May 29, 2015
Submitted Electronically
Andy Slavitt
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building,
200 Independence Avenue, S.W.,
Washington, DC 20201
Re: Medicare and Medicaid Programs; Electronic Health Record Incentive Program –
Stage 3 Notice of Proposed Rulemaking (CMS-3310-P)
Dear Mr. Slavitt:
The Consumer Partnership for e-Health (CPeH) and the undersigned 29 organizations
and individuals submit these formal comments on the proposed requirements for Stage 3
of Meaningful Use.1 CPeH is a coalition of more than 50 consumer, patient and labor
organizations working at the national, state and local levels to advance private and secure
health information technology (health IT) in ways that measurably improve the lives of
individuals and their families. The combined membership of CPeH represents more than
127 million Americans.
Health IT can empower individuals with the information and electronic tools necessary to
be active partners in their own health or the care of a loved one. Health IT can help
patients2 and their caregivers make more informed decisions; be better connected;
generate and share important health information; and set, track and achieve personal
health and wellness goals. While great advances have been made in recent years, we have
yet to fully realize the potential of health IT to meaningfully and consistently engage
patients and families in these ways. The MeaningfulU se incentive program remains a
critically important lever to ensure that patients are not just offered access to their health
1
The 29 organizations and members of the Consumer Partnership for eHealth, joined by others, who sign this letter do so
jointly in one letter rather than send 29 separate letters. If CMS counts responses for any particular purpose, please count
them as 29 responses rather than a single response.
2 For brevity, we refer throughout our comments to “patient” and “care,” given that many federal programs and initiatives are
rooted in the medical model. To some, these terms could imply a focus on episodes of illness and exclusive dependency on
professionals. Any effort to improve patient and family engagement must include the use of terminology that also resonates
with the numerous consumer perspectives not adequately reflected by medical model terminology. For example, people with
disabilities frequently refer to themselves as “consumers” or merely “persons” (rather than patients). Similarly, the health
care community uses the terminology “caregivers” and “care plans,” while the independent living movement may refer to
“peer support” and “integrated person-centered planning.”
information, but actually use it for better care and better health. We are pleased to see
proposals for Stage 3 that enhance individuals’ access to health information and facilitate
communication and information sharing with providers. We urge CMS to maintain the
commitment in this Stage 3 Notice of Proposed Rulemaking to strong online access
requirements as a core component of meaningfully using certified health IT.
Additionally, we believe that patients can play a significant role in accelerating and
intensifying efforts to realize an interoperable health care ecosystem. True
interoperability includes patients and their caregivers as equal partners in the continuum
of care, in electronic access to and use of health information, and in building and using
the learning health community. Equipped with online access, individuals can download
and share their health information with other doctors and trusted caregivers in case of
emergency or when seeking second opinions. We encourage CMS to preserve robust
patient and family engagement requirements in the Meaningful Use program as a way to
advance interoperability efforts.
CPeH appreciates the opportunity to provide input on advancements in the definition of
meaningful use of health IT. As the program moves to a single, consolidated definition
of meaningful use, we encourage CMS to use the opportunity to support a more
comprehensive, person- and family-centered model of health care. We offer high-level
feedback on several of the proposed structural changes to the Incentive Program below,
and more detailed comments on specific objectives and measures in the Appendix.
Programmatic / Structural Changes
We support the proposed direction to move to a single set of objectives and measures to
meet the definition of Meaningful Use, and applaud CMS for its efforts to simplify
reporting requirements and reduce program complexity.
While we recognize that developing and implementing certified health IT is neither
simple nor easy, we are disappointed with yet another proposed delay of Stage 3
(optional until 2018), which only further postpones better care quality and health
outcomes for patients and families. It is vital to keep the Meaningful Use program
moving forward without losing momentum in the final stage; we encourage CMS and
ONC to afford patient needs the same weighted consideration as the needs of providers
and vendors. Additionally, the proposed optional year will further delay improvements in
interoperability as many of the proposed objectives could make significant progress on
electronic exchange and use of health information, both among providers as well as
patients and families.
We agree that a single EHR reporting period based on the calendar year has benefits for
both providers and patients, and we agree that CMS should maintain full-year reporting
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periods as part of meaningful use. Full-year reporting periods are more likely to prompt
changes in practice policies and provider workflows that are essential to realizing the full
potential of health IT, and subsequently to transforming health care delivery.
Furthermore, patients and families deserve the ability to access their health information
through an API, submit patient-generated health data, etc. any day of the year, rather than
a particular three-month period. Conversely, a 90-day reporting period impairs
interoperability among different providers on different editions and health IT modules in
different 90-day periods. If a 90-day reporting period is finalized for any year, CMS
should consider the downstream effect on measures with exclusions that were originally
intended to apply to a full years’ worth of data (for example the transitions of care and
care coordination/engagement requirements).
We applaud CMS for continuing to require providers to meet all measures and associated
thresholds to meet meaningful use and receive an incentive payment (or avoid a
downward payment adjustment). We agree that the foundational goals of the program
would be undermined if providers were allowed to fail and still be considered meaningful
users. With our recommended changes, the proposal strikes an appropriate balance by
incorporating flexibility to allow providers to choose measures relevant to their practice
setting and patient population in the public health and health information exchange
objectives.
Coordination of Care through Patient Engagement
We appreciate the close connections between patient engagement and care coordination –
both are critical to high-quality health care systems. However, we are concerned that
collapsing coordination and engagement measures (as proposed for Objective 6)
may unintentionally undermine or dilute efforts to engage patients and families. For
example, a provider could elect to send a secure message to another provider and receive
information from a “non-clinical” setting (i.e., a non-Meaningful Use eligible provider) –
and successfully meet this objective, all without truly engaging a single patient. We offer
specific suggestions on the measures as proposed, as well as how to separate these two
concepts (and associated measures) in the Appendix.
Giving patients the ability to view, download, and transmit (VDT) their own health
information and securely message their providers were monumental advancements for
consumers in Stage 2 of Meaningful Use. We appreciate the Stage 3 proposals to
build on this progress and make access and use of electronic health information
more robust, meaningful and interoperable for both providers and patients.
National survey data from the National Partnership for Women & Families clearly show
that online access has a positive impact on a wide range of activities that are essential to
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better care and better health. For example, six in 10 people with online access report that
it improves their desire to do something about their health, which clearly has significant
implications for patient engagement and improving health status. Even more striking, not
only does online access hold the potential to improve patients’ health behaviors across a
range of domains (e.g., by increasing knowledge of health, ability to communicate with
doctor), but more frequent online access may increase these behaviors significantly more.
Notably, the more frequently individuals access their health information online, the more
they report that it motivates them to do something to improve their health, including a
dramatic 71 percent of those using online access three or more times per year who report
this, compared with 39 percent who used online access less frequently.
We understand that application programming interfaces (APIs) offer significant promise
with regard to new functionalities that support patient access and information exchange.
We do have some concerns, however, about the wide-scale adoption and implementation
of APIs, particularly with regard to the privacy and security of health information
transmitted to and stored in third-party applications. We encourage CMS to pursue the
transition to APIs prudently, and require both the API option and view/download/transmit
function for the time being. CMS should also clarify whether ONC-certified APIs will be
publicly available, and affirm that there will be no barriers placed on consumers for use
of APIs. For APIs to meet this objective, they must go beyond the mere ability to
respond to requests for patient data from other applications; they must ensure as well that
all functionalities required in the “View, Download, and Transmit to Third Party”
criterion are equally available through the API—for example, view, download, transmit,
patient-generated health data, and secure messaging. We offer more specific
recommendations with regard to patient electronic access in the Appendix.
Patients’ access to their health information is a crucial part of engaging patients and
families to achieve better care and improved health outcomes. But the National
Partnership survey revealed an equally compelling expectation that patients and other
caregivers be able to communicate with their providers and share patient-generated health
data. They reported expectations of a dialogue with providers — a partnership in both
directions, rather than one-directional access. As a result, we enthusiastically support
offering patients and family caregivers the ability to communicate electronically
with providers and (new to Stage 3) contribute information to their medical record
that is specific and material to their care.
Health Disparities
Finally, the value of and current barriers to electronically connected and coordinated care
are not the same for everyone, including underserved communities, communities of color,
people with disabilities, and people who speak languages other than English. To succeed,
we must consider all factors pertinent to individuals’ health, such as sexual orientation
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and gender identity, occupation, disability status, environmental factors and caregiver
presence, as well as race, ethnicity and language, when designing and implementing
health IT policy and practices.
We are pleased to see several references to identifying and reducing health disparities
woven throughout the 2015 Edition Health IT Certification Notice of Proposed
Rulemaking. However, we encourage CMS to consider parallel policy requirements
to ensure these capabilities are being used by providers to the benefit of patients,
families and populations across the nation (for example, filtering Clinical Quality
measure (CQM) results disparities variable; requiring the availability of patient-specific
education materials in the top five non-English languages nationally, or at least in
Spanish). Additionally, CMS and ONC should be considering how to ensure that
consumers can view, download, or transmit their health information using diverse and
accessible technology platforms, including mobile technologies, and in the patient’s
preferred language.
Clinical Quality Measures (CQMs)
We support efforts to align quality measurement and requirements across CMS programs,
and encourage, where feasible, greater alignment of quality measurement across private
and public payer initiatives. Currently, most electronic quality measures are retooled
clinical process measures. The kinds of measures necessary to support new payment and
delivery models are possible in an electronic environment, but systems and infrastructure
must be designed accordingly. Electronic quality measurement should look across longer
periods of time, utilize more data sources and consider care in other settings beyond
hospitals and ambulatory care such as long-term post-acute care, behavioral health and
palliative care. Technology developers must create and enable the functions and
capabilities necessary for capturing information required to populate measures of patient
engagement, care coordination, functional status, longitudinal (delta) measures, wellness
and health promotion, and population-based measures that can be used to improve health,
reduce disparities and decrease costs. Only then will we have quality metrics that both
reduce the burden of data collection and provide the kinds of data necessary to support
new payment and delivery models and achieve better care, healthier people and smarter
spending.
Our comments on specific objectives and measures are included in the Appendix. While
we have not commented on all objectives in the proposed rule, such as electronic
prescribing or computerized provider order entry, we nevertheless want to underscore
their importance to the delivery of safe, effective, person-centered high-quality care.
Thank you once again for the opportunity to provide input into this transformative
program. Robust advancement of Stage 3 Meaningful Use criteria that focus on
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improvement of outcomes is critical to ensure that the outlay of public funds through this
program results in better care, smarter spending, and healthier people. We look forward
to working with CMS, ONC, providers, and consumers across the nation to leverage
technology to enhance the quality of care, foster trust with patients, bolster meaningful
engagement and improve health outcomes.
Sincerely,
AARP
Association of Asian-Pacific Community Health Organizations
American Association on Health & Disability
American Cancer Society Cancer Action Network
Asian & Pacific Islander American Health Forum
Caring From a Distance
Center for Democracy & Technology
Consumers' Checkbook/Center for the Study of Services
Disability Rights Education and Defense Fund (DREDF)
Families USA
Family Caregiver Advocacy
Fenway Health
Genetic Alliance
Hannah's Hope Fund
Healthwise
Hermansky-Pudlak Syndrome Network
Informed Medical Decisions Foundation
MLD Foundation
National Consumers League
National Council of La Raza
National Health IT Collaborative for the Underserved
National Health Law Program
National Partnership for Women & Families
PXE International
RASopathies Network USA
The Children’s Partnership
The Fenway Institute
Universal Health Care Action Network of Ohio
MaryAnne Sterling
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Appendix: Proposed Objectives and Measures
Specific Comments & Suggestions
Objective 1: Protect Personal Health Information
We appreciate the continued attention paid to protecting the privacy and security of
consumers’ electronic health information. We acknowledge that there is confusion
amongst both providers and consumer surrounding existing privacy laws. In fact,
NPWF’s survey shows that although almost 90 percent of patients whose doctors use
EHRs state that it is important for them to know how their health information is collected
and used, only 55 percent stated that their doctors and staff did a good job of explaining
how their information is used. We appreciate CMS’s clarification of timing of security
risk analyses.
We support adding administrative safeguards (e.g. risk analysis, risk management,
training) and physical safeguards (e.g. facility access controls, workstation security),
consistent with previous Privacy and Security Tiger Team recommendations. These
provisions more closely align with CEHRT risk assessments and compliance
requirements for the HIPAA Security Rule.
Objective 3: Clinical Decision Support
Clinical decision support (CDS) measure design and certification specifications should
include all stakeholders – including patients, families and non-Meaningful Use eligible
providers. CDS as currently designed typically accommodates a machine and provider
interface and leaves out the patient. CDS that includes the patient is most often called
shared decision making. It is critical to link patient-generated data to CDS technologies in
order to generate alerts based on the non-clinical needs of patients, including their
preferences, values and goals for care; to promote discussion between the provider and
the patient; and to facilitate an informed, personalized decision.
Objective 5: Patient Electronic Access to Health Information
Measure 1: VDT—Patients Provided Access
We applaud CMS for explicitly including patient authorized representatives in the Patient
Electronic Access measure. Family and other caregivers play a significant role on the
care team, and have a tremendous need for information about their loved one’s care; it is
vital that they be included in strategies used by doctors and hospitals to meet this measure.
In general, we support the move towards application programming interfaces (APIs) as a
way for consumers to access and use their electronic health information. We do not have
the technical expertise to comment from a technical perspective on whether an API
provides the same level of access and use as VDT; however, we stress that whatever
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method is chosen must enhance the current level of electronic access and use of health
information available to individuals.
We have several outstanding questions about implementation of APIs, as well as the
privacy and security protections offered by third-party applications, and thus urge
CMS to require providers to continue to offer access through VDT while also
beginning to use APIs, at least for the time being. We support proposed Alternate A
(VDT and APIs) — to preserve existing electronic access and functionalities enabled
through patient portals while APIs are tested. This will give the marketplace time to best
meet the needs of both consumers and providers, to understand both intended and
unintended consequences of the shift to APIs, as well as to ensure continued availability
of existing patient-facing functions. Functions such as secure messaging, online
medication refills, appointment scheduling, etc., are part of many portals today, and
allowing providers to discontinue these functions without a reasonable replacement
would be highly disruptive for patients and families. Requiring both VDT and APIs is
particularly important for individuals who may be reliant on older, outdated technologies
(such as persons with disabilities) or who rely on public libraries for internet access, and
therefore are more likely to use established VDT functionalities.
We also have significant concerns about the privacy and security of patient health
information accessed through VDT or APIs that must be addressed as CMS moves
forward. Specifically, we remain concerned about the privacy and security implications
for patients who choose to download their data (through a portal or API) and upload it
into an application of their choice. These applications and devices may have poor
privacy policies, weak security controls and/or policies that explicitly share data liberally
with third parties or allow broad uses. Most applications are not under regulation by the
Federal Trade Commission (FTC), Office of Civil Rights (OCR) or other federal
authority. Additionally, many patients have limited knowledge and understanding of
how privacy and security protections change (or end) when they move health data from a
HIPAA-covered entity to a third-party application or device. We strongly encourage
ONC, OCR and CMS to collaborate on ways to both educate patients about their rights,
and steps they should take to protect their data, as well as to examine policy options that
improve privacy and security for patients using these methods to download their data.
Furthermore, concerted efforts to educate providers – especially those in small practices –
will be paramount. Providers are likely to receive questions from patients and family
members about APIs (what they mean, how they work, are they safe, etc.). Educational
materials for application developers to communicate their privacy policies to patients and
consumers will also be critical. We encourage CMS to publish additional privacy and
security guidance in the Stage 3 Final Rule to ensure its availability to vendors and
implementing providers.
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CMS notes it has a preference for APIs to be available at no cost to the patient. However,
we encourage CMS to clarify that any API used by a provider as a means for a patient or
patient-authorized representative to access and use the individual’s health information
must be available at no cost to the patient. Out-of-pocket costs should not prevent
individuals from accessing and using their own health information.
Measure 2: Patient-Specific Educational Materials
We support continuation of this measure and the increased threshold. Patients and
caregivers need patient-specific education resources and materials to help them
understand their health information and facilitate self-care. We appreciate that CMS still
encourages providers to provide paper-based information in honor of patient preference,
but realize that electronic information is required to demonstrate meaningful use of EHRs.
It is also critical that educational materials be written in plain language and should be
usable and accessible by a wide variety of consumers (including those with disabilities
and reading/comprehension impairments and those with specific linguistic and cultural
needs). We encourage CMS to make these critical materials available as well through
view/download/transmit (e.g. patient portals) to enhance access to meaningful, useful
education materials.
We are disappointed at the failure to require that these critical education materials
be available in languages other than English, at least in Spanish if not the top five
languages nationally. More than 60 million, or 21 percent, of Americans speak some
language other than English at home. We urge CMS to encourage providers to strive
to offer materials in the language spoken by their patients, no matter what that language
is.
Objective 6: Coordination of Care through Patient Engagement
We appreciate the close connections between patient engagement and care coordination;
however, the objective as proposed may inadvertently damage genuine patient
engagement by creating measures in which the two concepts are inextricable. Secure
messages sent between providers in which the patient is included as a carbon copy are not
truly patient engagement. Similarly, while we support the use of information from nonclinical settings to inform care that results in better outcomes and decreased costs
associated with unnecessary readmissions, collecting that information from home health
providers, physical therapists, or other professional care team members is not the same as
engaging patients and families directly. Both are important and should be preserved,
but we suggest separating them. If measures are finalized as proposed, providers
should be required to meet all three measures.
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Measure 1: Electronic Access to Health Information
As stated previously, we strongly support the requirement not only to offer access but to
document use of online access to truly engage patients and change clinical practices and
culture. We are also pleased to see the increased thresholds both for patients offered (80
percent) and using electronic access (25 percent). We applaud the advancement of this
criterion toward real-time health data access and inclusive electronic health information
exchange by accelerating the timeframe for making information available to 24 hours.
Measure 2: Secure Messaging
We strongly support including authorized representatives as those who can receive secure
messages to meet this measure. We also agree with not allowing administrative or
financial data to count as patient-centered communication towards the secure message
threshold.
We know that the lack of coordination and communication is a common consumer
frustration with the health care system. There are likely instances in which being
passively copied on a message will meet some individuals’ need to know that their
providers are communicating with each other, perhaps in response to a direct request
from the patient, and are sharing information on their behalf (without needing to respond
or provide input). However, we reiterate that communication of this type – while valuable
– is not truly patient engagement. If CMS finalizes the measure as proposed, it must
consider how to ensure (and measure) whether patients are actively engaged in these
communications, perhaps by requiring certified health IT to track both patient (or
authorized representative) views and responses.
Measure 3: Patient-Generated Health Data
Patients and family caregivers manage their health in the context of a multitude of
priorities and life circumstances. The information they can provide about their abilities
and support needs for self-management complements clinical information generated by
care teams to provide a comprehensive, person-centered view of an individual’s health.
This is a pivotal opportunity to improve performance on high priority health conditions,
address unnecessary readmissions and enhance patient and family engagement in care.
We agree that collecting and utilizing data from non-clinical settings is valuable and
contributes to person-centered care, but we encourage CMS to differentiate this data from
true patient-generated health data (PGHD). Furthermore, PGHD should be included or
referenced as part of any measure where the patient is the data source, for example drug
history for drug/drug checks, demographics, sexual orientation and gender identity
(SO/GI) information, etc.
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We support retaining the external data source’s provenance as part of the incorporation
process. Retaining data provenance should be standard practice, as it is particularly
important for incorporating patient-generated health data. We have also encouraged ONC
to incorporate such data provenance in the 2015 Edition to the extent possible. ONC should
confirm whether the 2015 Edition must add any specifications to the 2014 Edition in order
to include this functionality (provenance).
Alternate Measures:
As stated above, we strongly support patient engagement and care coordination as key
components of new models of care and delivery system reform. However, we suggest
that the concepts be separated and provide the following option for doing so. Because we
have separated the two concepts and require that all three measures be met, we are
willing to suggest lower thresholds on patient-engagement measures where carecoordination activities would no longer count toward the measure.
Note: 3 / 3 measures required.
Measure 1: 10% of unique patients view, download or transmit health information or use
ONC-certified API (Change: threshold lowered from 25 to 10 percent).
Measure 2: For 35% of unique patients, a secure message is sent to the patient or in
response to a secure message sent by the patient (No change; same as proposed).
Measure 3: For 10% of unique patients, provider-requested, patient-generated health
data are incorporated into the EHR (Change: Only data generated/contributed by the
patient, or patient’s authorized representative, count; threshold lowered to 10%; “nonclinical” data from a non-MU eligible provider moved to HIE Objective, #7).
Objective 7: Health Information Exchange
Measure 1: Create & Electronically Exchange Summary of Care Record
We support the increased exchange threshold from Stage 2, as well as the requirement
that summary of care (SoC) documents be sent electronically (without specifying a
standard for electronic exchange). We also appreciate use of the Common Clinical Data
Set, which contains critical information like granular race and ethnicity data (see further
discussion in the Consumer Partnership for eHealth’s comments on the 2015 Edition).
While CMS indicates that summary of care documents are expected to “contain the most
recent and up-to-date information on all elements,” we urge CMS to clarify that this
requires the documentation of the UDIs of implanted devices at the time of the procedure.
We note that if CMS elects to proceed with CPeH’s proposed alternate measures for
Objective 6 (particularly the change to the PGHD measure), then the first Health
Information Exchange measure would be amended to: Must electronically exchange
summary of care OR receive clinical information from a non-MU eligible provider.
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Measure 2: Incorporate Summary of Care Record
We appreciate the addition of Measure 2, which requires the provider receiving the
Summary of Care to incorporate it into the patient’s EHR. This measure effectively
closes the referral loop and realizes coordination of care. We also acknowledge the lack
of experience incorporating SoC records and other information into EHRs, as this
measure is new to the Incentive Program.
Measure 3: Clinical Information Reconciliation:
We support broader reconciliation (medication allergies and current problem lists) and
higher thresholds than were finalized in Stage 2. We note that reconciliation is a valuable
opportunity to engage patients and caregivers in their health and care.
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