March 2, 2012
On Thursday, Feb. 23, 2012, the Centers for Medicare & Medicaid Services
(CMS) announced a proposed rule for Stage 2 criteria for the Medicare and
Medicaid Electronic Health Record (EHR) Incentive Programs. Under the Health
Information Technology for Economic and Clinical Health (HITECH) Act, part of
the American Recovery and Reinvestment Act of 2009, eligible professionals
(EPs), eligible hospitals (EHs), and Critical Access Hospitals (CAHs) can
qualify for incentive payments when they demonstrate “meaningful use” of
Certified EHR Technology by meeting certain objectives. The incentives are part
of the federal government’s effort to facilitate the adoption of a nationwide
health information network. Publication of the proposed rule in the Federal
Register is expected on March 7, 2012. CMS is providing a 60-day period after
the date of publication to allow the public to comment on the proposed rule. A
final rule is expected to be published this summer.
In addition, on Friday, Feb. 24, 2012, the Office of the National Coordinator
for Health Information Technology (ONC) released companion proposed revisions to
the Standards, Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology. McGuireWoods will issue a separate summary
of the companion rule.
HHS announced in February that the number of hospitals utilizing health
information technology (IT) more than doubled over 2010 and 2011. To date, 2,000
hospitals and more than 41,000 physicians have received $3.1 billion in
incentive payments for ensuring meaningful use of health IT.
Below is a brief outline of some of the overarching elements of the proposed
Stage 2 Criteria
Meaningful use includes both a core set and a menu set of objectives that are
specific to EPs or EHs and CAHs. CMS proposes retaining the Stage 1 core and
menu structure for Stage 2. CMS proposes that EPs be required to meet, or
qualify for an exclusion to, 17 core objectives and three of five menu set
objectives. Stage 1 required EPs to meet 15 core objectives and five of 10 menu
set objectives. EHs and CAHs would be required to meet, or qualify for exclusion
to, 16 core objectives and two of four menu set objectives. Stage 1 required
these providers to meet 14 core objectives and five of 10 menu set objectives.
The functionality measures proposed for Stage 2 build upon Stage 1 criteria.
For example, CMS proposes to require that 60 percent of all medication,
laboratory, and radiology orders be recorded using computerized provider order
entry (CPOE). Stage 1 required only 30 percent of an EP’s orders be entered
using CPOE. Moreover, the proposed rule also requires that 65 percent—increased
from 40 percent under Stage 1—of all permissible prescriptions written by an EP
be compared to at least one drug formulary and transmitted electronically using
Certified EHR Technology. More than 50 percent of all patients seen by the EP
during a reporting period must be provided online access to their health
information within four business days after the information is available to the
EP, subject to the EP’s discretion to withhold certain information. Stage 1
required only a menu set objective of 10 percent of patients being provided this
information. For hospitals, this objective would require more than 50 percent of
all inpatient or emergency department patients of an EH or CAH to have
information available online within 36 hours of discharge.
Unlike Stage 1, which placed an emphasis on functionality, Stage 2 places
more emphasis on direct patient engagement. Stage 2 requires providers not only
to provide patients the ability to view online, download, and transmit their
health information, but also to provide patients with clinical summaries for
each office visit, to use Certified EHR Technology to identify patient-specific
education resources and provide those resources to the patient, and to use
secure electronic messaging to communicate with patients on relevant health
information, using the electronic messaging function of Certified EHR
EPs, EHs, and CAHs would continue to be required to report on clinical
quality measures (CQMs) that align with the existing quality programs—such as
measures for the Physician Quality Reporting System and CMS Shared Savings
Program—in order to qualify for incentive payments. Specifically, EPs must
report 12 CQMs, and EHs and CAHs must report 24 CQMs. The proposed rule
specifies that CQM data would be submitted electronically, although the method
for submission is open for commentary.
Changes to Stage 1 Criteria
Although many core and menu objectives are retained for Stage 2, CMS proposes
some changes to existing Stage 1 criteria for meaningful use. Changes include
modification to measurement of meaningful use of EHR for medication orders, the
elimination of age limits for requirements to measure height and weight, and
raising the age to begin recording blood pressure from two to three years old.
These changes are optional in 2013, but will be required in order to meet Stage
1 criteria in 2014.
The proposed rule eliminates some Stage 1 criteria entirely. Current Stage 1
criteria require providers to give patients electronic copies of health
information, such as test results, on request. Believing that continued online
access to health information is more valuable than a one-time provision of an
electronic copy, CMS proposes replacing this objective with a Stage 2 objective
giving patients the ability to “view online, download and transmit” their health
CMS also proposes to eliminate the core Stage 1 objective requiring
“capability to exchange key clinical information” in favor of a “transitions of
care” core objective in Stage 2 that requires electronic exchange of summary of
care documents to the receiving provider, or when the patient has been referred
to another provider while remaining under the care of the referring provider.
Transitions of care are the movement of patients from one setting of care
(hospital, primary care practice, specialty care practice, long-term care, home
health, or rehabilitation facility) to another. The proposed rule references the
ONC proposed rule on standards and certification, which includes standard fields
required to populate the summary of care document, so Certified EHR Technology
would be able to include required information. CMS also proposes to describe a
care plan as the structure used to define the management actions for various
conditions, problems, or issues. For meaningful use, a care plan must include,
at a minimum, the problem, the goal, and any instructions that the provider has
given to the patient.
In addition, the proposed rule would require imaging results and information
be accessible through Certified EHR Technology. CMS believes this objective will
increase utility and efficiency of imaging services, as well as reduce costs and
radiation exposure from tests that are repeated solely because a prior test is
not available to the provider. The measure for this objective would be more than
40 percent of all scans and tests ordered by the EP or an authorized provider of
the EH or CAH for patients admitted to its inpatient or emergency department
during a reporting period be accessible through Certified EHR Technology. The
rule does not propose any additional image retention requirements.
Payment Adjustments and Exceptions
CMS proposes that prior reporting periods determine whether providers are
subject to downward payment adjustments, which begin in 2015 for providers that
are not meaningful users of EHR technology. Specifically, any successful
meaningful user in 2013 would avoid payment adjustment in 2015. In addition, any
Medicare provider that first meets meaningful use in 2014 would avoid the
penalty if they are able to demonstrate meaningful use at least three months
prior to the end of the calendar or fiscal year, and meet the registration and
attestation requirement by July 1, 2014 (for EHs) or Oct. 1, 2014 (for EPs).
Providers located in rural areas without sufficient internet access, newly
practicing EPs, and providers faced with unforeseen circumstances, such as
natural disasters, would be eligible for exceptions to the penalty.
Modifications to the Medicaid EHR Incentive Program
CMS proposes to expand the definition of what constitutes a Medicaid patient
encounter by including individuals enrolled in a Medicaid program, including
Title XXI-funded Medicaid expansion (but not separate CHIP programs). In
addition, the look-back period for patient volume would be over 12 months
preceding attestation, not tied to the prior calendar year. The rule also
proposes including 12 children’s hospitals that have not been able to
participate because they do not have a CMS Certification Number because they do
not bill Medicare.
The Medicaid EHR incentive program has different rules from the Medicare EHR
incentive program regarding the number of payment years available. Medicaid EPs
and EHs can receive a Medicaid EHR incentive payment for adopting, implementing,
and upgrading (AIU) to Certified EHR Technology for their first payment year.
For example, a Medicaid EP who earns an incentive payment for AIU in 2013 would
have to meet Stage 1 of meaningful use in his or her next two payment years
(2014 and 2015).
Consistent with its announcement in November, CMS also proposes a one-year
extension of Stage 1 applicability to EPs, EHs, and CAHs. The proposed rule
would delay Stage 2 criteria for providers from 2013 to 2014 and, thus, would
provide additional time for vendors to develop Certified EHR Technology to meet
the new criteria.
Security of Protected Health Information
CMS also highlighted in this proposed rule that providers must conduct a
security risk analysis in accordance with the requirements of the HIPAA Security
Rule. Citing the large number of breaches that have occurred based on lost or
stolen devices, CMS emphasizes that a provider heed the HIPAA Security Rule,
including reviewing its practices on encryption/security of data at rest.
Moreover, in order to meet the meaningful use standards, providers would need to
conduct a review for each EHR reporting period, and any security updates and
deficiencies that are identified should be included in the provider’s risk
management process and implemented or corrected as dictated by that process.
For assistance drafting comments to CMS or with any other HITECH matter,
please contact the authors.
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