Final MU Objectives: Lab Results, Patient Lists, Quality Measures, Follow-up Reminders, and Clinical Decision Support

Final MU Objectives: Lab Results, Patient Lists, Quality Measures, Follow-up Reminders, and Clinical Decision Support

This is the fourth in a series of hospital-focused summaries of the final Stage 1 meaningful use objectives and measures. The goal of these entries is to support rural community hospital personnel in their efforts to meet specific meaningful use objectives. Notations marked “implications…” are my interpretations, which may or may not be correct.

Objectives # 1-11 were covered in previous blogs.

Objective #12: Incorporate Lab Results as Structured Data (Menu Set)

The proposed “incorporate lab results” objective for EPs and hospitals was: “Incorporate clinical lab-test results into EHR as structured data.”

The final “incorporate lab results” objective is: No change: finalized as proposed.

CMS supporting language: “We do not limit the EP, eligible hospital, or CAH to only counting structured data via electronic exchange, but count in the numerator all structured data. By entering these results into the patient’s medical record as structured data, the [provider] is accomplishing a task that must be performed…”

The objective must be achieved using certified EHR technology as defined in the final certification rule. The definition of incorporate lab results in the final certification rule is: “(1) Receive results: Electronically receive clinical laboratory test results in a structured format and display such results in human readable format. (2) Display test report information: Electronically display all the information for a test report specified at 42 CFR 493.1291(c) (1) through (7). (3) Incorporate results. Electronically attribute, associate, or link a laboratory test result to a laboratory order or patient record.”

Test Report Standard (42 CFR 493.1291) referenced above

(c) The test report must indicate the following:

1. For positive patient identification, either the patient’s name and identification number, or a unique patient identifier and identification number.
2. The name and address of the laboratory location where the test was performed.
3. The test report date.
4. The test performed.
5. Specimen source, when appropriate.
6. The test result and, if applicable, the units of measurement or interpretation, or both.
7. Any information regarding the condition and disposition of specimens that do not meet the laboratory’s criteria for acceptability.

ONC supporting language: “We clarify that we do not expect Certified EHR Technology to natively (or internally) support LOINC in its entirety … Given the diverse comments and requests for clarification on this specific aspect of the certification criterion, we agree with commenters that we should not require a LOINC code that has been received, to then be displayed. Accordingly, we have decided to remove this requirement from the certification criterion.

Implications of the above: Community hospital information systems (HIS) generally have lab modules through which lab test results (1) are entered in structured form (either directly by lab technicians or through interfaces with lab instruments and sometimes reference labs), (2) can be displayed with the test report standard data elements, and (3) are associated with lab orders and patient records. Because meeting the objective “does not rely on the electronic exchange of information between the lab and the provider,” and only relies on the information being entered into the certified EHR in structured form, it appears to me that the vast majority of community hospitals utilizing the lab module of a community HIS (assuming certification) are likely to meet the “incorporate lab result” objective. Providers should verify that existing vendors can (or at least are working to) meet the certification requirements as defined.

The proposed “incorporate lab results” measure for EPs and hospitals was: “At least 50% of all clinical lab test results ordered by the EP or by an authorized provider of an eligible hospital during the EHR reporting period whose results are either in a positive/negative or numerical format are incorporated in certified EHR as structured data.”

The final “incorporate lab results” measure is: “More than 40% of all clinical lab test results ordered by the EP or by an authorized provider of the eligible hospital or CAH for patients admitted to its inpatient or emergency departments (POS 21 or 23) during the EHR reporting period whose results are in either positive/negative or numerical format are incorporated into certified EHR technology as structured data.”

“Structured data is not fully dependent on an established standard. Established standards facilitate the exchange of the information across providers by ensuring data is structured in the same way. However, structured data within certified EHR technology merely requires the system be able to identify the data as providing specific information.”

The ability to calculate the measure will be included in the certified EHR technology as a certification requirement.

The Denominator is: “Number of lab tests ordered during the EHR reporting period by the EP or authorized providers of the eligible hospital or CAH for patients admitted to an eligible hospital’s or CAH’s inpatient or emergency departments (POS 21 & 23) whose results are expressed in a positive or negative affirmation or as a number.” (The only tests included in the denominator are those for patients whose records are maintained using certified EHR technology).

The Numerator is: “The number of lab tests whose results are expressed in a positive or negative affirmation or as a number which are incorporated as structured data.”

The Threshold is: “The resulting percentage must be more than 40% in order for an EP, eligible hospital, or CAH to meet this measure.”

Exclusion: An EP who orders no lab tests whose results are either in a positive/negative or numeric format during the EHR reporting period would be excluded… There is no exclusion for eligible hospitals and CAHs.

Objective #13: Generate Lists of Patients by Condition (Menu Set)

The proposed “generate lists of patients” objective for EPs and hospitals was: “Generate lists of patients by specific condition to use for quality improvement, reduction of disparities, research, and outreach.”

The final “generate lists of patients” objective is: “Generate lists of patients by specific condition to use for quality improvement, reduction of disparities, research, or outreach.”

The objective must be achieved using certified EHR technology as defined in the final certification rule. The definition of “generate lists of patients by condition” in the final certification rule is: “Generate patient lists. Enable a user to electronically select, sort, retrieve, and generate lists of patients according to, at a minimum, the data elements included in: (1) Problem list; (2) Medication list; (3) Demographics; and (4) Laboratory test results.”

Implications of the above: Community hospital information systems (HIS) generally have report writing tools through which lists of patients with the required data elements can be produced and then exported to a spreadsheet or database for sorting/analyzing. Assuming providers have implemented the appropriate registration (for demographics), pharmacy (for medications), lab (for lab results), and HIM (for problem lists) modules, generating the report required to meet this measure should be straightforward. Providers should verify that existing vendors can (or at least are working to) meet the certification requirements as defined.

The proposed “generate lists of patients” measure for EPs and hospitals was: “Generate at least one report listing patients of the EP or eligible hospital with a specific condition.”

The final “generate lists of patients” measure is: No change: finalized as proposed.

CMS supporting language: “…only one report is required for any given EHR reporting period. The report could cover every patient whose records are maintained using certified EHR technology or a subset of those patients at the discretion of the [provider].” Additionally, “we are not requiring submission of the report to CMS…” (i.e. the provider creates the report and attests to its creation, but submission of the actual report is not required).

The ability to calculate the measure will be included in the certified EHR technology as a certification requirement.

Exclusion: There are no exclusions.

Objective #14: Report Quality Measures (Core Set)

The proposed “report quality measures” objective for EPs was: “Report ambulatory quality measures to CMS (or for EPs seeking the Medicaid incentive payment, the States).” And for hospitals was: “Report ambulatory quality measures to CMS (or for EPs seeking the Medicaid incentive payment, the States).”

The final “report quality measures” objective for EPs is: “Report ambulatory clinical quality measures to CMS (or, for EPs seeking the Medicaid incentive payment, the States).” And for hospitals is: “Report hospital clinical quality measures to CMS (or, for eligible hospitals seeking the Medicaid incentive payment, the States).”

The objective must be achieved using certified EHR technology as defined in the final certification rule. The definition of quality measure reporting functionality in the final certification rule is:

For EPs, “(1) Calculate: (i) Electronically calculate all of the core clinical measures specified by CMS for eligible professionals; (ii) Electronically calculate, at a minimum, three clinical quality measures specified by CMS for eligible professionals, in addition to those clinical quality measures specified in paragraph (1)(i). (2) Submission: Enable a user to electronically submit calculated clinical quality measures in accordance with the standard and implementation specifications specified in §170.205(f).”

And for hospitals, “(1) Calculate: Electronically calculate all of the clinical quality measures specified by CMS for eligible hospitals and critical access hospitals. (2) Submission: Enable a user to electronically submit calculated clinical quality measures in accordance with the standard and implementation specifications specified in §170.205(f).

ONC supporting language on the standards: It is our understanding that the PQRI 2008 Registry XML specification is capable of serving as the “envelope” for aggregate, summary level data. Accordingly, we do not believe that, as some commenters suggested, an eligible hospital’s familiarity with the PQRI program is relevant to the adoption of this standard for this specified purpose. Nor do we believe that a specific implementation of this standard is necessary for hospital settings as the standard’s purpose and the type of data it will transmit to CMS will be the same – aggregate, summary level data. Through recent discussions with CMS since the publication of the Interim Final Rule we have determined that the PQRI 2009 Registry XML specification, a more recent version of the standards we adopted in the Interim Final Rule is a suitable replacement for 2008 version, and accordingly, we have adopted the 2009 version in its place.

Implications of the above will be discussed in a future analysis of the specific quality measures.

The proposed “report quality measures” measure for EPs was: “For 2011, an EP would provide the aggregate level data for the numerator, denominator, and exclusions through attestation as discussed in sections II.A.3 of this final rule. For 2012, an EP would electronically submit the measures that are discussed in section II.A.3 of this final rule.” And for eligible hospitals, “For 2011, an eligible hospital or CAH would provide the aggregate level data for the numerator, denominator, and exclusions through attestation as discussed in sections II.A.3 of this final rule. For 2012, an eligible hospital or CAH would electronically submit the measures that are discussed in section II.A.3 of this final rule.”

The final “report quality measures” measure is: No change: finalized as proposed.

We’ll have lot’s more on this topic when we analyze the specific quality measures in the coming weeks.

Objective #15: Reminders for Follow-up Care (Menu Set: for EPs only)

The proposed “follow-up care reminder” objective (for EPs) was: “Send reminders to patients per patient preference for preventive/follow-up care.”

The final “follow-up care reminder” objective is: No change: finalized as proposed.

CMS supporting language: “EPs meet the aspect of “per patient preference” of this objective if they are accommodating reasonable requests as outlined in 45 C.F.R. 164.522(b), which are the guidance established under HIPAA for accommodating patient requests.”

The objective must be achieved using certified EHR technology as defined in the final certification rule. The definition of follow-up care reminder functionality in the final certification rule is: “Patient reminders: Enable a user to electronically generate a patient reminder list for preventive or follow-up care according to patient preferences based on, at a minimum, the data elements included in: (1) Problem list; (2) Medication list; (3) Medication allergy list; (4) Demographics; and (5) Laboratory test results.”

The proposed “follow-up care reminder” measure for EPs was: “Reminder sent to at least 50% of all unique patients seen by the EP or admitted to the eligible hospital that are 50 and over.”

The final “follow-up care reminder” measure is: “More than 20% of all patients 65 years or older or 5 years old or younger were sent an appropriate reminder during the EHR reporting period.”

“Unique patient” means that if the patient is seen more than once during the reporting period, he or she only counts once in the denominator, which means that the objective has been met if the patient care reminder has been sent during at least one of the patient encounters.

The ability to calculate the measure will be included in the certified EHR technology as a certification requirement.

The Denominator is: “Number of unique patients 65 years old or older or 5 years old or younger.” (The only patients that are included in the denominator are those patients whose records are maintained using certified EHR technology).

The Numerator is: “The number of patients in the denominator who were sent an appropriate reminder.”

The Threshold is: “The resulting percentage must be more than 20% in order for an EP to meet this measure.”

Exclusion: “If an EP has no patients 65 years old or older or 5 years old or younger with records maintained using certified EHR technology that EP is excluded from this requirement…”

Objective #16: Clinical Decision Support Rules (Core Set)

The proposed “clinical decision support rule” objective for EPs was: “Implement 5 clinical decision support rules relevant to specialty or high clinical priority, including for diagnostic test ordering, along with the ability to track compliance with those rules.” And for hospitals was: “Implement 5 clinical decision support rules related to a high priority hospital condition, including diagnostic test ordering, along with the ability to track compliance with those rules.”

The final “clinical decision support rule” objective for EPs is: “Implement 1 clinical decision support rule relevant to specialty or high clinical priority along with the ability to track compliance with that rule.” And for hospitals is: “Implement 1 clinical decision support rule related to a high priority hospital condition along with the ability to track compliance with that rule.”

CMS supporting language: “…there is value in focusing initial CDS efforts on a single CDS rule in order to get it right the first time and lay the foundation for future, broader CDS implementation… We anticipate that this will set the foundation for much more expansive CDS support in the near future.”

The objective must be achieved using certified EHR technology as defined in the final certification rule. The definition of clinical decision support functionality in the final certification rule is: “(1) Implement rules: Implement automated, electronic clinical decision support rules (in addition to drug-drug and drug-allergy contraindication checking) based on the data elements included in: problem list; medication list; demographics; and laboratory test results. (2) Notifications: Automatically and electronically generate and indicate in real-time, notifications and care suggestions based upon clinical decision support rules.”

““Real-time” means at the point of clinical decision making (i.e., notifications must be provided when an eligible professional is using Certified EHR Technology and not run overnight and provided in the morning, for instance).”

Implications of the above: Community hospital information systems (HIS) generally have functionality that supports some level of decision support rules and “real time” notifications through their inpatient documentation, outpatient documentation (such as ER), and provider ordering modules. Providers should verify that existing vendors can (or at least are working to) meet the certification requirements as defined.

The proposed “clinical decision support rule” measure for EPs and hospitals was: “Implement 5 clinical decision support rules relevant to the clinical quality metrics the EP/Eligible Hospital is responsible for as described further in section II.A.3 of this rule.”

The final “clinical decision support rule” measure is: “Implement one clinical decision support rule.”

CMS supporting language: “In light of the decision to limit the objective to one clinical decision support rule, we do not believe that it is appropriate to further link that rule to specific requirements and therefore give the EP, eligible hospital, or CAH discretion on what to focus the clinical decision support rule used to satisfy this measure.”

The ability to calculate the measure will be included in the certified EHR technology as a certification requirement.

Exclusion: “There are no exclusions for this objective.”