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HAP Comment Letter to CMS about Stage 3 and Modifications to Meaningful Use in 2015 through 2016 Final Rule

December 14, 2015

Andrew M. Slavitt,   Acting Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G
Washington, DC 20201

Re: CMS-3310 & 3311-FC, Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017 Final Rule with Comment Period, October 15, 2015

Dear Mr. Slavitt:

On behalf of The Hospital & Healthsystem Association of Pennsylvania (HAP), which represents approximately 240 member institutions, including 125 stand-alone hospitals and another 120 hospitals that comprise 32 health systems across the state, we appreciate this opportunity to comment on the final rule for the Centers for Medicare & Medicaid Services’ (CMS) Electronic Health Record (EHR) Incentive Program—Stage 3 and Modifications to Meaningful Use during 2015 through 2017.

Hospitals strongly support the use of EHRs and other technology to support our shared goals of better coordinated, value-based care, and they have been working diligently to implement new health information technology (IT) to improve the coordination, quality and safety of care for patients. However, the complexity of the EHR Incentive Program has required excessive spending and focus on meeting meaningful use criteria; resources that could be better spent on patient care. HAP urges CMS to revise the EHR Incentive Program framework to reflect program experience to date, provide flexibility in the program measures so that providers can use certified EHRs to support high-quality clinical care and patient engagement, and delay new program requirements until the standards and infrastructure supporting the exchange of health information are mature.

To reach the goal of EHR adoption and use across a sizeable majority of eligible hospitals (EH), critical access hospitals (CAH) and eligible professionals (EP), the EHR Incentive Program framework and time frame must be reoriented to provide operational and strategic flexibility for participating providers to enable them to achieve our shared national vision of an e-enabled health care system.

This letter provides HAP’s recommendations on how to improve the structure of the EHR Incentive Program, increase flexibility to ensure program success, and base meaningful use requirements on mature standards. Detailed comments on the Stage 3 objectives and measures are at the end of this letter.

REVISE THE PROGRAM FRAMEWORK TO REFLECT EXPERIENCE TO DATE

The following recommendations would create a structure for meaningful use that supports program success.

Allow a reporting period of any 90 consecutive days in the first year of a new stage of meaningful use. HAP recommends that a 90-day reporting period be available for the first year of Stage 3 and any subsequent stages, and whenever there are changes to the definition of certified EHR, including a new edition of technology or new functionality. Experience to date indicates that the transition to new editions of certified EHRs is challenging due to lack of vendor readiness, the necessity to update other systems to support the new data requirements, the mandate to use immature standards, an insufficient information exchange infrastructure and a timeline that is too compressed to support successful change management. A 90-day reporting period would give providers additional time to meet these challenges.

Postpone the required start of Stage 3 until a date no sooner than 2019. HAP recommends that CMS refrain from increasing EHR Incentive Program complexity until the vast majority of eligible providers have attained the current stage. Specifically, HAP recommends that providers not be required to begin Stage 3 until at least 75 percent of EHs, 75 percent of CAHs and 75 percent of EPs have met Stage 2. A requirement to start Stage 3 should not occur in advance of the start of the new physician Merit-based Incentive Payment System (MIPS) and Advanced Payment Model (APM), currently scheduled to begin during 2019. The voluntary start of Stage 3 could be available during 2018.

EHR adoption rates among hospitals have increased steadily since the program began in 2011; however, according to data from CMS, fewer than 40 percent of hospitals attested to Stage 2 meaningful use readiness during 2014. According to a recent study, 67 percent of hospitals that had not yet met a proxy for Stage 2 during 2014 cited the ongoing costs of technology adoption as a challenge, while 57 percent cited the complexity of meeting meaningful use criteria.[1]

Additionally, the disparity in EHR adoption rates persists, as evidenced by a gap of more than 10 percent between small and large hospitals in adoption of at least a basic EHR.[2] More than half of hospitals reported challenges related to financial costs.[3] The requirement to meet full- year regulatory requirements and ongoing technology upgrades while the program moves from incentives to payment penalties could create even greater challenges for resource-constrained hospitals.

Moreover, failure to successfully attest to meaningful use results in annual negative payment adjustments. The reduction in Medicare reimbursement for those that do not meet meaningful use objectives is 1.2 percent for 2016, and will be higher during 2017 and later years. All providers require sufficient time to implement and upgrade technology and optimize performance before moving to more complex requirements for use.

Eliminate the all-or-nothing approach in meaningful use. The Health Information Technology for Economic and Clinical Health (HITECH) Act, which was part of the American Recovery and Reinvestment Act (ARRA) of 2009, defines a meaningful EHR user as an EH, CAH and EP that demonstrates to the satisfaction of the Secretary of Health and Human Services (HHS) during the reporting period: the use of certified EHR technology in a meaningful manner; that certified EHR technology is connected in a manner that provides for the electronic exchange of health information to improve the quality of health care, such as promoting care coordination; and that it submits information for the reporting period, in a form and manner specified by the Secretary, on clinical quality measures and such other measures as selected by the Secretary. CMS states that the statute does not permit a change to the all-or-nothing approach and requires more stringent measures of meaningful use to improve the use of EHRs and health care quality over time. We disagree and believe that the inclusion of more stringent measures does not prevent changes to the number of objectives and measures required to meet the program requirements. HAP urges CMS to adopt an alternate approach that advances widespread health IT adoption by all EHs, CAHs, and EPs and sets requirements that are achievable and practical. Specifically, HAP recommends that EHs, CAHs, and EPs that attest to meeting 70 percent of the meaningful use requirements be designated as having met meaningful use.

Provide an attestation period of sufficient length to accommodate all EHs, CAHs, and EPs that will attest simultaneously. HAP is concerned that the 60-day attestation time frame is too short to accommodate the simultaneous attestations by as many as 665,000 EHs, CAHs, and EPs. In previous years, CMS’s system has not been able to accommodate all those seeking to attest in an efficient manner. Indeed, as a result, CMS has extended the attestation period in the past due to these issues. Given past experience, we are concerned that the site will be overwhelmed and providers will not be able to attest by the deadline. Therefore, HAP recommends an attestation period of 120 days following the end of the reporting period, beginning during spring 2016.   

Provider experience in the EHR Incentive Program should inform future definitions of meaningful use. Stage 1 of meaningful use required program participants to electronically capture health information. Stage 2 requires program participants to electronically access and exchange health information with patients and other clinicians. With 40 percent of EHs and about 10 percent of EPs able to attest to Stage 2 during 2014, HAP recommends that CMS allow time for additional providers to attest to Stage 2, commission an independent study of the experience with Stage 2, and use the findings to inform Stage 3 requirements. Additionally, we recommend that CMS study the experience and lessons learned from health reform initiatives and new health care models that incentivize care coordination to provide insight on advanced uses of health IT in support of better health outcomes for patients, better health for populations and improved cost containment.

PROVIDE FLEXIBILITY IN PROGRAM REQUIREMENTS

The following recommendations would give providers the flexibility they need to meet meaningful use while pursuing our shared goals of better-coordinated, value-based care.

Focus on the availability of mature functionality in certified EHRs rather than thresholds that count the use of functionality. In the modifications rule 2015–2017, CMS revised the measure of patient engagement with the certified EHR to focus on the availability of functionality to share information with patients rather than counting how often the function was used. Similarly, HAP recommends CMS modify requirements in Stage 3 to emphasize the availability of EHR functionality, rather than counting the number of times functionality is used. This approach reduces measurement burden while ensuring capabilities are in place. We recommend this approach for the following Stage 3 objectives: clinical decision support (CDS), e-prescribing, patient electronic access to health information, and coordination of care through patient engagement.

For example, HAP recommends that CDS functionality in certified EHRs should be used by hospitals to focus on priority health conditions that map to their own quality improvement priorities, rather than specifically link use of CDS to a specified number of clinical quality measures. Similarly, the requirement to count the number of patients that receive electronic access to patient-specific education materials forces providers to focus resources on counting patients. Rather, providers should continue to utilize many tools—electronic and otherwise—to provide patients with health information in the format that is most relevant for each individual patient and easiest for the patient to access.

Provide a hardship exemption from meaningful use penalties for any EH, CAH or EP that changes vendors during a reporting period. In a September 2015 report on nonfederal efforts to help achieve health information interoperability, the Government Accountability Office found that one of several barriers to interoperability is the costs associated with achieving interoperability, such as interfaces and EHR customization.[4] HAP estimates that, between 2010 and 2013, hospitals collectively spent $47 billion each year on IT. The expense of adopting, implementing and upgrading technology are ongoing, while the program demands certified EHRs support information exchange for a full performance period. Given these conditions, a decision to change vendors during a reporting period places providers in an untenable position. Providers should not be penalized if their vendor is unable to support them in meeting regulatory requirements. HAP recommends expanding the hardship exception categories to allow providers to change EHR vendors during a reporting period to meet their needs without the additional burden of a payment adjustment.

Ensure that any modifications to the program requirements apply uniformly for all participants. The modifications rule includes several changes to the EHR Incentive Program that aligned requirements for EHs, and CAHs with those of EPs, including the shift to calendar year reporting, a common attestation period, and the requirement to report the same objectives and measures. HAP recommends that CMS modifications to the definitions, structure, and reporting requirement of the EHR Incentive Program for EHs and CAHs are aligned with requirements for EPs pursuant to the creation of MIPS. This alignment is critical to ensuring the ability to share information and improve care coordination among providers across the continuum.

Provide flexibility in the measures to support patient engagement with their providers. The availability of mature standards and the opportunity to innovate will allow EHs and CAHs to identify ways to promote patient engagement. Patient portal usage will increase as the sites become more user-friendly and useful. The EHR Incentive Program requirements are not the sole pathway to advance electronic patient engagement. The most recent data from the 2015 Most Wired survey indicate that hospitals with more mature health IT are going beyond meaningful use Stage 2 requirements to find ways to engage their patients. For example, 63 percent of the Most Wired hospitals offer self-management for chronic conditions through the patient portal, and 67 percent can incorporate patient-generated data through the portal. HAP recommends that CMS allow time for optimization of existing EHRs to support insight on approaches to patient engagement before requiring prescriptive patient engagement measures.

Additional flexibility in measures also will require a reconsideration of the applicability of measures intended to support patient engagement. In the Stage 3 final rule, CMS requires EHs and CAHs to use certified EHRs to send a secure message to a patient or in response to a secure message sent by a patient, and requires counting the secure messages in order to meet a specified threshold. HAP recommends that the secure messaging measure to support coordination of care through patient engagement be applicable to EPs only because patients typically engage with their physicians to coordinate their care.

Postpone mandatory electronic reporting of electronic clinical quality measures (eCQMs). HAP recommends that CMS allow time for EHs and CAHs to become experienced with electronic submission of eCQMs before requiring electronic submission of eCQMs for an entire reporting period in the EHR Incentive Program. Experience to date indicates that very few EHs and CAHs are electronically submitting eCQMs due to EHR inability to support accurate clinical quality reporting. We recommend that CMS use the experience of eCQM reporting in CMS quality programs to inform the requirements for eCQM reporting in Stage 3. Additionally, we recommend that CMS not impose requirements on providers that the certified EHRs are not required to support. Currently, EHRs are not required to support the reporting of all eCQMs. Providers must report on the eCQMs that the technology has been certified to support.

ADOPT PROGRAM REQUIREMENTS SUPPORTED BY MATURE INTEROPERABILITY STANDARDS AND INFRASTRUCTURE ONLY

The following recommendations would ensure that providers have the technical abilities and infrastructure available to make the program successful.

Mature standards must exist before providers are required by regulation to use them. The transition to new technology supporting Stage 2 has been a challenge for providers due to lack of vendor readiness, mandates to use untested standards, insufficient infrastructure to meet requirements to share information and compressed timelines. HAP recommends that CMS refrain from including requirements in regulations that providers use a standard or functionality in certified EHRs in advance of evidence that the standard or functionality is ready for nationwide use.

For example, it is premature to require that providers use Application Programming Interfaces (API) in the EHR to make health information accessible by any application (app) that requests to access to the information. Although the Office of the National Coordinator for Health Information Technology (ONC) finalized three certification criteria in support of APIs in the 2015 Edition Certification Rule, ONC specifically did not recognize a standard for APIs, citing standards immaturity. Additionally, ONC finalized the API requirements without specifying a certification approach or framework applicable to the apps that would extract data from the EHR.

Requirements to use new functionality such as APIs must be accompanied by standards that are mature, rigorously tested and are accompanied by implementation guidance that minimizes variation in the interpretation of the standard. Providers should not be required to use APIs that have not been certified by ONC, nor should they be required to share protected health information with apps that have not been certified by ONC. Furthermore, given the sensitive nature of health information, HHS should require all app developers to abide by HIPAA privacy and security rules, whether or not they are covered entities. In a Privacy Rights Clearinghouse study of mobile health and fitness applications, 43 percent of free applications were found to share user-generated personally identifiable information with advertisers and 43 percent of the apps had a link to the website’s privacy policy.[5] CMS should work with ONC to include a requirement in the certification criteria to address this gap in privacy and security protections.

Robust testing and implementation guidance of mature standards must precede requirements for provider use. The experience using the consolidated clinical data architecture (C-CDA) standard to exchange summary of care records illustrates the problems with using standards that have not been adequately specified. Hospitals that receive summary of care documents find they are too large and it is difficult to find what is relevant and pertinent. For example, for patients that require hospitalization: the patient record is managed by a provider who will send a summary of care record to the hospital; the hospital will send a summary of care record back to the provider upon discharge; and the provider will receive a record with all laboratory results (current and historic), imaging results and medications during the patient stay—a large amount of information that is unlikely to indicate the most pertinent information that will support ongoing management of the patient. This challenge has been acknowledged by providers, vendors, and the government. The creator of the C-CDA standard, HL7, is working to improve the C-CDA to make it more flexible so that all information can be   exchanged and relevant information can be presented in an accessible manner, but that work is ongoing and has not been tested in real-world settings. Therefore, HAP recommends that CMS keep the threshold for sharing summary of care documents at the modified Stage 2 level of 10 percent in Stage 3.

Focus on advancing interoperability. HAP recommends that CMS focus on accelerating the exchange of data that is currently collected instead of including requirements to collect new data. Prioritization of use cases that accelerate the exchange of the current meaningful use data set that is being captured to support care will build confidence and support for tackling the capture and exchange of additional data elements. For example, the transition to the unique device identifier (UDI) has just begun and will not be complete until 2020. It will be a complex transition, as there are three separate agencies that use different standards to create the UDI, which can be as long as 75 characters. In addition to accommodating multiple UDI formats, EHRs also will need to accept the data from different forms of automated ID technology (such as a barcode or radio frequency identification tag). At the same time, hospitals are learning how best to use the UDI and change operations to accommodate it. HAP supports the deployment of the UDI because of the safety and efficiency benefits it will bring. However, working through the standards development and implementation issues to support effective use of the UDI is a precursor to including the UDI as a data element in the common clinical data set. Given the significant investments made to date, the current certified EHRs must be a starting point for efforts to improve interoperability. The development and growth of new models of care are incentivizing information sharing by providers. HAP urges CMS to allow the current market pressures for information exchange from consumers and from new care delivery models to accelerate demand for information exchange.

While the demand for information exchange grows, HAP urges CMS to work with federal agencies to prioritize the development of a patient identifier. Providers are experiencing challenges in identifying patients and matching them to their medical records. The nation lacks a single national mechanism for identifying individuals such as a unique patient identifier. A single solution that would match individuals across IT systems would allow providers to know with confidence that a patient being treated in an emergency department is the same patient that a physician in another location diagnosed with an acute or chronic health condition that requires ongoing management. Patient safety concerns arise when data are incorrectly matched, such as a patient’s current medication not being listed in the medical record or the wrong medications are included in the record. Stage 3 includes a measure requiring a clinical information reconciliation that includes medications, medication allergy and current problem list for more than 80 percent of transitions or referrals in which the provider has never before encountered the patient. This requirement would be easier to achieve with advancement of a patient matching solution.

The ability to optimize the functionality of certified EHRs is equally important to the ability to use the EHRs in the delivery of safe and quality health care. During the October 2015 joint meeting of the Health IT Policy and Health IT Standards Committees, a committee member recounted the experience of nurses in a hospital taking two hours to complete the documentation for the nursing admission assessment. Two hours were required for the task due to the number of places in the record where information was requested and the 537 clicks required to enter the data. HAP recommends that CMS allow time for the evolution and maturation of EHRs so that they support providers with more nimble solutions supporting the time-sensitive and high-reliability environment in which they are used.

DETAILED COMMENTS ON THE STAGE 3 OBJECTIVES AND MEASURES

Protect Electronic Health Information

HAP supports retaining the measure as finalized for Stage 3.

e-Prescribing

Hospitals should only be required to attest that they are using e-prescribing at discharge. HAP opposes a threshold that is more than 10 percent. Hospitals are required to report e-prescribing for the first time in Modified Stage 2 and require time to address the technology upgrades, interfaces with other systems and workflow modifications necessary to support this required measure.

Clinical Decision Support (CDS)

HAP recommends removing the tie between CDS and clinical quality measures in favor of high-priority safety and quality improvement objectives of the hospital. This would allow hospitals to determine how to use their EHR to meet quality improvement goals and it would remove the measurement burden of tracking the links between CDS and clinical quality measures.

HAP recommends removing the “entire EHR reporting period” from the measure specifications to limit unnecessary measurement burden.

Computerized Provider Order Entry (CPOE)

HAP recommends the continuation of the three measures with thresholds in the published Stage 3 final rule.

HAP recommends that CMS not increase the thresholds above 60 percent.

HAP also recommends that CMS clarify the provider that may claim attribution for the order.

Patient-Specific Education

Measure 1. HAP opposes the requirement to use API functionality for patient engagement for educational resources or for health information exchange through patient engagement in advance of a mature standard and certification of patient-selected applications.

HAP opposes the requirement to make patient health information available within 36 hours of its availability to the provider for an eligible hospital or CAH through an API of the patient’s choice as it would present operational challenges to hospitals. We support continuation of making information available to view, download, or transmit

Measure 2. HAP opposes the use of a specific threshold to monitor electronic access to patient specific educational resources due to the absence of studies that indicate an appropriate threshold for all providers. In the absence of evidence, HAP recommends CMS focus on the functionality in the EHR and commission a study that evaluates provider experience with use and optimization of the functionality. We also recommend that CMS provide clarity about how the EH, CAH, or EP would discern that the patient-specific educational resources are actually generated by the certified EHR.

Patient Electronic Access (View, Download, and Transmit)

Measure 1. HAP opposes the requirement to use API functionality for patient engagement with a EH’s or CAH’s EHR in advance of a mature standard and certification of patient-selected applications.

HAP opposes the use of a specific threshold to monitor patient active engagement with the EHR and recommends the continuation of the Modified Stage 2 approach for Measure 1 that focuses on the availability of functionality in the EHR to support the objective.

A study and evaluation of provider experience with use and optimization of the functionality will inform future requirements such as what or if thresholds are necessary.

Measure 2. HAP recommends that the secure messaging measure be applicable only to EPs as a patient is more likely to seek information from a primary care provider following an acute care visit rather than contacting the hospital directly. In addition, we believe it is appropriate to measure the provider’s use of the secure messaging but not the patient’s responsiveness or utilization of this technology. If EH/CAH use of secure messaging is included, CMS should only require that functionality is enabled.

Measure 3. HAP believes it is premature to finalize a requirement that providers use certified EHR functionality to support receipt of patient-generated data or data from non-clinical settings from 15 percent of all unique patients. HAP recommends that CMS study the experience of hospitals that are using the patient-generated data to inform this regulatory proposal.

Summary of Care

Measure 1. HAP recommends retaining the modified Stage 2 threshold that EHs and CAHs use their certified EHR to create and electronically send a summary of care for more than 10 percent of transitions of for summary of care. There is no evidence that the 50 percent threshold is attainable. HAP also recommends that CMS allow access to a shared record to count for purposes of Measure 1. The use of health information exchanges to make information available to exchange participants also should count in the fulfillment of Measure 1.

Measure 2. HAP strongly recommends that the 40 percent performance threshold in Measure 2 be modified to demonstrate the ability to consume a summary of care record from at least one external EHR system.

Measure 3. HAP strongly opposes the 80 percent threshold for medical record information reconciliation for new patients. This requirement precedes the readiness of patient matching solutions and the availability of EHR interoperability that supports the exchange and use of accurate health information within a recipient’s EHR without manual effort.

Public Health

HAP recommends retaining the modified Stage 2 requirement concerning the number of measures reported for this objective. EHs and CAHs should report on three of four measures.

HAP recommends the retention of the modified Stage 2 specialized registry reporting option as one category that includes both the public health registry and clinical data registry. Case reporting can fit under the specialized registry reporting option, as it is in Modified Stage 2. CMS should not include separate categories for public health, clinical data, and case reporting registries.

HAP recommends a requirement that registries that receive data from certified EHRs also must be subject to certification. 

HAP recommends the continued availability of the alternate exclusions to the measures in the public health reporting objective until the database of national, regional, state registries is available to facilitate the measure reporting requirement.

HAP recommends that CMS continue efforts to support public health agencies in their ability to receive the data in accordance with the agreed upon standards.

Pennsylvania’s hospitals are working toward a health care system where all providers are meaningfully using certified EHRs to improve patient care and safety as well as achieve national goals for improvement in the care of patients and populations. HAP believes the recommendations presented in this letter will fulfill the goals of the ARRA legislation to create a constructive and positive pathway for nationwide adoption of EHRs. HAP believes the focus on increased EHR adoption and on interoperability will ensure that EHRs and other health IT tools can enable the efficient sharing of health information in support of care delivery, patient engagement, and new models of care.

Thank you for your consideration of our comments about this important final rule with comment. If you have any questions, please feel free to contact me, or MartinCiccocioppo, vice president, research, at (717) 561-5363.

Sincerely,

Michael J. Consuelos, MD MBA
Senior Vice President, Clinical Integration

[1] Adler-Milstein et.al., Electronic Health Record Adoption in US Hospitals: Progress Continues, But Challenges Persist, Health Affairs, November 2015.
[2] Ibid.
[3] Ibid.
[4] GAO-15-817, Electronic Health Records: Nonfederal Efforts to Help Achieve Health Information Interoperability, General Accountability Office, September 2015.
[5] Fact Sheet 39: Mobile Health and Fitness Apps: What Are the Privacy Risks, Privacy Rights Clearinghouse, revised December 2014.

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