CMS-10296 OMB Passback Responses

CMS-10296 OMB Passback Responses.docx

Electronic Health Records (EHR) Testing

CMS-10296 OMB Passback Responses

OMB: 0938-1090

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Comment A1: In relation to the new EHR incentive program, if hospitals have acquired EHR systems that comply with both the meaningful use requirements (from ONC’s rule) and the reporting requirements from CMS to qualify for incentives, would these hospitals automatically own a system capable of measuring the criteria for this project (ED Throughput, Stroke, and VTE)? Would these hospitals also own a system capable of capturing all RHQDAPU data?



Response:   Hospitals should own a system capable of producing these ED, Stroke and VTE measures, now or in the near future, as the ARRA allows for incentives to widely implement Electronic Health Records. The ED/VTE/Stroke measures are electronically specified to interact with EHR's and may become part of the certification criteria for inpatient EHRs.  However, currently, not all RHQDAPU measures have electronic specifications.  In anticipation for the potential for widespread adoption of EHR's and in support of the ARRA program, we look forward to electronically specify more RHQDAPU measure in the coming years. This is a goal that we are actively working towards, and it is conceivable that at some point, all RHQDAPU measures could be captured electronically by EHRs adopted for the meaningful use requirements.  

Comment A2: For our information, what is the OMB # and status of this project?

Response: The OMB control number is 0938-1059. The EHR testing for PQRI was successful, and EHR-based submission is now offered as a data reporting mechanism for PQRI. In the 2010 PFS final rule, CMS stated that ten measures are available for EHR-based reporting in 2010. Documentation for the electronic submission of these ten measures by participants using a "qualified" EHR is available at:

http://www.cms.hhs.gov/PQRI/20_AlternativeReportingMechanisms.asp#TopOfPage

Comment A3: If the purpose of this ICR is to clear the application form and selection process, will there be a separate ICR addressing the analysis and publication of results? In general, how will the success/results of this project be evaluated?



Response: Success will be evaluated by the number of participants qualified to test CMS systems from which CMS is able to receive timely and valid test data in the format specified by CMS. We do not intend to submit a separate ICR for this.

Comment A4: What was the rationale for choosing measures not currently collected under RHQDAPU? What was the rationale for choosing these measures specifically?

Response: In the past we have proposed these measures (ED throughput, Stroke and VTE) for the RHQDAPU program because they address areas of high salience for hospitalized Medicare beneficiaries. We have subsequently indicated that these measures are under consideration for future adoption into the RHQDAPU program. We specifically chose these non-RHQDAPU measures for EHR testing because: 1) electronic specifications had been developed for them, and 2) the selection of measures currently adopted for the RHQDAPU program for the EHR testing project would have created confusion regarding EHR testing requirements and RHQDAPU submission requirements.

Comment A5: How will hospitals be notified of the opportunity to apply?

Response: We will use our hospital listserve as well as HQA, AHA, AAMC, FAH listserves, and Joint Commission listerves.

Comment A6: In the instructions, it states that further communication will be forthcoming (see below). Please provide all communication materials shown to respondents in the ICR package.


You will be asked to submit 30 full patient test cases as would be captured in your Inpatient EHR product at a later date. You will also be asked to submit a DVD containing extracts of the data elements needed to calculate the measures from each test case. The test cases will be used to verify the extracts that you submit by DVD. We will then notify you of your eligibility to participate in testing the transmission of EHR test data to CMS systems via a Portal and Gateway.”



Response: We do not have such instructions at this time. However, we plan to model them after the PQRI submission instructions.

Comment A7: Please update all dates/timelines in Supporting Statement and application itself.

Response: We’ve postponed the whole process until after approval. Upon approval, we will revise the timeline, and plan to post a revised timeline on our website.

Comment A8: To clarify, “100% electronically” does not mean transmitting data by DVD, correct?

Response: Correct, this refers to electronic transmission of data to CMS via designated system. However, prior to selection for this stage of testing, applicants would need to demonstrate technical capacity to provide accurate data, which they will do by submitting DVDs for manual inspection.

Comment A9: Is this application process ongoing? Or is it a one-time process? Please clarify.

Response: We anticipate that this will be a one-time process with several stages that will take a number of months to complete.

Comment A10: If the term “confidential” is used anywhere in an ICR (including the Supporting Statement or information collection instruments), there must be statutory authority under which such protection can be claimed, as well as a statutory citation provided. If information will not be kept confidential, it is acceptable to write “information will be kept private to the extent permitted by law.” Please revise and be mindful when submitting future ICRs – Especially as these documents are posted for public comment, it is critical to have accurate language about participant information protections.


Response: We will change ‘confidential’ to ‘private’ on the form. 


Comment A11: Approx. how many of this number will be selected?


Response: As many of these applicants determined to be qualified to test CMS systems will be selected to test CMS systems


Comment A12: In the future, is CMS considering allowing different organizations to submit RHQDAPU data in different ways (as presumably not all hospitals will have access to compatible EHR systems)?



Response: Yes. We hope that in the future, we can offer hospitals a broader range of data submission options, including as EHR-based data submission, and registry-based data submission, for a number of RHQDAPU measures in addition to the existing CART tool and vendor-based submission methods for chart abstracted measures.

Comment A13: What does the process of preparing this letter involve? If information or instructions about this letter are provided to potential respondents, please include in ICR package.



Response: The letter of nomination is no more than a stated intention to participate along with the name of the EHR, the name of contact to which the application can be sent, and contact information. We may have overestimated the number of hours needed for this.

Comment A14: Please also include capital costs (see A.13) in this cost estimate.



Response: As stated in the supporting statement, CMS does not anticipate any.

Comment A15: Fix on ROCIS (currently $3).

Response: N/A

Comment A16: This field of the Supporting Statement is for CMS to state whether it objects to displaying the expiration date on information collection instruments. An acceptable response is “CMS does not object to displaying this collection’s expiration date on information collection instruments.” If CMS does object to this, please provide a justification of why the expiration date cannot be displayed.


If CMS does not object, please include expiration date on application itself.

Response: CMS does not object to displaying this collection’s expiration date on the information collection instrument, and will do so when approved.



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AuthorCMS
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