Advancing Interoperability and Health Information Exchange, 14793-14797 [2013-05266]
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Centers for Medicare & Medicaid
Services
[CMS–0038–NC]
Advancing Interoperability and Health
Information Exchange
Vern W. Hill,
Director, Bureau of Certification and
Licensing.
Office of the National
Coordinator for Health Information
Technology (ONC) and Centers for
Medicare & Medicaid Services (CMS),
Department of Health and Human
Services (HHS).
ACTION: Notice with comment; Request
for Information.
AGENCY:
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Vern W. Hill,
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY: HHS seeks input on a series
of potential policy and programmatic
changes to accelerate electronic health
information exchange across providers,
as well as new ideas that would be both
effective and feasible to implement. To
further accelerate and advance
interoperability and health information
exchange beyond what is currently
being done through ONC programs and
the EHR Incentive Program, HHS is
considering a number of policy levers
using existing authorities and programs.
DATES: To be assured consideration,
written or electronic comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
April 22, 2013.
ADDRESSES: You may submit comments
identified by any of the following
methods below (please do not submit
duplicate comments). Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
• Federal eRulemaking Portal: Follow
the instructions for submitting
comments. Attachments should be in
Microsoft Word or Excel, Adobe PDF;
however, we prefer Microsoft Word.
https://www.regulations.gov.
• Regular, Express, or Overnight Mail:
Department of Health and Human
Services, Office of the National
Coordinator for Health Information
Technology, Attention: Interoperability
RFI, Hubert H. Humphrey Building,
Suite 729D, 200 Independence Ave.
SW., Washington, DC 20201. Please
submit one original and two copies.
• Hand Delivery or Courier: Office of
the National Coordinator for Health
Information Technology, Attention:
Interoperability RFI, Hubert H.
Humphrey Building, Suite 729D, 200
Independence Ave. SW., Washington,
DC 20201. Please submit one original
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14793
and two copies. (Because access to the
interior of the Hubert H. Humphrey
Building is not readily available to
persons without federal government
identification, commenters are
encouraged to leave their comments in
the mail drop slots located in the main
lobby of the building.)
Inspection of Public Comments: All
comments received before the close of
the comment period will be available for
public inspection, including any
personally identifiable or confidential
business information that is included in
a comment. Please do not include
anything in your comment submission
that you do not wish to share with the
general public. Such information
includes, but is not limited to: A
person’s social security number; date of
birth; driver’s license number; state
identification number or foreign country
equivalent; passport number; financial
account number; credit or debit card
number; any personal health
information; or any business
information that could be considered to
be proprietary. We will post all
comments received before the close of
the comment period at https://
www.regulations.gov.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov or the Department
of Health and Human Services, Office of
the National Coordinator for Health
Information Technology, Hubert H.
Humphrey Building, Suite 729D, 200
Independence Ave. SW., Washington,
DC 20201 (call ahead to the contact
listed below to arrange for inspection).
FOR FURTHER INFORMATION CONTACT:
• Kelly Cronin, Health Care Reform
Coordinator; or
• Steven Posnack, Director, Federal
Policy Division
Office of the National Coordinator for
Health Information Technology, 202–
690–7151.
SUPPLEMENTARY INFORMATION:
I. Background
Since enactment of the Health
Information Technology for Clinical and
Economic Health Act as part of the
American Recovery and Reinvestment
Act, adoption and use of electronic
health records in the United States has
dramatically increased. Adoption of
EHRs that met the criteria for a basic
EHR system by office-based physicians
grew by over 80% between 2009 and
2012, from 22% in 2009 to 40% in
2012.1 2 Among non-federal acute care
1 Hsiao CJ, Hing E. Use and characteristics of
electronic health record systems among office-based
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hospitals, adoption of at least a basic
EHR system has increased by over 260%
since 2009, from 12% to 44%.3 4 Since
2009, there has been strong and steady
growth in adoption of EHR technology
to meet Meaningful Use objectives to
improve quality, safety and efficiency.
Adoption of many of the computerized
functionalities associated with
Meaningful Use has substantially
increased among both office-based
physicians as well as hospitals.5 6 For
example, physician adoption of five
core Meaningful Use functionalities—
ranging from e-prescribing to clinical
decision support—has grown by at least
66% since HITECH in 2009.
As part of stage 2 rulemaking HHS has
taken major steps to expand the
functionality and utility of EHRs to
providers and patients. We seek to build
on that work by engaging other policy
areas within HHS jurisdiction to
promote routine sharing of information
among health care providers across
settings of care to support care
coordination and delivery system
reform. We also recognize that economic
and regulatory barriers may impair the
development of a patient centered,
information rich, high performance
health care system where a persons’
health information follows them
wherever they access health care
services.
The Medicare and Medicaid
Electronic Health Record (EHR)
Incentive Programs and Office of the
National Coordinator (ONC) for Health
physician practices: United States, 2001–2012.
NCHS data brief, no 111. Hyattsville, MD: National
Center for Health Statistics. 2012.
2 A basic EHR system for office-based practices
includes the following functionalities: Patient
history and demographics, patient problem lists,
physician clinical notes, comprehensive list of
patients’ medications and allergies, computerized
orders for prescriptions, and ability to view
laboratory and imaging results electronically. Note
that functionalities associated with basic EHR differ
from functionalities required for meaningful use.
3 ONC analysis of data from the 2011 American
Hospital Association Survey Information
Technology Supplement. Data brief forthcoming.
4 A basic EHR system for hospitals includes the
following functionalities: Patient history and
demographics, patient problem lists, physician
clinical notes, nursing assessments, comprehensive
list of patients’ medications and allergies, discharge
summaries, computerized orders for prescriptions,
and the ability to view diagnostic test results,
laboratory reports and radiology reports
electronically. Note that functionalities associated
with basic EHR differ from functionalities required
for meaningful use.
5 King J, Patel V, Furukawa MF. Physician
Adoption of Electronic Health Record Technology
to Meet Meaningful Use Objectives: 2009–2012.
ONC Data Brief, no. 7. Washington, DC: Office of
the National Coordinator for Health Information
Technology. December 2012.
6 ONC analysis of data from the 2011 American
Hospital Association Survey Information
Technology Supplement. Data brief forthcoming.
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IT (HIT) Certification Program are
increasing standards based health
information exchange (HIE) across
health care providers and settings of
care to support greater coordination of
health care services. However, this
alone will not be enough to achieve the
widespread interoperability and
electronic exchange of information
necessary for delivery reform where
information will routinely follow the
patient regardless of where they receive
care. With fee-for-service
reimbursement and other business
motivations often being the stronger
influencer of provider behavior, both
providers and their vendors do not yet
have a business imperative to share
person level health information across
providers and settings of care.
For example, in 2011, 4 in 10
hospitals electronically sent laboratory
and radiology data to providers outside
their organization; however, only 1⁄4 of
hospitals could exchange medication
lists and clinical summaries with
outside providers.7 In addition in 2011,
only 31 percent of physicians are
exchanging clinical summaries with
other providers.8 There is even more
limited HIE involving post-acute and
institutional long-term care providers as
well as behavioral health and lab
providers who may not eligible for
incentive payments under the EHR
incentive program. Only 6 percent of
long-term acute care hospitals, 4 percent
of rehabilitation hospitals, and 2 percent
of psychiatric hospitals have a basic
electronic health record system.9 Close
to 1⁄3 of all Medicare beneficiaries
discharged from acute care hospitals are
discharged to post-acute care settings
such as rehabilitation hospitals but
there is little capacity in the system
today to support HIE across these
settings.10 Similarly consumers and
patients are not actively engaged in
accessing and using their personal
health information and requesting that
their providers do the same. Based upon
the 2012 ONC Privacy & Security
Survey, 19 percent of consumers
reported that they were given online
7 ONC analysis of data from the 2011 American
Hospital Association Survey Information
Technology Supplement.
8 ONC analysis of data from the 2011 National
Ambulatory Medical Care Survey Electronic Health
Record Supplement.
9 Wolf L, Harvell J, Jha A. Hospitals Ineligible For
Federal Meaningful-Use Incentives Have Dismally
Low Rates Of Adoption Of Electronic Health
Records https://content.healthaffairs.org/content/31/
3/505.full.
10 Wolf L, Harvell J, Jha A. Hospitals Ineligible
For Federal Meaningful-Use Incentives Have
Dismally Low Rates Of Adoption Of Electronic
Health Records https://content.healthaffairs.org/
content/31/3/505.full.
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access to a part of their medical record
by a health care provider within the last
12 months.
ONC has been advancing standards
based HIE through a variety of programs
and initiatives including the Standards
and Interoperability Framework, the
State HIE Cooperative Agreement
Program, the Direct Project, the
Nationwide Health Information Network
Exchange and the HIT Certification
Program. Other HHS policies also
encourage HIE through the adoption of
interoperable Electronic Health Record
(EHR) technology. For example we
recognize that the EHR exception to the
federal Physician Self-Referral law and
EHR safe harbor to the federal AntiKickback Statute which protect the
donation of certain software and related
training and services when various
requirements are met, have created a
pathway for arrangements that promote
EHR implementation and use. To
further accelerate and advance
interoperability and health information
exchange beyond what is currently
being done through ONC programs and
the EHR Incentive Program, HHS is
considering a number of policy levers
using existing authorities and programs.
The overarching goal is to develop and
implement a set of policies that would
encourage providers to routinely
exchange health information through
interoperable systems in support of care
coordination across health care settings.
This goal potentially could be achieved
through a combination of incentives,
payment adjustments, and requirements
that collectively result in a more
coordinated, value-driven health care
system over the next 1 to 3 years and
beyond. The Patient Protection and
Affordable Care Act (Pub. L. 111–148),
as amended by the Health Care and
Education Reconciliation Act of 2010
(Pub. L. 111–152) (collectively referred
to as the Affordable Care Act) has
created new opportunities to align
current and new policies in a way that
provides a compelling business and
patient care case to providers to change
culture and share clinical data with all
providers across the health care
spectrum as a part of their routine
delivery of care and services. The
Affordable Care Act initiatives
including the Medicare Shared Savings
Program, hospital readmission payment
adjustments, Medicaid health homes,
and new models being tested by the
Center for Medicare and Medicaid
Innovation are creating a stronger
business case for many providers to
exchange health information.
HHS recognizes the need to use
evidence and data on provider behavior
to inform ongoing policy development
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that will result in a connected, personcentric health care system where health
information is routinely shared across
providers and settings of care to
encourage the consistent provision of
high-quality care, promote efficient use
of health care resources, and ensure that
health outcomes are good and care is
affordable. As HHS, the provider, and
the health IT vendor communities gain
more experience with new delivery
models, meaningful use of health IT,
and HIE, these insights along with upto-date market data on provider
behavior will inform the evolution of
policies and programs that accelerate
HIE and contribute to better quality
care.
This request for information (RFI) lays
out some of the potential options to
accelerate the existing progress and
enhance a market environment that will
accelerate HIE across providers thereby
improving the likelihood of successful
delivery and payment reform. HHS is
seeking input on the options addressed
below, as well as other options that
stakeholders believe would be effective
and feasible.
A. Vision
We are on the dawn of a new era of
health care delivery—a transformed
system that is person-centered and
value-based. Existing CMS programs
and demonstrations, as well as new
programs and initiatives authorized by
the Affordable Care Act, focus on
improved care coordination and new
service delivery and payment models
that encourage and facilitate greater
coordination of care and improved
quality, including accountable care
organizations (ACOs), bundled
payments, health and medical homes,
and reductions in hospital readmission.
Critical to the success of these programs
and the ultimate goal of a transformed
health care system is the real-time
electronic exchange of health
information. Experts agree that greater
access to person level health
information is integral to improving the
quality, efficiency, and safety of health
care delivery.11
The lack of widespread electronic HIE
is a significant barrier to achieving truly
coordinated, person-centered health
care. The Medicare and Medicaid EHR
Incentive Programs and other valuebased payment programs are significant
11 McGlynn, E.A., S.M. Asch, J. Adams, J. Keesey,
J. Hicks, A. DeCristofaro, and E.A. Kerr, ‘‘The
Quality of Health Care Delivered to Adults in the
United States.’’ New England Journal of Medicine
2003 348: 2635–45. See also, Rosenbaum, R., ‘‘Data
Governance and Stewardship: Designing Data
Stewardship Entities and Advancing Data Access,’’
Health Services Research 2010 45:5, Part II.
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drivers of use of interoperable health
information technology and the
exchange of health information. We
introduced many concepts of
interoperability in Stage 2 and expect
that the Medicare and Medicaid EHR
Incentive Programs criteria for Stage 3 of
meaningful use will include
requirements for advanced
interoperability. As other value-based
payment programs evolve, they might
include a greater emphasis on HIE as
either a requirement for participation,
receipt of incentive payments, or
avoidance of payment adjustments.
However, gaps and challenges still
remain to wide-spread use of
interoperable systems and HIE across
providers, settings of care, consumers
and patients, and payers. CMS and ONC
will continue to collaborate on the EHR
Incentive Program and HIT Certification
Program to ensure they support delivery
and payment reform. In addition, HHS
intends to rely on all applicable and
appropriate statutory authorities,
regulations, policies, and programs to
accelerate rapid adoption of health
information exchange across the care
continuum in support of delivery and
payment reform. This combination of
diverse policies and programs will
ensure health information follows a
person regardless of where they access
health care services. HHS envisions an
information rich, person-centered, high
performance health care system where
every health care provider has access to
longitudinal data on patients they treat
to make evidence-based decisions,
coordinate care and improve health
outcomes. As the Affordable Care Act
continues to be implemented, HHS will
develop and evolve policies and
programs to achieve this vision.
B. Policies and Questions
CMS and ONC are jointly issuing this
RFI to seek input on policies and
programs that would further drive HIE
to support more person-centered,
coordinated, value-driven care. In
section II of this RFI, HHS discusses
policies and programs that may further
encourage HIE. They are organized by
various gaps and challenges that the
policies and programs are intended to
address (for example, low rates of
adoption and HIE among post-acute and
long-term care providers). HHS is
soliciting comments on these policy and
programmatic options, as well as
comments on other policy and
programmatic options HHS could
consider. In addition, the RFI includes
several questions in section III on which
HHS would like stakeholder input.
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II. Policies and Programs Under
Consideration by CMS and ONC
A. Low Rates of EHR Adoption and
Health Information Exchange Among
Post-Acute and Long-Term Care
Providers
There are a variety of options HHS
might pursue to encourage HIE among
post-acute and long-term care providers.
Some of these options are described
below.
• CMS has existing authority to allow
states flexibility to implement
innovative delivery and payment
models for Medicare and Medicaid
beneficiaries which could accelerate
HIE as a part of improving care
coordination across acute, post-acute
and long-term care providers, reducing
avoidable readmissions and improving
health outcomes. For example, under
section 1945 of the Social Security Act
(the Act), added by section 2703 of the
Affordable Care Act, states can establish
Medicaid health homes for certain
beneficiaries by amending their state
plans to include the new benefit. Use of
HIT is required to the extent ‘‘feasible
and appropriate’’ to link services.
• Section 1115 of the Act gives the
HHS Secretary authority to approve
experimental, pilot, or demonstration
projects that promote the objectives of
Medicaid and Childrens Health
Insurance Program (CHIP). These
demonstrations give states additional
flexibility to design and improve their
programs, demonstrate and evaluate
policy approaches such as providing
services not typically covered by
Medicaid or using innovative service
delivery systems that improve care,
increase efficiency, and reduce costs.
Some states use this authority to
advance and support their ability to
incentivize health outcomes
improvement and rely less on
traditional forms of payment that
reward high volume of discrete services.
Furthermore, some of these models
build on the concepts in the Medicare
Shared Savings Program and encourage
disparate providers to create formal
arrangements establishing responsibility
for managing all Medicaid services and
total cost of care for an assigned
population, including behavioral health
and long-term care. HIE could be an
important component of programs like
these or other programs that rely on care
coordination across settings of care.
Special terms and conditions (STCs) for
these demonstration projects can require
the use of HIE in delivery system and
payment reform efforts, to coordinate
and manage services, and monitor
quality of care. For example, in Oregon’s
recent section 1115(a) demonstration
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project (Oregon Health Plan),[1] HIE is
fundamental to the delivery system and
payment changes being demonstrated.
For this reason, the STCs required
coordination between the demonstration
project, Oregon’s HIE Operational Plan,
and the State Medicaid HIT Plan to
ensure that these systems support the
overall quality improvement and
decreased expenditures that are critical
to the state’s demonstration.
• Section 1915(c) of the Act permits
states to provide an array of home and
community based services (HCBS),
including long term supports and
services, to individuals who would
otherwise require the level of care
provided in certain institutions. Section
1915(i) of the Act permits states to
provide these services to certain eligible
individuals without considering
whether such individuals would
otherwise require an institutional level
of care. Section 1915(k) permits states to
provide home and community-based
attendant services to certain eligible
individuals that may include skills
training for daily life activities and
back-up systems to ensure continuity of
care and provides an increase in the
federal financial participation rate for
these services. Under these authorities,
states can offer an array of specified
home and community based services as
well as other services requested by the
state and approved by the Secretary that
serve the purposes of the benefit. These
services are important adjuncts to the
care people receive from other areas of
the health care system. Encouraging the
appropriate exchange of health and
other information across all providers
involved in caring for these individuals
is necessary to support effective care
coordination and cost-effective care
delivery. Furthermore, tracking their use
of the health care system through health
information technology will be critically
important to development of new
models of care delivery. Exchange of
health information as beneficiaries
transition to home or between providers
(including acute, specialty, and primary
care) could significantly improve
continuity and the quality of their
health care and result in reduced
expenditures when care is continually
managed in community settings.
• In addition, CMS issued a State
Medicaid Director (SMD) letter
regarding a cost allocation policy for
developing and sustaining HIE
infrastructure as a part of the
administration of the Medicaid EHR
Incentive Program. Certain state
[1] https://medicaid.gov/Medicaid-CHIP-ProgramInformation/By-Topics/Waivers/1115/downloads/
or/or-health-plan2-ca.pdf pgs 121–122.
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expenditures related to the development
and sustaining of HIE may be eligible for
90 percent Federal financial
participation (FFP) under this program,
however, CMS approval of funding for
HIE infrastructure costs requires
assurances that other payers and
providers will bear an appropriate share
of the costs, risks and governance. States
could propose to implement HIE
infrastructure enhancements that enable
the creation and exchange of health
information across settings of care,
including post-acute and long-term care
providers with the Medicaid program.
CMS’ Conditions of Participation or
Coverage are designed to ensure that
providers and suppliers maintain health
care quality and safety. CMS and State
staff oversee compliance with Medicare
health and safety standards in hospitals,
laboratories, nursing homes, home
health agencies, hospices, rural health
clinics, ambulatory surgical centers,
organ transplant centers, and End Stage
Renal Disease facilities. CMS has a role
in advancing clinical standards in
keeping with advancements in health IT
capacity and the implementation of
delivery and payment reforms in the
Affordable Care Act that increasingly
rely on coordination of care across
institutional and non-institutional
settings of care. CMS could require new
clinical standards in the form of
conditions of participation or
requirements to ensure timely,
electronic exchange of health
information to support patient
admissions, discharge, and transfers as
well as care planning to ensure care
continuity as patients receive care
across inpatient, post-acute and longterm care providers.
B. Low Rates of HIE Across Settings of
Care and Providers
There are several potential ways in
which HHS might accelerate HIE across
providers including ambulatory care,
post-acute and long-term care,
behavioral health, and lab providers.
Four examples of options are briefly
summarized below.
• HHS can collaborate in the
development of new e-specified
measures of care coordination that
encourage electronic sharing of
summary records following transitions
in care. This could be incorporated into
and aligned across multiple programs
including the EHR Incentive Program,
and other CMS quality reporting
programs.
• The Medicare Shared Savings
Program establishes requirements for
participating ACOs. CMS might
consider new ways to require or
encourage Medicare ACOs to exchange
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health information as a part of
coordination of care across aligned
providers or patient engagement
strategies. Currently, meaningful use of
EHRs is treated as a measure of quality,
which is used to determine ACO
eligibility for the shared savings and/or
shared losses.
• Under the Affordable Care Act,
CMS has the authority to test innovative
payment and service delivery models
that have the potential to reduce
Medicare, Medicaid, or CHIP
expenditures while maintaining or
improving the quality of care for
beneficiaries. Several new models are
underway that encourage the use of HIE
in support of care coordination such as
the Bundled Payments for Care
Improvement Initiative, Comprehensive
Primary Care Initiative, the Pioneer
ACO model and the State Innovation
Model Initiative. For future and new
models, CMS could request applicants
to explain how they are using
interoperable technology to advance HIE
strategies in support of care
coordination and quality improvement.
Their HIE capacity could be factored
into model participation decisions, as
well as requirements over the model
testing period, similar to meaningful use
requirements under the Pioneer ACO
model.
• Under the Affordable Care Act
authority, CMS is testing models to
better align the financing of Medicare
and Medicaid and integrate care
delivery for people who are enrolled in
both Medicare and Medicaid, also
known as dual eligibles. Under the
Capitated Financial Alignment model,
CMS will contract with states and
health plans, and the health plans will
receive a prospective, blended payment
to provide comprehensive, coordinated
care. CMS could address requirements,
expectations, and/or the role of HIE in
these new arrangements, which have the
potential to use HIE to deliver a higher
degree of coordinated care for this
fragile and costly population whose
members often see numerous types of
providers and require a high degree of
care.
C. Low Rates of Consumer and Patient
Engagement
CMS wants to encourage beneficiary
engagement in their care through
improved beneficiary access to their
personal health information and better
electronic communication between
beneficiaries and their health care team.
There are several ways CMS could
encourage beneficiary access to their
information through the use of new
measures or patient-reported care
experiences, new technology tools, and
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new financial models. These options are
described below.
• The Medicare Advantage Program
could encourage improved beneficiary
access to their personal health
information by incorporating new
measures in the Consumer Assessment
of Healthcare Providers and Systems
(CAHPS®) survey. The Medicare
CAHPS® surveys are a set of surveys
sponsored by CMS that collect
consumer evaluations of health care
experiences that are not currently
assessed by other means. Questions
could be expanded to include topics
such as the extent to which patients
believe they are able to participate
collaboratively in decisions about their
health, and the extent to which
information technology supports their
ability to share and communicate with
providers and other members of their
health care team, and manage their care
between various providers.
• CMS could promote the use of Blue
Button. The Blue Button provides easy
electronic access to personal health
information for consumers. To
strengthen its success, ONC released
guidelines for data holders and
application developers that support the
growth of an ecosystem of tools to help
consumers manage their health. The
Blue Button Plus guidelines include
specifications for a structured data
format (consistent with Meaningful Use
Stage 2), and enable updates of the
information contained in individual
consumer’s health records to be sent
automatically to the applications of
their choice. Tools built on Blue Button
Plus specifications could be made
available to all CMS beneficiaries, and
widely promoted by healthcare
providers and via avenues such as the
Medicare Handbook, Medicare.gov, and
Medicare Advantage plans.
• As stated previously, under the
Affordable Care Act, CMS has the
authority to test innovative payment
and service delivery models that have
the potential to reduce program
expenditures while maintaining or
improving the quality of care for
beneficiaries. In future and new models,
CMS could encourage applicants to
experiment with providing incentives
for consumers to more actively
participate in their health and health
care—including through shareddecision making—supported by the
collection, use, and sharing of electronic
health information.
• Modifications to Clinical Laboratory
Improvement Amendments of 1988
regulations and the Health Insurance
Portability and Accountability Act of
1996 (HIPAA) Privacy Rule could
enable patients’ direct access to their lab
VerDate Mar<15>2010
14:43 Mar 06, 2013
Jkt 229001
results from laboratories. CMS and the
HHS Office for Civil Rights (OCR)
received public comments on this
potential modification through a notice
for proposed rulemaking (76 FR 56712).
III. Questions for Public Comment
CMS and ONC are soliciting public
comments on the following questions:
1. What changes in payment policy
would have the most impact on the
electronic exchange of health
information, particularly among those
organizations that are market
competitors?
2. Which of the following programs
are having the greatest impact on
encouraging electronic health
information exchange: Hospital
readmission payment adjustments,
value-based purchasing, bundled
payments, ACOs, Medicare Advantage,
Medicare and Medicaid EHR Incentive
Programs (Meaningful Use), or medical/
health homes? Are there any aspects of
the design or implementation of these
programs that are limiting their
potential impact on encouraging care
coordination and quality improvement
across settings of care and among
organizations that are market
competitors?
3. To what extent do current CMS
payment policies encourage or impede
electronic information exchange across
health care provider organizations,
particularly those that may be market
competitors? Furthermore, what CMS
and ONC programs and policies would
specifically address the cultural and
economic disincentives for HIE that
result in ‘‘data lock-in’’ or restricting
consumer and provider choice in
services and providers? Are there
specific ways in which providers and
vendors could be encouraged to send,
receive, and integrate health
information from other treating
providers outside of their practice or
system?
4. What CMS and ONC policies and
programs would most impact post acute,
long term care providers (institutional
and HCBS) and behavioral health
providers’ (for example, mental health
and substance use disorders) exchange
of health information, including
electronic HIE, with other treating
providers? How should these programs
and policies be developed and/or
implemented to maximize the impact on
care coordination and quality
improvement?
5. How could CMS and states use
existing authorities to better support
electronic and interoperable HIE among
Medicare and Medicaid providers,
including post acute, long-term care,
and behavioral health providers?
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
14797
6. How can CMS leverage regulatory
requirements for acceptable quality in
the operation of health care entities,
such as conditions of participation for
hospitals or requirements for SNFs, NFs,
and home health to support and
accelerate electronic, interoperable
health information exchange? How
could requirements for acceptable
quality that involve health information
exchange be phased in overtime? How
might compliance with any such
regulatory requirements be best assessed
and enforced, especially since
specialized HIT knowledge may be
required to make such assessments?
7. How could the EHR Incentives
Program advance provider directories
that would support exchange of health
information between Eligible
Professionals participating in the
program. For example, could the
attestation process capture provider
identifiers that could be accessed to
enable exchange among participating
EPs?
8. How can the new authorities under
the Affordable Care Act for CMS test,
evaluate, and scale innovative payment
and service delivery models best
accelerate standards- based electronic
HIE across treating providers?
9. What CMS and ONC policies and
programs would most impact patient
access and use of their electronic health
information in the management of their
care and health? How should CMS and
ONC develop, refine and/or implement
policies and program to maximize
beneficiary access to their health
information and engagement in their
care?
What specific HHS policy changes
would significantly increase standards
based electronic exchange of laboratory
results?
Dated: February 22, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Dated: February 27, 2013.
Farzad Mostashari,
National Coordinator.
[FR Doc. 2013–05266 Filed 3–6–13; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
E:\FR\FM\07MRN1.SGM
07MRN1
Agencies
[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Notices]
[Pages 14793-14797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05266]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Centers for Medicare & Medicaid Services
[CMS-0038-NC]
Advancing Interoperability and Health Information Exchange
AGENCY: Office of the National Coordinator for Health Information
Technology (ONC) and Centers for Medicare & Medicaid Services (CMS),
Department of Health and Human Services (HHS).
ACTION: Notice with comment; Request for Information.
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SUMMARY: HHS seeks input on a series of potential policy and
programmatic changes to accelerate electronic health information
exchange across providers, as well as new ideas that would be both
effective and feasible to implement. To further accelerate and advance
interoperability and health information exchange beyond what is
currently being done through ONC programs and the EHR Incentive
Program, HHS is considering a number of policy levers using existing
authorities and programs.
DATES: To be assured consideration, written or electronic comments must
be received at one of the addresses provided below, no later than 5
p.m. on April 22, 2013.
ADDRESSES: You may submit comments identified by any of the following
methods below (please do not submit duplicate comments). Because of
staff and resource limitations, we cannot accept comments by facsimile
(FAX) transmission.
Federal eRulemaking Portal: Follow the instructions for
submitting comments. Attachments should be in Microsoft Word or Excel,
Adobe PDF; however, we prefer Microsoft Word. https://www.regulations.gov.
Regular, Express, or Overnight Mail: Department of Health
and Human Services, Office of the National Coordinator for Health
Information Technology, Attention: Interoperability RFI, Hubert H.
Humphrey Building, Suite 729D, 200 Independence Ave. SW., Washington,
DC 20201. Please submit one original and two copies.
Hand Delivery or Courier: Office of the National
Coordinator for Health Information Technology, Attention:
Interoperability RFI, Hubert H. Humphrey Building, Suite 729D, 200
Independence Ave. SW., Washington, DC 20201. Please submit one original
and two copies. (Because access to the interior of the Hubert H.
Humphrey Building is not readily available to persons without federal
government identification, commenters are encouraged to leave their
comments in the mail drop slots located in the main lobby of the
building.)
Inspection of Public Comments: All comments received before the
close of the comment period will be available for public inspection,
including any personally identifiable or confidential business
information that is included in a comment. Please do not include
anything in your comment submission that you do not wish to share with
the general public. Such information includes, but is not limited to: A
person's social security number; date of birth; driver's license
number; state identification number or foreign country equivalent;
passport number; financial account number; credit or debit card number;
any personal health information; or any business information that could
be considered to be proprietary. We will post all comments received
before the close of the comment period at https://www.regulations.gov.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov or the Department
of Health and Human Services, Office of the National Coordinator for
Health Information Technology, Hubert H. Humphrey Building, Suite 729D,
200 Independence Ave. SW., Washington, DC 20201 (call ahead to the
contact listed below to arrange for inspection).
FOR FURTHER INFORMATION CONTACT:
Kelly Cronin, Health Care Reform Coordinator; or
Steven Posnack, Director, Federal Policy Division
Office of the National Coordinator for Health Information
Technology, 202-690-7151.
SUPPLEMENTARY INFORMATION:
I. Background
Since enactment of the Health Information Technology for Clinical
and Economic Health Act as part of the American Recovery and
Reinvestment Act, adoption and use of electronic health records in the
United States has dramatically increased. Adoption of EHRs that met the
criteria for a basic EHR system by office-based physicians grew by over
80% between 2009 and 2012, from 22% in 2009 to 40% in
2012.1 2 Among non-federal acute care
[[Page 14794]]
hospitals, adoption of at least a basic EHR system has increased by
over 260% since 2009, from 12% to 44%.3 4 Since 2009, there
has been strong and steady growth in adoption of EHR technology to meet
Meaningful Use objectives to improve quality, safety and efficiency.
Adoption of many of the computerized functionalities associated with
Meaningful Use has substantially increased among both office-based
physicians as well as hospitals.5 6 For example, physician
adoption of five core Meaningful Use functionalities--ranging from e-
prescribing to clinical decision support--has grown by at least 66%
since HITECH in 2009.
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\1\ Hsiao CJ, Hing E. Use and characteristics of electronic
health record systems among office-based physician practices: United
States, 2001-2012. NCHS data brief, no 111. Hyattsville, MD:
National Center for Health Statistics. 2012.
\2\ A basic EHR system for office-based practices includes the
following functionalities: Patient history and demographics, patient
problem lists, physician clinical notes, comprehensive list of
patients' medications and allergies, computerized orders for
prescriptions, and ability to view laboratory and imaging results
electronically. Note that functionalities associated with basic EHR
differ from functionalities required for meaningful use.
\3\ ONC analysis of data from the 2011 American Hospital
Association Survey Information Technology Supplement. Data brief
forthcoming.
\4\ A basic EHR system for hospitals includes the following
functionalities: Patient history and demographics, patient problem
lists, physician clinical notes, nursing assessments, comprehensive
list of patients' medications and allergies, discharge summaries,
computerized orders for prescriptions, and the ability to view
diagnostic test results, laboratory reports and radiology reports
electronically. Note that functionalities associated with basic EHR
differ from functionalities required for meaningful use.
\5\ King J, Patel V, Furukawa MF. Physician Adoption of
Electronic Health Record Technology to Meet Meaningful Use
Objectives: 2009-2012. ONC Data Brief, no. 7. Washington, DC: Office
of the National Coordinator for Health Information Technology.
December 2012.
\6\ ONC analysis of data from the 2011 American Hospital
Association Survey Information Technology Supplement. Data brief
forthcoming.
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As part of stage 2 rulemaking HHS has taken major steps to expand
the functionality and utility of EHRs to providers and patients. We
seek to build on that work by engaging other policy areas within HHS
jurisdiction to promote routine sharing of information among health
care providers across settings of care to support care coordination and
delivery system reform. We also recognize that economic and regulatory
barriers may impair the development of a patient centered, information
rich, high performance health care system where a persons' health
information follows them wherever they access health care services.
The Medicare and Medicaid Electronic Health Record (EHR) Incentive
Programs and Office of the National Coordinator (ONC) for Health IT
(HIT) Certification Program are increasing standards based health
information exchange (HIE) across health care providers and settings of
care to support greater coordination of health care services. However,
this alone will not be enough to achieve the widespread
interoperability and electronic exchange of information necessary for
delivery reform where information will routinely follow the patient
regardless of where they receive care. With fee-for-service
reimbursement and other business motivations often being the stronger
influencer of provider behavior, both providers and their vendors do
not yet have a business imperative to share person level health
information across providers and settings of care.
For example, in 2011, 4 in 10 hospitals electronically sent
laboratory and radiology data to providers outside their organization;
however, only \1/4\ of hospitals could exchange medication lists and
clinical summaries with outside providers.\7\ In addition in 2011, only
31 percent of physicians are exchanging clinical summaries with other
providers.\8\ There is even more limited HIE involving post-acute and
institutional long-term care providers as well as behavioral health and
lab providers who may not eligible for incentive payments under the EHR
incentive program. Only 6 percent of long-term acute care hospitals, 4
percent of rehabilitation hospitals, and 2 percent of psychiatric
hospitals have a basic electronic health record system.\9\ Close to \1/
3\ of all Medicare beneficiaries discharged from acute care hospitals
are discharged to post-acute care settings such as rehabilitation
hospitals but there is little capacity in the system today to support
HIE across these settings.\10\ Similarly consumers and patients are not
actively engaged in accessing and using their personal health
information and requesting that their providers do the same. Based upon
the 2012 ONC Privacy & Security Survey, 19 percent of consumers
reported that they were given online access to a part of their medical
record by a health care provider within the last 12 months.
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\7\ ONC analysis of data from the 2011 American Hospital
Association Survey Information Technology Supplement.
\8\ ONC analysis of data from the 2011 National Ambulatory
Medical Care Survey Electronic Health Record Supplement.
\9\ Wolf L, Harvell J, Jha A. Hospitals Ineligible For Federal
Meaningful-Use Incentives Have Dismally Low Rates Of Adoption Of
Electronic Health Records https://content.healthaffairs.org/content/31/3/505.full.
\10\ Wolf L, Harvell J, Jha A. Hospitals Ineligible For Federal
Meaningful-Use Incentives Have Dismally Low Rates Of Adoption Of
Electronic Health Records https://content.healthaffairs.org/content/31/3/505.full.
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ONC has been advancing standards based HIE through a variety of
programs and initiatives including the Standards and Interoperability
Framework, the State HIE Cooperative Agreement Program, the Direct
Project, the Nationwide Health Information Network Exchange and the HIT
Certification Program. Other HHS policies also encourage HIE through
the adoption of interoperable Electronic Health Record (EHR)
technology. For example we recognize that the EHR exception to the
federal Physician Self-Referral law and EHR safe harbor to the federal
Anti-Kickback Statute which protect the donation of certain software
and related training and services when various requirements are met,
have created a pathway for arrangements that promote EHR implementation
and use. To further accelerate and advance interoperability and health
information exchange beyond what is currently being done through ONC
programs and the EHR Incentive Program, HHS is considering a number of
policy levers using existing authorities and programs. The overarching
goal is to develop and implement a set of policies that would encourage
providers to routinely exchange health information through
interoperable systems in support of care coordination across health
care settings. This goal potentially could be achieved through a
combination of incentives, payment adjustments, and requirements that
collectively result in a more coordinated, value-driven health care
system over the next 1 to 3 years and beyond. The Patient Protection
and Affordable Care Act (Pub. L. 111-148), as amended by the Health
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)
(collectively referred to as the Affordable Care Act) has created new
opportunities to align current and new policies in a way that provides
a compelling business and patient care case to providers to change
culture and share clinical data with all providers across the health
care spectrum as a part of their routine delivery of care and services.
The Affordable Care Act initiatives including the Medicare Shared
Savings Program, hospital readmission payment adjustments, Medicaid
health homes, and new models being tested by the Center for Medicare
and Medicaid Innovation are creating a stronger business case for many
providers to exchange health information.
HHS recognizes the need to use evidence and data on provider
behavior to inform ongoing policy development
[[Page 14795]]
that will result in a connected, person-centric health care system
where health information is routinely shared across providers and
settings of care to encourage the consistent provision of high-quality
care, promote efficient use of health care resources, and ensure that
health outcomes are good and care is affordable. As HHS, the provider,
and the health IT vendor communities gain more experience with new
delivery models, meaningful use of health IT, and HIE, these insights
along with up-to-date market data on provider behavior will inform the
evolution of policies and programs that accelerate HIE and contribute
to better quality care.
This request for information (RFI) lays out some of the potential
options to accelerate the existing progress and enhance a market
environment that will accelerate HIE across providers thereby improving
the likelihood of successful delivery and payment reform. HHS is
seeking input on the options addressed below, as well as other options
that stakeholders believe would be effective and feasible.
A. Vision
We are on the dawn of a new era of health care delivery--a
transformed system that is person-centered and value-based. Existing
CMS programs and demonstrations, as well as new programs and
initiatives authorized by the Affordable Care Act, focus on improved
care coordination and new service delivery and payment models that
encourage and facilitate greater coordination of care and improved
quality, including accountable care organizations (ACOs), bundled
payments, health and medical homes, and reductions in hospital
readmission. Critical to the success of these programs and the ultimate
goal of a transformed health care system is the real-time electronic
exchange of health information. Experts agree that greater access to
person level health information is integral to improving the quality,
efficiency, and safety of health care delivery.\11\
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\11\ McGlynn, E.A., S.M. Asch, J. Adams, J. Keesey, J. Hicks, A.
DeCristofaro, and E.A. Kerr, ``The Quality of Health Care Delivered
to Adults in the United States.'' New England Journal of Medicine
2003 348: 2635-45. See also, Rosenbaum, R., ``Data Governance and
Stewardship: Designing Data Stewardship Entities and Advancing Data
Access,'' Health Services Research 2010 45:5, Part II.
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The lack of widespread electronic HIE is a significant barrier to
achieving truly coordinated, person-centered health care. The Medicare
and Medicaid EHR Incentive Programs and other value-based payment
programs are significant drivers of use of interoperable health
information technology and the exchange of health information. We
introduced many concepts of interoperability in Stage 2 and expect that
the Medicare and Medicaid EHR Incentive Programs criteria for Stage 3
of meaningful use will include requirements for advanced
interoperability. As other value-based payment programs evolve, they
might include a greater emphasis on HIE as either a requirement for
participation, receipt of incentive payments, or avoidance of payment
adjustments. However, gaps and challenges still remain to wide-spread
use of interoperable systems and HIE across providers, settings of
care, consumers and patients, and payers. CMS and ONC will continue to
collaborate on the EHR Incentive Program and HIT Certification Program
to ensure they support delivery and payment reform. In addition, HHS
intends to rely on all applicable and appropriate statutory
authorities, regulations, policies, and programs to accelerate rapid
adoption of health information exchange across the care continuum in
support of delivery and payment reform. This combination of diverse
policies and programs will ensure health information follows a person
regardless of where they access health care services. HHS envisions an
information rich, person-centered, high performance health care system
where every health care provider has access to longitudinal data on
patients they treat to make evidence-based decisions, coordinate care
and improve health outcomes. As the Affordable Care Act continues to be
implemented, HHS will develop and evolve policies and programs to
achieve this vision.
B. Policies and Questions
CMS and ONC are jointly issuing this RFI to seek input on policies
and programs that would further drive HIE to support more person-
centered, coordinated, value-driven care. In section II of this RFI,
HHS discusses policies and programs that may further encourage HIE.
They are organized by various gaps and challenges that the policies and
programs are intended to address (for example, low rates of adoption
and HIE among post-acute and long-term care providers). HHS is
soliciting comments on these policy and programmatic options, as well
as comments on other policy and programmatic options HHS could
consider. In addition, the RFI includes several questions in section
III on which HHS would like stakeholder input.
II. Policies and Programs Under Consideration by CMS and ONC
A. Low Rates of EHR Adoption and Health Information Exchange Among
Post-Acute and Long-Term Care Providers
There are a variety of options HHS might pursue to encourage HIE
among post-acute and long-term care providers. Some of these options
are described below.
CMS has existing authority to allow states flexibility to
implement innovative delivery and payment models for Medicare and
Medicaid beneficiaries which could accelerate HIE as a part of
improving care coordination across acute, post-acute and long-term care
providers, reducing avoidable readmissions and improving health
outcomes. For example, under section 1945 of the Social Security Act
(the Act), added by section 2703 of the Affordable Care Act, states can
establish Medicaid health homes for certain beneficiaries by amending
their state plans to include the new benefit. Use of HIT is required to
the extent ``feasible and appropriate'' to link services.
Section 1115 of the Act gives the HHS Secretary authority
to approve experimental, pilot, or demonstration projects that promote
the objectives of Medicaid and Childrens Health Insurance Program
(CHIP). These demonstrations give states additional flexibility to
design and improve their programs, demonstrate and evaluate policy
approaches such as providing services not typically covered by Medicaid
or using innovative service delivery systems that improve care,
increase efficiency, and reduce costs. Some states use this authority
to advance and support their ability to incentivize health outcomes
improvement and rely less on traditional forms of payment that reward
high volume of discrete services. Furthermore, some of these models
build on the concepts in the Medicare Shared Savings Program and
encourage disparate providers to create formal arrangements
establishing responsibility for managing all Medicaid services and
total cost of care for an assigned population, including behavioral
health and long-term care. HIE could be an important component of
programs like these or other programs that rely on care coordination
across settings of care. Special terms and conditions (STCs) for these
demonstration projects can require the use of HIE in delivery system
and payment reform efforts, to coordinate and manage services, and
monitor quality of care. For example, in Oregon's recent section
1115(a) demonstration
[[Page 14796]]
project (Oregon Health Plan),[1] HIE is fundamental to the
delivery system and payment changes being demonstrated. For this
reason, the STCs required coordination between the demonstration
project, Oregon's HIE Operational Plan, and the State Medicaid HIT Plan
to ensure that these systems support the overall quality improvement
and decreased expenditures that are critical to the state's
demonstration.
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\[1]\ https://medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Waivers/1115/downloads/or/or-health-plan2-ca.pdf pgs 121-122.
---------------------------------------------------------------------------
Section 1915(c) of the Act permits states to provide an
array of home and community based services (HCBS), including long term
supports and services, to individuals who would otherwise require the
level of care provided in certain institutions. Section 1915(i) of the
Act permits states to provide these services to certain eligible
individuals without considering whether such individuals would
otherwise require an institutional level of care. Section 1915(k)
permits states to provide home and community-based attendant services
to certain eligible individuals that may include skills training for
daily life activities and back-up systems to ensure continuity of care
and provides an increase in the federal financial participation rate
for these services. Under these authorities, states can offer an array
of specified home and community based services as well as other
services requested by the state and approved by the Secretary that
serve the purposes of the benefit. These services are important
adjuncts to the care people receive from other areas of the health care
system. Encouraging the appropriate exchange of health and other
information across all providers involved in caring for these
individuals is necessary to support effective care coordination and
cost-effective care delivery. Furthermore, tracking their use of the
health care system through health information technology will be
critically important to development of new models of care delivery.
Exchange of health information as beneficiaries transition to home or
between providers (including acute, specialty, and primary care) could
significantly improve continuity and the quality of their health care
and result in reduced expenditures when care is continually managed in
community settings.
In addition, CMS issued a State Medicaid Director (SMD)
letter regarding a cost allocation policy for developing and sustaining
HIE infrastructure as a part of the administration of the Medicaid EHR
Incentive Program. Certain state expenditures related to the
development and sustaining of HIE may be eligible for 90 percent
Federal financial participation (FFP) under this program, however, CMS
approval of funding for HIE infrastructure costs requires assurances
that other payers and providers will bear an appropriate share of the
costs, risks and governance. States could propose to implement HIE
infrastructure enhancements that enable the creation and exchange of
health information across settings of care, including post-acute and
long-term care providers with the Medicaid program.
CMS' Conditions of Participation or Coverage are designed to ensure
that providers and suppliers maintain health care quality and safety.
CMS and State staff oversee compliance with Medicare health and safety
standards in hospitals, laboratories, nursing homes, home health
agencies, hospices, rural health clinics, ambulatory surgical centers,
organ transplant centers, and End Stage Renal Disease facilities. CMS
has a role in advancing clinical standards in keeping with advancements
in health IT capacity and the implementation of delivery and payment
reforms in the Affordable Care Act that increasingly rely on
coordination of care across institutional and non-institutional
settings of care. CMS could require new clinical standards in the form
of conditions of participation or requirements to ensure timely,
electronic exchange of health information to support patient
admissions, discharge, and transfers as well as care planning to ensure
care continuity as patients receive care across inpatient, post-acute
and long-term care providers.
B. Low Rates of HIE Across Settings of Care and Providers
There are several potential ways in which HHS might accelerate HIE
across providers including ambulatory care, post-acute and long-term
care, behavioral health, and lab providers. Four examples of options
are briefly summarized below.
HHS can collaborate in the development of new e-specified
measures of care coordination that encourage electronic sharing of
summary records following transitions in care. This could be
incorporated into and aligned across multiple programs including the
EHR Incentive Program, and other CMS quality reporting programs.
The Medicare Shared Savings Program establishes
requirements for participating ACOs. CMS might consider new ways to
require or encourage Medicare ACOs to exchange health information as a
part of coordination of care across aligned providers or patient
engagement strategies. Currently, meaningful use of EHRs is treated as
a measure of quality, which is used to determine ACO eligibility for
the shared savings and/or shared losses.
Under the Affordable Care Act, CMS has the authority to
test innovative payment and service delivery models that have the
potential to reduce Medicare, Medicaid, or CHIP expenditures while
maintaining or improving the quality of care for beneficiaries. Several
new models are underway that encourage the use of HIE in support of
care coordination such as the Bundled Payments for Care Improvement
Initiative, Comprehensive Primary Care Initiative, the Pioneer ACO
model and the State Innovation Model Initiative. For future and new
models, CMS could request applicants to explain how they are using
interoperable technology to advance HIE strategies in support of care
coordination and quality improvement. Their HIE capacity could be
factored into model participation decisions, as well as requirements
over the model testing period, similar to meaningful use requirements
under the Pioneer ACO model.
Under the Affordable Care Act authority, CMS is testing
models to better align the financing of Medicare and Medicaid and
integrate care delivery for people who are enrolled in both Medicare
and Medicaid, also known as dual eligibles. Under the Capitated
Financial Alignment model, CMS will contract with states and health
plans, and the health plans will receive a prospective, blended payment
to provide comprehensive, coordinated care. CMS could address
requirements, expectations, and/or the role of HIE in these new
arrangements, which have the potential to use HIE to deliver a higher
degree of coordinated care for this fragile and costly population whose
members often see numerous types of providers and require a high degree
of care.
C. Low Rates of Consumer and Patient Engagement
CMS wants to encourage beneficiary engagement in their care through
improved beneficiary access to their personal health information and
better electronic communication between beneficiaries and their health
care team. There are several ways CMS could encourage beneficiary
access to their information through the use of new measures or patient-
reported care experiences, new technology tools, and
[[Page 14797]]
new financial models. These options are described below.
The Medicare Advantage Program could encourage improved
beneficiary access to their personal health information by
incorporating new measures in the Consumer Assessment of Healthcare
Providers and Systems (CAHPS[supreg]) survey. The Medicare
CAHPS[supreg] surveys are a set of surveys sponsored by CMS that
collect consumer evaluations of health care experiences that are not
currently assessed by other means. Questions could be expanded to
include topics such as the extent to which patients believe they are
able to participate collaboratively in decisions about their health,
and the extent to which information technology supports their ability
to share and communicate with providers and other members of their
health care team, and manage their care between various providers.
CMS could promote the use of Blue Button. The Blue Button
provides easy electronic access to personal health information for
consumers. To strengthen its success, ONC released guidelines for data
holders and application developers that support the growth of an
ecosystem of tools to help consumers manage their health. The Blue
Button Plus guidelines include specifications for a structured data
format (consistent with Meaningful Use Stage 2), and enable updates of
the information contained in individual consumer's health records to be
sent automatically to the applications of their choice. Tools built on
Blue Button Plus specifications could be made available to all CMS
beneficiaries, and widely promoted by healthcare providers and via
avenues such as the Medicare Handbook, Medicare.gov, and Medicare
Advantage plans.
As stated previously, under the Affordable Care Act, CMS
has the authority to test innovative payment and service delivery
models that have the potential to reduce program expenditures while
maintaining or improving the quality of care for beneficiaries. In
future and new models, CMS could encourage applicants to experiment
with providing incentives for consumers to more actively participate in
their health and health care--including through shared-decision
making--supported by the collection, use, and sharing of electronic
health information.
Modifications to Clinical Laboratory Improvement
Amendments of 1988 regulations and the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) Privacy Rule could enable patients'
direct access to their lab results from laboratories. CMS and the HHS
Office for Civil Rights (OCR) received public comments on this
potential modification through a notice for proposed rulemaking (76 FR
56712).
III. Questions for Public Comment
CMS and ONC are soliciting public comments on the following
questions:
1. What changes in payment policy would have the most impact on the
electronic exchange of health information, particularly among those
organizations that are market competitors?
2. Which of the following programs are having the greatest impact
on encouraging electronic health information exchange: Hospital
readmission payment adjustments, value-based purchasing, bundled
payments, ACOs, Medicare Advantage, Medicare and Medicaid EHR Incentive
Programs (Meaningful Use), or medical/health homes? Are there any
aspects of the design or implementation of these programs that are
limiting their potential impact on encouraging care coordination and
quality improvement across settings of care and among organizations
that are market competitors?
3. To what extent do current CMS payment policies encourage or
impede electronic information exchange across health care provider
organizations, particularly those that may be market competitors?
Furthermore, what CMS and ONC programs and policies would specifically
address the cultural and economic disincentives for HIE that result in
``data lock-in'' or restricting consumer and provider choice in
services and providers? Are there specific ways in which providers and
vendors could be encouraged to send, receive, and integrate health
information from other treating providers outside of their practice or
system?
4. What CMS and ONC policies and programs would most impact post
acute, long term care providers (institutional and HCBS) and behavioral
health providers' (for example, mental health and substance use
disorders) exchange of health information, including electronic HIE,
with other treating providers? How should these programs and policies
be developed and/or implemented to maximize the impact on care
coordination and quality improvement?
5. How could CMS and states use existing authorities to better
support electronic and interoperable HIE among Medicare and Medicaid
providers, including post acute, long-term care, and behavioral health
providers?
6. How can CMS leverage regulatory requirements for acceptable
quality in the operation of health care entities, such as conditions of
participation for hospitals or requirements for SNFs, NFs, and home
health to support and accelerate electronic, interoperable health
information exchange? How could requirements for acceptable quality
that involve health information exchange be phased in overtime? How
might compliance with any such regulatory requirements be best assessed
and enforced, especially since specialized HIT knowledge may be
required to make such assessments?
7. How could the EHR Incentives Program advance provider
directories that would support exchange of health information between
Eligible Professionals participating in the program. For example, could
the attestation process capture provider identifiers that could be
accessed to enable exchange among participating EPs?
8. How can the new authorities under the Affordable Care Act for
CMS test, evaluate, and scale innovative payment and service delivery
models best accelerate standards- based electronic HIE across treating
providers?
9. What CMS and ONC policies and programs would most impact patient
access and use of their electronic health information in the management
of their care and health? How should CMS and ONC develop, refine and/or
implement policies and program to maximize beneficiary access to their
health information and engagement in their care?
What specific HHS policy changes would significantly increase
standards based electronic exchange of laboratory results?
Dated: February 22, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: February 27, 2013.
Farzad Mostashari,
National Coordinator.
[FR Doc. 2013-05266 Filed 3-6-13; 8:45 am]
BILLING CODE 4150-45-P