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Observation Services Method Nuances

In September of 2010, CMS issued FAQ 10126 giving providers options on counting patients in numerator and denominator of Meaningful Use Measures.  However, guidance on criteria and processes by which EHR software would be certified were issued in the Federal Register prior to this guidance (January of 2010), and have not been re-issued since. 

So … does your standard EHR automatically know what decision you have made?    

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Action Item:  Verify that the list of 12 Meaningful Use Reports providing the option for “all ED Patients” or “Observation Services Patients”, and test numerator / denominator for completeness and accuracy.

CMS has stated their desire to include in the denominator visits to the emergency department (ED) of sufficient duration and complexity, that all of the Meaningful Use objectives for which the ED is included would be relevant.   Giving hospitals the option to select between “All ED Patients” and “Observation Services Patients” seems to recognize impracticalities on counting ED patients who may move quickly in and out of the hospital and may not receive a level of services that would qualify the hospital under meaningful use, by limiting numerator and denominators to patients actually receiving ED services.  Although this guidance helps, our subscribers have asked us to research a few additional questions to help stay in compliance.

 

• Question 1: Do we include all inpatients or only inpatients admitted through the ED? 

Choosing Observation Services Method has no impact on defining how Inpatient visits will be measured.  It does define a population of patients (ED patients who have been admitted to IP wards), for whom the provider must include all visits and activities in numerator and denominator.  Since all these patients should be included in inpatient reporting (independently of Observation Services Method) the practical matter here seems to be the requirement (and opportunity) to include documentation of services performed during the ED portion of the encounter for those patients. 

 

• Question 2: For the observation patients, do we include all observation service patients, or only those who present through the ED?

In providing a choice of using Observation Services patients (as a subset of ED Patients), CMS seems to be reacting to some of the practical problems of reporting on a broader, more volatile patient population of everyone who presents to the ED.  We do not think their intent is an across-the-board substitution of Observation Services Patients for ED patients, so the safest option seems to be making sure your reporting correctly identifies those Observation Services Patients who initially presented to the ED, and as in the prior question, accounting in the numerator for all documentation occurring in the ED setting on those patients.  Any Observation Services patients coded with a Place of Service Code other than 21 or 23 (Inpatient or ED) would be excluded from your numerator / denominator (except for those initially presenting through the ED). 

• Question 3: How does the selection of Observation Services Patients impact Clinical Quality Measure calculations?
  • First, the language of FAQ 10126 addresses numerator and denominator of Meaningful Use Objectives explicitly.  In the Final Rule for EHR Incentives, CMS consistently lists those specific Objectives, and identifies Clinical Quality Measures separately. 
  • Secondly, the Clinical Quality Measures contain specific calculations, data elements, and exclusion rules via independently-published HITSP specifications. 
  • Finally, in a separate related FAQ # 10883 issued on December 22, 2011, CMS answers a question  regarding  CQMs ED-1, ED-2, and Stroke-4, on how should hospitals define an Emergency Department patient since the UB-04 data set referred to in the HITSP specifications no longer provides this information?  In this FAQ, CMS recommends that hospitals use the data element 'ED Patient', defined as any patient receiving care or services in the Emergency Department (without comment regarding Observation Services Method). 
  • Therefore, while none of these statements are definitive, we believe the trend is to isolate Observation Services Method calculations to Meaningful Use Measures, independently of Quality Measures. 

 

So, the bottom line is that it is probably prudent to test following 12 reports in your Certified EHR to validate that they are correctly counting ED patients consistently, based on your decision on using Observation Services Method:

• CPOE
• Record Demographics
• Problem List
• Maintain Active Medication List
• Maintain Active Medication Allergies List
• Record Vital Signs
• Record Smoking Status
• Provide patients with an Electronic Copy of their Health Records  Upon Request
• Provide Patients with an Electronic Copy of their Discharge Instructions Upon Request
• Use Certified EHR Technology to Identify Patient-Specific  Education Resources
• Perform Medication Reconciliation
• Provide Summary Care Record for each Transition of Care

All other reports would fall under either Clinical Quality Measures, or require a Yes / No attestation (which would be probably be independent of your ED patients), or explicitly exclude ED patients in their definition. 

CMS's Multiple Choice Quiz - If your Certified EHR generates an inaccurate result, are you liable?

I wish I could come up with the definitive answer to this question.  Inside our firm, and across our subscriber base, we engage in stimulating discussion on the topic.  Based on relevant CMS publications (appended to the end of this article) a reasonable person could come up with either of the following interpretations:

Interpretation 1: It will not be acceptable to rely on the fact you are using a certified EHR.  Accuracy is the responsibility of the provider, not the vendor.

Interpretation 2:  If the Certified EHR generates a number, CMS will deem the number to be accurate. 

Of course, those of us with products or services to sell will try to drive you to Interpretation 1.  That perspective points out that definitions of patient population for numerators and denominators has, in some cases been changed (or at least clarified) by CMS pronouncement after the issuance of NIST testing procedures for certifying EHR software.  And further, those test procedures do not explicitly provide an ATCB with the detail calculations of Meaningful Use Measures and  Quality Measures, under all assumptions and choices a provider might make (i.e., there are some instances of CPOE that should not be counted if entered by an individual inappropriate to the CMS regulations, or our hospital has chosen to count only Observation Services Patients).  Under this interpretation, prudence dictates at least a modest testing program against patient-level detail to validate the completeness and accuracy of each report. 

Under Interpretation 2, comes the reasonable assumption that CMS today relies on their testing processes to certify software.  And that for the next six years (period open for audit), that interpretation will be consistently applied. 

To provide some context for these interpretations, let's consider CPOE.  For Hospital A (or EP A), let's assume the certified EHR reports 32%, which is above the 30% threshold.  Further, CMS states that each provider must to evaluate on a case-by-case basis whether a given situation is entered according to state, local, and professional guidelines, allows for clinical judgment before the medication is given, and is the first time the order becomes part of the patient's medical record.  So one logical extension (relative to EHR reports,then) is that providers should also evaluate the reporting from their EHR as to compliance with the regulatory processes in their environment. 

So, rather than apply more of my interpretations, here's the CMS FAQ defining the issue.  This is also part of the statements you'll agree to during the registration and attestation processes.  Take a look, and share your thoughts ... which interpretation shall drive your efforts?

Published 04/22/2011 01:58 PM   |    Updated 04/26/2011 05:48 PM   |    Answer ID 10589

To what attestation statements must an eligible professional (EP), eligible hospital, or critical access hospital (CAH) agree in order to submit an attestation, successfully demonstrate meaningful use, and receive an incentive payment under the Medicare Electronic Health Record (EHR) Incentive Program?

Currently, the attestation process requires EPs, eligible hospitals, and CAHs to indicate that they agree with the following attestation statements:

• The information submitted for clinical quality measures (CQMs) was generated as output from an identified certified EHR technology.
• The information submitted is accurate to the knowledge and belief of the EP or the person submitting on behalf of the EP, eligible hospital, or CAH.
• The information submitted is accurate and complete for numerators, denominators, exclusions, and measures applicable to the EP, eligible hospital, or CAH.
• The information submitted includes information on all patients to whom the measure applies.

CMS considers information to be accurate and complete for CQMs insofar as it is identical to the output that was generated from certified EHR technology. Numerator, denominator, and exclusion information for CQMs must be reported directly from information generated by certified EHR technology. By agreeing to the above statements, the EP, eligible hospital, or CAH is attesting that the information for CQMs entered into the Registration and Attestation System is identical to the information generated from certified EHR technology.

CMS does not require EPs, eligible hospitals, or CAHs to provide any additional information beyond what is generated from certified EHR technology in order to satisfy the requirement for submitting CQM information.

Please note that quality performance results for CQMs are not being assessed at this time under the EHR Incentive Programs. Complete and accurate information for the remaining meaningful use core and menu set measures does not necessarily have to be entered directly from information generated by certified EHR technology. By definition, for each meaningful use objective with a percentage-based measure, certified EHR technology must include the capability to electronically record the numerator and denominator and generate a report including the numerator, denominator, and resulting percentage for these measures. However, with the exception of CQMs, meaningful use measures do not specify that this capability must be used to calculate the numerators and denominators. EPs, eligible hospitals, and CAHs can use a separate, uncertified system to calculate numerators and denominators and to generate reports on all measures of the core and menu set meaningful use objectives except CQMs.

In order to provide complete and accurate information for certain of these measures, they may also have to include information from paper-based patient records or from records maintained in uncertified EHR technology. By agreeing to the above statements, the EP, eligible hospital, or CAH is attesting to providing all of the information necessary from certified EHR technology, uncertified EHR technology, and/or paper-based records in order to render complete and accurate information for all meaningful use core and menu set measures except CQMs.

What reporting period for Meaningful Use Clinical Quality Measures?

This has been an interesting question in my mind for a while now. CMS has been consistent in referencing back to the published technology specs in the HITSP Guide (HITSP Quality Measures Technical Note ED, VTE, and Stroke Examples for Implementation of the HITSP Quality Interoperability Specification) for Inpatient and a series of NQF specifications for Ambulatory.  Those specifications include requirements for the period over which the CQM is to be calculated, and in most cases that period is a full year.  Oops.  If our EHR Reporting period gives us a break in the first year, and we are only required to attest to Meaningful Use for 90 days, what about CQM’s?   

Well, we can rest easy.  The short answer is that CQM’s should be calculated and reported on over the same 90 day period as the balance of our Meaningful Use calculations.  Here’s the quote from the Federal Register from July 2010, Page 44421, Column 1:

 “We also proposed that to demonstrate an eligible hospital or CAH is a meaningful EHR user, the eligible hospital or CAH would be required to electronically submit information on each clinical quality measures for each patient to whom the clinical quality measure applies, regardless of payer, discharged from the hospital during the EHR reporting period and for whom the clinical quality measure is applicable.” 

If this is not clear enough, I also found a quote on the CMS site for Quality Measures Electronic Specifications elaborating that position. 

 "Reporting Period: The reporting period for the EHR Incentive program using a certified EHR is any continuous 90 day period during the first payment year. Please note that although the measure specifications assume a full calendar year you should only calculate the denominator and numerator from the first day of the 90 day reporting period to the last day of the 90 day reporting period."

http://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp#TopOfPage

So now I’m feeling better about those CQM’s. They are sufficiently risky and complex that matching reporting period with ARRA reporting period should take some risk off the table.  Don’t get overly complacent, though.  CMS still expects the results to be “complete and accurate” over your 90 day period.  Here’s the quote taken from the same Federal Register as above, on page 44381:

"we  proposed to require … eligible hospitals use certified EHR technology to capture the data elements and calculate the results for certain clinical quality measures.  …  We also proposed to require that Medicare EPs, eligible hospitals, and CAHs attest to the accuracy and completeness of the numerators and denominators for each of the applicable measures.  Finally…we proposed that EPs, eligible hospitals, and CAHs demonstrate their use of certified EHR technology to capture the data elements and calculate the results for the applicable clinical quality measures by reporting the results to us for all applicable patients. "

So it is still more than just a checkbox.  We have to create CQM’s as if we were to be submitting them “for real”, just against a shorter period, which should help those of us getting new data into our EHR’s for the first time.  Don’t forget the potential of a CMS auditor on your doorstep one day, asking to prove your attestation! 

Jay Fisher | @JayRFisher

Navigating the Final Rule for Clinical Quality Measures for EP's

We recently had a question on where to find information on Clinical Quality Measures for EP's, so I did  a little digging around. 

First, you should review the portion of the Final Rule that lists the Measures and which are required for each specialty.  The Final Rule document is available from CMS on this web page:

http://healthit.hhs.gov/portal/server.pt?open=512&objID=2996&mode=2

On the right-hand panel, upper corner will be a link to the PDF containing the Final Rule document.  Within the Final Rule Document, there is a general discussion of Clinical Quality Measures starting on page 44380, but the list of specific measures, and which are required under which circumstances, is on pages 44398-44408.  Of course, this section does not give you much insight into the detail specifications of each report, but there is a pretty good PDF on the CMS site containing the specifications for each quality measure.  The Site URL is:

http://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp 

Near the bottom of the resulting page is a section for Downloads.  In that section is a PDF titled "EP Measure Specifications".  That document contains the calculations and data fields for each Quality Measure. 

We think it is prudent for each provider to create a matrix, listing for each relevant quality measure, the required data elements, and mapping those elements to their EHR(s), and further determining that the  relevant data elements are being populated by your clinicians sufficiently to meet the data gathering requirements.  Big job!

Jay Fisher

MeaningfulUseMonitor.com

Measuring ED Throughput Might be Hard for Measuring Meaningful Use

When we first started reading about Quality Reporting, our first thought was, why bother making this a HITECH Requirement?  Most of us do it already, right?  Then came the observation that all the requisite data needed to be part of a Certified EHR.  Then we started looking at some of the data.  Here's one interesting item.  Quality Report

 "ED-2NQF 0497: Emergency Department Throughput – admitted patients.  Admission decision time to ED departure time for admitted patients"

This item has at least one tricky element.  The admission decision is made by someone outside the ED!  This means that the time of the decision is not likely to reside in the ED's EHR (unless, of course, the hospital has one common EHR that includes ED). 

Jay Fisher | @JayRFisher

Because of Quality Reporting, you may need eMAR to Qualify for Meaningful Use

In one of our Advisory Panel discussions recently, we uncovered a need that may be quite advanced for Stage 1 hospitals.  Consider the following text from Quality Measure NQF 0374 on Page 1897 of the Federal Register:

"This measure assesses the number of patients diagnosed with confirmed VTE who received intravenous (IV) UFH therapy dosages AND had their platelet counts monitored using defined parameters such as a nomogram or protocol."

Since  each data element for your quality reports needs to reside in your EHR (The Two-Headed Beast of Quality Reporting), the above referenced quality report would need to store data on patients who "received intravenous UFH therapy dosages".   Once we state a need to track patients who received medications, we move from the realm of Order Entry, to Medication Administration.  Regardless of whether our EHR has this capability internally, or your hospital uses a separate sytem, you need to get that Medication Administration data into your EHR! 

A similar requirement for Medication Administration data exists in Quality Reports NQF 0437, NQF 0438, NQF 0371, NQF 0372, NQF 0373, NQF 0374, NQF 0376, NQF 0163, NQF 0148, NQF 0528, NQF 0151, NQF 0356, NQF 0527, NQF 0529. 

This is a high bar indeed!  According to the HIMSS EMR Adoption model's 2009 data, only 6.1% of hospitals have reached this far.  Regardless of your EHR Vendor's capabilities, this set of requirements implies implementation of practices (and possibly add-on tools) that will take many hospitals a while to get in place. 

Action Suggested: HHS has invited comment on which of the proposed qualilty measures should be deferred to 2012, and why. We think this set of measures should be deferred, based on HIMSS Adoption Model data, indicating that it is a bar too high in the short term.  If you are considering a filing of comment, perhaps this should be in your report to HHS!

Jay Fisher | @JayRFisher