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Stage 2 Meaningful Use Request for Comments

Posted Jan 24 2011 3:00pm
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


Proposed Stage 3
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)
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
80% of orders (outpatient and hospital discharge) transmitted as eRx 
90% of patients have demographics recorded (including IOM categoriesi) and can use them to produce stratified quality reports
Report CQM electronically
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%)
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%)
Expect to drive list to be up-to-date via medication reconciliation

Maintain active medication allergy list (80%)
Expect to drive the list to be up-to-date by making it part of visit summary

Record vital signs (50%)


Record smoking status (50%)


Implement 1 CDS rule


Implement drug formulary checks* 
What is the availability of formularies for eligible professionals?

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
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
Patient lists are used to manage patients for high-priority health conditions

20% of active patients who prefer to receive reminders electronically receive preventive or follow-up reminders
90% of visits have at least one electronic EP note
80% of EH patient days have at least one electronic note by a physician, NP, or PA
80% of EH inpatient medication orders are automatically tracked via electronic medication administration recording
Proposed Stage 3
90% of patients have timely access to copy of health information from electronic health record, upon request
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)
20% offered patient-specific educational resources online in the common primary languages
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). 
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)

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). 

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
EPs: online secure patient messaging is in use

Patient preferences for communication medium recorded for 80% of patients
Offer electronic self-management tools to patients with high priority health conditions
EHRs have capability to exchange data with
Patients offered capability to report experience of care measures online
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
Proposed Stage 3
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
Medication reconciliation conducted at 90% of care transitions by receiving provider

Summary care record provided electronically for 80% of transitions and referrals 
List of care team members (including the PCP) available for 50% of patients via electronic exchange

Longitudinal care plan available for electronic exchange for 50% of patients with high-priority health conditions

Proposed Stage 3
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.

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)
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.
Patient-generated data submitted to public health agencies
Proposed Stage 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
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)

Drug-drug/drug-allergy interaction checks 

Employ drug-drug interaction checking and drug allergy checking 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 
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

Continue as per Quality Measures Workgroup and CMS
Continue as per Quality Measures Workgroup and CMS
Continue Stage 1
80% problem lists are up-to-date
Continue Stage 1
80% medication lists are up-to-date
Continue Stage 1
80% medication allergy lists are up-to-date
80% of unique patients have vital signs recorded
80% of unique patients have vital signs recorded
80% of unique patients have smoking status recorded
90% of unique patients have smoking status recorded
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
Move current measure to core
80% of medication orders are checked against relevant formularies
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
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


Generate patient lists for specific conditions*
Make core requirement. Generate patient lists for multiple patient-specific parameters

Send patient reminders (20%)*
Make core requirement. 
How should ―active patient‖ be defined?

(NEW)
30% 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
Can be scanned, narrative, structured, etc.
(NEW)
30% of EH medication orders automatically tracked via electronic medication administration recording

Engage Patients and Families in Their Care
Stage 1 Final Rule
Proposed Stage 2
Comments
Provide electronic copy of health information, upon request (50%)
Continue Stage 1

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 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


(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). 
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)

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). 

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

(NEW)
EPs: online secure patient messaging is in use


(NEW)
Patient preferences for communication medium recorded for 20% of patients
How should ―communication medium‖ be delineated?


We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3 objective


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


We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective


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
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
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)

Provide summary of care record (50%)*

Move to Core


(NEW)
List of care team members (including PCP) available for 10% of patients in EHR


(NEW)
Record a longitudinal care plan for 20% 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
 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
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).

Submit syndromic surveillance data*

Move to core.




We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective


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
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).
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