Medicaid Program; Federal Funding for Medicaid Eligibility Determination and Enrollment Activities, 21950-21975 [2011-9340]
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Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 433
[CMS–2346–F]
RIN 0938–AQ53
Medicaid Program; Federal Funding for
Medicaid Eligibility Determination and
Enrollment Activities
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule will revise
Medicaid regulations for Mechanized
Claims Processing and Information
Retrieval Systems. We are also
modifying our regulations so that the
enhanced Federal financial
participation (FFP) is available for
design, development and installation or
enhancement of eligibility
determination systems until December
31, 2015. This final rule also imposes
certain defined standards and
conditions in terms of timeliness,
accuracy, efficiency, and integrity for
mechanized claims processing and
information retrieval systems in order to
receive enhanced FFP.
DATES: Effective Date: These regulations
are effective on April 19, 2011.
FOR FURTHER INFORMATION CONTACT:
Richard Friedman, (410) 786–4451.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
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A. The Current State of the Medicaid
Management Information System
(MMIS)
A Medicaid management information
system (MMIS) is a mechanized system
of claims processing and information
retrieval used in State Medicaid
programs under title XIX of the Social
Security Act (the Act). The system is
used to process Medicaid claims from
providers and to retrieve and produce
utilization data and management
information about medical care and
services furnished to Medicaid
recipients. The system also is
potentially eligible to receive enhanced
administrative funding from the Federal
government under section 1903(a)(3) of
the Act. Specifically, section
1903(a)(3)(A)(i) of the Act provides that
Federal financial participation (FFP) is
available at 90 percent of expenditures
for the design, development, or
installation of mechanized claims
processing and information retrieval
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systems as the ‘‘Secretary determines are
likely to provide more efficient,
economical and effective administration
of the plan and to be compatible with
the claims processing and information
retrieval systems utilized in the
administration of title XVIII [Medicare].’’
In addition, section 1903(a)(3)(B) of the
Act provides for the availability of FFP
at 75 percent of expenditures
attributable to operating the ‘‘systems
* * * of the type described in [section
1903(a)(3)] subparagraph (A)(i),’’ which
are approved by the Secretary and meet
certain other requirements (including
requirements relating to explanations of
benefits). For purposes of this final rule,
we refer to 90 percent and 75 percent
FFP as ‘‘enhanced’’ FFP since it is
greater than the 50 percent FFP
available for most Medicaid
administrative expenses. In addition,
section 1903(r) of the Act places
conditions on a State’s ability to receive
Federal funding for automated data
systems in the administration of the
State plan.
To receive an enhanced match, the
Secretary must find that the mechanized
claims and information retrieval system
is adequate to provide more efficient,
economical, and effective
administration of the State plan. The
Patient Protection and Affordable Care
Act of 2010 (Pub. L. 111–148, enacted
on March 23, 2010), as amended by the
Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152, enacted on March 30, 2010)
(collectively referred to as the
Affordable Care Act) also made
additional changes to the requirements
within section 1903(r) of the Act
relating to the reporting of data to the
Secretary; guidance on these
requirements will be issued in a
separate rulemaking document. Our
Federal regulations concerning
mechanized claims processing and
information retrieval systems are at 42
CFR part 433, subpart C. A State that
chooses to develop, enhance, or replace
its required system or subsystems must
first submit for approval an Advanced
Planning Document (APD). The general
Health and Human Services (HHS)
requirements for approval of APDs are
found at 45 CFR part 95, subpart F.
B. Availability of Enhanced FFP for
Automated Eligibility Systems
Historically, Medicaid eligibility for
many applicants and recipients was
determined by an agency other than the
State Medicaid agency. Under section
1902(a)(10)(A)(i) of the Act, States were
required to provide Medicaid to
recipients under the Aid to Families
with Dependent Children (AFDC)
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program, as well as recipients of the
Supplemental Security Income (SSI)
program. In these cases, eligibility
determinations were derived from the
cash welfare-assistance determination.
As a result, States that maintained a
Medicaid eligibility determination
system usually integrated these systems
into the public welfare systems. In the
October 13, 1989 Federal Register (54
FR 41966, effective November 13, 1989),
we published a final rule excluding
eligibility determination systems from
the enhanced funding that was available
under section 1903(a)(3) of the Act,
reasoning that the close
interrelationship between these cash
assistance programs and Medicaid
eligibility rendered such enhanced
assistance redundant and unnecessary
(54 FR 41966 through 41974). As a
result, we revised the definition of
mechanized claims processing and
information retrieval systems to exclude
eligibility determination systems.
We also indicated in the 1989 final
rule that to receive any FFP for
Medicaid purposes for an eligibility
determination system after November
13, 1989, a State must submit an APD
for funding in accordance with the
requirements of 45 CFR Part 95, Subpart
F. If we approved the APD, the State
agency would receive 50 percent FFP
for administrative costs under section
1903(a)(7) of the Act for the system’s
design, development, and installation,
and operation.
C. Changes in Medicaid Eligibility
Policies
Since we issued the October 13, 1989
final rule, a series of statutory changes
have dramatically affected eligibility for
Medicaid and how Medicaid eligibility
is determined. Among other things, new
eligibility coverage groups were created
and expanded, and in 1996, Medicaid
eligibility was ‘‘de-linked’’ from the
receipt of cash assistance when the
AFDC program was replaced by the
Temporary Assistance to Needy
Families (Pub. L. 104–193, enacted on
August 22, 1996) (TANF) program
created by the Personal Responsibility
and Work Opportunity Reconciliation
Act (PRWORA) (Pub. L. 104–193,
enacted on August 22, 1996).
With the passage of the Balanced
Budget Act of 1997 (Pub. L. 105–33,
enacted on August 5, 1997) (BBA),
States were required to coordinate
eligibility for and enrollment in
Medicaid with the new Children’s
Health Insurance Program (CHIP) to
ensure enrollment of children in the
appropriate program. With passage of
the ‘‘Express Lane Eligibility’’ provisions
in section 203 of the Children’s Health
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Insurance Program Reauthorization Act
of 2009 (Pub. L. 111–3) (CHIPRA), States
were provided with the option, and are
encouraged, to coordinate and expedite
eligibility for children in Medicaid and
CHIP by using findings regarding
income and other eligibility criteria
made by other agencies, such as the
Supplemental Nutrition Assistance
Program (SNAP), as the basis for
Medicaid and CHIP eligibility
adjudications.
With the passage of the Affordable
Care Act, we expect that changes to
Medicaid eligibility policies and
business processes need to be adopted.
States will need to apply new rules to
adjudicate eligibility for the program;
enroll millions of newly eligible
individuals through multiple channels;
renew eligibility for existing enrollees;
operate seamlessly with newly
authorized Health Insurance Exchanges
(see section 1311 of the Affordable Care
Act) whether run by the State or the
U.S. Department of Health and Human
Services (HHS) if the State chooses not
to operate a State Exchange (hereafter
referred to as ‘‘Exchanges’’); participate
in a system to verify information from
applicants electronically; incorporate a
streamlined application used to apply
for multiple sources of coverage and
health insurance assistance; and
produce notices and communications to
applicants and beneficiaries concerning
the process, outcomes, and their rights
to dispute or appeal. We further
anticipate, following consultation with
States and other stakeholders,
additional standard Federal
requirements for more timely and
detailed reporting of eligibility and
enrollment status statistics, including
breakdowns by eligibility group,
demographic characteristics, enrollment
in managed care plans, and
participation in waiver programs.
System transformations will be
needed in most States to accomplish
these changes. These systems
transformations should be undertaken
in full partnership with Exchanges in
order to meet coverage goals, minimize
duplication, ensure effective reuse of
infrastructure and applications, produce
seamless enrollment for consumers, and
ensure accuracy of program placements
(see sections 1413 and 2201 of the
Affordable Care Act). Extensive
coordination and collaboration will be
required between Exchanges and
Medicaid, including on oversight and
evaluation of the interoperability of the
Exchange and Medicaid systems. In
addition, States may consider how to
coordinate systems changes with the
eligibility determination systems used
for other health and human services
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programs, such as SNAP, because a
large share of individuals who are
eligible for Medicaid also are eligible for
other programs as well.
II. Provisions of the Proposed
Regulations
In the November 8, 2010 Federal
Register (75 FR 68583), we published a
proposed rule that revised the Medicaid
regulations for Mechanized Claims
Processing and Information Retrieval
Systems. Specifically, we proposed to
amend the definition of Mechanized
Claims Processing and Information
Retrieval Systems to include
mechanized eligibility determination
systems, which would include the
enrollment and eligibility reporting
activities associated with such systems.
We also proposed that the enhanced
FFP would be available for design,
development and installation or
enhancement of eligibility
determination systems until December
31, 2015.
III. Analysis of and Responses to Public
Comments
We received 40 timely comments on
the November 8, 2010 proposed rule
(75 FR 68583 through 68595).
Commenters expressed general
support for the policies outlined in the
proposed rule. Specifically, commenters
agreed that providing enhanced
matching funds for Medicaid eligibility
systems is appropriate and necessary.
Commenters expressed almost universal
agreement that this enhanced match is
critical to support State efforts to
modernize their eligibility systems, and
will allow States to bring these systems
into the 21st Century so that they can
provide cost-effective, accurate, reliable,
and beneficiary-friendly assessments of
eligibility for the Medicaid program. In
light of the substantial changes made by
the Affordable Care Act, commenters
agreed that it is more important than
ever to ensure that eligibility
determination systems are designed and
operated using the most up-to-date
technological and business process
solutions. With States expected to enroll
millions of newly eligible individuals
into Medicaid and to ensure seamless
coordination with the new Exchanges, it
is essential that States have modern and
cost-effective eligibility systems that
will accurately enroll eligible
individuals, without unnecessarily
cumbersome processes or delays.
Commenters also believed that such
initial investments would ultimately
lower ongoing maintenance and
operational expenses, driving savings
for both States and the Federal
government.
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Commenters also noted that HHS had
released additional documents at
approximately the same time as the
November 8, 2010 proposed rule, which
reinforced our strategic direction and
received their support. Specifically,
commenters acknowledged the joint
guidance released by CMS and the
Office of Consumer Information and
Insurance Oversight (now CMS’ Center
for Consumer Information and
Insurance Oversight (CCIIO)) entitled,
‘‘Exchange/Medicaid Information
Technology Guidance, version 1.0,’’ and
the Funding Opportunity
Announcement for Cooperative
Agreements to Support Early Innovator
Grants for Exchanges. Commenters
indicated that they greatly appreciated
the foresight of CMS and CCIIO, and are
supportive of the guidance providing
direction towards a service-oriented IT
infrastructure based on interoperable
systems and that they fully support the
concept of a collaborative IT
development approach among States,
CMS and CCIIO.
A summary of additional major issues
and our responses follow. Since many of
the comments were general in nature
and not specific to any particular
regulatory provision, we have identified
the comments by nine categories:
• Requests for enhanced Federal
funding.
• Requests for additional guidance.
• Public feedback and suggestions
related to the seven standards and
conditions.
• Public feedback and suggestions
related to the APD process.
• Issues related to the transition
period for compliance.
• Comments regarding CMS’ strategy
for monitoring and oversight, including
performance reviews.
• Issues related to partial systems
improvements or modernizations.
• Specific issues by regulatory
provision.
• Issues related to the Regulatory
Impact Analysis including the cost
estimates, and information collection.
A. Requests for Enhanced Federal
Funding
Comment: Numerous commenters
requested that the enhanced FFP for
design, development, and installation or
enhancement of eligibility
determination systems be extended
beyond the December 31, 2015 deadline.
Commenters indicated that new and
significant enhancements may be
needed beyond December 31, 2015,
particularly in order to affect future
legislative changes to Medicaid
eligibility or to keep pace with
technological innovations. The
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commenters noted that State budgets
continue to be in a state of crisis and
State revenues may not fully recover
until 2016 or later; consequently, the
Federal government must take
responsibility for ensuring adequate
funding of the program infrastructure to
ensure compliance by January 1, 2014.
Commenters recommended several
different options in this regard. Some
commenters indicated that CMS should
consider that the requirement apply to
funds allocated rather than expended.
Other commenters believed that CMS
could allow for the possibility of a
continued enhanced match beyond the
deadline in specified circumstances
(many outside the control of State
governments), such as new Federal
requirements or major advances in
computer technology. Other exception
categories suggested by commenters
included unforeseen issues in
implementation and/or new
opportunities for interoperability with
other health and human services
programs. Other commenters indicated
that CMS should extend funding if
States have approved APDs on or before
December 31, 2015 and the project has
not been completed or if States are
planning to leverage improvements from
other State Medicaid eligibility systems.
The commenters further indicate that
they are concerned that they will be
unable to receive legislative approval to
begin their project, develop an APD,
receive Federal approval, and then
complete work on the project while
meeting the standards and conditions
before the enhanced FFP ends on
December 31, 2015. Still other
commenters believed the date should be
changed to coincide with the end of the
Federal fiscal year 2015 and 2016, so
that enhanced funding would expire
September 30, 2016. One commenter
suggests that the deadline should be
interpreted to apply to costs for projects
receiving enhanced funding and
obligated by that date rather than
expended by December 31, 2015. One
commenter expressed concern that a
requirement for States to maintain
existing eligibility processes for
pregnant women and children until
September 30, 2019 will mean States
have to maintain dual eligibility systems
during this time period. At the end of
2019, the IT systems will need to be
updated to remove this function and
that enhanced funding should be
extended for States to make changes to
eligibility systems when this
requirement ends.
Response: We appreciate the
significant number of comments we
received on this aspect of our proposed
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rule and the view of commenters that
we should eliminate, extend, or modify
the deadline for expiration of the
enhanced match for eligibility systems.
Nonetheless, while we appreciate the
opinions of commenters, we continue to
believe that the deadline we established
in the proposed rule is appropriate and
proper. We believe it is within our
authority to determine that by a certain
date, additional investments in
eligibility determination systems will no
longer continue to result in ‘‘more’’
efficient, effective or economical
administration of the State Plan, as
required by section 1903(a)(3)(A)(i) of
the Act. Further, we continue to believe
that December 31, 2015 is a reasonable
and proper end-point for when
investments cease to result in acceptable
increases in efficiency, economy, or
effectiveness. Our reason is threefold:
First, changes imposed by the
Affordable Care Act will require
immediate attention and commitment to
new technologies for eligibility and
enrollment systems. Second, once
appropriate systems are deployed to
support the coverage expansions and
other eligibility changes required by the
Affordable Care Act, we anticipate
significant efficiencies in both
application maintenance and business
operations. Third, the additional 2 years
we provided to States after the Medicaid
expansion goes into effect allows ample
time for States to refine and enhance the
capability of the systems, and to
capitalize on the efficiencies of these
investments.
We articulated in the proposed rule
that additional investments are unlikely
to yield similar rates of improvement
and a regular administrative match
should be sufficient for efficient and
effective administration of State
Medicaid programs. We anticipate that
the improved underlying infrastructure
supporting both Medicaid and
Exchanges will be strongly leveraged in
support of a State’s person-centric
outreach, eligibility and enrollment
activities across the health and human
services spectrum.
With respect to the request made by
some commenters to establish an
exceptions process, we believe this is
already sufficiently provided for
through our extension of enhanced FFP
for an additional 2 years beyond the
date for operation of the Exchanges. We
are concerned that broadening or
codifying exceptions to the deadline in
the way suggested by the commenters
would effectively render the deadline
moot for many purposes and projects.
The September 30, 2019 date noted by
one commenter is the end-date for
maintenance of effort (MOE) provisions
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for children (not pregnant women).
Because of these MOE provisions, States
must not have more restrictive
‘‘eligibility standards, methodologies, or
procedures’’ for children than those in
effect on March 23, 2010. The MOE
requirement does not mean that States
must maintain identical standards,
methodologies or procedures as those in
effect on March 23, 2010, and it does
not mean that the same IT system or IT
system processes be used. Rather, the
MOE requires that the eligibility
standards, methods, and procedures be
no more restrictive than those in effect
on March 23, 2010.
We are not certain of what the
commenter is concerned about in terms
of States’ needing to maintain dual
eligibility processes, but we assume he
or she may be concerned about the
interaction of the MOE requirements
and the requirement under section 2002
of the Affordable Care Act. The
conversion to a MAGI-equivalent
income standard required under section
2002 of the Affordable Care Act is
designed in the statute to ensure that
individuals who meet the eligibility
requirements in effect as of March 23,
2010 do not lose eligibility as a result
of the shift to MAGI. Guidance will be
provided by the Secretary regarding
how States can accomplish the required
conversion, and once the new MAGIequivalent income standard has been
determined, the MOE requirements will
be applied to such converted standard,
using the MAGI methodologies to
determine an individual’s income, as
required under the Affordable Care Act.
Therefore, the MOE requirements will
not require operating dual eligibility
systems.
After consideration of the public
comments received, we are maintaining
the December 31, 2015 deadline in our
regulations for eligibility determination
systems.
Comment: One commenter requested
that CMS consider interpreting the
deadline of December 31, 2015 for
projects receiving enhanced Federal
funding to requiring the funds be
obligated by that date rather than
expended.
Response: We indicated in the
proposed rule (75 FR 68589) that States
would need to incur costs for goods and
services furnished no later than
December 31, 2015 to receive 90 percent
FFP for design, development,
installation, or enhancement of an
eligibility system. For further
clarification, this means that States must
ensure that goods and services (for
example, eligibility and enrollment
modules, applications, systems, etc.) are
provided to States no later than close of
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business December 31, 2015. Thus, for
example, if an amount has been
obligated by December 31, 2015, but the
good or service has not yet been
furnished by that date, then such
expenditure would not be eligible for
enhanced FFP.
As a result of this comment, we are
adding language to the regulations text
to clarify this point.
Comment: Numerous commenters
asked whether enhanced funding is
available for subsystems that interface
with and/or are part of the eligibility
process since such subsystems will
require modifications to meet the
requirements of the Affordable Care Act.
Additionally, commenters sought
enhanced FFP for projects that meet
Medicaid Information Technology
Architecture (MITA) guidance, yet still
may need to integrate with legacy
systems, with the understanding that,
where feasible, open rules and
specifications developed for programs
will be used to read, insert, or update
data into systems that currently do not
have the functionality of being
interoperable. The commenters agreed
that APDs would need to be put in place
and approved to modernize the legacy
systems/subsystems.
Response: We agree that enhanced
funding can be available for subsystems
that meet the standards and conditions
outlined in this final rule. However, to
the extent that such subsystems are
reliant on or tied to a larger legacy
system or suite of systems that
introduce performance risk or ongoing
costs to the operation of the subsystem,
we may find that the system as a whole
is not meeting the standards and
conditions of this final rule and decline
to approve enhanced match on that
basis. It is our desire to acknowledge
that subsystem modernization may be
an entirely appropriate pathway to a
high performing Medicaid program,
while at the same time not binding
ourselves to approve enhanced match
for minor components of a large,
fragmented legacy system that has little
chance of delivering to expected
business results. CMS will review APDs
and make determinations regarding
such subsystems, and to the extent that
such subsystems meet with the
standards and conditions outlined in
this final rule and States can document
that there is no performance risk or
ongoing unnecessary costs, as a result of
the subsystem being a part of larger
legacy system, CMS will make
determinations regarding enhanced
funding accordingly.
Comment: Several commenters want
to ensure that enhanced FFP is available
to States that are not completely MITA
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compliant, but rather to States that can
demonstrate efficiencies are being
achieved, redundancy is being
decreased/eliminated, and system
integration is being realized through
application programming interfaces
(API). States could demonstrate that
APIs, in which a particular set of rules
and specifications for services and
resources have been developed by one
software program that can be accessed
and used by another software program
implementing the API, can be used and
serve as an interface between different
software programs and facilitating their
interaction, and thus, leading to
efficiencies. Commenters added that
with an approved APD reasonable and
measureable milestones of system
compliance can be demonstrated.
Response: Enhanced FFP is available
for those systems that comply with the
standards and conditions of this final
rule. Aligning to, and advancing
increasingly, in MITA maturity for
business, architecture, and data is one of
the standards and conditions that must
be met. We did not use the term ‘‘MITA
compliant’’ in our proposed rule because
MITA maturity is by definition, a matter
of degree. We agree that achieving
increasing levels and degrees of MITA
maturity is likely to happen in stages.
Recognizing this, we will be requiring a
MITA roadmap that delineates how the
proposed system enhancements for
eligibility and enrollment functions will
fit into the States’ greater MITA
framework. Such requirement will align
with our expectations to see States
continuing to make measurable progress
in implementing their MITA roadmaps.
We believe it is critical to build on and
accelerate the modernization we have
collectively begun under MITA, so that
States achieve the final vision of MITA
and have a comprehensive framework
with which to meet the technical and
business demands required by an
environment that will increasingly rely
on health information technology and
the electronic exchange of healthcare
information to improve health outcomes
and lower program costs.
Comment: One commenter requested
clarification as to whether enhanced
FFP will be available where a project
has some components that meet the
standards and guidelines required for
enhanced FFP, but may include other
components that do not.
Response: We believe it is entirely
appropriate to accomplish system
modernization through phasing. In cases
such as the one raised by the
commenter, the changes being made to
various system components will need to
be reviewed through submission of an
APD and review. We will need to ensure
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that component-based development is
on a path toward an entire system or
subsystem coming into compliance with
the standards and conditions of this
final rule. We would expect that if the
components that do not meet the
standards and conditions are essentially
preventing the entire system or
subsystem from meeting the standards
and conditions, then the State would
have a plan for updating such
components, even if all components are
not updated at the same time. For
example, we do not expect that we
would offer enhanced FFP for
improvements to just the reporting
aspect of the traditional, legacy
eligibility system, if the State does not
have a plan for bringing this entire
legacy system into compliance with the
standards and conditions. In addition,
to receive enhanced FFP, States may not
ignore any single standard or condition
regardless of the level or breadth of their
compliance with the remaining
standards, although if a State is weaker
or more at risk with certain standards or
conditions, the State should include a
roadmap in their APD demonstrating
how they intend to come into
compliance. We intend to carefully
track progress against approved
roadmaps when determining if system
updates continue to meet the standards
and conditions for enhanced match.
Comment: One commenter suggests
that CMS clarify that enhanced funding
is also available for ‘‘traditional’’
eligibility determinations, such as those
made on behalf of medically needy
clients, buy-in, elderly, disabled, longterm care and home and communitybased individuals.
Response: To the extent that
eligibility systems meet all
requirements, standards, and conditions
contained in this final rule, States will
be eligible for enhanced FFP, and such
enhanced funding is not dependent
upon the eligibility group using the
system.
Comment: One commenter
recommended that CMS clarify that
enhanced funding is available for
personnel costs, as well as the costs of
physical systems. Specifically, the
commenter notes that Federal
regulations at § 432.50(b) provide for
enhanced funding at 75 percent for the
costs of staff ‘‘engaged directly in the
operation of mechanized claims
processing and information retrieval
systems’’ and for enhanced funding at 90
percent for staff costs related to the
design, development, and installation of
these systems. FFP is provided at 50
percent for the costs of training
personnel when new systems are
developed.
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Response: We did not propose
amendments to the regulations at
§ 432.50(b); thus, enhanced funding is
available for staff time spent on
mechanized eligibility determination
systems in the same manner that they
apply to all mechanized claims
processing and information retrieval
systems, since mechanized eligibility
determination systems are now
considered to be part of such systems,
assuming the requirements of this
section are met.
Comment: One commenter asked that
we extend the enhanced funding to
encompass the testing of the
effectiveness of the eligibility systems,
including testing beneficiary experience
such as allowing States to receive
reimbursement for conducting focus
groups with community-based workers
and/or beneficiaries who rely on the
system to apply for and renew Medicaid
coverage.
Response: Again, to the extent these
costs would be reimbursable under
§ 432.50(b), they would be eligible for
reimbursement under this rule as well
(assuming all standards and conditions
are met). States would need to ensure
that the expenditures are tied to the
mechanized eligibility determination
system and follow all procedures for
seeking approval.
Comment: Several commenters
requested that CMS require States to
pass enhanced match through to
counties. The commenters stated that
CMS should ensure that if a State
requires counties to contribute to the
non-Federal share of Medicaid and
Medicaid administrative costs, and that
receives enhanced FFP; the State should
be required to share the enhanced FFP
in proportion to the counties’
contribution. The commenters stated
that this requirement would reflect the
clear Congressional intent as expressed
in the enhanced Federal Medical
Assistance Percentage (FMAP)
requirements for certain States in
section 5001(g)(2) of the American
Recovery and Reinvestment Act (Pub. L.
111–5, enacted on February 17, 2009)
and strengthened by section 10201(c)(6)
of the Affordable Care Act.
Response: The commenters cite
section 10201(c)(6) of the Affordable
Care Act, which added section 1905(cc)
to the Act. Under this provision, a State
may not be eligible for certain increased
FMAPs associated with health care
reform and disaster recovery if the State
‘‘requires that political subdivisions pay
a greater percentage of the non-Federal
share * * * than the respective
percentages that would have been
required by the State under the State
plan under this title, State law, or both,
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as in effect on December 31, 2009.’’
Since the level of Federal funding
available for the costs of the eligibility
and enrollment determination systems
under this final rule will increase and
the level of the non-Federal share
specific to such expenditures will
decrease, there could be an effect on the
level of required political subdivision
contributions that would be subject to
this limitation. We already issued
guidance on how the political
subdivision contribution limitations
under section 1905(cc) apply in an SMD
letter issued November, 9, 2010 (see
https://www.cms.gov/smdl/downloads/
SMD10023.pdf). Rather than reiterate
what is already in that guidance, we
refer States and counties to such
guidance. States and counties may also
work with CMS to determine whether
any required contributions by political
subdivisions toward the non-federal
share of these expenditures would be in
compliance with political subdivision
contribution provision.
Comment: One commenter urged
CMS to encourage States to consider in
establishing actuarially sound Medicaid
managed care rates, the additional
systems-related investments by
Medicaid health plans that are likely to
be needed to interface with new State
systems.
Response: We believe this commenter
is asking about managed care rates, and
not the proposal we issued with regard
to mechanized claims processing and
information retrieval systems, and when
they will be eligible for enhanced FFP.
As our proposed rule did not address
Medicaid managed care rates, we
believe this comment is outside the
scope of the proposed rule.
Comment: One commenter asked for
clarification on whether the addition of
eligibility determination and enrollment
systems is limited to stand-alone
systems administered directly by the
single State Medicaid Agency. The
commenter indicates that some State
eligibility systems are a joint venture
with the HHS and the United States
Department of Agriculture and are used
to determine eligibility for financial
assistance programs in addition to
medical assistance programs.
Response: The enhanced funding can
apply to ‘‘stand alone’’ systems or
‘‘integrated eligibility’’ systems,
assuming they meet the standards and
conditions specified in this final rule.
Many States are considering ways to
coordinate Medicaid, CHIP and
Exchange eligibility with other health
and human services programs. However,
we will only provide enhanced funding
for the portion of the costs that can be
directly attributed to Medicaid
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eligibility and enrollment functions. We
also direct the commenter to the
discussion on cost-allocation in OMB
Circular A–87 (https://
www.whitehouse.gov/omb/
circulars_a087_2004) specifying
appropriate allocation of costs when the
system includes various benefiting
programs.
Comment: Other commenters have
asked whether the enhanced funding
can be used to support updating and
completing the MITA assessment and
roadmap, and performance
measurement.
Response: We agree with the
commenters that it is appropriate to
request enhanced funding for updating
the MITA assessment and the roadmap,
since one of the standards and
conditions listed in § 433.112 speaks
directly to MITA maturity. Enhanced
funding is available assuming that
updates are related to the standards and
conditions and the State’s plan for
meeting them. We are making no further
additions to the rule in response to this
comment.
Comment: Some commenters believed
the timeframes related to the enhanced
funding for the development of
eligibility solutions seems to be
extremely aggressive. Many of the
activities related to the planning,
design, development, and deployment
of eligibility solutions will be new
activities for both State and vendor staff.
States will need to consider how they
will integrate and leverage eligibility
solutions into their Health Insurance
Exchanges, their integrated human
services eligibility solutions, their
MMIS, and other points of intersection.
Just the planning phase leading up to an
approved APD and FFP release could
easily consume more than a year. The
commenters suggested that CMS should
consider lengthening the timeframes for
the completion of these efforts related to
eligibility components.
Response: We recognize that the
timelines for developing new eligibility
systems, and for submitting and
approving new APDs, must be greatly
accelerated from historical and
traditional experiences and approaches
in order to meet the timelines in the
Affordable Care Act and to take
advantage of enhanced match prior to
December 31, 2015. We emphasize that
we expect to operate efficiently in
processing APDs and work
collaboratively with States to implement
these changes, and we expect States to
operate quite differently in how they
pursue new development, share and
reuse assets, and take advantage of
‘‘lightweight’’ applications and new
technologies to meet these needs. We
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noted in our proposed rule that
dramatic systems transformations would
be necessary and while the timeframes
may appear aggressive to some, the
Department is committed to providing
leadership, technical assistance, and
financial support to produce the IT
infrastructure necessary to accomplish
the tasks required by the Affordable
Care Act according to the timelines
specified in the law. We note that the
Affordable Care Act requires that States
be able to enroll the newly eligible
individuals and coordinate with Health
Insurance Exchanges by January 1 of
2014. Thus, our timeline accounts for
this statutory deadline, while still
maintaining a period of two years
(through December 31, 2015) to account
for potential delays or unforeseen
obstacles in developing new or
improved eligibility determination
systems.
We are making no further revisions to
the rule as a result of this comment.
B. Requests for Additional Guidance
Comment: One commenter requested
that CMS produce and make available to
the States a project planning template
illustrating key entry points to major
phases of the projects.
Response: We will be providing a
whole series of artifacts and supporting
tools, documentation, diagrams to States
as part of our technical assistance,
collaboration, and governance. We will
consider the usefulness of a template for
project planning as we develop and
publish these materials.
Comment: Several commenters
requested additional guidance on the IT
enterprise.
Response: We will issue additional
Guidance for Exchange and Medicaid
Information Technology Systems (IT
guidance). We issued IT guidance
version 1.0 on November 30, 2010, and
expect to issue, expand and renew that
guidance over time. These guidance
documents will help States with the
business rules necessary to design,
develop, and implement State eligibility
systems that can meet the requirements
of the Affordable Care Act.
Comment: Several commenters
inquired about future guidance on
MITA, the MITA alignment process, and
whether the process for certifying and/
or validating MITA alignment will be
detailed in the final rule.
Response: We have provided
continued guidance and artifacts
associated with MITA since the MITA
Initiative began. We will continue to
provide that guidance and related
toolsets and details. We will consider a
number of elements in reviewing states’
alignment with MITA and increasing
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MITA maturity, including States’ selfassessments and MITA roadmaps.
Comment: Several commenters
inquired about the ‘‘modular, flexible
approach to systems development’’ and
increasing MITA alignment
requirements, as well as whether such
requirements apply to all MMISs or only
eligibility determination systems. The
commenters believed that to promote
the feasibility of a ‘‘modular, flexible
approach to systems development’’ of
Medicaid systems, CMS should
continue to fund and aggressively
develop necessary interfaces and
technical standards that are required to
facilitate MMIS interoperability.
Response: As stated in the above
responses, we intend to issue a series of
tools for States to use in ensuring the
facilitation of interoperability. It should
be noted that the requirements of this
final rule apply to all MMISs, not just
eligibility determination systems (which
will now be considered part of the
MMIS). We are making no further
additions to the rule as a result of this
comment.
Comment: Several commenters urged
CMS to develop stronger Federal
guidelines for enrollment and renewal
procedures to accompany new
eligibility systems, including guidance
on acceptable data matches creating safe
harbors for data sources used in
electronic income verification, to allow
States to move to paperless income
verification with confidence that they
comply with quality and accuracy
standards. In developing additional
requirements, the commenters urged
CMS to ensure that Medicaid’s
application, renewal and verification
procedures are no more paperwork
intensive or burdensome than those for
Exchange tax credit applicants.
Response: We agree with the
commenters that simplification and
streamlining of the consumer
experience are expected outcomes of the
Affordable Care Act. However, business
process and policy requirements for
determining eligibility are outside the
scope of this regulation and will be
addressed in separate rulemaking. As
discussed later in the response to
comments concerning performance
measures, we will also publish
measures concerning expected business
outcomes in separate notices. We are
making no further additions to this
section of the final rule.
Comment: Some commenters
requested reforms and clarifications
regarding cost allocation principles.
Response: Our proposed rule did not
contain any proposals to alter cost
allocation principles, and we believe it
is prudent that CMS and the States
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continue to follow the cost allocation
principles outlined by OMB in Circular
A–87. As stated in the proposed rule, for
integrated eligibility systems, assuming
those systems meet the standards and
conditions outlined in the final rule,
only the costs associated with Medicaid
eligibility and enrollment functions will
be eligible for the enhanced funding and
funding for Exchange activities is fully
Federally funded through January 1,
2015. We discussed cost allocation and
the principles of cost allocation in
guidance that was released on
November 2010; that is, the IT guidance
version 1.0 and in the Funding
Opportunity Announcement for the
Early Innovator Grants. States can
access the OMB Circular A–87 at
https://www.whitehouse.gov/omb/
circulars_a087_2004.
Comment: Several commenters asked
for guidance on commercial off-the-shelf
(COTS) software products, and
indicated that such products are often
modular, reusable, sharable, leveraged,
and aligned with MITA. Commenters
also stated that enhanced FFP should be
available for COTS initial licensing and
implementation service costs as well as
ongoing software licensing and
maintenance costs. Commenters also
questioned why there is no language
confirming established protections for
COTS pre-existing intellectual property
(IP) and newly developed IP used in
eligibility modernization initiatives.
Response: We are not dictating
specific solutions to States as they
undertake their technology projects, as
long as the standards and conditions of
this final rule are met and we expect to
work with States in an effort to share,
reuse, and leverage other State
solutions. For COTS products, we have
a longstanding rule that the State must
own any software that is designed,
developed, installed or improved with
90 percent FFP (see § 433.112(b)(5)). In
other words, software that is developed
with public funds must be owned by the
public and as a ‘‘public product’’ is
available to be shared with other States.
COTS-based solutions may still receive
a 75 percent enhanced funding (that is,
for licensing and implementation
services costs), if they are related to the
MMIS (including the eligibility
determination system) and meet all the
requirements of this final rule. In
addition, current rules protecting
intellectual property (such as copyright
and/or patent laws) would simply apply
in the way that they already do apply
to intellectual property. Nothing in this
final rule is attempting to alter those
rules.
Comment: Several commenters asked
that we define the terms ‘‘modular’’,
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‘‘modules’’, ‘‘models’’, and ‘‘successful
models.’’ Commenters indicated they are
unclear about whether a model is
equivalent to an architecture, reference
model, process design, etc. for a given
customer or class of customers and
consistent with MITA architecture
framework, process and planning
guidelines, and maturity model.
Response: We believe it is important
to frame our response in terms of the IT
Guidance jointly issued by CMS and
CCIIO. This guidance outlined a set of
expectations and principles for sharing
solutions and approaches between both
Medicaid and the Exchanges.
Consequently, we believe it is
imperative for States and vendors to
view all IT activities much more broadly
than a single physical implementation
of a set of technical capabilities.
‘‘Modular’’ means reducing the
complexity of a larger problem by
breaking it down into small well
defined pieces. For example, MITA
business architecture reduced the
complexity of the Medicaid program
into eight high-level business areas.
Each business area is further broken
down/decomposed into smaller and
manageable business processes. These
business processes can be described as
‘‘modules’’. System components can also
perform tasks in a similar fashion.
‘‘Modularity’’, if done right,
accomplishes re-usability,
maintainability, and reliability. The
term also underscores our strong desire
for States and the vendor community to
develop ‘‘lighter-weight’’ and ‘‘looselycoupled’’ approaches to the design of
health care systems, including, but not
limited to eligibility determination and
enrollment functions.
In the MITA initiative, we have urged
States to focus on designing sets of
overarching and reusable functions that
traditionally might have been included
within one particular application and
that would have been specific to that
particular application, but that now
could be used, in a consistent manner,
by multiple applications used by the
State. Additionally, we want to
emphasize that the rules for processing
data should be written in such a way as
to be available to more than just one
application. For example, whether it is
a Web service querying for a response,
or an Extract Transformation and Load
(ETL) set of tools to move data from a
database to an external interface, the
rules that are invoked are the same, thus
ensuring the underlying data maintains
its inherent ability to consistently
transform to the same information.
‘‘Reference Models’’ focus on
classification and conceptual structure.
Typically, a Technical Reference Model,
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for example, consists of infrastructure
and business applications that interface
with a number of operating and network
services through a variety of specific
applications such as graphics and
imaging, data management, data
interchange, user interface, transaction
processing, security and system/
network management.
‘‘Reference Architecture’’ is about
proven solutions and best practices,
typically without being vendor/platform
specific. Typically arrayed in different
tiers (access client tier, middle tier and
data tier, for example), a technical
reference architecture includes a client
browser and an XML appliance to allow
for access, a presentation layer using a
portal with HTML and an application/
Web server, business services
applications, enterprise information
integration, and operational data storage
facility typically through a data base
with data exploration capabilities
sometimes arrayed via data marts.
We believe MITA 2.0 addresses all of
the defined terms. We also urge readers
interested in these and related topics to
familiarize themselves with the MITA
Framework, look for additional
guidance in the various iterations of the
IT Guidance, and contact CMS staff for
additional clarifications related to
specific circumstances.
Comment: Other commenters
requested that the term ‘‘eligibility
determination system’’ be defined. The
term should indicate that eligibility
determination system includes the
technology interfaces for program
applicants and beneficiaries, such as
Web sites that include on-line
applications and other Web features that
allow individuals to use eligibility
estimators, to report changes, to renew
eligibility, or to seek information about
their case status. Likewise, ‘‘eligibility
determination system’’ should be
defined to include computer generated
notices and data.
Response: Our final rule considers
systems that process claims for
eligibility to be part of mechanized
claims processing and information
retrieval systems. Thus, to the extent
that a function is part of processing the
claim for eligibility, we believe it could
be eligible for enhanced FFP under this
final rule. We believe building an online
application would likely be part of the
system that processes claims and
applications for eligibility. Additionally,
we can envision how all of the
components identified by the
commenters will be part of an eligibility
determination system, but we would
need to understand more fully how such
components are integrated into a system
that processes claims for eligibility.
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States will explain in their APDs how
the various components are part of the
mechanized claims processing and
information retrieval system and will
meet with our standards and conditions.
We are making no further additions to
this section of the final rule.
Comment: One commenter indicated
that it would be helpful if CMS
provided additional leadership and
technical assistance in further
standardizing data semantics and
information nomenclature across the
eligibility function.
Response: We agree with the
commenter and look forward to working
in close partnership with States,
Exchanges, and the Office of the
National Coordinator for Health
Information Technology, and the HIT
Policy and Standards Committees on
this activity. We intend to enforce
industry standards as they develop in
order to promote interoperability,
improve reliability of outputs and
outcomes, and reduce development
costs.
Comment: A few commenters spoke
of the importance of ensuring that
county governments act as full partners
in the planning, design, oversight and
operations of necessary Medicaid
eligibility system transformations. To
ensure that counties are poised to best
assist Medicaid applicants and
recipients, the commenters suggested
that the Secretary develop model
systems and deploy the necessary
resources for implementation including
technical assistance and support for
capital investment.
Response: We agree with the
commenter that States, Tribal
organizations, County governments, and
Federal government agencies should
work together to ensure effective
interoperability and to develop model
systems, as well as to deploy the
necessary resources for implementation
including technical assistance and
support for capital investment. We
recognize the historical contribution
made by counties to making eligibility
determinations in most States. We look
to States to determine how best to
deploy and optimize assets within the
State to accomplish the purpose and
requirements of the Affordable Care Act.
Comment: Several commenters
believe that, to support the one
application concept and streamlined
eligibility determinations for Medicaid
and related programs (including CHIP,
TANF, Food Stamps, and WIC), CMS
should work with other Federal
agencies to obtain agreement to allow
sharing of data across those related
programs.
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Response: Our standard and condition
regarding data exchange requires
seamlessness with the Exchanges and
also requires that States allow for
interoperability with other health and
human services programs. We also note
that our standards and conditions
require compliance with the standards
and protocols adopted by the Secretary
under sections 1104 and 1561 of the
Affordable Care Act. We expect that
such standards and protocols will
promote reuse and data exchange.
Comment: One commenter believes
that to support timely processing of
eligibility, CMS should work with other
Federal agencies that interface with
State Medicaid agencies to allow a
single point for correction of client data
errors, including birthdates and
erroneously posted death dates.
Response: We believe this comment
addresses the actual program
instructions and policy requirements for
eligibility systems, and not the
information technology solutions that
will be needed for the systems
themselves. Our requirements regarding
these matters will be established in
separate rulemaking.
Comment: One commenter requested
that CMS offer strong guidance to the
States on privacy and confidentiality
issues that need to be observed in the
new State systems.
Response: We agree that
confidentiality and privacy are critical
to protecting beneficiaries and
providers. The final rule includes as a
standard that systems ensure alignment
with the HIPAA privacy, security and
transaction standards.
Comment: One commenter indicates
that we should issue guidance more
definitively discussing the standards
developed in response to section 1561
of the Affordable Care Act. The
commenter noted that while section
1561 the Affordable Care Act is an
outstanding source of ideas and
information, section 1561 the Affordable
Care Act standards appear to stop short
of creating specific, concrete
requirements.
Response: Section 1561 the
Affordable Care Act requires HHS, in
consultation with the Health
Information Technology (HIT) Policy
Committee and the HIT Standards
Committee, to develop interoperable
and secure standards and protocols that
facilitate electronic enrollment of
individuals in Federal and State health
and human services programs. The HIT
Policy and Standards Committees
approved initial recommendations, and
in September 2010, the Secretary
adopted these recommendations. The
recommendations include initial
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standards and protocols that encourage
adoption of modern electronic systems
and processes that allow a consumer to
seamlessly obtain and maintain the full
range of available health coverage and
other human services benefits.
The HIT Policy and Standards
Committees recommendations are
available at https://healthit.hhs.gov/
portal/server.pt?open=512&
mode=2&objID=3161. We wish to note
that one of the seven standards and
conditions specifically requires States to
ensure alignment with, and
incorporation of, industry standards and
specifies several national standards
including standards and protocols
adopted by the Secretary under section
1561 of the Affordable Care Act.
Comment: Another commenter
suggested that we make all guidance
documents, including the State
Medicaid manual readily available.
Response: We agree. We are currently
working to gather all applicable
guidance documents on the CMS Web
site. Guidance documents are already
posted to several web sites, including
the proposed rule (see regulations.gov),
the IT guidance version 1.0, (see
https://www.hhs.gov/ociio/regulations/
joint_cms_ociio_guidance.pdf),
Overview on the MITA framework, (see
https://www.cms.gov/
MedicaidInfoTechArch), and Overview
of the MMIS (see https://www.cms.gov/
MMIS). Please note that Chapter 11 of
the State Medicaid Manual can be
accessed electronically at https://
www.cms.gov/Manuals/PBM/
itemdetail.asp?filterType=
none&filterByDID=-99&sortByDID=1&
sortOrder=ascending&
itemID=CMS021927.
In summary, we are making no
revisions to regulation text as a result of
these comments.
Comment: Several commenters
suggested that CMS provide educational
materials to ensure consumers get
individualized assistance and have their
questions answered to assure
enrollment in Medicaid and the
Exchanges.
Response: We believe this comment
addresses the actual program
instructions and policy requirements for
eligibility systems, and not the
information technology solutions that
will be needed for the systems
themselves. Our requirements regarding
these matters will be established in
separate rulemaking.
Comment: Commenters also requested
that CMS issue ‘‘Frequently Asked
Questions,’’ establishing a direct contact
line for assistance, make available a
complete contact list of all of the States
and their designated person/
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representatives, and develop a
Webpage/module to the existing Web
site that will use this information and
any ongoing data exchange information
for the State. Commenters further
recommended that CMS Regional
Offices be fully trained and educated on
the regulations and standards.
Response: We will consider these
recommendations as we begin
implementation of this final rule. We
expect to provide numerous venues for
sharing of information, including
conferences, information posted to the
CMS.gov Web site, letters, program
memoranda, and training materials. The
final rule and additional IT guidance
will provide information regarding
funding standards and conditions. We
expect to release additional guidance on
performance matrices. We are currently
exploring several approaches to
expedite the APD process and will be
providing guidance on this process soon
after publication of this final rule.
Additionally, we have recently
awarded seven cooperative agreements
to help a group of ‘‘Early Innovator’’
States design and implement the IT
infrastructure needed to operate
Exchanges. We expect to share
information among these Innovator
States and, as Exchanges are being
developed, we expect to share
information from these Innovator States
with other States as well through the
use of the CMS.gov Web site,
conferences, and face-to-face meetings.
C. Public Feedback and Suggestions
Related to the Seven Standard and
Conditions
Comment: Several commenters
requested clarification on the standards
and conditions, and questioned how
progress would be measured.
Specifically, several commenters were
concerned about our reference at
§ 433.112(b)(13) to ‘‘promoting sharing,
leverage, and reuse of Medicaid
technologies and systems within and
among States.’’ Commenters requested
that CMS define ‘‘promoting’’ and
specify how States will be required to
leverage this information between
States. Further, the commenters
questioned when CMS will provide
States with information regarding
‘‘promising State systems that can be
leveraged and used by other States.’’
They also questioned how these
‘‘promising State systems’’ will be
identified. The commenters noted that it
will be important for CMS to provide
sufficient time for States to leverage
promising systems and qualify for
enhanced FFP to fund the development
of those Medicaid eligibility systems.
Other commenters expressed concern
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that to meet the standards and
conditions required for the Medicaid
eligibility system to qualify for the
enhanced funding, significant systems
changes will be necessary to integrate
Medicaid/CHIP eligibility and develop a
single client identifier for all Medicaid
and CHIP members to establish seamless
coordination for eligibility and
enrollment. Some commenters
requested that CMS provide clarity on
the criteria CMS will use to assess how
States have demonstrated compliance
with these standards and conditions
including what documentation States
will be expected to provide.
Several commenters questioned the
phrase ‘‘seamless coordination.’’ That is,
§ 433.112(b)(16) requires seamless
Medicaid coordination and integration
between Medicaid eligibility systems
and the Exchange, allowing for
interoperability with the Exchanges, and
other health information systems. The
required interoperability would involve
the exchange of eligibility and
enrollment status to the health
information system, however, the rule
did not specify the health information
being exchanged among the eligibility
and enrollment systems. The
commenters believed it would be
important for CMS to provide additional
guidance on the type of data to be
exchanged between eligibility and
enrollment systems and other health
information systems; thus, the
commenters requested a definition of
‘‘seamless coordination.’’ Additionally,
the commenters requested that CMS
provide clarity around whether other
programs, such as the Supplemental
Nutrition Assistance Program and the
Temporary Assistance for Needy
Families Program, are considered part of
CMS’ vision for ‘‘seamless coordination’’
and whether enhanced Medicaid funds
would be used to make related changes
to eligibility systems for these programs
as well.
One commenter suggested that we
add stronger language to the list of
standards and conditions in § 433.112(b)
consistent with the preamble language
included in the proposed rule regarding
the emphasis on the customer
experience. Specifically, the commenter
stated CMS references the goal of
creating an ecosystem designed to
deliver person- and citizen-centric
services and benefits. The commenter
requested similar language be added in
regulations text.
Numerous commenters were
supportive of our proposed standards
and conditions. Specifically, several
commenters have indicated they
welcome our efforts to identify
‘‘promising State systems’’ that can be
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leveraged and used by other States.
Commenters indicated that they support
our perspective that State eligibility and
enrollment systems must be conceived
of as contributing to a ‘‘system of
systems.’’ To achieve interconnected,
functional systems in time to implement
the Affordable Care Act, States must
leverage existing systems to the greatest
extent possible and successfully connect
across silos. Commenters further stated
that CMS should develop a repository or
method of sharing information and
support the development of reference
applications. Additionally, commenters
stated CMS should establish a means for
communication between agencies at the
Federal level in a manner that can be
replicated at the State level. The
commenters also stated that CMS
should also provide support to those
States that choose to ‘‘phase in’’ some of
the changes, to ensure that they can
proceed while also receiving enhanced
funds. Additionally, the commenters
requested that CMS should consider the
MITA governance model for
disseminating more detailed
specifications for the standards and
conditions; that is, the MITA
governance model which includes the
Business, Information, and Technical
Review Boards, organized to support the
MITA model for review, approval, and
adoption of national standards.
Response: All of these comments are
specific to § 433.112 and § 433.116 in
which we have required that to receive
enhanced funding for development,
design, installation or enhancement of
mechanized claims processing and
information retrieval systems and
operation of such systems, the standards
and conditions specified in
§ 433.112(b)(10) through (16) must be
met. The standards and conditions are
prescriptive in nature; we did, however,
recognize that for State systems to meet
these standards and conditions, it
would be necessary to provide
additional guidance that clearly
articulates our criteria for meeting these
standards and conditions, the
performance measures that we will use
to ensure that State systems are
complying with these standards and
conditions, and the collaboration efforts
we will take with CCIIO and other
human services programs.
As mentioned previously, we released
several guidance materials last year
including the proposed rule and the IT
guidance version 1.0, and we are
committed to releasing additional
guidance in the near future which will
detail our criteria for ensuring
compliance with the standards and
conditions. States should consider that
we will be interested in partnering with
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them to ensure that they are making
progress and meeting measurable goals.
We consider that States may progress in
several phases and ensure compliance
by meeting goals along the way. Some
examples that States may wish to
consider in meeting the standards and
conditions would be (1) That States
should supply roadmaps for major
improvements in current systems based
on ‘‘as/is’’ MITA assessments and
demonstrate how they will increase in
MITA maturity by at least one maturity
level; (2) States should identify how
they plan to achieve full MITA maturity
and in what timeframe; (3) States should
ensure that their business architecture
conforms to concept of operation and
business process models distributed by
CMS for specific business functions, or
identify divergences to CMS; and
(4) States should use a business rules
engine which is maintained and
operated separate from transactional
programming language, which allow for
modification and updates on an
emergency as well as a regularly
scheduled (at least quarterly) change
control process.
Additionally, we will be releasing IT
guidance version 2.0 soon and we will
be releasing future versions of IT
guidance, as the January 1, 2014
deadline approaches. We will also be
issuing guidance surrounding APDs. We
continue to work with the Early
Innovator grant awardees to ensure that
State ‘‘early innovator’’ systems will
meet the goal of seamless coordination
with the Exchange. Furthermore, we
continue to provide technical assistance
and support to States through several
vehicles including CMS State calls,
State workgroups, and conferences. We
will convene an annual MMIS
conference in which States can share
their experiences and provide feedback
and request assistance regarding issues
surrounding the implementation of the
Affordable Care Act. We have
committed to providing leadership and
technical assistance in not only
developing national standards and
conditions but in ensuring systems
transformation will provide that the
goals of the Affordable Care Act goals
can be met. That is, with systems
transformation, States can meet
coverage goals, minimize duplication,
ensure effective reuse of infrastructure
and applications, produce seamlessness
for consumers, and ensure accuracy of
program placements.
In terms of our plans for use of the
MITA governance model which
includes the Business, Information, and
Technical Review Boards, organized to
support the MITA model for review,
approval and adoption of national
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standards, it should be noted that the
standards and conditions were
developed considering many
perspectives; that is, the Office of the
National Coordinator’s standards for
enrollment, the HIPAA standards for
privacy and security, the Office of Civil
Right’s views on the Rehabilitation Act
and other accessibility standards, other
Federal government agencies, States and
other stakeholders.
Comment: Several commenters
requested that we promote transparency
and provide opportunities for
beneficiary input since the proposed
§ 433.112(b)(14) would require effective
communications with providers,
beneficiaries, and the public. The
commenters believed that States should
be required to consult with
beneficiaries, advocates, provider
groups, including safety net providers
such as Federally Qualified Health
Centers, and public workers as they
plan their new or improved eligibility
systems; to make public copies of the
business rules used to determine the
decisions on eligibility that will be
made by their new systems; and to
gather data directly from beneficiaries
on their experiences with eligibility
determinations (for example, via fieldtested procedures such as focus groups
or meetings with beneficiaries or lowincome advocates) on a periodic basis.
Additionally, commenters believed that
States must demonstrate that their
modernized eligibility systems produce
communications with beneficiaries
(regardless of whether they are
distributed through the mail, on-line, or
through other alternative means) that
are appropriate for their literacy level
and consider the needs of people with
disabilities. Commenters believed that
policies regarding notices help ensure
user-friendly notices which should
include involvement of stakeholders,
such as beneficiaries. Similarly, the
commenters believed that CMS should
actively solicit and include data on
beneficiaries’ perspectives when it
conducts its periodic reviews of State’s
eligibility systems. Lastly, commenters
believed that this standard and
condition will be difficult to measure,
and therefore, should include definable
metrics.
Response: We believe it is wise for
States to consult with their stakeholders
as they implement the Affordable Care
Act, and in developing business process
models and technology roadmaps.
While we do not intend to set Federal
requirements regarding consultation in
this rule and specific to this activity, we
do note that other eligibility policy
rulemaking may address this issue. One
of our standards and conditions
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specifically states the expectation that
business rules should be maintained in
human readable form; we agree with the
recommendations of the HIT Policy and
Standards Committees considering the
requirements of section 1561 of the
Affordable Care Act that such business
rules should be submitted and
maintained in a common repository,
and are designing approaches to support
that activity. These rules will be
available to the public to the fullest
extent possible and practicable, and we
urge States to make their business rules
public on the same basis. As for the
request that we define the metrics that
will be used in periodic reviews of State
systems, such metrics will be published
in a subsequent notice or notices. We
will consider the suggestion to add
beneficiary feedback and user
experience in these measures.
Comment: One commenter questioned
if the standards and conditions for
Medicaid eligibility systems apply also
to MMISs and claims adjudication and
whether States have to meet the
standards and conditions for MMISs to
collect the enhanced FFP.
Response: Yes, under our proposed
and final regulations, a State’s entire
MMIS (including its eligibility
determination system) will be required
to comply with all of the standards and
conditions outlined in § 433.112. Please
see our proposed rule (75 FR 68585)
where we clarify that we were
proposing standards and conditions that
would apply to both ‘‘traditional claims
processing systems, as well as eligibility
systems to be eligible for the enhanced
match.’’
We are making no further additions to
this section of the final rule.
Comment: Several commenters
requested that CMS ensure eligibility
systems comply with all civil rights
laws and provide beneficiaries with the
opportunity to secure information in a
culturally and linguistically appropriate
manner. Commenters requested that
CMS ensure that the experiences of
people with disabilities are considered
when CMS conducts its periodic
reviews of the system. In addition,
commenters believed that CMS should
more clearly delineate that eligibility
systems must be in compliance with all
civil rights protections based on race,
color, and national origin and be
designed in a culturally and
linguistically appropriate manner. Some
commenters expressed concern
regarding eligible children in immigrant
families and individuals with limited
English proficiency and the difficulties
they experience in communicating with
public assistance caseworkers and in
navigating the Medicaid application
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process in general. Commenters
suggested that new systems and/or
modifications to current systems
address these needs. Additionally,
commenters suggest that the eligibility
systems qualifying for the enhanced
match should be in compliance with
Title VI of the Civil Rights Act of 1964,
section 1557 of the Affordable Care Act,
and all related rules, regulations and
guidance, including the Department of
Justice’s policy document, ‘‘Guidance to
Federal Financial Assistance Recipients
Regarding Title VI Prohibition Against
National Origin Discrimination
Affecting Limited English Proficient
Persons.’’
Response: While we believe the
majority of these comments address
determinations of eligibility, but are not
specifically addressed to the actual
systems technical requirements that are
the subject of our proposed and final
rules, we wish to clarify that we are
requiring that States meet the standards
and conditions outlined in § 433.112
and that one of the standards and
conditions relates to effective
communication with beneficiaries.
States should consider that State
systems should provide a 21st Century
customer experience for all individuals
and should provide for person-centric
outreach, eligibility, and enrollment. In
terms of determining eligibility, we are
happy to work with States regarding
assistance to individuals with limited
English proficiency in the context of the
Department’s ‘‘Guidance to Federal
Financial Assistance Recipients
Regarding Title VI Prohibition Against
National Origin Discrimination
Affecting Limited English Proficient
Persons’’ (‘‘Revised HHS LEP Guidance’’)
accessible at: https://www.hhs.gov/ocr/
civilrights/resources/specialtopics/lep/
policyguidancedocument.html.
Additionally, we note that section
201(b) of the Children’s Health
Insurance Program Reauthorization Act
of 2009 (Pub. L. 111–3, enacted on
February 4, 2009) (CHIPRA), added
section 1903(a)(2)(E) to the Act to
provide increased Federal funding for
translation and/or interpretation
services provided in connection with
the enrollment of, retention of, and use
of services by children of families where
English is not their primary language.
Further, we note that our current
regulation at 45 CFR 95.633 holds that
State agencies that acquire automated
data processing equipment and services
are subject to nondiscrimination
requirements in 45 CFR parts 90, 84 and
80 (nondiscrimination on the basis of
age; disability; and national origin, race
or color, respectively). Federal guidance
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issued on September 21, 2000 by the
Office of Civil Rights and the U.S.
Department of Agriculture,
Administration for Children and
Families and the Health Care Financing
Administration (as CMS was formerly
known) ‘‘Policy Guidance Regarding
Inquiries into Citizenship, Immigration
Status and Social Security Numbers in
State Applications for Medicaid, State
Children’s Health Insurance program
(SCHIP), Temporary Assistance for
Needy Families (TANF), and Food
Stamp Benefits’’ (‘‘Tri-Agency
Guidance’’) also discusses application
practices involving the citizen/legal
immigrant children of immigrant
parents, where questions asked of
nonapplicant parents may deter the
eligible children from enjoying equal
participation in and access to the
Medicaid program, thereby potentially
violating prohibitions on national origin
discrimination in Title VI of the Civil
Rights Act). (See https://www.hhs.gov/
ocr/civilrights/resources/specialtopics/
tanf/triagencyletter.html). We also will
continue to consider the Institute of
Medicine’s, 2009 report, ‘‘Race,
Ethnicity, and Language Data:
Standardization for Health Care Quality
Improvement,’’ for collecting race,
ethnicity, and language. Finally, we
expect to address section 1557 of the
Affordable Care Act in separate
rulemaking.
Comment: One commenter suggested
that, in considering the standard and
condition supporting accurate and
timely processing and adjudications/
eligibility determinations and effective
communications with providers,
beneficiaries, and the public, CMS
should require States to adopt and
implement translated notices and
taglines in their eligibility systems to
ensure effective communication with
limited English proficient applicants
and enrollees.
Response: We will consider this
suggestion as we develop further
technical guidance and additional
rulemaking. We agree that such
practices are worthy of consideration in
development activities.
Comment: Other commenters
expressed concerns regarding current
barriers that immigrant families face
when applying for public assistance
benefits. Some of the barriers identified
include the following: Requests for
Social Security numbers in the
application for non-applicants (that is,
undocumented parents that wish to
apply on behalf of their United States
citizen children), requirements for
income verification that nontraditional
workers cannot access; and lack of
translated forms and interpretive
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services for individuals with limited
English proficiency. Commenters
wanted CMS to consider the ‘‘TriAgency Guidance,’’ discussed in the
responses above and require that
eligibility determination systems should
ensure that individuals can seek all of
the benefits for which they or their
family members may be eligible without
providing unnecessary information.
Response: These comments address
program and policy requirements, and
will be addressed in separate
rulemaking.
Comment: One commenter wanted
CMS to require that State systems
determine eligibility for low-income,
lawfully present immigrants who are
income eligible for Medicaid but whose
immigration status makes them
ineligible for Federal Medicaid.
Specifically, since these individuals
would not be eligible for Federal
Medicaid but may be eligible for tax
credits and Exchange coverage, their
applications should be delivered to the
Exchange without requiring a new
application be submitted, while also
providing the applicant clear notice of
the status of their application and
eligibility.
Response: These comments address
program and policy requirements, and
will be addressed in separate
rulemaking. However, we wish to clarify
that one standard and condition that
must be met to receive enhanced match
is seamless coordination and integration
with the Exchange.
Comment: One commenter requested
that CMS require that eligibility
determination systems demonstrate how
they will comply with sections 1411(e)
and (g) of the Affordable Care Act.
Section 1411(e) of the Affordable Care
Act provides that certain procedures
governing verification of eligibility in
the Medicaid program, including its due
process protections, apply to the
Exchange. Section 1411(g) of the
Affordable Care Act prohibits
unnecessary questions during the
application process and limits the use of
information provided to the Exchange.
Response: These comments address
program and policy requirements and
will be addressed in separate
rulemaking.
Comment: One commenter suggested
that CMS prohibit States from
delegating responsibility to private
entities for administering on-line
Medicaid eligibility systems without the
State accepting the legal responsibility
for the system.
Response: These comments address
program and policy requirements, and
will be addressed in separate
rulemaking.
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Comment: A commenter suggested
that CMS oversee providing periodic
notice to Medicaid beneficiaries for
their individual use of medical services,
similar to an explanation of benefits
(EOB). The commenter believed this
would alert Medicaid beneficiaries of
fraud, provide treatment history, and
could help with redeterminations.
Response: While we appreciate the
commenter’s proposal, such provisions
are beyond the scope of the regulation
of the final rule. As such, we are making
no changes in response to the comment.
Comment: The commenters believed
that the requirements for timely and
accurate processing of claims and
adjudications should take into account
what is known about the major factors
that contribute to system performance,
such as system architecture, capacity,
and usability by workers. Commenters
recommended that decision logic and
coding used by eligibility systems be
publicly available, and States should be
required to have a process for
identifying errors and promptly
correcting them. Further, the
commenters believed that systems
should be capable of producing audit
trails of decisions.
Response: We agree with the
commenter. We expect to address these
issues when we issue performance
metrics in a separate notice.
Comment: Several commenters agreed
with our requirements that the
eligibility determination system
produce performance data and reports
that contribute to program, evaluation,
continuous improvement, and
transparency and accountability. The
commenters suggested that we further
specify the minimum data and
performance reports that the system
must generate and provide the
specifications for these reports and that
we should aim for basic program and
performance data that is comparable
across States and that addresses
fundamental program objectives and
compliance with key requirements.
Commenters believed this information
should be posted to Web sites on a
regular and timely basis.
Response: We agree with the
commenters’ suggestions, and further
clarify the applicability of this standard
to all MMISs and not just eligibility
systems. While the regulation
establishes standards and conditions for
transaction data, reports and
performance information, additional
specifications will be addressed in
future subregulatory IT guidance
continuously as the January 1, 2014
deadline approaches.
Comment: Some commenters stated
that the proposed regulatory changes
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did not address the needs of Medicare
beneficiaries for seamless enrollment to
Medicaid, Medicare Savings Programs
(MSPs), and Part D low income subsidy
(LIS) support older people and people
with disabilities.
Response: Because the regulatory
changes addressed availability of
enhanced Federal funding for Medicaid
eligibility and enrollment functions and
necessary standards, specific provisions
impacting enrollment of Medicare
recipients was outside the scope of
these changes. We would like to note
that the newly established Federal
Coordinated Health Care Office within
CMS, under section 2602 of the
Affordable Care Act, will be addressing
administrative and regulatory barriers
between the Medicare and Medicaid
programs in order to better serve this
population and it is our belief that
improvements in Medicaid eligibility
systems will benefit many populations
including individuals that are dually
eligible for Medicaid and Medicare.
Comment: Several commenters noted
that the systems should be built in a
manner that allows for the effective
expansion to other populations.
Response: We agree that systems
should be built to allow for expansion
and leverage, and indeed note that many
of the standards and conditions (such as
separation of business rules, serviceoriented architecture, MITA, etc.) will
effectively enable such downstream
activities and extensions.
Comment: Several commenters
believed that CMS standards and
conditions should not be the only factor
in considering enhanced FFP. For
example, commenters believed that
Federal leadership, technical assistance,
and sub-regulatory guidance should
focus on outcomes, as well as the
standards and conditions.
Response: We concur that Federal
(and State) leadership, technical
assistance and subregulatory guidance
needs to increasingly focus on
outcomes. One of the standards and
conditions is that systems effectively
support and contribute to intended
business results. We expect to publish
proposed performance measures to help
assess compliance with this condition
and standard.
Comment: Commenters stated that the
standard and condition regarding use of
a modular, flexible approach to systems
development and the separation of
business rules from core programming
available in human and machine
readable formats do not address the
maintainability, quality or governance
process for changes to the rule sets
which they believe have a much greater
effect on quality and timeliness than the
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particular syntax structure of the rules
source code.
Response: While we do not believe
this particular standard and condition
will solve all of these challenges, we
believe it will significantly reduce
maintenance costs and provide added
systems flexibility in an environment
that is continually evolving. Use of a
modular, flexible approach to systems
development and the separation of
business rules from core programming
will allow States to make changes more
quickly and efficiently than the
situation in place today for most States.
We did not attempt to tackle the
governance process as we believe that,
while very important, the relationship
between systems performance and
governance can be accommodated using
different approaches depending upon
the specific conditions within the
States.
Comment: Several commenters
recommended that the separation of
business rules from core programming
should recommend the use of
commercially available business rules
engines as opposed to custom or one-ofa-kind implementation of rules
processing techniques.
Response: One of our standards and
conditions focuses on reuse and
leveragability. This encourages and even
demands consideration of existing
solutions, including proprietary and
open source solutions, solutions in
place at other States, or solutions
already in place within a State, before
embarking on ground up custom
development. We believe this standard
and condition adequately ensures that
States give due attention and
consideration to these options without
dictating specific solutions.
Comment: Several commenters
requested that CMS provide additional
guidance on the business rules and
specifically requested that since every
State will have to meet the business
rules requirement, it might be more
efficient for CMS to develop a repository
of business rules along the lines of the
recommendations transmitted to HHS
(recommendation 3.2) by the HIT Policy
and Standards Committees. States could
then adopt and adapt the rules to their
own systems.
Response: We agree with the
commenters that we should provide
additional guidance on the business
rules. As mentioned, we will continue
to provide leadership, technical
assistance, and guidance with an eye
toward the January 1, 2014 date for
required operation of the Exchanges and
Medicaid expansion. We have also
provided that States should consider
other documents that articulate the
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21961
Department’s strategy such as the IT
guidance 1.0, Guidance for Exchange
and Medicaid Information Technology
Systems, and continue to consider such
guidance in meeting the requirements of
this final rule. As the commenters
stated, the HIT Policy and Standards
Committees’ recommendations should
be considered when developing systems
that comply with the standard and
condition regarding ensuring alignment
with, and incorporation of, industry
standards: HIPAA security, privacy, and
transaction standards; accessibility
standards under section 508 of the
Rehabilitation Act and compliance with
Federal civil rights laws; and standards
adopted by Secretary under sections
1104 and 1561 of the Affordable Care
Act. Our final rules will require that
systems include usability features or
functions that accommodate the needs
of persons with disabilities, including
those who use assistive technology. As
noted in the IT guidance issued
November 30, 2010, State enrollment
and eligibility systems already are
subject to the program accessibility
provisions of section 504 of the
Rehabilitation Act, which include an
obligation to provide individuals with
disabilities an equal and effective
opportunity to benefit from or
participate in a program, including
those offered through electronic and
information technology. The
Department noted in that guidance that
a State’s Web sites, interactive kiosks,
and other information systems
addressed by section 508 Standards
would be viewed as being in
compliance with section 504 if such
technologies meet the 508 standards.
The Department also encouraged States
to follow either the 508 guidelines or
guidelines that provider greater
accessibility to individuals with
disabilities, and noted that States could
consult the latest Section 508 guidelines
issued by the US Access Board or W3C’s
Web Content Accessibility Guidelines
(WCAG) 2.0 (see https://www.accessboard.gov/sec508/guide/index.htm).
Therefore, we believe that as a result of
complying with section 504, many
States will already be in or moving
toward compliance with the
accessibility standards we have
included in this final rule.
Lastly, we will be developing a
repository of business rules; however,
we wish to clarify that it may take some
time to populate. Considering the
deadlines imposed by the Affordable
Care Act, we realize a repository of
business rules may be helpful to some
States and not others depending upon a
given State’s IT configuration at the time
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it is in need of such rules. We are also
considering the possibility of the
development of model rules, in a
collaborative project with States.
Comment: One commenter requested
further clarification for the standards
and conditions listed in § 433.112(b)(2)
that require that the system meet the
requirements of Part 11 of the State
Medicaid Manual, and § 433.112(b)(12)
that require that ensuring alignment
with, and incorporation of, industry
standards: HIPAA security, privacy, and
transaction standards; accessibility
standards under section 508 of the
Rehabilitation Act and compliance with
Federal civil rights laws; and standards
adopted by Secretary under sections
1104 and 1561 of the Affordable Care
Act. The commenter questioned how
CMS will measure compliance with
these requirements and if States are
found to be out of compliance with this
requirement in one area such as a small
part of the conversion to ICD–10 coding
or revision of the 5010 transaction
standards, will States risk losing all
enhanced FFP.
Response: States are required to meet
all conditions for their mechanized
claims processing and information
retrieval system described in Title XIX
of the Act in order to receive FFP. We
have the authority to withhold
enhanced FFP (or potentially all FFP)
for issues of noncompliance with the
conditions listed in Title XIX of the Act.
It is not our intention to withhold FFP
for a frivolous or insubstantial reason.
We will give States the opportunity to
correct any failures that might endanger
FFP. However, a States’ continued or
persistent failure to adopt industry
standards in a timely and compliant
way would, in fact, place enhanced FFP
at risk. We note that we have outlined
a transition period for State MMIS
systems to come into compliance that
allows for up to 38 months of transition
while, at the same time, still ensuring
that State systems move expeditiously
towards improvement and advanced
technology (see our discussion below in
section III.E. regarding the transition
period).
D. Public Feedback and Suggestions
Related to the APD Process
Comment: Several commenters
suggested that the APD process and the
Federal organizations responsible for its
administration will likely be taxed in an
unprecedented way by the volume of
work spurred by the implementation of
the Health Information Technology for
Economic and Clinical Health Act and
the Affordable Care Act. The
commenters noted that even when
applied to projects supporting a single
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program with a fairly limited set of
requirements, the many moving parts in
the APD process can work more slowly
than anticipated and lead to unforeseen
outcomes. Consequently, the
commenters suggested that the APD
process be reformed. Commenters
suggested that CMS make the APD
process more transparent and that
making the large history of APD
documents and outcomes available to
other States would promote increased
collaboration. Other commenters agreed
and indicate that with many States
submitting APDs for both eligibility and
MMIS systems within the same window
of time, the APD approval process will
put increased pressure on both State
and Federal agencies to meet deadlines.
The commenters urged CMS to provide
an APD template and to examine ways
to expedite the APD process to make
sure it can support the critical
timeframe and urged CMS to consult
with States and the vendor community
to identify options to ensure timely
approval of APDs. Additionally,
commenters recommended that CMS
consider the waiver option in 45 CFR
95.627 as a method to streamline the
enhanced funding approval process
during this time limited availability of
enhanced funds. This could allow States
to submit alternative approaches to
hasten implementation of needed
systems changes.
Response: On October 28, 2010, HHS
released a final rule (75 FR 66319) that
introduced a new concept of ‘‘high risk’’
APDs that specified software
development as a ‘‘high risk’’ trigger.
Additionally, the period for Federal
review currently identified in 45 CFR
95.611(d) allows up to 60 days for APD
approval, disapproval, or requests for
information.
We realize it will be important to
conduct APD reviews quickly so as not
to delay the projects the States are
pursuing. As we are issuing this rule,
we are also preparing additional
guidance for APDs, and for the
governance and collaboration process
we will use to work with States to
minimize project risk, optimize
outcomes, and to ensure successful
compliance with the seven standards
and conditions added by this final rule.
In response to the commenters’
suggestions to make APDs more
transparent and public, we agree. We
are evaluating how, and in what form,
to make APDs available as they are
submitted.
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E. Issues Related to the Transition
Period for Compliance
Comment: One commenter proposed
that the regulation not be retroactive to
initiatives with an APD already.
Response: While not directly
suggested here, we believe it is
important to clarify that enhanced
funding is currently not available for
eligibility initiatives that have already
been approved by CMS. However, we
have provided that States currently
receiving enhanced FFP for MMIS have
a period of transition to come into
compliance with the standards and
conditions outlined in this rule.
Specifically, for new MMIS
development (new APDs requesting 90
percent FFP for design, development,
installation, and enhancement), we
provide for no transition period. For
MMIS development already underway
(approved APDs providing 90 percent
enhanced FFP), we proposed a 12month transition period (beginning with
the effective date of this final rule) in
which to submit an updated
Implementation APD (IAPD) detailing
how systems would be modified to meet
the required conditions and standards.
For maintenance and operations of
MMIS currently receiving 75 percent
FFP, we proposed a 36-month transition
period in which to submit an IAPD with
plans to upgrade or modify systems to
meet the required conditions and
standards. Since we are providing that
this final rule is effective upon
publication, we are revising the
transition periods by 2 months (to 14
and 38 months, respectively).
For new MMIS development (new
APDs requesting 90 percent FFP for
design, development, installation, and
enhancement), we will continue to
provide for no transition period. For
MMIS development already underway
(approved APDs providing 90 percent
enhanced FFP), we provide for a 14month transition period (beginning with
the effective date of this final rule) in
which to submit an updated
Implementation APD (IAPD) detailing
how systems would be modified to meet
the required conditions and standards.
For maintenance and operations of
MMIS currently receiving 75 percent
FFP, we provide for a 38-month
transition period (beginning with the
effective date of this final rule) in which
to submit an IAPD with plans to
upgrade or modify systems to meet the
required conditions and standards.
Additionally, we have discussed a
period of transition to come into
compliance with the standards and
conditions outlined in this rule for
eligibility systems as well. Specifically,
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for eligibility systems (currently
receiving 50 percent for development
and maintenance and operations), we
are providing for no transition period
for new requests for enhanced funding
for eligibility systems. States with
eligibility systems currently under
development (approved APDs providing
50 percent FFP) can update their APDs
to reflect how they would comply with
these standards and conditions in order
to begin receiving 90 percent FFP.
Similarly, eligibility systems currently
receiving 50 percent FFP for State
expenditures would need to comply
with our final standards and conditions
to receive a 75-percent FFP.
We are making no change to the
transition period for eligibility
determination systems.
Comment: One commenter questioned
whether CMS will impose additional
deadlines on States following the
submission of an IAPD requesting
funding and specifying the plans for
updating MMISs within the 36 month
(now 38 month) transition period.
Response: In the context of this
regulation, any more standards and
conditions (in addition to the 7 finalized
in this rule) would be subject to notice
and public comment. Consequently,
States would have an opportunity to
provide CMS with feedback.
Comment: One commenter stated
strong objections to the transition period
for existing development projects and
established MMIS applications for the
submission of an IAPD to achieve CMS’
proposed new MMIS standards. The
commenter believed that this time
limitation is extremely burdensome to
States at a time when resources are
already strapped. The commenter
believed the development of an IAPD
will require a planning period and this
will be occurring at the same time that
States are overhauling their eligibility
and determination systems. Further, the
commenter believed that States are
already struggling to meet the HIPAA
5010 and the ICD–10 mandates. The
State staff, contractors, and vendors
conducting the work on these mandates
are the same ones who would be
involved in the planning necessary to
submit an IAPD and they would be the
same ones implementing the changes to
the MMIS. The commenter believed the
rule requires adherence to standards
that don’t exist and from the State’s
perspective the MMIS requirements
represent an unfunded mandate. The
commenter expressed concern that the
requirement to ‘‘hurry up and meet’’ the
new standards and conditions will turn
current MMISs into ‘‘lame duck’’
systems. The commenter noted that
with all States required to undertake
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major eligibility systems projects,
implement 5010 and ICD–10, and
already facing impossible budget
constraints, now is not the time to
mandate onerous new requirements that
in many cases require replacement of
perfectly workable MMIS systems.
Response: In the January 16, 2009
Federal Register, HHS published two
final rules: The ASC X12 Version 5010,
NCPDP Version D.0, NCPDP Version 3.0
(74 FR 3296) and the ICD–10 code sets
(74 FR 3328) were published by HHS on
January 16, 2009 in 2 separate final
rules. These rules are available at
www.regulations.gov. In NCPDP
Version D.0, NCPDP Version 3.0, HHS
adopted ASC X12 Version 5010 and
NCPDP Version D.0 for the HIPAA
transactions that currently require the
use of the ASC X12 Version 4010/4010A
and NCPDP Version 5.1 standards. In
that rule, HHS also adopts a new
standard for Medicaid subrogation for
pharmacy claims transactions, known as
NCPDP Version 3.0. For Version 5010
and Version D.0, the compliance date
for all covered entities is January 1,
2012. This gives the industry enough
time to test the standards internally, to
ensure that systems have been
appropriately updated, and then to test
between trading partners before the
compliance date. The compliance date
for the Medicaid subrogation standard is
also January 1, 2012, except for small
health plans, which have until January
1, 2013 to come into compliance.
In ICD–10 code sets final rule, HHS
modified the standard medical data
code sets for coding diagnoses and
inpatient hospital procedures by
concurrently adopting the International
Classification of Diseases, 10th
Revision, Clinical Modification (ICD–
10–CM) for diagnosis coding and the
International Classification of Diseases,
10th Revision, Procedural Coding
System (ICD–10–PCS) for inpatient
hospital procedure coding. These new
code sets replace the current
International Classification, 9th
Revision, Clinical Modification,
Volumes 1 and 2 and the International
Classification, 9th Revision, Clinical
Modification, Volume 3 for diagnosis
and procedure codes respectively. The
implementation date for ICD–10–CM
and ICD–10–PCS is October 1, 2013 for
all covered entities. Thus, we believe
there has been ample time and ample
guidance to States so that they can move
towards compliance with these
requirements.
We disagree that the new standards
and conditions and the timeframe for
meeting them represent an ‘‘unfunded
mandate.’’ We are not imposing any
mandate on the State, but rather are
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creating standards which States will
need to meet if they wish to receive an
enhanced 90 or 75 percent FFP rate
under the Act. States that do not wish
to come up to these standards would
continue to be eligible for a 50 percent
FFP.
Additionally, in considering the
deadlines outlined in the Affordable
Care Act for operation of the Exchanges
and the requirement that Exchanges also
determine Medicaid eligibility, we
believe, and States have agreed, that the
procurement process for projects of the
size and scope required to meet the
challenges of the Affordable Care Act
can take several months to complete.
Thus, we considered these challenges
and determined it necessary to provide
flexibility by instituting a transition
period and by providing additional
financial support, additional IT
guidance, Federal technical assistance,
and leadership so that States can design
systems that can meet the requirements
of the Affordable Care Act.
Comment: One commenter questioned
whether MMIS upgrades and
modifications (as envisioned by a States
IAPD) may be phased in over a period
of years, so that by a certain end-date,
the MMIS is fully compliant, or whether
our final rule would require that the
IAPD provide that the MMIS actually
meet all standards and conditions by the
end of the transition period.
Response: We believe the commenter
is referring to the 36-month (now 38month) transition period that applies to
current MMISs receiving 75 percent FFP
for maintenance and operations. For this
purpose, States will have up to 38
months to submit an IAPD. This
transition period ensures that new
systems receiving Federal funding are
eventually designed in a manner that
results in the most efficient use of
technology. In reviewing APDs, we will
be considering individual State factors
such as budget, schedule and risk, and
we will be evaluating the State’s
proposed timeline and pathway in an
effort to ensure full compliance with the
standards and conditions at the earliest
opportunity.
F. Comments Regarding CMS’ Strategy
for Monitoring and Oversight, Including
Performance Reviews
Comment: One commenter asked
CMS to elaborate on how frequently the
agency will perform periodic reviews—
such as would reviews occur every 6
months, every year, or less frequently.
Response: We are not, at this time,
creating specific deadlines for the
periodic reviews. As mentioned earlier,
large systems transformations will be
needed in order to accomplish the
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requirements outlined in the Affordable
Care Act. As such, we plan to work with
States, and as systems are designed and
developed, we will be conducting
reviews on a continuous basis keeping
in mind the January 1, 2014 and
December 31, 2015 deadlines. We are
making no further revisions to the rule
as a result of this comment.
Comment: A few commenters
supported ‘‘the back-end review’’ of
MMIS solutions, including certification
and on-going performance monitoring.
Many commenters requested to see
more explicit details regarding
oversight, frequency of reporting, record
layout, and the specific performance
metrics CMS will use to ensure ongoing
successful performance. Other
commenters suggested a ‘‘modernized’’
approach to the performance of these
activities. Rather than basing the
processes on the 30-year old traditional
review of output, the commenters
suggested focusing on whether ‘‘the
implementation achieves the business
goals that the funding was supposed to
accomplish.’’ The commenters believed
that aligning these reviews to the goals
set forth in the approved planning
documents will result in solutions that
more closely align with program
objectives and will result in substantial
reductions in burdens for both State and
CMS staff.
Additionally, the commenters
requested clarification on whether CMS
is considering adopting a modular
certification process in order to
complement and align with the modular
system development process.
Response: We appreciate the support
for conducting periodic reviews of
MMISs. Our performance measures will
tie directly to the standards and
conditions that are being issued in this
final rule, and will be communicated to
States through subsequent documents.
We intend to publish performance
metrics in a Federal Register notice, and
then allow a period for public
comments. The performance results of
States and systems will be the primary
driver of the periodicity and intensity of
any CMS reviews. We also intend to
focus reviews on whole systems,
modules or components, based on those
results.
Comment: Many commenters asked
that CMS outline the expected
timeframe for setting up the
performance measures. Commenters
believed that the timeframe could
potentially impact the timeline for
planning, design, and implementation
of system enhancements for compliance.
The commenters proposed an alignment
of standards for ongoing review with
standards used to evaluate States’
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eligibility for enhanced funding, to
ensure that proposed systems
modifications lead to achieving
standards established for ongoing
monitoring.
Response: As stated above, we intend
to publish performance metrics in
subsequent notices, with a request for
comments. We will consult with States
and others prior to publishing metrics.
To guide States in their development
activities, we will issue a series of
documents in concert with or shortly
after publication of this rule, including
IT Guidance 2.0, sub-regulatory
guidance on complying with the seven
standards and conditions, and
instructions and protocols for APD
submission and review. MITA 3.0
guidance will follow later this year. We
emphasize to States that we expect to
see a highly iterative and fluid approach
to business process development,
blueprinting, specifications, and
development as we approach
implementation of the coverage
expansions and eligibility
simplifications within the Affordable
Care Act. We will give strong
recognition of the iterative and
collaborative approach and we intend to
support Affordable Care Act
implementation as we enforce the
standards and conditions in this rule.
G. Issues Related to Partial Systems
Improvements or Modernizations
Comment: One commenter
recommended that the requirement for
tracking ongoing progress should be
eliminated for enhancement(s) made to
address a specific requirement. These
may be reviewed for compliance, once
after implementation of enhancement,
and subsequently any time changes are
made that would impact the initial
enhancement.
Response: We disagree with the
commenter. To receive enhanced
funding, State systems must meet with
the standards and conditions outlined
in this rule. We expect that a key
outcome of our technology investments
is a much higher degree of interaction
and interoperability in order to
maximize value and minimize burden
and costs on providers, beneficiaries,
and States. Additionally, we wish to
ensure that enhanced FFP is approved
only when infrastructure and
application projects maximize the
extent to which they utilize current
technology development and
deployment practices and produce
reliable business outputs and outcomes.
Further, MITA principles also require
ongoing improvement—such that the
system continues to meet certain
milestones. Thus, States making
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enhancements to address a specific
requirement would, in accordance with
MITA principles, have to continue to
look to industry standards to ensure that
the enhancement is evolving along with
such standards. Tracking ongoing
progress is critical to success.
H. Specific Issues by Regulatory
Provision
Comment: One commenter noted that
CMS has removed the authority in
§ 433.110(a)(2)(iii) and § 433.130 to
provide for waivers of conditions of
approval, conditions of re-approval, and
FFP reductions in certain
circumstances. The commenter
expressed concern that removal of the
current waiver flexibility to take into
account State-specific circumstances
will increase the potential for loss of
enhanced Federal match with
catastrophic budget impact to States.
Response: We agree with the
commenter that language in sections
433.110(a)(2)(iii) and 433.130 is
removed. These sections implemented
section 1903(r) of the Act which
requires reductions in FFP due to a
State under section 1903(a) of the Act if
a State fails to meet certain deadlines for
operating a mechanized claims
processing and information retrieval
systems or if the system fails to meet
certain conditions of approval or reapproval. We determined it is necessary
to delete the waiver authority in
§ 433.110(a)(2)(iii) and § 433.130 since it
is redundant and we noted in the
preamble of the proposed rule to make
conforming changes to 42 CFR part 433,
subpart C in an effort to remove
redundancy. We have, however,
retained the authority in § 433.131
which provides for waivers of an FFP
reduction in certain circumstances if the
State is unable to comply with the
conditions of approval or of reapproval.
Comment: One commenter requests
that we clarify whether the intent of
striking § 433.111(b)(3) includes
deleting approved enhancements to
mechanized systems, including claims
processing and information retrieval
systems, rather than merely removing
the exclusion for eligibility
determination systems.
Response: To clarify the striking of
§ 433.111(b)(3), we intended to
specifically remove the language
indicating that eligibility determination
systems are not part of mechanized
claims processing and information
retrieval systems. However, in doing so,
we realized that some may question our
removal of the language in
§ 433.111(b)(3) relating to
enhancements; and since we agree with
the commenter that enhancements are
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necessary to ensure that technology
continues to improve, we are revising
the regulation text in this final rule to
include this language relating to
enhancements.
Comment: One commenter remarked
that in § 433.112, we have linked
paragraph (a) with paragraph (c) thus
creating, in the commenter’s view, the
elimination of the current opportunity
for enhanced FFP at 90 percent for
MMIS development and enhancements.
The commenter believed that we have
failed to recognize the true status of
States’ claims processing systems and
future evolution.
Response: We disagree with the
commenter. While States will continue
to have an opportunity to receive
enhanced FFP at 90 percent for most
MMIS development and enhancements,
assuming such systems meet the
regulatory standards and conditions,
§ 433.112(c) simply indicates the more
limited rule for eligibility determination
systems that funding at enhanced rates
will not be available for the design,
development, installation or
enhancement of such State eligibility
determination systems after December
31, 2015. However, this deadline
applies only to the eligibility
component of MMIS, not the entire
MMIS.
Comment: One commenter is
concerned that we have not clearly
defined the regulatory requirements
specified in § 433.112(b)(10), (11), and
(13) through (16) and that these
regulatory requirements lack explicit
and nationally-recognized standards for
measuring achievement.
Response: In proposing the 7
standards and conditions that States
must meet in order to receive enhanced
funding, we included information as to
the importance of each of the standards
and conditions. In addition, in some
cases, we provided examples of how we
will ensure that State systems meet the
standards and conditions. For example,
for the standard and condition that
speaks to promoting sharing, leverage,
and reuse of Medicaid technologies and
systems within and among States, we
specified that we would examine APDs
to ensure that States make appropriate
use and reuse of components and
technologies available off the shelf or
with minimal customization to
maximize return on investment and
minimize project risk. Further, we
indicated in the proposed rule that we
intend to issue further interpretations
regarding each standard. In our
preamble, we also provided an example
of measurement; that is; we indicated
that we would measure how a system
meets requirements for providing
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notices to beneficiaries, claims, and
applications and renewals, proper
determinations, and experience with
appeals, interoperability with
Exchanges, as well as traditional
systems standards such as availability
and down time. Thus, while we have
provided detailed information regarding
the standards and conditions, we also
recognize that future interpretations will
be forthcoming. We intend to ensure
that any such interpretations, as well as
performance metrics, are developed
with input from the State agencies. As
stated above, for performance measures,
we will publish such measures in a
Federal Register notice and provide for
a period of comment.
Comment: One commenter requested
that we reinstate the stepped down
reduction in FFP that was outlined in
§ 433.113 prior to our proposed rule and
eliminate the 25 percent reduction
proposed in § 433.119 should there be a
decertification action.
Response: We do not believe we have
the authority to provide for the stepped
down reductions in FFP as previously
outlined in § 433.113. The specific
authority to provide such stepped down
reductions that previously existed in
section 1903(r) of the Act was repealed
by section 4753 of BBA. However, as
explained elsewhere in preamble, we do
have the authority to, on the basis of our
review, determine that a system is no
longer leading to more effective,
efficient, or economical operation of the
State plan, under section 1903(a)(3) of
the Act, and therefore, to remove the
enhanced FFP.
Comment: One commenter asks CMS
to reconsider the proposed limit on the
opportunity for enhanced funding at 75
percent for eligibility determination
systems operation to only those systems
approved prior to December 31, 2015.
The commenter believed that the new
standards and conditions listed in
§ 433.112 coupled with the typical
timeframes for design, development,
and implementation make it unlikely
that the majority of States will achieve
approval by the specified date.
Response: We disagree with the
commenter. As stated elsewhere in this
preamble, the Affordable Care Act
requires that eligibility changes be in
place by January 1, 2014, and we have
already provided an additional 2 years
beyond that date for States to meet the
standards and conditions for enhanced
funding for design, development, or
installation.
Comment: One commenter requested
that CMS reinstate the criteria
previously listed in § 433.120(b)
indicating that any reductions in FFP
would be tied to a reasoned
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determination that a system is failing to
meet certification requirements in a
significant manner.
Response: First, we are clarifying that
any deficiencies found as the result of
future reviews would be subject to a
period of corrective action before
making a determination that enhanced
FFP would be discontinued.
Additionally, while we will be issuing
future guidance regarding the specific
performance review measurements, we
do agree that it is likely that enhanced
FFP would only be discontinued in
situations where the system is failing to
meet the standards and conditions in a
significant manner.
I. Issues Related to the Regulatory
Impact Analysis, Including the Cost
Estimates, and Information Collection
Comment: One commenter stated that
CMS underestimated States’ eligibility
system replacement costs. The
commenter pointed out that the impact
analysis assumes that new systems, on
average, would cost $50 million over 3
years for each State and that assumption
includes design, development, and
implementation. The commenter
indicated that one State’s plan to
modernize/replace their Medicaid
Eligibility System cost a total of $200
million over the course of 4 years.
Response: In the Regulatory Impact
Analysis of the proposed rule, we
outlined the uncertainty surrounding
the assumptions and associated cost
estimates relating to the expenditures
for the necessary technology,
innovation, and implementation
requirements. This uncertainty not only
included recognizing the difficulty
surrounding the extent of the necessary
technology advancements, but how
these changes would affect State
systems. We concluded that time,
money, resources, and considerable
effort would be necessary for States to
make changes to their current
technology. Our estimates also
accounted for the additional uncertainty
surrounding the rate of adoption for
States to make necessary changes in the
proposed rule. As a result of the
uncertainty in our assumptions
surrounding State behavior, including
adoption rates and the associated costs
for implementing new systems within
the timeframe assessed, we presented
our concluding aggregate cost estimates
within a 25 percent lower and upper
range. This allowed us to reflect a larger
cost estimate range, so that both States
throughout the lower to higher bands of
expenditures may be reflected.
In further substantiating the initial
estimates, our experience regarding
State costs for eligibility systems is
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based on considerably larger integrated
systems involving SNAP and ACF
programs, of which Medicaid typically
has a 30 to 45 percent share based on
how States choose to allocate costs.
Thus, we recognize that total system
costs may be higher than the $50
million (total computable Medicaid
costs) originally estimated, but the
specific Medicaid share of those costs
reflects a portion of the total; that is, on
average $50 million (total computable).
The focus of our estimates for this rule
is strictly Medicaid costs and not total
system costs. Furthermore, we recognize
larger States may have higher costs,
while smaller States may experience
lower costs. The $50 million estimate is
our best effort to estimate the midpoint
for the Medicaid-only costs, with the
estimated majority of States
experiencing costs somewhere within
the 25 percent lower to upper cost range
provided in the regulatory impact
analysis. As a result, we are not making
revisions to the Regulatory Impact
Analysis or associated cost estimates as
a result of this comment.
Comment: One commenter noted that
we indicate there are no additional
information collection requirements;
however, the commenter questioned the
evolving certification requirements and
asked if this means that additional
information collection will be
necessary.
Response: We considered that
additional data may be necessary in
terms of the performance measurements
and compliance with our standards and
conditions. However, we believe this
process will be part and parcel to the
APD process; that is, we believe that
States will submit information to us as
part of the APDs. We indicated in our
proposed rule that States already submit
to us for review and approval APDs for
funding for automated data processing
in accordance with Federal regulations
at 45 CFR Part 95, Subpart F. However,
we agree with the commenter that any
new APDs for Medicaid systems that
perform eligibility and enrollment
functions will need to address the
requirements of this final rule.
Consequently, we developed an
expedited APD checklist specific to the
purposes of this rule and submitted to
OMB for review and approval the
burden associated with the information
collection.
IV. Provisions of the Final Regulations
After consideration of the comments
reviewed and further analysis of specific
issues, with a few modifications, we are
adopting the provisions of the
November 8, 2010 proposed rule as
final.
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Specifically, we are finalizing the
following provisions:
A. Medicaid Eligibility Determinations
In § 433.112, we have revised the
definitions such that Medicaid
eligibility determinations will be
considered ‘‘claims’’ of eligibility and
Medicaid eligibility determination
systems are potentially eligible for the
enhanced 90 and 75 percent FFP under
section 1903(a)(3) of the Act. This final
policy will apply only upon the
effective date of this final rule.
Additionally, enhanced FFP does not
eliminate the responsibility of States to
ensure compliance with cost allocation
principles outlined in OMB Circular A–
87.
Further, enhanced FFP at the 90
percent rate for design, development,
installation, or enhancement of
eligibility determination systems will be
available for State expenditures only
through calendar year (CY) 2015, even
if work on approved APDs continues
after 2015. Enhanced FFP at the 75
percent rate to maintain and operate
systems that previously qualified for 90
percent FFP will be available after 2015
if those systems continue to meet the
requirements specified in this final rule.
Additionally, enhanced funding at 75
percent to maintain and operate systems
meeting the standards and conditions is
available prior to December 31, 2015,
(but after the effective date of any final
rule), in recognition of the fact that
some States may have already invested
in improvements that will allow
systems to qualify without the need for
additional enhanced development,
design, installation or enhancement
funding. For any State receiving
enhanced FFP at 90 percent or 75
percent prior to December 31, 2015,
systems must continue to meet the
requirements, standards and conditions
specified in this rule in order to
continue receiving 75 percent enhanced
funding after December 31, 2015.
We are limiting the timeframe for
which enhanced 90 percent FFP is
available for design, development,
installation or enhancement of
automated eligibility systems because
we view the changes made by the
Affordable Care Act for the new
eligibility rules in Medicaid as requiring
an immediate, substantial commitment
to, and investment in, technologies. In
order words, we expect that changes to
State systems will be completed with
the start of the new Affordable Care Act
provisions and support the operation of
Exchanges on January 1, 2014. However,
we realize that States may need to make
additional changes to State systems to
provide for additional functionality in
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support of Medicaid eligibility rule
modifications. Thus, we are providing
for an additional 2 years of 90 percent
enhanced FFP so that States’ systems
would have additional time to ensure
the peak performance of their systems.
States would need to incur costs for
goods and services furnished no later
than December 31, 2015 to receive 90
percent FFP for the design,
development, installation or
enhancement of an eligibility
determination system. This would mean
that if an amount has been obligated by
December 31, 2015, but the good or
service has not yet been furnished by
that date, then such expenditure would
not be eligible for enhanced FFP.
Further, we are limiting the availability
of 75 percent enhanced funding for
maintenance and operations to those
eligibility determination systems that
have complied with the standards and
conditions in this rule by December 31,
2015.
B. Standards and Conditions for
Receiving Enhanced Funding
Under sections 1903(a)(3)(A)(i) and
1903(a)(3)(B) of the Act, we are
delineating standards and conditions
that must be met by States in order for
their Medicaid technology investments
(including traditional claims processing
systems, as well as eligibility systems)
to be eligible for the enhanced match.
These authorities provide that the
enhanced FFP of 90 percent is not
available unless the Secretary
determines that a system is ‘‘likely to
provide more efficient, economical, and
effective administration of the plan’’ as
described in section 1903(a)(3)(A)(i) of
the Act. Similarly, section 1903(a)(3)(B)
of the Act specifies that enhanced FFP
of 75 percent is not available for
maintenance or operations unless the
system is ‘‘of the type described in
subparagraph (A)(i)’’ and is approved by
the Secretary.
We define MITA at § 433.111(c) and
we build on the work of MITA by
codifying that enhanced FFP (either at
the 90 percent rate for design,
development, installation or
enhancement; or at the 75 percent rate
for maintenance and operations) is only
available when certain standards and
conditions are met. Specifically, we
articulate a set of standards and
conditions that States must commit to in
order to receive enhanced FFP:
• Use of a modular, flexible approach
to systems development, including the
use of open interfaces and exposed
application programming interfaces; the
separation of business rules from core
programming; and the availability of
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business rules in both human and
machine readable formats.
• Align to and advance increasingly
in MITA maturity for business,
architecture, and data.
• Ensure alignment with, and
incorporation of, industry standards: the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
security, privacy and transaction
standards; accessibility standards
established under section 508 of the
Rehabilitation Act, or standards that
provide greater accessibility for
individuals with disabilities, and
compliance with Federal civil rights
laws; standards adopted by the
Secretary under section 1104 of the
Affordable Care Act; and standards and
protocols adopted by the Secretary
under section 1561 of the Affordable
Care Act.
• Promote sharing, leverage, and
reuse of Medicaid technologies and
systems within and among States.
• Support accurate and timely
processing of claims (including claims
of eligibility), adjudications, and
effective communications with
providers, beneficiaries, and the public.
• Produce transaction data, reports,
and performance information that
would contribute to program evaluation,
continuous improvement in business
operations, and transparency and
accountability.
• Ensure seamless coordination and
integration with the Exchange (whether
run by the State or Federal government),
and allow interoperability with health
information exchanges, public health
agencies, human services programs, and
community organizations providing
outreach and enrollment assistance
services.
To ensure that States have an
opportunity to come into compliance
with these requirements, the States
currently receiving enhanced FFP for
MMIS will have a period of transition to
come into compliance with the
standards and conditions listed above.
Under our schedule, the following
transition periods will apply:
• For new MMIS development (new
APDs requesting 90 percent FFP for
design, development, installation, and
enhancement): No transition period.
• For MMIS development already
underway (approved APDs providing 90
percent enhanced FFP): 14-month
transition period (beginning with the
effective date of this final rule) in which
to submit an updated Implementation
APD (IAPD) detailing how systems will
be modified to meet the required
conditions and standards.
• For maintenance and operations of
MMIS currently receiving 75 percent
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FFP: 38-month transition period
(beginning with the effective date of this
final rule) in which to submit an IAPD
with plans to upgrade or modify
systems to meet the required conditions
and standards.
• Eligibility systems (currently
receiving 50 percent for development
and maintenance and operations):
Because eligibility systems are not
currently receiving enhanced funding,
there is no transition period and no
need for a transition period for new
requests for enhanced funding for
eligibility systems. Any APDs
requesting enhanced funding for
eligibility systems funding following the
effective date of this regulation will
have to meet the standards and
conditions above. States with eligibility
systems currently under development
(approved APDs providing 50 percent
FFP) can update their APDs to reflect
how they will comply with these
standards and conditions in order to
begin receiving 90 percent FFP.
Similarly, eligibility systems currently
receiving 50 percent FFP for State
expenditures will need to comply with
our final standards and conditions to
receive a 75-percent FFP.
Our standards and conditions will be
enforced through both front-end and
back-end review processes. Front-end
review will entail APD review and prior
approval processes where States apply
for enhanced match before entering into
IT investment projects. Back-end
reviews will entail certifications of the
systems capabilities, as well as ongoing
performance monitoring.
C. Reviews and Performance Monitoring
of MMISs
In this final rule, we are also
reinstituting periodic performance
reviews of MMISs (including eligibility
determination systems receiving
enhanced funding). Our reviews will
focus on performance measures we set
to determine whether States are meeting
the standards and conditions in this
final rule. For example, we will measure
how a system meets requirements for
providing notices to beneficiaries,
claims and applications intake and
acceptance, efficient timely and
accurate processing of claims,
applications and renewals, proper
determinations, and experience with
appeals, interoperability with
Exchanges, as well as traditional
systems standards such as availability
and down time. We expect to see such
data automatically generated by the
systems in which we invest, with
standards and conditions established in
consultation with States and
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21967
stakeholders, and based on industry
experience.
Additionally, we will evaluate
systems based upon their
interoperability with other Federal and
State health programs. Thus, in
operating their systems, States will need
to ensure that they consult documents
articulating the Department’s strategy on
interoperability, such as the Guidance
for Exchange and Medicaid Information
Technology Systems.
Any failures or deficiencies will be
the basis for investigation and
opportunity for corrective action before
making a determination that enhanced
FFP will be discontinued.
To reflect the passage of the BBA, we
have modified § 433.119 through
§ 433.121 to eliminate any reference to
Systems Performance Reviews (SPRs)
but, more importantly, to reflect the
requirements for performance
monitoring and review.
D. Partial Systems Improvements or
Modernizations
As discussed in response to comment,
as well as in the proposed rule, in
referring to ‘‘system’’ or ‘‘technology,’’ we
recognize that States will likely use a
system of systems in support of MMIS
functions. States submitting partial
system updates will need to submit and
have an approved roadmap for
achieving full compliance with the
standards and conditions in the
regulation. We will track progress
against an approved roadmap when
determining if system updates meet the
standards and conditions for the
enhanced match. For enhancements
intended to satisfy a specific
requirement or to address a compliance
issue, for example, ICD–10 or
implementation of the National Correct
Coding Initiative, our final policy is that
States making enhancements to address
a specific requirement would have to
continue to make improvements and
continue to look to industry standards
to ensure that the enhancement is
evolving along with such standards.
E. Changes to Federal Regulations at 42
CFR Part 433 Subpart C—Mechanized
Claims Processing and Information
Retrieval Systems
We are deleting § 433.113 (referencing
the need to have mechanized claims
processing and information retrieval
systems by a certain deadline, or face
reduced Federal Medicaid funds as a
consequence) and § 433.130 (referencing
waiver provisions for qualifying States
with a certain 1976 population and
expenditures). We have also deleted
various cross-references to these
provisions.
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We have also made conforming
amendments to various provisions in
part 433, subpart C to conform to our
final policy that eligibility
determination systems may now be
considered part of mechanized claims
processing and information retrieval
systems. We have eliminated the
statement in the current § 433.111(b)(3)
that ‘‘Eligibility determination systems
are not part of mechanized claims
processing and information retrieval
systems or enhancements to those
systems.’’ In response to comments we
have reinserted language in
§ 433.111(b)(3) to include information
regarding approved enhancements to
mechanized systems, including claims
processing and information retrieval
systems. We have also eliminated the
provision at § 433.112(c), which
currently states that ‘‘eligibility
determination systems are not part of
mechanized claims processing and
information retrieval systems and are
not eligible for 75 percent FFP under
this Subpart. These systems are also not
eligible for 90 percent FFP for any APD
approved after November 13, 1989.’’ We
have replaced this with language
making clear that 90 percent FFP for the
design, development, installation, or
enhancement of an eligibility
determination system is available only
before December 31, 2015, even if work
on an approved APD continues after
2015. In this final rule, we also are
amending the regulation to make clear
that States will need to incur costs for
goods and services furnished no later
than December 31, 2015 to receive
90 percent FFP for the design,
development, installation, or
enhancement of an eligibility
determination system. We are also
codifying in this final rule that FFP at
75 percent is not available for eligibility
determination systems that do not meet
the standards and conditions by
December 31, 2015.
States will be required to supply
information and demonstrate
consideration of the standards and
conditions to CMS for review and
approval and as part of the APD before
we will grant approval of enhanced
funding. We will scrutinize all
investments and will decline to approve
enhanced funding (resulting in 50
percent FFP) that do not demonstrate
careful consideration and application of
these standards and conditions.
V. Waiver of Delay in Effective Date
Section 553(d) of the Administrative
Procedure Act (APA) (5 U.S.C. 553(d))
ordinarily requires a 30-day delay in the
effective date of final rules after the date
of their publication. In addition, the
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Congressional Review Act at 5 U.S.C.
801, requires a major rule to take effect
no earlier than 60 days after the date the
rule is published in the Federal
Register. Both the 30- and 60-day delays
in effective date can be waived,
however, if an agency finds for good
cause that the delay is impracticable,
unnecessary, or contrary to the public
interest, and the agency incorporates a
statement of the findings and its reasons
in the rule issued. 8 U.S.C. 808(2).
We find that it is both unnecessary
and contrary to the public interest to
delay the effective date of this final rule.
This rule is altering the definition of a
mechanized claims processing and
information retrieval system, such that
the definition will now include
automated eligibility determination
systems. As a result, enhanced Federal
funding should be available to States
that seek to alter their systems, or that
have already altered their systems, in a
manner that meets all of our
requirements.
We believe it is in the public interest
to immediately ensure the availability of
such enhanced funding, so that States
are able to begin the process of altering
their systems as soon as possible. States
will be required to have systems in
place that comply with the Affordable
Care Act by the beginning of 2014, and
the sooner States are able to start relying
on Federal funding to begin
modernizing their systems, the more
likely they will be able to meet these
deadlines. In addition, at least a few
States already have systems that would
comply with all of our standards and
conditions. Therefore, an immediate
effective date would allow such States
to receive funding immediately to
support such modernization efforts. For
these reasons, it would be contrary to
the public interest to delay the
availability of enhanced funding.
In addition, given that States will
have a period of time to come into
compliance with the terms and
conditions we have promulgated in this
final rule, it is unnecessary to delay an
effective date, as an immediate effective
date will not require any State to
immediately alter its systems. Rather,
for eligibility determination systems, the
rule simply conditions enhanced
funding on States being in compliance
with the terms and conditions of this
final rule—but there is no immediate
requirement that systems change. For
current MMISs already receiving
enhanced funding, the rule does impose
new terms and conditions to continue
the receipt of such enhanced funding,
but a transition period is built in to
allow States time to comply and this
transition period has been extended by
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2 months to account for the immediate
effective date in this final rule.
For the above reasons, we find good
cause, based on both public interest,
and lack of necessity for a delayed
effective date, to waive both the 30- and
60-day delayed effective dates and to
make this rule effective upon
publication.
VI. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide
60-day notice in the Federal Register
and solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
The changes specified in this final
rule impose new reporting,
recordkeeping or disclosure
requirements for submission of APDs.
Initially, we indicated that States
already submit to us for review and
approval APDs for funding for
automated data processing in
accordance with Federal regulations at
45 CFR Part 95, Subpart F. We noted,
however, in section III.I. of this final
rule that we received one comment on
the burden associated with this final
rule. As a result of review of this
comment and the development of a new
expedited ADP checklist specific to the
purposes of this final rule, we are
seeking emergency review and approval
from OMB in order for the expedited
APD checklist to be available to States
at the time this rule becomes effective.
In addition, we are soliciting public
comments on the information
collections and associated burden
contained in this final rule.
An Expedited Eligibility and
Enrollment (E&E)—APD checklist
(CMS–10385; OMB number 0938–NEW)
has been developed for States that
participate in Early Innovator grants or
Establishment grants to complete and
submit to CMS for review and prior
approval in order to receive enhanced
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federal funding for Medicaid
Information Technology (IT) system(s)
projects related to eligibility and
enrollment functions.
Specifically, this checklist:
(1) Guides States in obtaining prior
approval to secure 90 percent Federal
financial participation (FFP) for the
design, development, implementation
(DDI), and/or enhancements of a
system(s); and 75 percent FFP for
maintenance and operations [42 CFR
§ 433 Subpart C].
(2) Contains Seven Standards &
Conditions that the State’s APD must
meet.
(3) Contains Federal requirements for
both Planning and Implementation
activities of an APD [45 CFR part 95
subpart F (Revised October 28, 2010)].
(4) Streamlines the process for States
by requiring fewer documents, as well
as potentially shortening the review
timeframe for CMS, and if applicable,
other Agencies, of system projects
related to the Affordable Care Act.
Although Federal Regulations allow up
to 60 days for APD approvals, our goal
is to provide an approval within 30
business days upon receipt.
We estimate that there are 56 State
Medicaid programs (including the
District of Columbia and 5 territories)
and that it will take approximately 5
hours for each State program to
complete the APD template with the
21969
requested information which in
aggregate will take 280 total hours to
complete one checklist, and 840 total
hours to complete the anticipated
average response of 3 per Medicaid
program. We reviewed 2009 National
Labor Statistics and speculate that the
job role of Management Analyst (13–
1111) with a mean hourly wage estimate
rate of $40.70 would be completing the
data for the template. Based on these
estimates, the total cost to complete the
APD template would be $2,279.20 (15
hours × hourly rate of 40.70 = 610.50 ×
56 programs = $34,188.00). We
acknowledge that there are uncertainties
regarding these burden estimates.
ESTIMATED ANNUAL REPORTING BURDEN REPORTING
[States]
Estimated
number of
respondents
Frequency of
responses
Average
number of
annual
responses
Average
burden per
response
(hours)
Annual
burden hours
42 CFR Part 433 Subpart C
and 45 CFR Part 95 Subpart F.
56
3
168
5
840
.............................................
56
3
168
5
840
Section
States that participate in
Early Innovator grants or
Establishment grants
complete expedited
checklist.
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Total .............................
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access our Web site at
https://www.cms.gov/
PaperworkReductionActof1995/PRAL/
list.asp#TopOfPage or e-mail your
request, including your address, phone
number, OMB number, and CMS
document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office at 410–786–
1326.
In commenting on the information
collections please reference the
document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by June 20, 2011:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
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Security Boulevard, Baltimore,
Maryland 21244–1850.
VII. Regulatory Impact Analysis
A. Statement of Need
This regulation is important, since
with the passage of the Affordable Care
Act, we expect that changes to eligibility
policies and business processes will
need to be adopted. System
transformations will be needed in most
States to apply new rules to adjudicate
eligibility for the program; enroll
millions of newly eligible individuals
through multiple channels; renew
eligibility for existing enrollees; operate
seamlessly with newly authorized
Health Insurance Exchanges
(‘‘Exchanges’’); participate in a system to
verify information from applicants
electronically; incorporate a streamlined
application used to apply for multiple
sources of coverage and financial
assistance; and produce notices and
communications to applicants and
beneficiaries concerning the process,
outcomes, and their rights to dispute or
appeal.
We wish to ensure that a key outcome
of our technology investments is a much
higher degree of interaction and
interoperability in order to maximize
value and minimize burden and costs
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on providers, beneficiaries, and States.
Thus, we are committed to providing 90
percent FFP for design, development,
and installation of eligibility
determination systems through CY 2015
or 75 percent FFP for maintenance and
operations of such systems that meet the
new regulatory requirements. We have
provided that States must commit to a
set of standards and conditions to
receive the enhanced FFP. This
enhanced FFP reduces the financial
burden on States to 10 percent of the
costs compared to the 50 percent
financial burden currently in place and
ensures that States utilize current
technology development and
deployment practices and produce
reliable business outputs and outcomes.
B. Overall Impact
The estimated costs of the Federalshare for Medicaid administration have
been reflected in the FY 2012
President’s Budget.
We have examined the impact of this
final rule as required by Executive
Order 12866 (September 30, 1993,
Regulatory Planning and Review),
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011), the Regulatory
Flexibility Act (September 19, 1980;
Pub. L. 96–354) (RFA), section 1102(b)
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Federal Register / Vol. 76, No. 75 / Tuesday, April 19, 2011 / Rules and Regulations
of the Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (March
22, 1995; Pub. L. 104–4), Executive
Order 13132 on Federalism (August 4,
1999), and the Congressional Review
Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. A
regulatory impact analysis (RIA) must
be prepared for rules with economically
significant effects ($100 million or more
in any 1 year). This final rule is
anticipated to have an annual effect on
the economy of $100 million or more,
making it an economically significant
rule under the Executive Order 12866
and hence a major rule under the
Congressional Review Act. Accordingly,
we have prepared a RIA that to the best
of our ability presents the costs and
benefits of this final rule.
States will continue to receive the
traditional 50 percent FFP for
reasonable administrative expenditures
for designing, developing, installing, or
enhancing the Medicaid portion of their
integrated eligibility determination
systems. Similarly, States will continue
to receive 50 percent FFP for
expenditures associated with the
maintenance and operation of such
systems.
This final rule, however, addresses
the impact related to enhanced FFP for
mechanized claims processing and
information retrieval systems, including
those that perform eligibility
determination and enrollment activities,
as well as the Medicaid portion of
integrated eligibility determination
systems that the Secretary determines
are likely to provide more efficient,
economical, and effective
administration of the State plan.
In projecting the impact to the Federal
government and State Medicaid
agencies, we considered how the
standards and conditions on MMIS and
the availability of enhanced match for
State eligibility systems through CY
2015 will impact State investments over
the 10-year period of 2011 through
2020. As discussed in section VI.C of
this final rule, we considered the
expected costs to the Federal
government of providing the enhanced
match rate, changes in State investments
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due to the application of standards and
conditions on MMIS (including
eligibility systems), and possible savings
as a result of the use of more modern,
reusable, and efficient technologies.
C. Potential Savings
We considered a number of ways in
which application of the standards and
conditions, including increased use of
MITA, could result in savings; however,
as no States have yet reached MITA
maturity, it is difficult to predict the
savings that may accrue over any certain
timeframe. These areas include the
following:
(1) Modular technology solutions: As
States, or groups of States, will begin to
develop ‘‘modular’’ technology
solutions, these solutions will be used
by others through a ‘‘plug and play’’
approach, in which pieces of a new
MMIS will not need to be reinvented
from scratch every time, but rather,
could be incorporated into the MMIS
framework. We assume that savings
associated with reusable technology
could be achieved in both the
development and operation of new
systems. We expect that States will
dispense with the need to engage in
significant requirements analyses and
the need to pay for new modules to be
built when there are successful models
around the country that they can draw
down from a ‘‘technology bank’’
maintained by the Federal or State
governments.
(2) Increased use of industry
standards and open source technologies:
While HIPAA administrative transaction
standards have existed for 5 to 7 years,
use of more specific industry standards
to build new systems will allow such
systems to exchange information
seamlessly—a major goal of the
Affordable Care Act, and one that is the
explicit purpose of the standards work
envisioned within section 1561 of the
Act. We also believe that more open
source technology will encourage the
development of software solutions that
address the needs of a variety of diverse
activities—such as eligibility, member
enrollment, and pharmacy analysis of
drug claims. Software that is sufficiently
flexible to meet different needs and
perform different functions could result
in cost savings, as States are able to use
the systems without making major
adaptations to them.
(3) Maintenance and operations: As
States take up the changes in this final
rule, the maintenance/operation costs of
new systems should decrease. Less
maintenance should be required than
that necessary to reengineer special,
highly customized systems every time
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there is a new regulatory or legal
requirement.
(4) Reengineering business processes,
more Web-based solutions, serviceoriented architecture (SOA): Savings are
likely to result from the modular design
and operation of systems, combined
with use of standardized business
processes, as States are compelled to
rethink and streamline processes as a
result of greater reliance on technology.
D. Calculation of MMIS Costs
MMIS costs are estimated at
approximately $10.0 billion over the 5year budget window and $23.0 billion
over the 10-year budget window. These
costs represent only the Federal share.
To calculate the impact of the
regulation on MMIS costs, we assumed
that new systems on average will cost
$150 million over 3 years for each State
($50 million total cost per year, or $45
million Federal costs at 90 percent FFP
per year). We have identified that ten
States have sophisticated systems that
are very close to meeting the
implemented regulation standards. As a
result, we assumed the remaining 41
States will have approved APDs in place
to replace or update their MMIS
between FY 2011 and FY 2013 to
comply with the new regulation
standards and conditions.
We assumed that the States
modernizing earlier in the cycle will see
increased development, design, and
installation costs, whereas States
moving later will see increased
development, design, and installation
savings as they are able to take
advantage of efficiencies gained by the
early adopter States. Specifically, for
those States that update or build new
systems in FY 2011 and FY 2012, we
assumed a 10 percent annual cost
increase to new MMIS systems for
design, development, and installation.
For those States that build new systems
in FY 2013 and FY 2014, we assumed
a 5 percent annual savings to new MMIS
systems for design, development, and
installation. While it is difficult to
predict State behavior, we believe all
States will comply with the standards
and conditions in this regulation to
receive the 90 percent FFP, and have
assumed that for the purpose of these
estimates.
For maintenance, we assumed those
States that have implemented the new
regulation requirements would see a 20
percent annual savings, and for
operations, we assumed those States
that have implemented the new
regulation requirements would see a 5
percent annual savings.
Based on these assumptions, we
estimate the net Federal budgetary
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impact on baseline MMIS costs from FY
2011 through 2015 of implementing the
new regulation is approximately $1.1
billion, and the net Federal budgetary
impact from FY 2011 through 2020 is
approximately $557 million in savings.
E. Calculation of Eligibility Systems
Costs
For eligibility systems, we applied the
same methodology we used to calculate
net Federal costs to MMIS under the
new regulation.
To meet the requirements of the
Affordable Care Act, States would have
to build new systems or modernize
existing systems. Most States will add
new functionalities to interface with the
Exchanges and implement new
adaptability standards and conditions
(such as incorporation of new mandated
eligibility categories). We assume
baseline costs for development, design,
and installation at 50 percent FFP for all
States are approximately $815 million
from FY 2011 through 2015 and $1.1
billion from FY 2011 through 2020.
Eligibility systems costs for
maintenance and operations at 50
percent for all States are approximately
$1.2 billion from FY 2011 through 2015
and $2.7 billion from FY 2011 through
2020. These costs represent only the
Federal share.
To calculate the impact of the
implemented regulation, we assumed
that new systems on average will cost
$50 million over 3 years for each State
($16.7 million total cost per year, or $15
million Federal costs at 90 percent FFP
per year). We assumed that 25 States
will replace their eligibility systems in
FY 2011 through CY 2015. We assumed
no States will build new systems past
FY 2014 (beyond what is assumed in the
baseline) due to the timing of the start
of major coverage provisions in the
Affordable Care Act, the length of time
needed to build new systems
(approximately 3 years), and the
enhanced match ending after CY 2015.
For maintenance, we assumed States
that have implemented new systems
meeting the required standards and
conditions will see a 20 percent annual
savings, and for operations, we assumed
those States that have implemented the
new systems would see a 5 percent
annual savings. These assumptions are
consistent with our approach for savings
under MMIS in the regulation.
The net Federal cost impact from FY
2011 through 2015 of implementing our
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regulation on eligibility systems is
approximately $2.2 billion, and the net
Federal cost from FY 2011 through 2020
is $2.9 billion. These costs represent
only the Federal share.
F. Total Net Cost Impact
Combining the impact of the
regulation, the total net Federal cost
impact is approximately $3.3 billion for
FY 2011 through 2015 and
approximately $2.3 billion for FY 2011
through 2020. We see lower costs over
the 10-year budget window due to the
increased savings to MMIS over time.
Aligned with these Federal net costs,
States will see a corresponding decrease
in their net State share due to the
enhanced Federal match for eligibility
systems they will receive through CY
2015 and the benefits accrued to their
systems by putting in place the set of
standards and conditions articulated in
our regulation. Combining the impact of
the regulation, the total net State budget
impact is approximately $792.5 million
in savings for FY 2011 through 2015 and
approximately $1.9 billion in savings
from for FY 2011 through 2020. Similar
to the Federal budget impact, we expect
to see higher savings achieved by States
over the 10-year budget window due to
the increased savings to MMIS over
time.
The projections in this analysis are
subject to considerable uncertainty, as
they reflect projected costs based on
technology and innovation. While we
believe that advancements in
technology will likely have an impact
on States’ systems, it is difficult to
predict with certainty how significant
the technology advancements may be
and how they would affect State
systems. For example, we have worked
for many years developing the MITA
maturity model. We believe that States
should adopt the MITA framework as
the basis for all MMIS replacements and
major system upgrades related to the
MMIS, and while we are requiring that
States move to a MITA framework in
order to receive enhanced funding, to
date there are no States that have
reached full MITA maturity.
Consequently, having no States at full
MITA maturity indicates that it takes
time, money, and considerable effort for
States to make changes to their current
technology.
Additional uncertainty exists because
we are unsure of the rate of adoption for
States to make the changes in this final
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rule. The enhanced FFP is available for
approximately 5 years, from CY 2011
through CY 2015, and States could
upgrade or replace their systems at any
point within the 5-year period. Further,
States may simply choose to make
moderate changes to existing systems,
and even with the 90 and 75 percent
enhanced FFP, such moderate changes
could be less costly overall for States
than replacing their systems.
Additional uncertainty exists about
the rate of State adoption since some
States may consider the costs needed to
move to a more advanced system to be
too high to undertake such a project.
Similarly, States may decide not to
make changes due to implementation of
performance requirements and the
performance reviews.
We acknowledge that there are
uncertainties regarding our
assumptions, including State behavior,
and the associated cost estimates with
respect to States implementing new
systems within the timeframe assessed.
However, we have offered our estimates
with a 25 percent upper and lower range
to capture such uncertainty in actual
implementation outcomes. Due to a
number of uncertainties in our
assumptions, we believe a range of
estimates better represents the net cost
impact of this regulation. Tables 1 and
2 represent a 25 percent range for these
aggregate net costs to the Federal and
State government, respectively. It is
important to point out that we believe
that systems transformation is necessary
to meet the vision of the Affordable Care
Act and consequently, these costs are
necessary and will provide for efficient
systems that in the end will provide for
more efficient and effective
administration of the State plan. The
separate impacts to MMIS and eligibility
systems are summarized below.
TABLE 1—NET FEDERAL COST IMPACT
OF REGULATION
[Dollars in millions] *
FY 2011–2020
MMIS (excluding eligibility) ...................
Eligibility Systems .....
(417.4)–(695.7)
2,154.6–3,591.0
Total ...................
1,737.2–2,895.3
* Numbers in parentheses represent savings
to the Federal government.
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TABLE 1.1—NET FEDERAL COST IMPACT OF REGULATION BY FISCAL YEAR
[Dollars in millions] *
2011
2012
MMIS (excluding Eligibility) ..............
Eligibility Systems ............................
231.1
328.9
469.4
436.7
Total ..........................................
560.0
906.1
2014
2015
2016
2017
2018
2019
2020
2011–
2020
435.6
634.6
54.3
469.3
(83.0)
337.4
(322.6)
127.9
(329.0)
130.5
(333.1)
133.1
(337.4)
135.8
(341.8)
138.5
(556.6)
2,872.8
1,070.2
523.6
254.4
(194.7)
(198.5)
(200.0)
(201.6)
(203.3)
2,316.2
2013
* Numbers in parentheses represent savings to the Federal government.
TABLE 2—NET STATE COST IMPACT
OF REGULATION
TABLE 2—NET STATE COST IMPACT
OF REGULATION—Continued
TABLE 2—NET STATE COST IMPACT
OF REGULATION—Continued
[Dollars in Millions] *
[Dollars in Millions] *
[Dollars in Millions] *
FY 2011–2020
Eligibility Systems .....
MMIS (excluding eligibility) ...................
FY 2011–2020
FY 2011–2020
(1,255.4)–(2,092.3)
(170.6)–(284.4)
Total ...................
(1,426.0)–(2,376.7)
* Numbers in parentheses represent savings
to State governments.
TABLE 2.1—NET STATE COST IMPACT OF REGULATION BY FISCAL YEAR
[Dollars in millions] *
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2011–2020
MMIS (excluding eligibility) ...................
Eligibility Systems ....
25.7
(285.6)
52.2
(276.7)
48.4
(258.0)
1.3
(139.9)
(24.1)
64.3
(61.6)
(149.5)
(65.2)
(152.5)
(66.6)
(155.5)
(68.0)
(158.6)
(69.5)
(161.8)
(227.5)
(1,673.8)
Total ..................
(259.9)
(224.6)
(209.6)
(138.6)
40.2
(211.1)
(217.7)
(222.1)
(226.6)
(231.3)
(1,901.3)
srobinson on DSKHWCL6B1PROD with RULES2
* Numbers in parentheses represent savings to State governments.
G. Regulatory Flexibility Analysis
The Regulatory Flexibility Act (RFA)
requires agencies to prepare a
Regulatory Flexibility Analysis to
describe and analyze the impact of final
rule on small entities unless the
Secretary can certify that the regulation
will not have a significant impact on a
substantial number of small entities. In
the healthcare sector, Small Business
Administration size standards define a
small entity as one with between $7
million and $34 million in annual
revenues. For the purposes of the RFA,
essentially all non-profit organizations
are considered small entities, regardless
of size. Individuals and States are not
included in the definition of a small
entity.
Since this rule will affect States,
which are not considered small entities,
the Secretary has determined that this
final rule will not have a significant
economic impact on a substantial
number of small entities. Therefore, we
have not prepared a regulatory
flexibility analysis.
Additionally, section 1102(b) of the
Act requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operation of a
substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604 of the
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RFA. For purposes of section 1102(b) of
the Act, we define small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area and has
fewer than 100 beds. We are not
preparing an analysis for section 1102(b)
of the Act because we have determined
that this rule will not have a significant
impact on the operations of a substantial
amount of small rural hospitals. There
is no negative impact on the program or
on small businesses.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule that may result in expenditures in
any one year of $100 million in 1995
dollars (updated annually for inflation),
by State, local, or tribal governments, in
the aggregate, or by the private sector. In
2011, that threshold is approximately
$136 million. This final rule does not
mandate expenditures by the State
governments, local governments, tribal
governments, in the aggregate, or the
private sector, of $136 million. This rule
provides that States can receive
enhanced FFP if States ensure that the
mechanized claims processing and
information retrieval systems (MMIS)
including, for a limited time, those that
perform eligibility determination and
enrollment activities, as well as the
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Medicaid portion of integrated
eligibility determination systems, meet
with certain conditions including
migrating to the MITA framework and
meet certain performance requirements.
This is a voluntary activity; that is,
States can continue to receive the
traditional 50 percent FFP match rate
for reasonable administrative
expenditures for the design,
development, or enhancement and
maintenance and operations to the
Medicaid portion of integrated
eligibility determination systems to
make eligibility determinations for Title
XIX of the Act. This final rule imposes
no substantial mandates on States. The
State role in determining Medicaid
eligibility is dependent upon the
population type; specifically, some
populations such as the elderly, blind,
and disabled are typically determined
by the Medicaid State agency whereas
other population types may have their
Medicaid eligibility determined by cashassistance programs. Mechanized claims
processing and information retrieval
systems, including those that perform
eligibility determination and enrollment
activities and the Medicaid portion of
integrated eligibility determination
systems, at a minimum, will need to be
updated. However, providing 90 percent
FFP for design, development, and
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installation or 75 percent FFP for
maintenance and operations of such
systems reduces the financial burden on
States to 10 percent of the costs
compared to the 50 percent financial
burden currently in place. Specifically,
while this entails certain procedural
responsibilities, these activities do not
involve substantial State expense;
providing 90 percent and 75 percent
FFP reduces the total State outlay.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
We wish to note again that this is a
voluntary activity and as such this
regulation does not mandate any direct
costs on State or local governments.
Consequently, the requirements of
Executive Order 13132 are not
applicable.
H. Alternatives Considered
We considered that an alternative to
our final rule could be that we not
provide enhanced match for a limited
time for State systems builds and not
provide Federal standards and
conditions. In fact, States could
continue to receive the traditional 50
percent FFP for reasonable
administrative expenditures for
designing, developing, installing, or
enhancing Medicaid eligibility
determination systems. Similarly, States
could continue to receive 50 percent
FFP for expenditures associated with
the maintenance and operation of such
systems.
However, States must continue to
meet the requirements of Federal
legislation. Since the Affordable Care
Act significantly alters Medicaid
eligibility and requires coordination
with the Exchanges, it is imperative that
States have the resources and systems to
be able to meet this challenge.
21973
Therefore, we believe that if States
were left to develop eligibility systems
without Federal standards and
conditions and without the benefit of
enhanced match, States systems may
not comport with our ultimate goal; that
is, that design, development,
implementation, and operation of IT
and systems projects are in support of
the Affordable Care Act.
I. Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/omb/circulars/
a004/a-4.pdf), in Table 3, we have
prepared an accounting statement
showing the classification of the
expenditures associated with the
provisions of this rule. This table
provides our best estimate of the net
costs decrease in Medicaid payments as
a result of the changes presented in this
rule.
TABLE 3—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED NET COSTS, FROM FY 2011 TO FY 2020
[In $millions]
Transfers
Category
Year dollar
Units discount rate
Period covered
2010
Annualized Monetized Transfers ..............
Primary Estimate ..........................................
Low Estimate ................................................
High Estimate ...............................................
From .............................................................
Annualized Monetized Transfers ..............
srobinson on DSKHWCL6B1PROD with RULES2
List of Subjects in 42 CFR Part 433
Administrative practice and
procedure, Child support Claims, Grant
programs—health, Medicaid, Reporting
and recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PART 433—STATE FISCAL
ADMINISTRATION
1. The authority citation for part 433
continues to read as follows:
■
Authority: Section 1102 of the Social
Security Act, (42 U.S.C. 1302).
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3%
$311.31
233.48
389.14
$266.55
199.91
333.19
FYs 2011–2020
FYs 2011–2020
FYs 2011–2020
¥$189.82
¥142.36
¥237.28
FYs 2011–2020
FYs 2011–2020
FYs 2011–2020
Federal Government to State Governments
Primary Estimate ..........................................
Low Estimate ................................................
High Estimate ...............................................
From .............................................................
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
7%
¥$189.87
¥142.40
¥237.34
State Governments to System Vendors, Integrators
Subpart C—Mechanized Claims
Processing and Information Retrieval
Systems
2. Section 433.110 is amended by
revising paragraph (a)(2) to read as
follows:
■
§ 433.110 Basis, purpose, and
applicability.
(a) * * *
(2) Section 1903(r) of the Act, which
imposes certain standards and
conditions on mechanized claims
processing and information retrieval
systems (including eligibility
determination systems) in order for
these systems to be eligible for Federal
funding under section 1903(a) of the
Act.
*
*
*
*
*
■ 3. Section 433.111 is amended by—
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A. Revising paragraph (b)(3).
B. Adding paragraph (c).
The revision and addition read as
follows:
■
■
§ 433.111
Definitions.
*
*
*
*
*
(b) * * *
(3) Approved enhancements to the
system.
(c) ‘‘Medicaid Information Technology
Architecture (MITA)’’ is defined at
§ 495.302 of this chapter.
■ 4. Section 433.112 is amending by–
■ A. Revising paragraphs (a), (b)(2), and
(c).
■ B. Amending paragraph (b)(7) by
removing the reference ‘‘45 CFR 74.171’’
and adding in its place, the reference
‘‘45 CFR 74.27(a)’’.
■ C. Adding paragraphs (b)(10) through
(b)(16).
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The revisions and additions read as
follows:
srobinson on DSKHWCL6B1PROD with RULES2
§ 433.112 FFP for design, development,
installation or enhancement of mechanized
claims processing and information retrieval
systems.
(a) Subject to paragraph (c) of this
section, FFP is available at the 90
percent rate in State expenditures for
the design, development, installation, or
enhancement of a mechanized claims
processing and information retrieval
system only if the APD is approved by
CMS prior to the State’s expenditure of
funds for these purposes.
(b) * * *
(2) The system meets the system
requirements, standards and conditions,
and performance standards in Part 11 of
the State Medicaid Manual, as
periodically amended.
*
*
*
*
*
(10) Use a modular, flexible approach
to systems development, including the
use of open interfaces and exposed
application programming interfaces; the
separation of business rules from core
programming, available in both human
and machine readable formats.
(11) Align to, and advance
increasingly, in MITA maturity for
business, architecture, and data.
(12) Ensure alignment with, and
incorporation of, industry standards:
The HIPAA privacy, security and
transaction standards; accessibility
standards established under section 508
of the Rehabilitation Act, or standards
that provide greater accessibility for
individuals with disabilities, and
compliance with Federal civil rights
laws; standards adopted by the
Secretary under section 1104 of the
Affordable Care Act; and standards and
protocols adopted by the Secretary
under section 1561 of the Affordable
Care Act.
(13) Promote sharing, leverage, and
reuse of Medicaid technologies and
systems within and among States.
(14) Support accurate and timely
processing and adjudications/eligibility
determinations and effective
communications with providers,
beneficiaries, and the public.
(15) Produce transaction data, reports,
and performance information that
would contribute to program evaluation,
continuous improvement in business
operations, and transparency and
accountability.
(16) Ensure seamless coordination
and integration with the Exchange, and
allow interoperability with health
information exchanges, public health
agencies, human services programs, and
community organizations providing
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outreach and enrollment assistance
services.
(c) FFP is available at 90 percent of a
State’s expenditures for the design,
development, installation, or
enhancement of an eligibility
determination system that meets the
requirements of this subpart and only
for costs incurred for goods and services
provided on or after April 19, 2011 and
on or before December 31, 2015.
§ 433.113
[Removed]
5. Section 433.113 is removed.
■ 6. Section 433.114 is amended by—
■ A. Amending paragraph (a) by
removing the reference ‘‘(h)’’ and by
adding in its place the reference ‘‘(i)’’.
■ B. Revising paragraph (b).
The revision reads as follows:
■
§ 433.114 Procedures for obtaining initial
approval; notice of decision.
*
*
*
*
*
(b) If CMS disapproves the system, the
notice will include all of the following
information:
(1) The findings of fact upon which
the determination was made.
(2) The procedures for appeal of the
determination in the context of a
reconsideration of the resulting
disallowance to the Departmental
Appeals Board.
■ 7. Section 433.116 is amended by —
■ A. Amending paragraph (a) by
removing the phrase ‘‘Subject to 42 CFR
433.113(c),’’ and by adding in its place
‘‘Subject to paragraph (j) of this
section,’’.
■ B. Amending paragraph (b) by
removing the reference ‘‘(h)’’ and by
adding in its place the reference ‘‘(i)’’.
■ C. Adding new paragraphs (i) and (j).
The additions read as follows:
§ 433.116 FFP for operation of mechanized
claims processing and information retrieval
systems.
*
*
*
*
*
(i) The standards and conditions of
§ 433.112(b)(10) through (b)(16) of this
subpart must be met.
(j) Beginning and no earlier than,
April 19, 2011, FFP is available at 75
percent of a State’s expenditures for the
operation of an eligibility determination
system that meets the requirements of
this subpart. FFP at 75 percent is not
available for eligibility determination
systems that do not meet the standards
and conditions by December 31, 2015.
§ 433.117
[Amended]
8. Section 433.117 is amended by—
A. Amending paragraph (a) by
removing the phrase ‘‘all conditions’’
and adding in its place the phrase ‘‘all
standards and conditions’’.
■
■
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B. Amending paragraph (c)(2) by
removing the reference ‘‘(h)’’ and adding
in its place the reference ‘‘(j)’’.
■ 9. Section 433.119 is amended by
revising paragraphs (a) and (c) to read as
follows:
■
§ 433.119 Conditions for reapproval;
notice of decision.
(a) CMS periodically reviews each
system operation initially approved
under § 433.114 of this subpart and
reapproves it for FFP at 75 percent of
expenditures if the following standards
and conditions are met:
(1) The system meets the
requirements of § 433.112(b)(1), (3), (4),
(7) through (16) of this subpart.
(2) The system meets the conditions
of § 433.116 (d) through (j).
(3) The system meets the standards,
conditions, and performance standards
for reapproval and the system
requirements in part 11 of the State
Medicaid Manual as periodically
amended.
(4) A State system must meet all of the
requirements of this subpart within the
appropriate period CMS determines
should apply as required by § 433.123(b)
of this subpart.
*
*
*
*
*
(c) After performing the review under
paragraph (a) of this section, CMS will
issue to the Medicaid agency a written
notice informing the agency whether the
system is reapproved or disapproved. If
the system is disapproved, the notice
will include the following information:
(1) CMS’s decision to reduce FFP for
system operations from 75 percent to 50
percent of expenditures, beginning with
the first day of the first calendar quarter
after CMS issues the written notice to
the State.
(2) The findings of fact upon which
the determination was made.
(3) A statement that State claims in
excess of the reduced FFP rate will be
disallowed and that any such
disallowance will be appealable to the
Departmental Appeals Board.
■ 10. Section 433.120 is amended by
revising paragraph (b) to read as follows:
§ 433.120 Procedures for reduction of FFP
after reapproval review.
*
*
*
*
*
(b) CMS will reduce FFP in
expenditures for system operations from
75 percent to 50 percent.
■ 11. Section 433.121 is amended by
revising paragraph (a) to read as follows:
§ 433.121 Reconsideration of the decision
to reduce FFP after reapproval review.
(a) The State Medicaid agency may
appeal (to the Departmental Appeals
Board under 45 CFR Part 16) a
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disallowance concerning a reduction in
FFP claimed for system operations
caused by a disapproval of the State’s
system.
*
*
*
*
*
§ 433.130
[Removed]
12. Section 433.130 is removed.
■ 13. Section 433.131 is amended by
adding a new paragraph (c) to read as
follows:
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■
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§ 433.131 Waiver for noncompliance with
conditions of approval and reapproval.
*
*
*
*
*
(c) Waiver of deadline. In no case will
CMS waive the December 31, 2015
deadlines referenced in § 433.112(c) and
§ 433.116(j).
Authority: Catalog of Federal Domestic
Assistance Program No. 93.778, Medical
Assistance Program.
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21975
Dated: March 16, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: April 12, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2011–9340 Filed 4–14–11; 11:15 am]
BILLING CODE 4120–01–P
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Agencies
[Federal Register Volume 76, Number 75 (Tuesday, April 19, 2011)]
[Rules and Regulations]
[Pages 21950-21975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9340]
[[Page 21949]]
Vol. 76
Tuesday,
No. 75
April 19, 2011
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Part 433
Medicaid Program; Federal Funding for Medicaid Eligibility
Determination and Enrollment Activities; Final Rule
Federal Register / Vol. 76 , No. 75 / Tuesday, April 19, 2011 / Rules
and Regulations
[[Page 21950]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 433
[CMS-2346-F]
RIN 0938-AQ53
Medicaid Program; Federal Funding for Medicaid Eligibility
Determination and Enrollment Activities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule will revise Medicaid regulations for
Mechanized Claims Processing and Information Retrieval Systems. We are
also modifying our regulations so that the enhanced Federal financial
participation (FFP) is available for design, development and
installation or enhancement of eligibility determination systems until
December 31, 2015. This final rule also imposes certain defined
standards and conditions in terms of timeliness, accuracy, efficiency,
and integrity for mechanized claims processing and information
retrieval systems in order to receive enhanced FFP.
DATES: Effective Date: These regulations are effective on April 19,
2011.
FOR FURTHER INFORMATION CONTACT: Richard Friedman, (410) 786-4451.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Current State of the Medicaid Management Information System
(MMIS)
A Medicaid management information system (MMIS) is a mechanized
system of claims processing and information retrieval used in State
Medicaid programs under title XIX of the Social Security Act (the Act).
The system is used to process Medicaid claims from providers and to
retrieve and produce utilization data and management information about
medical care and services furnished to Medicaid recipients. The system
also is potentially eligible to receive enhanced administrative funding
from the Federal government under section 1903(a)(3) of the Act.
Specifically, section 1903(a)(3)(A)(i) of the Act provides that Federal
financial participation (FFP) is available at 90 percent of
expenditures for the design, development, or installation of mechanized
claims processing and information retrieval systems as the ``Secretary
determines are likely to provide more efficient, economical and
effective administration of the plan and to be compatible with the
claims processing and information retrieval systems utilized in the
administration of title XVIII [Medicare].'' In addition, section
1903(a)(3)(B) of the Act provides for the availability of FFP at 75
percent of expenditures attributable to operating the ``systems * * *
of the type described in [section 1903(a)(3)] subparagraph (A)(i),''
which are approved by the Secretary and meet certain other requirements
(including requirements relating to explanations of benefits). For
purposes of this final rule, we refer to 90 percent and 75 percent FFP
as ``enhanced'' FFP since it is greater than the 50 percent FFP
available for most Medicaid administrative expenses. In addition,
section 1903(r) of the Act places conditions on a State's ability to
receive Federal funding for automated data systems in the
administration of the State plan.
To receive an enhanced match, the Secretary must find that the
mechanized claims and information retrieval system is adequate to
provide more efficient, economical, and effective administration of the
State plan. The Patient Protection and Affordable Care Act of 2010
(Pub. L. 111-148, enacted on March 23, 2010), as amended by the Health
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, enacted
on March 30, 2010) (collectively referred to as the Affordable Care
Act) also made additional changes to the requirements within section
1903(r) of the Act relating to the reporting of data to the Secretary;
guidance on these requirements will be issued in a separate rulemaking
document. Our Federal regulations concerning mechanized claims
processing and information retrieval systems are at 42 CFR part 433,
subpart C. A State that chooses to develop, enhance, or replace its
required system or subsystems must first submit for approval an
Advanced Planning Document (APD). The general Health and Human Services
(HHS) requirements for approval of APDs are found at 45 CFR part 95,
subpart F.
B. Availability of Enhanced FFP for Automated Eligibility Systems
Historically, Medicaid eligibility for many applicants and
recipients was determined by an agency other than the State Medicaid
agency. Under section 1902(a)(10)(A)(i) of the Act, States were
required to provide Medicaid to recipients under the Aid to Families
with Dependent Children (AFDC) program, as well as recipients of the
Supplemental Security Income (SSI) program. In these cases, eligibility
determinations were derived from the cash welfare-assistance
determination. As a result, States that maintained a Medicaid
eligibility determination system usually integrated these systems into
the public welfare systems. In the October 13, 1989 Federal Register
(54 FR 41966, effective November 13, 1989), we published a final rule
excluding eligibility determination systems from the enhanced funding
that was available under section 1903(a)(3) of the Act, reasoning that
the close interrelationship between these cash assistance programs and
Medicaid eligibility rendered such enhanced assistance redundant and
unnecessary (54 FR 41966 through 41974). As a result, we revised the
definition of mechanized claims processing and information retrieval
systems to exclude eligibility determination systems.
We also indicated in the 1989 final rule that to receive any FFP
for Medicaid purposes for an eligibility determination system after
November 13, 1989, a State must submit an APD for funding in accordance
with the requirements of 45 CFR Part 95, Subpart F. If we approved the
APD, the State agency would receive 50 percent FFP for administrative
costs under section 1903(a)(7) of the Act for the system's design,
development, and installation, and operation.
C. Changes in Medicaid Eligibility Policies
Since we issued the October 13, 1989 final rule, a series of
statutory changes have dramatically affected eligibility for Medicaid
and how Medicaid eligibility is determined. Among other things, new
eligibility coverage groups were created and expanded, and in 1996,
Medicaid eligibility was ``de-linked'' from the receipt of cash
assistance when the AFDC program was replaced by the Temporary
Assistance to Needy Families (Pub. L. 104-193, enacted on August 22,
1996) (TANF) program created by the Personal Responsibility and Work
Opportunity Reconciliation Act (PRWORA) (Pub. L. 104-193, enacted on
August 22, 1996).
With the passage of the Balanced Budget Act of 1997 (Pub. L. 105-
33, enacted on August 5, 1997) (BBA), States were required to
coordinate eligibility for and enrollment in Medicaid with the new
Children's Health Insurance Program (CHIP) to ensure enrollment of
children in the appropriate program. With passage of the ``Express Lane
Eligibility'' provisions in section 203 of the Children's Health
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Insurance Program Reauthorization Act of 2009 (Pub. L. 111-3) (CHIPRA),
States were provided with the option, and are encouraged, to coordinate
and expedite eligibility for children in Medicaid and CHIP by using
findings regarding income and other eligibility criteria made by other
agencies, such as the Supplemental Nutrition Assistance Program (SNAP),
as the basis for Medicaid and CHIP eligibility adjudications.
With the passage of the Affordable Care Act, we expect that changes
to Medicaid eligibility policies and business processes need to be
adopted. States will need to apply new rules to adjudicate eligibility
for the program; enroll millions of newly eligible individuals through
multiple channels; renew eligibility for existing enrollees; operate
seamlessly with newly authorized Health Insurance Exchanges (see
section 1311 of the Affordable Care Act) whether run by the State or
the U.S. Department of Health and Human Services (HHS) if the State
chooses not to operate a State Exchange (hereafter referred to as
``Exchanges''); participate in a system to verify information from
applicants electronically; incorporate a streamlined application used
to apply for multiple sources of coverage and health insurance
assistance; and produce notices and communications to applicants and
beneficiaries concerning the process, outcomes, and their rights to
dispute or appeal. We further anticipate, following consultation with
States and other stakeholders, additional standard Federal requirements
for more timely and detailed reporting of eligibility and enrollment
status statistics, including breakdowns by eligibility group,
demographic characteristics, enrollment in managed care plans, and
participation in waiver programs.
System transformations will be needed in most States to accomplish
these changes. These systems transformations should be undertaken in
full partnership with Exchanges in order to meet coverage goals,
minimize duplication, ensure effective reuse of infrastructure and
applications, produce seamless enrollment for consumers, and ensure
accuracy of program placements (see sections 1413 and 2201 of the
Affordable Care Act). Extensive coordination and collaboration will be
required between Exchanges and Medicaid, including on oversight and
evaluation of the interoperability of the Exchange and Medicaid
systems. In addition, States may consider how to coordinate systems
changes with the eligibility determination systems used for other
health and human services programs, such as SNAP, because a large share
of individuals who are eligible for Medicaid also are eligible for
other programs as well.
II. Provisions of the Proposed Regulations
In the November 8, 2010 Federal Register (75 FR 68583), we
published a proposed rule that revised the Medicaid regulations for
Mechanized Claims Processing and Information Retrieval Systems.
Specifically, we proposed to amend the definition of Mechanized Claims
Processing and Information Retrieval Systems to include mechanized
eligibility determination systems, which would include the enrollment
and eligibility reporting activities associated with such systems. We
also proposed that the enhanced FFP would be available for design,
development and installation or enhancement of eligibility
determination systems until December 31, 2015.
III. Analysis of and Responses to Public Comments
We received 40 timely comments on the November 8, 2010 proposed
rule (75 FR 68583 through 68595).
Commenters expressed general support for the policies outlined in
the proposed rule. Specifically, commenters agreed that providing
enhanced matching funds for Medicaid eligibility systems is appropriate
and necessary. Commenters expressed almost universal agreement that
this enhanced match is critical to support State efforts to modernize
their eligibility systems, and will allow States to bring these systems
into the 21st Century so that they can provide cost-effective,
accurate, reliable, and beneficiary-friendly assessments of eligibility
for the Medicaid program. In light of the substantial changes made by
the Affordable Care Act, commenters agreed that it is more important
than ever to ensure that eligibility determination systems are designed
and operated using the most up-to-date technological and business
process solutions. With States expected to enroll millions of newly
eligible individuals into Medicaid and to ensure seamless coordination
with the new Exchanges, it is essential that States have modern and
cost-effective eligibility systems that will accurately enroll eligible
individuals, without unnecessarily cumbersome processes or delays.
Commenters also believed that such initial investments would ultimately
lower ongoing maintenance and operational expenses, driving savings for
both States and the Federal government.
Commenters also noted that HHS had released additional documents at
approximately the same time as the November 8, 2010 proposed rule,
which reinforced our strategic direction and received their support.
Specifically, commenters acknowledged the joint guidance released by
CMS and the Office of Consumer Information and Insurance Oversight (now
CMS' Center for Consumer Information and Insurance Oversight (CCIIO))
entitled, ``Exchange/Medicaid Information Technology Guidance, version
1.0,'' and the Funding Opportunity Announcement for Cooperative
Agreements to Support Early Innovator Grants for Exchanges. Commenters
indicated that they greatly appreciated the foresight of CMS and CCIIO,
and are supportive of the guidance providing direction towards a
service-oriented IT infrastructure based on interoperable systems and
that they fully support the concept of a collaborative IT development
approach among States, CMS and CCIIO.
A summary of additional major issues and our responses follow.
Since many of the comments were general in nature and not specific to
any particular regulatory provision, we have identified the comments by
nine categories:
Requests for enhanced Federal funding.
Requests for additional guidance.
Public feedback and suggestions related to the seven
standards and conditions.
Public feedback and suggestions related to the APD
process.
Issues related to the transition period for compliance.
Comments regarding CMS' strategy for monitoring and
oversight, including performance reviews.
Issues related to partial systems improvements or
modernizations.
Specific issues by regulatory provision.
Issues related to the Regulatory Impact Analysis including
the cost estimates, and information collection.
A. Requests for Enhanced Federal Funding
Comment: Numerous commenters requested that the enhanced FFP for
design, development, and installation or enhancement of eligibility
determination systems be extended beyond the December 31, 2015
deadline. Commenters indicated that new and significant enhancements
may be needed beyond December 31, 2015, particularly in order to affect
future legislative changes to Medicaid eligibility or to keep pace with
technological innovations. The
[[Page 21952]]
commenters noted that State budgets continue to be in a state of crisis
and State revenues may not fully recover until 2016 or later;
consequently, the Federal government must take responsibility for
ensuring adequate funding of the program infrastructure to ensure
compliance by January 1, 2014. Commenters recommended several different
options in this regard. Some commenters indicated that CMS should
consider that the requirement apply to funds allocated rather than
expended. Other commenters believed that CMS could allow for the
possibility of a continued enhanced match beyond the deadline in
specified circumstances (many outside the control of State
governments), such as new Federal requirements or major advances in
computer technology. Other exception categories suggested by commenters
included unforeseen issues in implementation and/or new opportunities
for interoperability with other health and human services programs.
Other commenters indicated that CMS should extend funding if States
have approved APDs on or before December 31, 2015 and the project has
not been completed or if States are planning to leverage improvements
from other State Medicaid eligibility systems. The commenters further
indicate that they are concerned that they will be unable to receive
legislative approval to begin their project, develop an APD, receive
Federal approval, and then complete work on the project while meeting
the standards and conditions before the enhanced FFP ends on December
31, 2015. Still other commenters believed the date should be changed to
coincide with the end of the Federal fiscal year 2015 and 2016, so that
enhanced funding would expire September 30, 2016. One commenter
suggests that the deadline should be interpreted to apply to costs for
projects receiving enhanced funding and obligated by that date rather
than expended by December 31, 2015. One commenter expressed concern
that a requirement for States to maintain existing eligibility
processes for pregnant women and children until September 30, 2019 will
mean States have to maintain dual eligibility systems during this time
period. At the end of 2019, the IT systems will need to be updated to
remove this function and that enhanced funding should be extended for
States to make changes to eligibility systems when this requirement
ends.
Response: We appreciate the significant number of comments we
received on this aspect of our proposed rule and the view of commenters
that we should eliminate, extend, or modify the deadline for expiration
of the enhanced match for eligibility systems. Nonetheless, while we
appreciate the opinions of commenters, we continue to believe that the
deadline we established in the proposed rule is appropriate and proper.
We believe it is within our authority to determine that by a certain
date, additional investments in eligibility determination systems will
no longer continue to result in ``more'' efficient, effective or
economical administration of the State Plan, as required by section
1903(a)(3)(A)(i) of the Act. Further, we continue to believe that
December 31, 2015 is a reasonable and proper end-point for when
investments cease to result in acceptable increases in efficiency,
economy, or effectiveness. Our reason is threefold: First, changes
imposed by the Affordable Care Act will require immediate attention and
commitment to new technologies for eligibility and enrollment systems.
Second, once appropriate systems are deployed to support the coverage
expansions and other eligibility changes required by the Affordable
Care Act, we anticipate significant efficiencies in both application
maintenance and business operations. Third, the additional 2 years we
provided to States after the Medicaid expansion goes into effect allows
ample time for States to refine and enhance the capability of the
systems, and to capitalize on the efficiencies of these investments.
We articulated in the proposed rule that additional investments are
unlikely to yield similar rates of improvement and a regular
administrative match should be sufficient for efficient and effective
administration of State Medicaid programs. We anticipate that the
improved underlying infrastructure supporting both Medicaid and
Exchanges will be strongly leveraged in support of a State's person-
centric outreach, eligibility and enrollment activities across the
health and human services spectrum.
With respect to the request made by some commenters to establish an
exceptions process, we believe this is already sufficiently provided
for through our extension of enhanced FFP for an additional 2 years
beyond the date for operation of the Exchanges. We are concerned that
broadening or codifying exceptions to the deadline in the way suggested
by the commenters would effectively render the deadline moot for many
purposes and projects.
The September 30, 2019 date noted by one commenter is the end-date
for maintenance of effort (MOE) provisions for children (not pregnant
women). Because of these MOE provisions, States must not have more
restrictive ``eligibility standards, methodologies, or procedures'' for
children than those in effect on March 23, 2010. The MOE requirement
does not mean that States must maintain identical standards,
methodologies or procedures as those in effect on March 23, 2010, and
it does not mean that the same IT system or IT system processes be
used. Rather, the MOE requires that the eligibility standards, methods,
and procedures be no more restrictive than those in effect on March 23,
2010.
We are not certain of what the commenter is concerned about in
terms of States' needing to maintain dual eligibility processes, but we
assume he or she may be concerned about the interaction of the MOE
requirements and the requirement under section 2002 of the Affordable
Care Act. The conversion to a MAGI-equivalent income standard required
under section 2002 of the Affordable Care Act is designed in the
statute to ensure that individuals who meet the eligibility
requirements in effect as of March 23, 2010 do not lose eligibility as
a result of the shift to MAGI. Guidance will be provided by the
Secretary regarding how States can accomplish the required conversion,
and once the new MAGI-equivalent income standard has been determined,
the MOE requirements will be applied to such converted standard, using
the MAGI methodologies to determine an individual's income, as required
under the Affordable Care Act. Therefore, the MOE requirements will not
require operating dual eligibility systems.
After consideration of the public comments received, we are
maintaining the December 31, 2015 deadline in our regulations for
eligibility determination systems.
Comment: One commenter requested that CMS consider interpreting the
deadline of December 31, 2015 for projects receiving enhanced Federal
funding to requiring the funds be obligated by that date rather than
expended.
Response: We indicated in the proposed rule (75 FR 68589) that
States would need to incur costs for goods and services furnished no
later than December 31, 2015 to receive 90 percent FFP for design,
development, installation, or enhancement of an eligibility system. For
further clarification, this means that States must ensure that goods
and services (for example, eligibility and enrollment modules,
applications, systems, etc.) are provided to States no later than close
of
[[Page 21953]]
business December 31, 2015. Thus, for example, if an amount has been
obligated by December 31, 2015, but the good or service has not yet
been furnished by that date, then such expenditure would not be
eligible for enhanced FFP.
As a result of this comment, we are adding language to the
regulations text to clarify this point.
Comment: Numerous commenters asked whether enhanced funding is
available for subsystems that interface with and/or are part of the
eligibility process since such subsystems will require modifications to
meet the requirements of the Affordable Care Act. Additionally,
commenters sought enhanced FFP for projects that meet Medicaid
Information Technology Architecture (MITA) guidance, yet still may need
to integrate with legacy systems, with the understanding that, where
feasible, open rules and specifications developed for programs will be
used to read, insert, or update data into systems that currently do not
have the functionality of being interoperable. The commenters agreed
that APDs would need to be put in place and approved to modernize the
legacy systems/subsystems.
Response: We agree that enhanced funding can be available for
subsystems that meet the standards and conditions outlined in this
final rule. However, to the extent that such subsystems are reliant on
or tied to a larger legacy system or suite of systems that introduce
performance risk or ongoing costs to the operation of the subsystem, we
may find that the system as a whole is not meeting the standards and
conditions of this final rule and decline to approve enhanced match on
that basis. It is our desire to acknowledge that subsystem
modernization may be an entirely appropriate pathway to a high
performing Medicaid program, while at the same time not binding
ourselves to approve enhanced match for minor components of a large,
fragmented legacy system that has little chance of delivering to
expected business results. CMS will review APDs and make determinations
regarding such subsystems, and to the extent that such subsystems meet
with the standards and conditions outlined in this final rule and
States can document that there is no performance risk or ongoing
unnecessary costs, as a result of the subsystem being a part of larger
legacy system, CMS will make determinations regarding enhanced funding
accordingly.
Comment: Several commenters want to ensure that enhanced FFP is
available to States that are not completely MITA compliant, but rather
to States that can demonstrate efficiencies are being achieved,
redundancy is being decreased/eliminated, and system integration is
being realized through application programming interfaces (API). States
could demonstrate that APIs, in which a particular set of rules and
specifications for services and resources have been developed by one
software program that can be accessed and used by another software
program implementing the API, can be used and serve as an interface
between different software programs and facilitating their interaction,
and thus, leading to efficiencies. Commenters added that with an
approved APD reasonable and measureable milestones of system compliance
can be demonstrated.
Response: Enhanced FFP is available for those systems that comply
with the standards and conditions of this final rule. Aligning to, and
advancing increasingly, in MITA maturity for business, architecture,
and data is one of the standards and conditions that must be met. We
did not use the term ``MITA compliant'' in our proposed rule because
MITA maturity is by definition, a matter of degree. We agree that
achieving increasing levels and degrees of MITA maturity is likely to
happen in stages. Recognizing this, we will be requiring a MITA roadmap
that delineates how the proposed system enhancements for eligibility
and enrollment functions will fit into the States' greater MITA
framework. Such requirement will align with our expectations to see
States continuing to make measurable progress in implementing their
MITA roadmaps. We believe it is critical to build on and accelerate the
modernization we have collectively begun under MITA, so that States
achieve the final vision of MITA and have a comprehensive framework
with which to meet the technical and business demands required by an
environment that will increasingly rely on health information
technology and the electronic exchange of healthcare information to
improve health outcomes and lower program costs.
Comment: One commenter requested clarification as to whether
enhanced FFP will be available where a project has some components that
meet the standards and guidelines required for enhanced FFP, but may
include other components that do not.
Response: We believe it is entirely appropriate to accomplish
system modernization through phasing. In cases such as the one raised
by the commenter, the changes being made to various system components
will need to be reviewed through submission of an APD and review. We
will need to ensure that component-based development is on a path
toward an entire system or subsystem coming into compliance with the
standards and conditions of this final rule. We would expect that if
the components that do not meet the standards and conditions are
essentially preventing the entire system or subsystem from meeting the
standards and conditions, then the State would have a plan for updating
such components, even if all components are not updated at the same
time. For example, we do not expect that we would offer enhanced FFP
for improvements to just the reporting aspect of the traditional,
legacy eligibility system, if the State does not have a plan for
bringing this entire legacy system into compliance with the standards
and conditions. In addition, to receive enhanced FFP, States may not
ignore any single standard or condition regardless of the level or
breadth of their compliance with the remaining standards, although if a
State is weaker or more at risk with certain standards or conditions,
the State should include a roadmap in their APD demonstrating how they
intend to come into compliance. We intend to carefully track progress
against approved roadmaps when determining if system updates continue
to meet the standards and conditions for enhanced match.
Comment: One commenter suggests that CMS clarify that enhanced
funding is also available for ``traditional'' eligibility
determinations, such as those made on behalf of medically needy
clients, buy-in, elderly, disabled, long-term care and home and
community-based individuals.
Response: To the extent that eligibility systems meet all
requirements, standards, and conditions contained in this final rule,
States will be eligible for enhanced FFP, and such enhanced funding is
not dependent upon the eligibility group using the system.
Comment: One commenter recommended that CMS clarify that enhanced
funding is available for personnel costs, as well as the costs of
physical systems. Specifically, the commenter notes that Federal
regulations at Sec. 432.50(b) provide for enhanced funding at 75
percent for the costs of staff ``engaged directly in the operation of
mechanized claims processing and information retrieval systems'' and
for enhanced funding at 90 percent for staff costs related to the
design, development, and installation of these systems. FFP is provided
at 50 percent for the costs of training personnel when new systems are
developed.
[[Page 21954]]
Response: We did not propose amendments to the regulations at Sec.
432.50(b); thus, enhanced funding is available for staff time spent on
mechanized eligibility determination systems in the same manner that
they apply to all mechanized claims processing and information
retrieval systems, since mechanized eligibility determination systems
are now considered to be part of such systems, assuming the
requirements of this section are met.
Comment: One commenter asked that we extend the enhanced funding to
encompass the testing of the effectiveness of the eligibility systems,
including testing beneficiary experience such as allowing States to
receive reimbursement for conducting focus groups with community-based
workers and/or beneficiaries who rely on the system to apply for and
renew Medicaid coverage.
Response: Again, to the extent these costs would be reimbursable
under Sec. 432.50(b), they would be eligible for reimbursement under
this rule as well (assuming all standards and conditions are met).
States would need to ensure that the expenditures are tied to the
mechanized eligibility determination system and follow all procedures
for seeking approval.
Comment: Several commenters requested that CMS require States to
pass enhanced match through to counties. The commenters stated that CMS
should ensure that if a State requires counties to contribute to the
non-Federal share of Medicaid and Medicaid administrative costs, and
that receives enhanced FFP; the State should be required to share the
enhanced FFP in proportion to the counties' contribution. The
commenters stated that this requirement would reflect the clear
Congressional intent as expressed in the enhanced Federal Medical
Assistance Percentage (FMAP) requirements for certain States in section
5001(g)(2) of the American Recovery and Reinvestment Act (Pub. L. 111-
5, enacted on February 17, 2009) and strengthened by section
10201(c)(6) of the Affordable Care Act.
Response: The commenters cite section 10201(c)(6) of the Affordable
Care Act, which added section 1905(cc) to the Act. Under this
provision, a State may not be eligible for certain increased FMAPs
associated with health care reform and disaster recovery if the State
``requires that political subdivisions pay a greater percentage of the
non-Federal share * * * than the respective percentages that would have
been required by the State under the State plan under this title, State
law, or both, as in effect on December 31, 2009.'' Since the level of
Federal funding available for the costs of the eligibility and
enrollment determination systems under this final rule will increase
and the level of the non-Federal share specific to such expenditures
will decrease, there could be an effect on the level of required
political subdivision contributions that would be subject to this
limitation. We already issued guidance on how the political subdivision
contribution limitations under section 1905(cc) apply in an SMD letter
issued November, 9, 2010 (see https://www.cms.gov/smdl/downloads/SMD10023.pdf). Rather than reiterate what is already in that guidance,
we refer States and counties to such guidance. States and counties may
also work with CMS to determine whether any required contributions by
political subdivisions toward the non-federal share of these
expenditures would be in compliance with political subdivision
contribution provision.
Comment: One commenter urged CMS to encourage States to consider in
establishing actuarially sound Medicaid managed care rates, the
additional systems-related investments by Medicaid health plans that
are likely to be needed to interface with new State systems.
Response: We believe this commenter is asking about managed care
rates, and not the proposal we issued with regard to mechanized claims
processing and information retrieval systems, and when they will be
eligible for enhanced FFP. As our proposed rule did not address
Medicaid managed care rates, we believe this comment is outside the
scope of the proposed rule.
Comment: One commenter asked for clarification on whether the
addition of eligibility determination and enrollment systems is limited
to stand-alone systems administered directly by the single State
Medicaid Agency. The commenter indicates that some State eligibility
systems are a joint venture with the HHS and the United States
Department of Agriculture and are used to determine eligibility for
financial assistance programs in addition to medical assistance
programs.
Response: The enhanced funding can apply to ``stand alone'' systems
or ``integrated eligibility'' systems, assuming they meet the standards
and conditions specified in this final rule. Many States are
considering ways to coordinate Medicaid, CHIP and Exchange eligibility
with other health and human services programs. However, we will only
provide enhanced funding for the portion of the costs that can be
directly attributed to Medicaid eligibility and enrollment functions.
We also direct the commenter to the discussion on cost-allocation in
OMB Circular A-87 (https://www.whitehouse.gov/omb/circulars_a087_2004)
specifying appropriate allocation of costs when the system includes
various benefiting programs.
Comment: Other commenters have asked whether the enhanced funding
can be used to support updating and completing the MITA assessment and
roadmap, and performance measurement.
Response: We agree with the commenters that it is appropriate to
request enhanced funding for updating the MITA assessment and the
roadmap, since one of the standards and conditions listed in Sec.
433.112 speaks directly to MITA maturity. Enhanced funding is available
assuming that updates are related to the standards and conditions and
the State's plan for meeting them. We are making no further additions
to the rule in response to this comment.
Comment: Some commenters believed the timeframes related to the
enhanced funding for the development of eligibility solutions seems to
be extremely aggressive. Many of the activities related to the
planning, design, development, and deployment of eligibility solutions
will be new activities for both State and vendor staff. States will
need to consider how they will integrate and leverage eligibility
solutions into their Health Insurance Exchanges, their integrated human
services eligibility solutions, their MMIS, and other points of
intersection. Just the planning phase leading up to an approved APD and
FFP release could easily consume more than a year. The commenters
suggested that CMS should consider lengthening the timeframes for the
completion of these efforts related to eligibility components.
Response: We recognize that the timelines for developing new
eligibility systems, and for submitting and approving new APDs, must be
greatly accelerated from historical and traditional experiences and
approaches in order to meet the timelines in the Affordable Care Act
and to take advantage of enhanced match prior to December 31, 2015. We
emphasize that we expect to operate efficiently in processing APDs and
work collaboratively with States to implement these changes, and we
expect States to operate quite differently in how they pursue new
development, share and reuse assets, and take advantage of
``lightweight'' applications and new technologies to meet these needs.
We
[[Page 21955]]
noted in our proposed rule that dramatic systems transformations would
be necessary and while the timeframes may appear aggressive to some,
the Department is committed to providing leadership, technical
assistance, and financial support to produce the IT infrastructure
necessary to accomplish the tasks required by the Affordable Care Act
according to the timelines specified in the law. We note that the
Affordable Care Act requires that States be able to enroll the newly
eligible individuals and coordinate with Health Insurance Exchanges by
January 1 of 2014. Thus, our timeline accounts for this statutory
deadline, while still maintaining a period of two years (through
December 31, 2015) to account for potential delays or unforeseen
obstacles in developing new or improved eligibility determination
systems.
We are making no further revisions to the rule as a result of this
comment.
B. Requests for Additional Guidance
Comment: One commenter requested that CMS produce and make
available to the States a project planning template illustrating key
entry points to major phases of the projects.
Response: We will be providing a whole series of artifacts and
supporting tools, documentation, diagrams to States as part of our
technical assistance, collaboration, and governance. We will consider
the usefulness of a template for project planning as we develop and
publish these materials.
Comment: Several commenters requested additional guidance on the IT
enterprise.
Response: We will issue additional Guidance for Exchange and
Medicaid Information Technology Systems (IT guidance). We issued IT
guidance version 1.0 on November 30, 2010, and expect to issue, expand
and renew that guidance over time. These guidance documents will help
States with the business rules necessary to design, develop, and
implement State eligibility systems that can meet the requirements of
the Affordable Care Act.
Comment: Several commenters inquired about future guidance on MITA,
the MITA alignment process, and whether the process for certifying and/
or validating MITA alignment will be detailed in the final rule.
Response: We have provided continued guidance and artifacts
associated with MITA since the MITA Initiative began. We will continue
to provide that guidance and related toolsets and details. We will
consider a number of elements in reviewing states' alignment with MITA
and increasing MITA maturity, including States' self-assessments and
MITA roadmaps.
Comment: Several commenters inquired about the ``modular, flexible
approach to systems development'' and increasing MITA alignment
requirements, as well as whether such requirements apply to all MMISs
or only eligibility determination systems. The commenters believed that
to promote the feasibility of a ``modular, flexible approach to systems
development'' of Medicaid systems, CMS should continue to fund and
aggressively develop necessary interfaces and technical standards that
are required to facilitate MMIS interoperability.
Response: As stated in the above responses, we intend to issue a
series of tools for States to use in ensuring the facilitation of
interoperability. It should be noted that the requirements of this
final rule apply to all MMISs, not just eligibility determination
systems (which will now be considered part of the MMIS). We are making
no further additions to the rule as a result of this comment.
Comment: Several commenters urged CMS to develop stronger Federal
guidelines for enrollment and renewal procedures to accompany new
eligibility systems, including guidance on acceptable data matches
creating safe harbors for data sources used in electronic income
verification, to allow States to move to paperless income verification
with confidence that they comply with quality and accuracy standards.
In developing additional requirements, the commenters urged CMS to
ensure that Medicaid's application, renewal and verification procedures
are no more paperwork intensive or burdensome than those for Exchange
tax credit applicants.
Response: We agree with the commenters that simplification and
streamlining of the consumer experience are expected outcomes of the
Affordable Care Act. However, business process and policy requirements
for determining eligibility are outside the scope of this regulation
and will be addressed in separate rulemaking. As discussed later in the
response to comments concerning performance measures, we will also
publish measures concerning expected business outcomes in separate
notices. We are making no further additions to this section of the
final rule.
Comment: Some commenters requested reforms and clarifications
regarding cost allocation principles.
Response: Our proposed rule did not contain any proposals to alter
cost allocation principles, and we believe it is prudent that CMS and
the States continue to follow the cost allocation principles outlined
by OMB in Circular A-87. As stated in the proposed rule, for integrated
eligibility systems, assuming those systems meet the standards and
conditions outlined in the final rule, only the costs associated with
Medicaid eligibility and enrollment functions will be eligible for the
enhanced funding and funding for Exchange activities is fully Federally
funded through January 1, 2015. We discussed cost allocation and the
principles of cost allocation in guidance that was released on November
2010; that is, the IT guidance version 1.0 and in the Funding
Opportunity Announcement for the Early Innovator Grants. States can
access the OMB Circular A-87 at https://www.whitehouse.gov/omb/circulars_a087_2004.
Comment: Several commenters asked for guidance on commercial off-
the-shelf (COTS) software products, and indicated that such products
are often modular, reusable, sharable, leveraged, and aligned with
MITA. Commenters also stated that enhanced FFP should be available for
COTS initial licensing and implementation service costs as well as
ongoing software licensing and maintenance costs. Commenters also
questioned why there is no language confirming established protections
for COTS pre-existing intellectual property (IP) and newly developed IP
used in eligibility modernization initiatives.
Response: We are not dictating specific solutions to States as they
undertake their technology projects, as long as the standards and
conditions of this final rule are met and we expect to work with States
in an effort to share, reuse, and leverage other State solutions. For
COTS products, we have a longstanding rule that the State must own any
software that is designed, developed, installed or improved with 90
percent FFP (see Sec. 433.112(b)(5)). In other words, software that is
developed with public funds must be owned by the public and as a
``public product'' is available to be shared with other States. COTS-
based solutions may still receive a 75 percent enhanced funding (that
is, for licensing and implementation services costs), if they are
related to the MMIS (including the eligibility determination system)
and meet all the requirements of this final rule. In addition, current
rules protecting intellectual property (such as copyright and/or patent
laws) would simply apply in the way that they already do apply to
intellectual property. Nothing in this final rule is attempting to
alter those rules.
Comment: Several commenters asked that we define the terms
``modular'',
[[Page 21956]]
``modules'', ``models'', and ``successful models.'' Commenters
indicated they are unclear about whether a model is equivalent to an
architecture, reference model, process design, etc. for a given
customer or class of customers and consistent with MITA architecture
framework, process and planning guidelines, and maturity model.
Response: We believe it is important to frame our response in terms
of the IT Guidance jointly issued by CMS and CCIIO. This guidance
outlined a set of expectations and principles for sharing solutions and
approaches between both Medicaid and the Exchanges. Consequently, we
believe it is imperative for States and vendors to view all IT
activities much more broadly than a single physical implementation of a
set of technical capabilities.
``Modular'' means reducing the complexity of a larger problem by
breaking it down into small well defined pieces. For example, MITA
business architecture reduced the complexity of the Medicaid program
into eight high-level business areas. Each business area is further
broken down/decomposed into smaller and manageable business processes.
These business processes can be described as ``modules''. System
components can also perform tasks in a similar fashion. ``Modularity'',
if done right, accomplishes re-usability, maintainability, and
reliability. The term also underscores our strong desire for States and
the vendor community to develop ``lighter-weight'' and ``loosely-
coupled'' approaches to the design of health care systems, including,
but not limited to eligibility determination and enrollment functions.
In the MITA initiative, we have urged States to focus on designing
sets of overarching and reusable functions that traditionally might
have been included within one particular application and that would
have been specific to that particular application, but that now could
be used, in a consistent manner, by multiple applications used by the
State. Additionally, we want to emphasize that the rules for processing
data should be written in such a way as to be available to more than
just one application. For example, whether it is a Web service querying
for a response, or an Extract Transformation and Load (ETL) set of
tools to move data from a database to an external interface, the rules
that are invoked are the same, thus ensuring the underlying data
maintains its inherent ability to consistently transform to the same
information.
``Reference Models'' focus on classification and conceptual
structure. Typically, a Technical Reference Model, for example,
consists of infrastructure and business applications that interface
with a number of operating and network services through a variety of
specific applications such as graphics and imaging, data management,
data interchange, user interface, transaction processing, security and
system/network management.
``Reference Architecture'' is about proven solutions and best
practices, typically without being vendor/platform specific. Typically
arrayed in different tiers (access client tier, middle tier and data
tier, for example), a technical reference architecture includes a
client browser and an XML appliance to allow for access, a presentation
layer using a portal with HTML and an application/Web server, business
services applications, enterprise information integration, and
operational data storage facility typically through a data base with
data exploration capabilities sometimes arrayed via data marts.
We believe MITA 2.0 addresses all of the defined terms. We also
urge readers interested in these and related topics to familiarize
themselves with the MITA Framework, look for additional guidance in the
various iterations of the IT Guidance, and contact CMS staff for
additional clarifications related to specific circumstances.
Comment: Other commenters requested that the term ``eligibility
determination system'' be defined. The term should indicate that
eligibility determination system includes the technology interfaces for
program applicants and beneficiaries, such as Web sites that include
on-line applications and other Web features that allow individuals to
use eligibility estimators, to report changes, to renew eligibility, or
to seek information about their case status. Likewise, ``eligibility
determination system'' should be defined to include computer generated
notices and data.
Response: Our final rule considers systems that process claims for
eligibility to be part of mechanized claims processing and information
retrieval systems. Thus, to the extent that a function is part of
processing the claim for eligibility, we believe it could be eligible
for enhanced FFP under this final rule. We believe building an online
application would likely be part of the system that processes claims
and applications for eligibility. Additionally, we can envision how all
of the components identified by the commenters will be part of an
eligibility determination system, but we would need to understand more
fully how such components are integrated into a system that processes
claims for eligibility. States will explain in their APDs how the
various components are part of the mechanized claims processing and
information retrieval system and will meet with our standards and
conditions.
We are making no further additions to this section of the final
rule.
Comment: One commenter indicated that it would be helpful if CMS
provided additional leadership and technical assistance in further
standardizing data semantics and information nomenclature across the
eligibility function.
Response: We agree with the commenter and look forward to working
in close partnership with States, Exchanges, and the Office of the
National Coordinator for Health Information Technology, and the HIT
Policy and Standards Committees on this activity. We intend to enforce
industry standards as they develop in order to promote
interoperability, improve reliability of outputs and outcomes, and
reduce development costs.
Comment: A few commenters spoke of the importance of ensuring that
county governments act as full partners in the planning, design,
oversight and operations of necessary Medicaid eligibility system
transformations. To ensure that counties are poised to best assist
Medicaid applicants and recipients, the commenters suggested that the
Secretary develop model systems and deploy the necessary resources for
implementation including technical assistance and support for capital
investment.
Response: We agree with the commenter that States, Tribal
organizations, County governments, and Federal government agencies
should work together to ensure effective interoperability and to
develop model systems, as well as to deploy the necessary resources for
implementation including technical assistance and support for capital
investment. We recognize the historical contribution made by counties
to making eligibility determinations in most States. We look to States
to determine how best to deploy and optimize assets within the State to
accomplish the purpose and requirements of the Affordable Care Act.
Comment: Several commenters believe that, to support the one
application concept and streamlined eligibility determinations for
Medicaid and related programs (including CHIP, TANF, Food Stamps, and
WIC), CMS should work with other Federal agencies to obtain agreement
to allow sharing of data across those related programs.
[[Page 21957]]
Response: Our standard and condition regarding data exchange
requires seamlessness with the Exchanges and also requires that States
allow for interoperability with other health and human services
programs. We also note that our standards and conditions require
compliance with the standards and protocols adopted by the Secretary
under sections 1104 and 1561 of the Affordable Care Act. We expect that
such standards and protocols will promote reuse and data exchange.
Comment: One commenter believes that to support timely processing
of eligibility, CMS should work with other Federal agencies that
interface with State Medicaid agencies to allow a single point for
correction of client data errors, including birthdates and erroneously
posted death dates.
Response: We believe this comment addresses the actual program
instructions and policy requirements for eligibility systems, and not
the information technology solutions that will be needed for the
systems themselves. Our requirements regarding these matters will be
established in separate rulemaking.
Comment: One commenter requested that CMS offer strong guidance to
the States on privacy and confidentiality issues that need to be
observed in the new State systems.
Response: We agree that confidentiality and privacy are critical to
protecting beneficiaries and providers. The final rule includes as a
standard that systems ensure alignment with the HIPAA privacy, security
and transaction standards.
Comment: One commenter indicates that we should issue guidance more
definitively discussing the standards developed in response to section
1561 of the Affordable Care Act. The commenter noted that while section
1561 the Affordable Care Act is an outstanding source of ideas and
information, section 1561 the Affordable Care Act standards appear to
stop short of creating specific, concrete requirements.
Response: Section 1561 the Affordable Care Act requires HHS, in
consultation with the Health Information Technology (HIT) Policy
Committee and the HIT Standards Committee, to develop interoperable and
secure standards and protocols that facilitate electronic enrollment of
individuals in Federal and State health and human services programs.
The HIT Policy and Standards Committees approved initial
recommendations, and in September 2010, the Secretary adopted these
recommendations. The recommendations include initial standards and
protocols that encourage adoption of modern electronic systems and
processes that allow a consumer to seamlessly obtain and maintain the
full range of available health coverage and other human services
benefits.
The HIT Policy and Standards Committees recommendations are
available at https://healthit.hhs.gov/portal/server.pt?open=512&mode=2&objID=3161. We wish to note that one of the
seven standards and conditions specifically requires States to ensure
alignment with, and incorporation of, industry standards and specifies
several national standards including standards and protocols adopted by
the Secretary under section 1561 of the Affordable Care Act.
Comment: Another commenter suggested that we make all guidance
documents, including the State Medicaid manual readily available.
Response: We agree. We are currently working to gather all
applicable guidance documents on the CMS Web site. Guidance documents
are already posted to several web sites, including the proposed rule
(see regulations.gov), the IT guidance version 1.0, (see https://www.hhs.gov/ociio/regulations/joint_cms_ociio_guidance.pdf),
Overview on the MITA framework, (see https://www.cms.gov/MedicaidInfoTechArch), and Overview of the MMIS (see https://www.cms.gov/MMIS). Please note that Chapter 11 of the State Medicaid
Manual can be accessed electronically at https://www.cms.gov/Manuals/PBM/itemdetail.asp?filterType=none&filterByDID=-99&sortByDID=1&sortOrder=ascending&itemID=CMS021927.
In summary, we are making no revisions to regulation text as a
result of these comments.
Comment: Several commenters suggested that CMS provide educational
materials to ensure consumers get individualized assistance and have
their questions answered to assure enrollment in Medicaid and the
Exchanges.
Response: We believe this comment addresses the actual program
instructions and policy requirements for eligibility systems, and not
the information technology solutions that will be needed for the
systems themselves. Our requirements regarding these matters will be
established in separate rulemaking.
Comment: Commenters also requested that CMS issue ``Frequently
Asked Questions,'' establishing a direct contact line for assistance,
make available a complete contact list of all of the States and their
designated person/representatives, and develop a Webpage/module to the
existing Web site that will use this information and any ongoing data
exchange information for the State. Commenters further recommended that
CMS Regional Offices be fully trained and educated on the regulations
and standards.
Response: We will consider these recommendations as we begin
implementation of this final rule. We expect to provide numerous venues
for sharing of information, including conferences, information posted
to the CMS.gov Web site, letters, program memoranda, and training
materials. The final rule and additional IT guidance will provide
information regarding funding standards and conditions. We expect to
release additional guidance on performance matrices. We are currently
exploring several approaches to expedite the APD process and will be
providing guidance on this process soon after publication of this final
rule.
Additionally, we have recently awarded seven cooperative agreements
to help a group of ``Early Innovator'' States design and implement the
IT infrastructure needed to operate Exchanges. We expect to share
information among these Innovator States and, as Exchanges are being
developed, we expect to share information from these Innovator States
with other States as well through the use of the CMS.gov Web site,
conferences, and face-to-face meetings.
C. Public Feedback and Suggestions Related to the Seven Standard and
Conditions
Comment: Several commenters requested clarification on the
standards and conditions, and questioned how progress would be
measured. Specifically, several commenters were concerned about our
reference at Sec. 433.112(b)(13) to ``promoting sharing, leverage, and
reuse of Medicaid technologies and systems within and among States.''
Commenters requested that CMS define ``promoting'' and specify how
States will be required to leverage this information between States.
Further, the commenters questioned when CMS will provide States with
information regarding ``promising State systems that can be leveraged
and used by other States.'' They also questioned how these ``promising
State systems'' will be identified. The commenters noted that it will
be important for CMS to provide sufficient time for States to leverage
promising systems and qualify for enhanced FFP to fund the development
of those Medicaid eligibility systems. Other commenters expressed
concern
[[Page 21958]]
that to meet the standards and conditions required for the Medicaid
eligibility system to qualify for the enhanced funding, significant
systems changes will be necessary to integrate Medicaid/CHIP
eligibility and develop a single client identifier for all Medicaid and
CHIP members to establish seamless coordination for eligibility and
enrollment. Some commenters requested that CMS provide clarity on the
criteria CMS will use to assess how States have demonstrated compliance
with these standards and conditions including what documentation States
will be expected to provide.
Several commenters questioned the phrase ``seamless coordination.''
That is, Sec. 433.112(b)(16) requires seamless Medicaid coordination
and integration between Medicaid eligibility systems and the Exchange,
allowing for interoperability with the Exchanges, and other health
information systems. The required interoperability would involve the
exchange of eligibility and enrollment status to the health information
system, however, the rule did not specify the health information being
exchanged among the eligibility and enrollment systems. The commenters
believed it would be important for CMS to provide additional guidance
on the type of data to be exchanged between eligibility and enrollment
systems and other health information systems; thus, the commenters
requested a definition of ``seamless coordination.'' Additionally, the
commenters requested that CMS provide clarity around whether other
programs, such as the Supplemental Nutrition Assistance Program and the
Temporary Assistance for Needy Families Program, are considered part of
CMS' vision for ``seamless coordination'' and whether enhanced Medicaid
funds would be used to make related changes to eligibility systems for
these programs as well.
One commenter suggested that we add stronger language to the list
of standards and conditions in Sec. 433.112(b) consistent with the
preamble language included in the proposed rule regarding the emphasis
on the customer experience. Specifically, the commenter stated CMS
references the goal of creating an ecosystem designed to deliver
person- and citizen-centric services and benefits. The commenter
requested similar language be added in regulations text.
Numerous commenters were supportive of our proposed standards and
conditions. Specifically, several commenters have indicated they
welcome our efforts to identify ``promising State systems'' that can be
leveraged and used by other States. Commenters indicated that they
support our perspective that State eligibility and enrollment systems
must be conceived of as contributing to a ``system of systems.'' To
achieve interconnected, functional systems in time to implement the
Affordable Care Act, States must leverage existing systems to the
greatest extent possible and successfully connect across silos.
Commenters further stated that CMS should develop a repository or
method of sharing information and support the development of reference
applications. Additionally, commenters stated CMS should establish a
means for communication between agencies at the Federal level in a
manner that can be replicated at the State level. The commenters also
stated that CMS should also provide support to those States that choose
to ``phase in'' some of the changes, to ensure that they can proceed
while also receiving enhanced funds. Additionally, the commenters
requested that CMS should consider the MITA governance model for
disseminating more detailed specifications for the standards and
conditions; that is, the MITA governance model which includes the
Business, Information, and Technical Review Boards, organized to
support the MITA model for review, approval, and adoption of national
standards.
Response: All of these comments are specific to Sec. 433.112 and
Sec. 433.116 in which we have required that to receive enhanced
funding for development, design, installation or enhancement of
mechanized claims processing and information retrieval systems and
operation of such systems, the standards and conditions specified in
Sec. 433.112(b)(10) through (16) must be met. The standards and
conditions are prescriptive in nature; we did, however, recognize that
for State systems to meet these standards and conditions, it would be
necessary to provide additional guidance that clearly articulates our
criteria for