gilroy (check out his blog here) where we discussed the Office of the National Coordinator for Health Information Technology (ONC) Annual Meeting, the historic signing of an MOU between the United States and Great Britain on sharing health IT tools, health information exchange, EHR adoption, the Direct Project, mobile health, and the current state of health IT in the nation.

I gave some background on my involvement in health information technology and an overview of the landscape in health IT and how we are building out an infrastructure to improve our healthcare system. This was a lot of fun, and hopefully helped get the word out that the state of health IT in this country is strong, and we are looking at the best year ever ahead. The bottom line is that it is time to drag the US healthcare system (albeit kicking and screaming) into the 21st century of technology.

Stage 2 Meaningful Use - Patient Engagement and HIE

Some of the most important changes in the rules for Stage 2 Meaningful Use and the 2014 Edition Standards & Certification Criteria (S&CC) are around patient engagement and health information exchange. While these requirements were backed off some from the proposed rule, there is still a strong emphasis on these aspects of the program. I think these are two of the most critical aspects of meaningful use and could help us eventually achieve the goals of improving the patient experience and lowering healthcare costs.

One new Stage 2 Meaningful Use Core Objective that all providers must meet is to use secure electronic messaging to communicate with patients on relevant health information. Another new Stage 2 Core Objective that all providers must meet is to provide patients the ability to view online, download and transmit their health information within four business days of the information being available. The specifics require that 50% of all unique patients are given access to information, and that five percent (down from 10% in the proposed rule) are able to view, download or transmit to a third party relevant health information. These measures require patients to take action in order for a provider to achieve meaningful use and receive an EHR incentive payment.

In the proposed rule CMS would have required 10% of patients to send a secure message, and 10% to actually view, download or transmit relevant information contained in the longitudinal record. But the final rule reduced these thresholds to 5%. The continued implementation of patient portals and PHRs incorporated into EHR functionality could make this an achievable goal if care providers implement and then offer them to their patients.

The American Hospital Association had reacted strongly to the proposed rule, stating that the requirements "raise the bar too high and are not feasible for the majority of hospitals to achieve." And in a statement indicated they were still not entirely pleased with the final rule. "While we appreciate that CMS has allowed for a shorter meaningful use reporting period for 2014," they said, "we are disappointed that this rule sets an unrealistic date by which hospitals must achieve the initial meaningful use requirements to avoid penalties. In addition, CMS complicated the reporting of clinical quality measures and added to the meaningful use objectives, creating significant new burdens."

The Health Information Management and Systems Society (HIMSS) noted in a statement that the final rule both adopts and concurs with a number of HIMSS recommendations made in comments on the proposed rule. Specifically they were pleased that the rule appears to streamline the administrative process of certifying EHR products. However, there did not appear to be any emphasis on utilizing mobile technology. I spoke with Pam Matthews, RN, MBA, the Senior Director of Regional Affairs at HIMSS who said, "We had made comments in several places where mobile could be considered in terms of being a benefit for patient engagement and data exchange, yet in the final rule they remained silent on mobile. HIMSS supports the development of guidelines to achieve transitions of care through patient centered mobile interfaces. We encourage consideration of including mobile health technology in future stages of meaningful use."

Stage 2 criteria also place an emphasis on health information exchange between providers to improve care coordination for patients. One of the core objectives for both eligible providers (EPs) and eligible hospitals and Critical Access Hospitals (CAHs) requires providers who transition or refer a patient to another setting of care or provider of care to provide a summary of care record for more than 50% of those transitions of care and referrals.

There are also new requirements for the electronic exchange of summary of care documents:

• For more than 10% of transitions and referrals, EPs, eligible hospitals, and CAHs that transition or refer their patient to another setting of care or provider of care must provide a summary of care record electronically.
• The EP, eligible hospital, or CAH that transitions or refers their patient to another setting of care or provider of care must either 

1. conduct one or more successful electronic exchanges of a summary of care record with a recipient using technology that was designed by a different EHR developer than the sender's, or
2. conduct one or more successful tests with the CMS-designated test EHR during the EHR reporting period.

There is also a movement in the right direction for interoperability under the S&CC rule with the cementing of data content utilizing Consolidated CDA, CCD/C32 and CCR standards which is imperative to a platform all stakeholders can now design for. Also, including Direct Project as a requirement for transport is a smart move. You can use it with XDM, or with XDR (over the Exchange SOAP Stack)

The exchange requirements are a bit weaker than in the proposed rule and elicited some robust discussion from a post by Wes Rishel on the subject. The discussion thread is very interesting and Wes adds some clarity to his comments. The whole issue is from statements made by Farzad Mostashari, MD, ScM the National Coordinator for Health Information Technology. I highly recommend you listen to them HERE. He gives an artistic and eloquent rendering of a segment of the final rule, which also contains a warning:

"We continue to believe that making vendor-to-vendor standards-based exchange attainable for all meaningful EHR users is of paramount importance. In that regard, and as we look toward meaningful use Stage 3, we will monitor the ease with which EPs, eligible hospitals, and CAHs engage in electronic exchange, especially across different vendors EHRs," Dr. Mostashari read, "If we do not see sufficient progress or that continued impediments exist such that our policy goals for standards-based exchange are not being met, we will revisit these more specific measurement limitations and consider other policies to strengthen the interoperability requirements." 

He the said, "I want there to be no question about the seriousness of our intent on this issue. The bottom line is it's what's right for the patient and it's what we have to do as a country to get to better healthcare and lower costs."

Rules for Stage 2 Meaningful Use

The U.S. Department of Health and Human Services has announced the release of the final rule for Stage 2 of meaningful use and ONC has updated the standards and certification criteria. When these rules were proposed they received over 6000 comments.

Through the Stage 2 requirements of the Medicare and Medicaid EHR Incentive Programs, the Centers for Medicare & Medicaid Services (CMS) hopes to expand the meaningful use of certified EHR technology. Certified EHR technology used in a meaningful way is one piece of a broader health IT infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety. “The changes we’re announcing today will lead to more coordination of patient care, reduced medical errors, elimination of duplicate screenings and tests and greater patient engagement in their own care,” Secretary Sebelius said.

The Office of the National Coordinator for Health Information Technology (ONC) rule proposes the capabilities and related standards and implementation specifications that Certified EHR Technology will need to include to, at a minimum, support the achievement of "meaningful use" by eligible health care providers beginning with the EHR reporting periods in FY/CY 2014. The rule also provides revisions to the permanent certification program for health information technology, which include changing the name of the program to the "ONC HIT Certification Program."

In this rule, CMS will maintain the same core and menu structure for the program for Stage 2. For Stage 2 EPs must meet or qualify for an exclusion to 17 core objectives and 3 of 5 menu objectives. Eligible hospitals and CAHs must meet or qualify for an exclusion to 16 core objectives and 2 of 4 menu objectives.

There are at least three focus areas in the requirements for stage 2 meaningful use:

• Standard data formats that allow health data to be captured and shared
• Patients must have the ability to download, view and transmit their health information
• Quality reporting is expanded

The Stage 2 Meaningful Use requirements will:

• Make clear that stage two of the program will begin as early as 2014. No providers will be required to follow the Stage 2 requirements outlined today before 2014.
• Outline the certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they use will work, help them meaningfully use health information technology, and qualify for incentive payments.
• Modify the certification program to cut red tape and make the certification process more efficient.
• Allow current “2011 Edition Certified EHR Technology” to be used until 2014.

The CMS final rule also provides a flexible reporting period for 2014 to give providers sufficient time to adopt or upgrade to the latest EHR technology certified for 2014. In the Stage 1 meaningful use regulations, CMS established an original timeline that would have required Medicare providers who first demonstrated meaningful use in 2011 to meet the Stage 2 criteria in 2013. The Stage 2 rule delays the onset of Stage 2 criteria. Any provider that attests to Stage 1 of meaningful use in 2011 or 2012 will attest to Stage 2 in 2014 instead of 2013. Therefore providers will not be required to demonstrate Stage 2 of meaningful use before 2014. A fact sheet on CMS’s final rule is available at http://www.cms.gov/apps/media/fact_sheets.asp.

Changes in the rule from Stage 1 Meaningful Use include:

• Substituting “transitions of care” for “exchange of key clinical information” as a core objective, and providing patients electric and online access to their health records instead of providing electronic copies of the information.
• Adding two new core objectives: using secure electronic messaging to communicate with patients, and automatically tracking medications from order to administration using assistive technologies in conjunction with an electronic medication administration record (eMAR.)
• Allowing a batch reporting process for attesting to meaningful use, allowing information to be submitted in one file.
• Reducing the patient engagement thresholds from 10 percent to 5 percent.
• Reducing the threshold for sending summary-of-care records for care transitions and referrals from 65 percent to 50 percent, and requiring at least one exchange with a provider using EHR technology from a different vendor.

The ONC rule describes standards and certification criteria changes, including:

• Adopting certification criteria for transitions of care ensuring EHR technology supports standards-based electronic health information exchange.
• Requiring that test reports for EHR certification be publicly available, with developers following specific price transparency practices.
• Allowing “gap certification” for certain criteria, which ONC says will make the process more efficient.

I will be publishing a deeper analysis after reviewing the new regulations.

UPDATE

After reading Steven Posnack's tweet below I uploaded the slides and embedded them:

Check out "do you have CEHRT"infographics healthit.gov/policy-researc…
— Steven Posnack (@HealthIT_Policy) August 23, 2012

Do you have EHR Technology that meets the new Certified EHR Technology definition for Meaningful Use Stage 2? 

Do you have EHR Technology that meets the new Certified EHR Technology definition for Meaningful Use Stage 1? 

Information Exchange Workgroup Provider Directory Task Force 1-24-11

The Information Exchange Workgroup Provider Directory Task Force met on January 24, 2011 and continued their discussion on Individual Level Provider Directories. The webinar is below:

Stage 2 Meaningful Use Request for Comments

The Health Information Technology Policy Committee, which advises the Department of Health and Human Services, is seeking comments through Feb. 25 on an initial set of proposed requirements for stage 2 meaningful use of electronic health records. The committee plans to hold public hearings this spring, and to issue final recommendations to HHS this summer for consideration in rulemaking. We should all plan to submit comments on the proposed stage 2 requirements currently under consideration. This will give ample opportunity for broad stakeholder input into the process before the proposed rule and final rule are published. Comments can be submitted here on regulations.gov. Below is information on the request for comment from the Meaningful Use Workgroup Regarding Meaningful Use Stage 2 [PDF]

HIT Policy Committee:

Meaningful Use Workgroup Request for Comments Regarding Meaningful Use Stage 2

I. Background

The Health Information Technology Policy Committee (HITPC) is a federal advisory committee that advises the U.S. Department of Health and Human Services (HHS) on federal HIT policy issues, including how to define the ―meaningful use‖ (MU) of electronic health records (EHRs) for the purposes of the Medicare and Medicaid EHR incentive programs. The HITECH portion of the American Recovery and Reinvestment Act (ARRA) of 2009 specifically mandated that incentives should be given to Medicare and Medicaid providers not for EHR adoption but for ―meaningful use‖ of EHRs. In July of 2010, HHS released that program’s final rule, thus defining stage 1 MU and strongly signaling that the bar for what constitutes MU would be raised in subsequent stages in order to improve advanced care processes and health outcomes.

The HITPC held six public hearings in 2010 including testimony from several dozen stakeholders and received additional dozens of public comments via its blog. All of this input helped to inform its many hours of public deliberations regarding the future vision of MU (e.g., stage 3) as well as the interim stepping stone of stage 2 MU that will set expectations for 2013 and 2014.

The HITPC has developed a preliminary set of recommendations specifically designed to solicit additional public feedback. The goal of sending out this request for comment (RFC) early is threefold.

1. Provide some signal to the industry of potential new EHR functionalities that the HITPC may recommend to help the industry get a head start on developing new functionalities.
2. Extend the public discussion of future stage MU definitions through a more formal public comment process well in advance of its formal final stage 2 recommendations to be issued in the summer of 2011.
3. Request input on specific questions.

Following analysis of the comments received through the approximately 45-day public comment period, the HITPC intends to revisit these recommendations in its public meetings in the spring of 2011. At that time, the HITPC will be able to review public comments in the context of the early feedback from providers on experience with stage 1 MU. That input will come through many vehicles: the Medicare program, the Medicaid program (both federal and state constituencies), the HIT regional extension program, and other sources. Note, this RFC solely represents the preliminary thinking of the HITPC and its Meaningful Use Workgroup.

Structure and Relevant Concurrent HITPC Activities

The HITPC has created a matrix of objectives and measures that it is considering for its recommendations to HHS. These objectives are organized into four of the five health outcome priorities that formed the stage 1 MU organizing structure. The HITPC approached its task of developing proposed stage 2 objectives by first developing a longer-term vision for MU and then determining what an appropriate stage 2 stepping stone is to get there. For this reason, the matrix includes possible stage 3 objectives, but they are only included in the matrix in order to provide context for the Stage 2 recommendations. Therefore, for the purpose of this Request for Comments, the HITPC is primarily interested in comments on the proposed Stage 2 objectives at this time.

The HITPC has a concurrent activity that is developing Stage 2 and 3 recommendations for the fifth health outcome priority — ensure adequate privacy and security protections for personal health information. The HITPC and its Privacy & Security Tiger Team will subsequently release recommendations for this domain.

In addition, the HITPC has a Quality Measures (QM) Workgroup that is concurrently developing a framework for the evolution of clinical quality measures to be electronically reported as part of Stages 2 and 3 MU. The HITPC recently collected public input through a request for comment on a set of proposed measure concepts, and it will provide more guidance on its measure development priorities in the near future following synthesis and analysis of those public comments. Other recommendations about information exchange are being developed by the HITPC’s Information Exchange Workgroup.

Proposed MU Objectives and Measures for Stages 2 and 3

Meaningful Use: Stage 1 Final Rule and Proposed Objectives for Stages 2 and 3
Improving Quality, Safety, Efficiency & Reducing Health Disparities
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
CPOE for medication orders (30%)		CPOE (by licensed professional) for at least 1 medication,  and 1 lab or radiology order for 60% of unique patients who have at least 1 such order (order does not have to be transmitted electronically)		CPOE (by licensed professional) for at least 1 medication, and 1 lab or radiology order on 80% of patients who have at least 1 such order (order does not have to be transmitted electronically)
Drug-drug/drug-allergy interaction checks		Employ drug-drug interaction checking and drug allergy checking on appropriate evidence-based interactions		Employ drug-drug interaction checking, drug allergy checking, drug age checking (medications in the elderly), drug dose checking (e.g., pediatric dosing, chemotherapy dosing), drug lab checking, and drug condition checking (including pregnancy and lactation)  on appropriate evidence-based interactions	Reporting of drug interaction checks to be defined by  quality measures workgroup
E-prescribing (eRx) (EP) (40%)		50% of orders (outpatient and hospital discharge) transmitted as eRx		80% of orders (outpatient and hospital discharge) transmitted as eRx	If receiving pharmacy cannot accept eRx, automatically generating electronic fax to pharmacy OK
Record demographics (50%)		80% of patients have demographics recorded and can use them to produce stratified quality reports		90% of patients have demographics recorded (including IOM categoriesi) and can use them to produce stratified quality reports
Report CQM electronically	Continue as per Quality Measures Workgroup and CMS		Continue as per Quality Measures Workgroup and CMS			The HIT Policy Committee’s Quality Measures Workgroup issued a request for comment in December; new measures will be considered after review of public comments
Maintain problem list (80%)	Continue Stage 1		80% problem lists are up-to-date			Expect to drive list to be up-to-date by making it part of patient visit summary and care plans
Maintain active med list (80%)	Continue Stage 1		80% medication lists are up-to-date			Expect to drive list to be up-to-date via medication reconciliation
Maintain active medication allergy list (80%)	Continue Stage 1		80% medication allergy lists are up-to-date			Expect to drive the list to be up-to-date by making it part of visit summary
Record vital signs (50%)	80% of unique patients have vital signs recorded		80% of unique patients have vital signs recorded
Record smoking status (50%)	80% of unique patients have smoking status recorded		90% of unique patients have smoking status recorded
Implement 1 CDS rule	Use CDS to improve performance on high-priority health conditions. Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action		Use CDS to improve performance on high-priority health conditions. Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action
Implement drug formulary checks*	Move current measure to core		80% of medication orders are checked against relevant formularies			What is the availability of formularies for eligible professionals?
Record existence of advance directives (EH) (50%)*		Make core requirement. For EP and EH: 50% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists		For EP and EH: 90% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists	Potential issues include: state statutes; challenges in outpatient settings; age; privacy; specialists; needs to be accessible and certifiable; need to define a standard
Incorporate lab results as structured data (40%)*		Move current measure to core, but only where results are available		90% of lab results electronically ordered by EHR are stored as structured data in the EHR and are reconciled with structured lab orders, where results and structured orders available
Generate patient lists for specific conditions*		Make core requirement. Generate patient lists for multiple patient-specific parameters		Patient lists are used to manage patients for high-priority health conditions
Send patient reminders (20%)*		Make core requirement.		20% of active patients who prefer to receive reminders electronically receive preventive or follow-up reminders	How should ―active patient‖ be defined?
(NEW)		30% of visits have at least one electronic EP note		90% of visits have at least one electronic EP note	Can be scanned, narrative, structured, etc.
(NEW)		30% of EH patient days have at least one electronic note by a physician, NP, or PA		80% of EH patient days have at least one electronic note by a physician, NP, or PA	Can be scanned, narrative, structured, etc.
(NEW)		30% of EH medication orders automatically tracked via electronic medication administration recording		80% of EH inpatient medication orders are automatically tracked via electronic medication administration recording
Engage Patients and Families in Their Care
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Provide electronic copy of health information, upon request (50%)		Continue Stage 1		90% of patients have timely access to copy of health information from electronic health record, upon request	Only applies to information already stored in the EHR
Provide electronic copy of discharge instructions (EH) at discharge (50%)		Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 80% of patients (patients may elect to receive only a printed copy of the instructions)		Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 90% of patients in the common primary languages (patients may elect to receive only a printed copy of the instructions)	Electronic discharge instructions should include a statement of the patient’s condition, discharge medications, activities and diet, follow-up appointments, pending tests that require follow up, referrals, scheduled tests  [we invite comments on the elements listed above]
EHR-enabled patient-specific educational resources (10%)		Continue Stage 1		20% offered patient-specific educational resources online in the common primary languages
(NEW for EH)		80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human-readable and structured forms (HITSC to define).		80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human readable and structured forms (HITSC to define).	Inpatient summaries include: hospitalization admit and discharge date and location; reason for hospitalization; providers; problem list; medication lists; medication allergies; procedures; immunizations; vital signs at discharge; diagnostic test results (when available); discharge instructions; care transitions summary and plan; discharge summary (when available); gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
Provide clinical summaries for each office visit (EP) (50%)		Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human-readable and structured forms (HITSC to define)		Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human readable and structured forms (HITSC to define)	The following encounter data are included (where relevant): encounter date and location; reasons for encounter; provider; problem list;medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders: future appointment requests, referrals, scheduled tests; gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
		demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human-readable and structured forms (HITSC to define).		demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human readable and structured forms (HITSC to define).	locations; reasons for encounters; providers; problem list; medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders; longitudinal care plan;gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
This objective sets the measures for ―Provide timely electronic access (EP)‖ and for ―Provide clinical summaries for each office visit (EP)‖		EPs: 20% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet		EPs: 30% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet
(NEW)		EPs: online secure patient messaging is in use		EPs: online secure patient messaging is in use
(NEW)		Patient preferences for communication medium recorded for 20% of patients		Patient preferences for communication medium recorded for 80% of patients	How should ―communication medium‖ be delineated?
				Offer electronic self-management tools to patients with high priority health conditions	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3 objective
				EHRs have capability to exchange data with	We are seeking comment on what
PHRs using standards-based health data exchange				steps will be needed in stage 2 to achieve this proposed stage 3objective
				Patients offered capability to report experience of care measures online	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
				Offer capability to upload and incorporate patient-generated data (e.g., electronically collected patient survey data, biometric home monitoring data, patient suggestions of corrections to errors in the record) into EHRs and clinician workflow	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Improve Care Coordination
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Perform test of HIE		Connect to at least three external providers in ―primary referral network‖ (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange		Connect to at least 30% of external providers in ―primary referral network‖ or establish an ongoing bidirectional connection to at least one health information exchange	Successful HIE will require development and use of infrastructure like entity-level provider directories (ELPD)
Perform medication reconciliation (50%)*		Medication reconciliation conducted at 80% of care transitions by receiving provider (transitions from another setting of care, or from another provider of care, or the provider believes it is relevant)		Medication reconciliation conducted at 90% of care transitions by receiving provider
Provide summary of care record (50%)*		Move to Core		Summary care record provided electronically for 80% of transitions and referrals
(NEW)		List of care team members (including PCP) available for 10% of patients in EHR		List of care team members (including the PCP) available for 50% of patients via electronic exchange
(NEW)		Record a longitudinal care plan for 20% of patients with high-priority health conditions		Longitudinal care plan available for electronic exchange for 50% of patients with high-priority health conditions	What elements should be included in a longitudinal care plan including: care team members; diagnoses; medications; allergies;goals of care; other elements?
Improve Population and Public Health
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Submit immunization data*		EH and EP: Mandatory test. Some immunizations are submitted on an ongoing basis to Immunization Information System (IIS), if accepted and as required by law		EH and EP: Mandatory test. Immunizations are submitted to IIS, if accepted and as required by law. During well child/adult visits, providers review IIS records via their EHR.	Stage 2 implies at least some data is submitted to IIS. EH and EP may choose not, for example, to send data through IIS to different states in Stage 2. The goal is to eventually review IIS-generated recommendations
Submit reportable lab data*		EH: move Stage 1 to core  EP: lab reporting menu. For EPs, ensure that reportable lab results and conditions are submitted to public health agencies either directly or through their performing labs (if accepted and as required by law).		Mandatory test. EH: submit reportable lab results and reportable conditions if accepted and as required by law. Include complete contact information (e.g., patient address, phone and municipality) in 30% (EH) of reports. EP: ensure that reportable lab results and reportable conditions are submitted to public health agencies either directly or through performing labs (if accepted and as required by law)
Submit syndromic surveillance data*		Move to core.		Mandatory test; submit if accepted
				Public Health Button for EH and EP: Mandatory test and submit if accepted. Submit notifiable conditions using a reportable public-health submission button. EHR can receive and present public health alerts or follow up requests.	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
				Patient-generated data submitted to public health agencies	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Ensure Adequate Privacy and Security Protections for Personal Health Information
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Conduct security review analysis & correct deficiencies					Additional privacy and security objectives under consideration via the HIT Policy Committee’s Privacy & Security Tiger Team

* menu option for Stage 1

Additional Specific Questions for Public Comment
The Health Information Technology Policy Committee welcomes public comment on all proposed objectives and their associated definitions. In addition, the Committee seeks specific input on the following additional questions.

1. How can electronic progress notes be defined in order to have adequate specificity?
2. For patient/family access to personal health information, what standards should exist regarding accessibility for people with disabilities (e.g., interoperability with assistive technologies to support those with hearing, visual, speech, or mobile impairments)?
3. What strategies should be used to ensure that barriers to patient access – whether secondary to limited internet access, low health literacy and/or disability – are appropriately addressed?
4. What are providers’ and hospitals’ experiences with incorporating patient-reported data (e.g., data self-entered into PHRs, electronically collected patient survey data, home monitoring of biometric data, patient suggestions of corrections to errors in the record) into EHRs?
5. For future stages of meaningful use assessment, should CMS provide an alternative way to achieve meaningful use based on demonstration of high performance on clinical quality measures (e.g., can either satisfy utilization measures for recording allergies, conducting CPOE, drug-drug interaction checking, etc, or demonstrate low rates of adverse drug events)?
6. Should Stage 2 allow for a group reporting option to allow group practices to demonstrate meaningful use at the group level for all EPs in that group?
7. In stage 1, as an optional menu objective, the presence of an advance directive should be recorded for over 50% of patients 65 years of age or older. We propose making this objective required and to include the results of the advance-directive discussion, if available. We invite public comment on this proposal, or to offer suggestions for alternative criteria in this area.
8. What are the reasonable elements that should make up a care plan, clinical summary, and discharge summary?
9. What additional meaningful-use criteria could be applied to stimulate robust information exchange?
10. There are some new objectives being considered for stage 3 where there is no precursor objective being proposed for stage 2 in the current matrix. We invite suggestions on appropriate stage 2 objectives that would be meaningful stepping-stone criteria for the new stage 3 objectives.

E. Evidence Base/Rationale for Proposed New Objectives

The HITPC identified proposed new objectives because of their potential impact on the five health outcome priorities to be achieved through the meaningful use of EHRs. Some of the relevant evidence to these proposed objectives is reflected below.

Patient and Family Engagement

In a randomized control trial assessing the efficacy of a home-based computer system in providing information and decision support as well as expert and other patient contacts to patients with HIV, findings were significant for improved quality of life indicators such as cognitive function, social support and participation in their health care, and also for decreased time spent during ambulatory visits, fewer phone calls to providers, and decreased number and length of hospitalizations.

Qualitative data analysis of provider impressions of a patient centered CDSS (Patient Assessment, Care and Education) designed to increase identification and treatment of chemotherapy related symptoms affirmed the increased awareness of underreported symptoms and additional benefits such as better communication with patients.

A retrospective cross-sectional study analyzing the adoption of and patient satisfaction with a PHR reported 25% of patients registered with PHR and reported over 90% satisfaction with the PHR, with greatest satisfaction with test results, medication refills, and secure messaging.

A CDSS electronic checklist specifically aimed to improve delivery of evidence based discharge instructions for patients with heart failure (HF) or acute myocardial infarction (AMI) was evaluated to be effective in increasing delivery of discharge instructions (from 37.2% pre-intervention to 93.0% post-intervention). In addition, prescription of ACEI or ARB in patients with HF and AMI improved to 96.7% from 80.7% and to 100% from 88.1%, respectively.

An interventional study assessing the effect of patient messaging reminding patients of screening, diagnostic and monitoring tests in accordance with evidence based guidelines found an increase in adherence to clinical recommendations by 12.5% (p < 0.001).

A randomized control trial of 246 patients who were newly diagnosed with breast cancer assessed the effect of a home-based computer system with information, decision-making and emotional support. The study found that patients in the intervention group were significantly more competent in seeking information, more comfortable participating in care, and more confident in their interactions with physicians at two months post intervention and had better social support and information competence at five months post intervention. Furthermore, the relative benefits in the intervention group were greater for patients in underserved populations.

Quality and Safety

A randomized control trial evaluating effect of CDSS alerting physicians to order venous thromboembolism (VTE) prophylaxis showed the intervention resulted in 41% decreased risk for VTE at 90 days.

Using CDS to alert physicians and pharmacists to 8 critical drug interactions resulted in 31% decrease in dispensed drugs known to have adverse interactions.

A prospective analysis of an antimicrobial surveillance system using evidence based guidelines in a children’s hospital showed successful identification of prescribing errors allowing for early intervention.

Analysis of a CDS system intervention aimed at improving asthma documentation and management in the emergency department found that asthma severity, asthma precipitants, ICU admission history and smoking status were recorded significantly more often with the CDSS. Additionally, 76% of patients received a discharge asthma plan compared with 16% before the intervention.

A prospective cohort study assessed efficacy of CDSS in identifying patients with acute lung injury (ALI) compared to physician diagnosis alone. This study is significant because early treatment of ALI is critical to overall prognosis. The CDSS had a sensitivity of 96.3% and specificity of 89.4% whereas physician diagnosis was 26.5% sensitive and 99.5% specific. Although the CDSS was less specific, physician diagnosis alone missed 239 cases while the CDSS missed 12.

A survey of ambulatory care providers assessed attitudes toward CPOE and e-prescribing systems and found that the majority reported improved quality of care and efficiency, prevention of medical errors, and increased patient satisfaction as advantages to the system. More than one third reported that in the last month they had avoided a medication error because of system alerts In addition, slightly less than half reported better counseling of adverse effects and improved monitoring. (Despite this only 47% reported satisfaction with the system. Complaints included alerts regarding medications discontinued, alert fatigue, and alerts inappropriately identifying drug interactions.)

Implementation of a web-based laboratory information system to treat multi-drug resistant tuberculosis patients in Peru greatly improved timely access to lab results and user satisfaction. The system was expanded to other institutions based on its success to serve a network for over 3.1 million patients. The system is at relatively low cost amounting to 1% of National Peruvian Tuberculosis annual budget.

Population Health

Population based surveillance system in a large multicenter primary care network identified patients overdue for mammography screening. The interventional study showed that providers successfully contacted 63% of over 3,000 patients at risk.

A computer based smoking cessation program designed after extensive review of the literature on the barriers associated with such a program, was found to be effective, inexpensive and required little time or skill from staff. The program was continued following the conclusion of the study because of the satisfaction rates from providers and patients.

Study showed feasibility and reliability of EHR based chronic kidney disease (CKD) registry composed of 57,276 patients in accurately relaying demographics and most comorbidities when compared to individual EHR chart review (κ >0.80). Study concluded such a registry has the potential to improve quality of care in this patient population and contribute to the development of a national CKD surveillance project.

Care Coordination

A study assessing the effect of a medication reconciliation program in an ambulatory oncology clinic found at least one error in 81% of all patients’ medication lists. In the group that received the intervention, 90% of incorrect medication lists were corrected, while only 2% were corrected in the control group (p < 0.001).

2007 cross-sectional survey of US home health and hospice agencies found 33% increase in use of EHRs since 2000. The agencies used available EHR functionalities in general, including telemedicine and information sharing..

Efficiency

Antibiotic approval system guiding use of 28 restricted antibiotics improved appropriate use of antibiotics and led to increased susceptibility of S. aureus to methicillin and of pseudomonas to several antibiotics. Patients with gram negative bacteremia did not suffer increased adverse outcomes as a result.

An interventional study (n=2200) compared RBC transfusions in critically ill patients before and after evidence based CDS intervention significant decrease in number of RBC transfusions per patient and percentage of patients transfused (p = 0.045 and p = 0.01 respectively) and net savings of almost $60,000 (n=1100 patients).