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? 

Consumer/Patient Engagement Power Team Unveils Recommendations

The Consumer/Patient Engagement Power Team is assessing the Standards and Certification Criteria NPRM and providing recommendations for strengthening consumer/patient engagement components. The Power Team has prioritized recommendations to enable patients to participate as partners in their care. These recommendations can be downloaded here, and I have embedded them below. The presentation to the April 18, 2012 HIT Standards Committee meeting by Leslie K. Hall was truly outstanding. Take a few minutes to listen to this presentation:

Patient Engagement Power Team Comments – Leslie Kelly Hall, Chair

Jim Hansen, Dossia Consortium in the document "Two key EHR-related catalysts to support patient engagement and accelerated health system transformation: Effective view, download and transmit capabilities and actionable recorded patient preferences" outlined the work of this group very well. One of the areas of focus was effective EHR View, Download and Transmit (VDT) Capabilities:

Effective view, download and transmit EHR capabilities are foundational not only for patient engagement but also to support the transformational shift to a learning health and health care system. Each function (view, download and transmit) plays a complementary role in addressing the required use scenarios.
Three core principals emerged from the Power Team discussions in support of this premise:

• Designated Proxy - The patient has the right to designate a proxy (or proxies) indicating that interactions traditionally intended for the patient are handled by the designee(s) with and/or instead of the patient herself. Thus all comments related to patients below also apply to their designee(s), if any.

• CC:ME - Any health information that is shared with providers and/or with the patient as an information exchange, discussion item or handout should be made available electronically with discrete computable fields and/or human readable format, based on patient preferences.

• Incorporation of Patient Generated Data – Much of the information required to inform care decisions is gathered through a variety of inefficient and ad-hoc methods which can be significantly streamlined for efficiency and effectiveness. Standards developed for surveys of patient experience of care can be used in other applications.

The FACA Template for Input on the Certification Criteria to Support MU Stage 2 Objectives and Measures
FACA Template for Input on the Certification Criteria to Support MU Stage 2 Objectives and Measures

Proposed Rules for Stage 2 Meaningful Use

Stage 2 Meaningful Use Has Arrived finally

We have known that the proposed rules for stage 2 meaningful use under the EHR Incentive Program were on their way. I had hoped that they would be released on Febraury 17, 2012, which was the third anniversary of the passage of the HITECH Act. Sadly, we did not get to read them prior to HIMSS. Nor did we get to read them prior to many of the learning sessions on stage 2 meaningful use scheduled at HIMSS the first two days. But, finally they are here (and sadly not even in time for Farzad Mostashari's keynote address as some had predicted). This will certainly be a major topic of conversation after the HIMSS conference (along with clouds, mobile and collaboration). There are two rules pertaining to stage 2 meaningful use: Medicare and Medicaid Electronic Health Record Incentive Program--Stage 2; and the New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology which is not yet published. I will be posting some deeper analysis coming weeks on each of the rules once I have had some time to actually read them in more detail and the S&C rule is published.

Stage 2 Meaningful Use

First, let's look at the NPRM for Stage 2 meaningful use. The final rule for the Medicare and Medicaid EHR Incentive Programs, which was published in the Federal Register on July 28, 2010, specifies that CMS will expand on the criteria for meaningful use established for Stage 1 to advance the use of certified EHR technology by eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs). This proposed rule would establish the requirements for Stage 2. As stated in the July 28 final rule, "Our goals for the Stage 2 meaningful use criteria, consistent with other provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results."

One of the significant changes is in the timing for implementation of stage 2 meaningful use. This change was expected and will become official under the final rule expected this summer. Under the current requirements, eligible doctors and hospitals that began participating in the Medicare EHR Incentive Programs in 2011 would have had to meet new standards for the program in 2013. If they did not participate in the program until 2012, they could wait to meet these new standards until 2014 and still be eligible for the same incentive payment. To encourage faster adoption the rule allows doctors and hospitals to adopt health IT in 2011, without meeting the new standards until 2014. The proposed rule would move all menu set items to core measures, and many of the percentages are increased, and some new menu objectives added.

Other significant aspects of the rule are around improving care transitions and patient engagement, including health information exchange and interoperability of EHRs. The requirement that patients have electronic access to their information is proposed to become that patients have used the capability to access and download their information and have communication preferences stated, as well as a requirement that 10% patients get reminders for preventive, follow-up care. Patients will have the right to view and download (on demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patients should be able to filter or organize information by date, encounter, etc. Patient engagement will be critical to allow patients to share accountability for their care and obtain better health. There is also a new requirement for Eligible Hospitals (EH)s that 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. It will be required that data are available in human-readable and structured forms. (A web portal as defined as online access to health information. Therefore all web portals defined as such are subject to HIPPA rules and regulations.)

The requirement that a summary of care record must be transmitted between providers at transitions in care is ramped up and using paper is no longer an option. Secure messaging is a requirement, and there is a standards and certification requirement that Direct Project protocols are enabled in the EHR. The health information exchange requirement goes from merely performing one test to the ability to connect to at least three external providers in the 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 organization. Sharing health data among providers is necessary to be accountable for care and the health of a patient population. The requirements for quality reporting in meaningful use are increasing at the same time that new reimbursement models are tied to performance. Quality reporting will eventually need to be in real time so that gaps in care can be avoided, rather than simply reported.

Medicare and Medicaid Programs; Electronic Health Record Incentive Program-- Stage 2

Stage 2 Standards and Certification Criteria

In order to successfully meet the requirements for meaningful use, hospitals and EPs must meet Stage 2 objectives and measures using “Certified EHR Technology.” Certified EHR Technology is defined as an EHR (either a Complete EHR or combination of EHR Modules) that has been certified against all applicable certification criteria adopted by ONC for a given payment year. With the delay of Stage 2 Meaningful Use implementation, this allows additional time for EHR vendors to design, develop and release new functionality, which was also cited as one of the reasons behind the recommended delay.

Below is the NPRM on Standards, Implementation Specifications, and Certification Criteria for stage 2 meaningful use. The final rule that established the initial set of standards, implementation specifications, and certification criteria was published in the Federal Register on July 28, 2010. The initial set represented the first round of an incremental approach to adopting future sets of standards, implementation specifications, and certification criteria to enhance electronic health record (EHR) interoperability, functionality, and utility. Under the authority provided by section 3004 of the Public Health Service Act (PHSA), this notice of proposed rulemaking would propose that the Secretary adopt revisions to the initial set as well as new standards, implementation specifications and certification criteria. The proposed new and revised standards, implementation specifications, and certification criteria would establish the technical capabilities that certified EHR technology would need to include to support meaningful use under the CMS Medicare and Medicaid EHR Incentive Programs.

The ONC has created a new certification called Certified EHR Technology that will replace current certification. This will begin at the implementation of Stage 2 Meaningful Use in 2014 (they are creatively calling this the 2014 edition). There will be two types of certification: a Base EHR and a Core EHR. Some of the baseline capabilities of a Base EHR are history and problem list, clinical decision support, CPOE, capture quality data and data query. privacy and security, and health information exchange.

One of the requirements is the View and Download for patients certification criterion which combines several previous certification requirements:
Enable a user to provide patients with the ability to view and download their longitudinal health information online, and to electronically transmit this information directly to patients. Also, enable users to track transmission events and when information is viewed and downloaded. Information must include, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, procedures, clinical summaries and discharge instructions, and be provided in:
(i) Human readable format;
(ii) The standard (and applicable implementation specifications) specified in the new single standard and implementation guide and with data elements using applicable standards;
(iii) Track the number of patient online accesses (view and download) or transmission events.

Electronic access via online access is intended to include an online portal and/or PHR directly tied to the EHR or a third party patient portal and or PHR that is connected to the EHR. The third party solution (PHR and/or patient portal) may be directly connected to that EHR or through an HIE connection that offers electronic patient access. Similarly, the intention here is that the EHR needs to demonstrate one of these options for certification (not all of them). There is also the criteria that secure messaging is enabled that would allow a user to electronically send a secure message to a patient; and also receive a secure message from a patient. As mentioned previously Direct Project protocols must be enabled, which shows a continued emphasis on promoting these standards.

Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technolog...

Get Ready for EHR and NwHIN Rules

Stage 2 Meaningful Use and NwHIN Governance Rules

Sometime in the next month three long awaited proposed rules from CMS and the ONC should be published. You can see below the links to the Unified Regulatory Agenda submission. These rules are under review by the Office of Management and Budget (OMB) and should be published in the Federal Register within the next month or so:

Medicare and Medicaid Electronic Health Record Incentive Program--Stage 2 (CMS-0044-P)

New and Revised Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology

Governance for a Nationwide Health Information Network

The Office of Information and Regulatory Affairs (OIRA) is located within the OMB. OIRA has a great dashboard that gives an overview of rules under review. This dashboard graphically presents information about rules under OIRA review through an easy-to-use interactive display, and it allows the public to sort rules by agency, length of review, state of rulemaking, economic significance, and international impacts. I will be following the rule making process closely and posting updates as information is available.

The NwHIN Governance rule is being done with a Advance Notice of Proposed Rulemaking (ANPRM). This is a step that entails publishing the agency's initial analysis of the subject matter, often asking for early public input on key issues. Any data or communications regarding the upcoming rule would be made available to the public for review. Occasionally, a board of potentially affected parties is comprised to do give-and-take bargaining over rulemaking subject-matter which would otherwise result in deadlocked opposition by an interested party. This is commonly called "negotiated rulemaking", and usually results in a more custom-tailored proposed rule.

Stage 2 Meaningful Use will be deferred for an extra year for those who attested in 2011