Federal Register, Volume 80 Issue 211 (Monday, November 2, 2015)

[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Rules and Regulations]
[Pages 67576-67612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27697]

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Vol. 80

Monday,

No. 211

November 2, 2015

Part III

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Part 447

Medicaid Program; Methods for Assuring Access to Covered Medicaid
Services; Final Rule

Federal Register / Vol. 80 , No. 211 / Monday, November 2, 2015 /
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 447

[CMS-2328-FC]
RIN 0938-AQ54

Medicaid Program; Methods for Assuring Access to Covered Medicaid
Services

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This final rule with comment period provides for a transparent
data-driven process for states to document whether Medicaid payments
are sufficient to enlist providers to assure beneficiary access to
covered care and services consistent with section 1902(a)(30)(A) of the
Social Security Act (the Act) and to address issues raised by that
process. The final rule with comment period also recognizes electronic
publication as an optional means of providing public notice of proposed
changes in rates or ratesetting methodologies that the state intends to
include in a Medicaid state plan amendment (SPA). We are providing an
opportunity for comment on whether future adjustments would be
warranted to the provisions setting forth requirements for ongoing
state reviews of beneficiary access.

DATES: Effective Date: These regulations are effective on January 4,
2016.
Comment Date: To be assured of consideration, comments on Sec.
447.203(b)(5) must be received at one of the addresses provided below,
no later than 5 p.m. on January 4, 2016.

ADDRESSES: In commenting, please refer to file code CMS-2328-FC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-2328-FC, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-2328-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period: a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Room 445-G, Hubert H. Humphrey Building, 200
Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Jeremy Silanskis, (410) 786-1592.

SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will be also available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Provisions for Public Comment: We are issuing this final rule with
comment period to provide the opportunity for further comment on Sec.
447.203(b)(5) to determine whether further adjustments to the access
review requirements would be warranted, including the scope of regular
state access reviews in the absence of a triggering circumstance. After
consideration of public comments, this final rule with comment period
limits the scope of services for which states will be required to
review beneficiary access, in order to balance the need for stronger
data and processes to ensure beneficiary access with minimizing
administrative burden. We believe that additional input would be useful
to determine whether modifications of these state access review
requirements may be warranted. Therefore, we are providing an
opportunity for comment specifically on the access review requirements,
including the service categories required for ongoing review, elements
of the review, and the timeframe for submission. CMS also requests
comment on whether we should allow exemptions based on state program
characteristics (for example, high managed care enrollment), the
provisions of this rule from which states could be exempted based on
these specific program characteristics, and alternatives to ensuring
compliance with section 1902(a)(30)(A) of the Act for any exempted
services in lieu of the procedures described in this final rule with
comment period. For example, the proposed rule included the requirement
for states to conduct an access review for all services every 5 years
and this final rule with comment period will require that states
conduct an access review on five specific service categories (and other
categories when the state or CMS has received a significantly higher
than usual volume of beneficiary or provider access complaints for a
geographic area) every 3 years. The changes in this final rule with
comment period resulted in large part from our consideration of
comments received from the public, including requests for additional
clarity with respect to some of these matters. While we believe these
changes will assist states in implementing the access review and
monitoring requirements, we are seeking additional comment on

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these provisions so that we can determine whether future adjustment of
these requirements through additional rulemaking would be warranted. In
addition, we are publishing a request for information (RFI) that
solicits feedback from stakeholders on whether and which core access
measures, thresholds, and appeals processes would provide additional
information or approaches that would be useful to us and states in
ensuring access to care for Medicaid beneficiaries. We are interested
in access measures that would apply regardless of the service delivery
approach adopted by the state, and would include access measures
applicable for populations enrolled in managed care. Ultimately, our
RFI-related goals are to better measure, monitor, and ensure Medicaid
access across state program and delivery systems and understand the
economic and policy factors that affect access to care. The RFI is
published elsewhere in this Federal Register along with information on
where respondents can send their responses.

I. Background

A. General Information

In the May 6, 2011 Federal Register (76 FR 26342), we published the
``Medicaid Program; Methods for Assuring Access to Covered Medicaid
Services'' proposed rule (hereinafter referred to as the ``May 6, 2011
proposed rule'') that outlined a standardized, transparent, data-driven
process for states to document that provider payment rates are
consistent with efficiency, economy, and quality of care and are
sufficient to enlist enough providers so that care and services are
available under the plan at least to the extent that such care and
services are available to the general population in the geographic area
as required by section 1902(a)(30)(A) of the Social Security Act (the
Act). In the May 6, 2011 proposed rule, we recognized that states must
have some flexibility in designing appropriate approaches to
demonstrate and monitor access to care, which reflects unique and
evolving state service delivery models and service rate structures.
Within the proposed rule, we discussed how a uniform approach to
meeting the statutory requirement under section 1902(a)(30)(A) of the
Act could prove difficult given current limitations on data, local
variations in service delivery, beneficiary needs, and provider
practice roles. For these reasons, we proposed federal guidelines to
frame alternative approaches for states to demonstrate consistency with
the access requirement using a standardized, transparent process,
rather than setting nationwide standards.
In this final rule with comment period, we are providing increased
state flexibility within a framework to document measures supporting
beneficiary access to services. This final rule with comment period
implements methods for states to use in complying with section
1902(a)(30)(A) of the Act by requiring that states review data and
trends to evaluate access to care for covered services and conduct
public processes to obtain public input on the adequacy of access to
covered services in the Medicaid program. This information will be
updated and monitored regularly. Should the data reveal short-comings
in Medicaid beneficiaries' access to care, states must take corrective
actions. The final rule with comment period also recognizes electronic
publication as an optional means of providing public notice of proposed
changes in rates or ratesetting methodologies that the state intends to
include in a Medicaid state plan amendment (SPA). This final rule with
comment period will meet the expectations of the May 6, 2011 proposed
rule to establish a transparent data-driven process that ensures that
rates are consistent with section 1902(a)(30)(A) of the Act.

B. State Ratesetting and Access to Care

The Medicaid statute requires that states provide coverage to
certain groups of individuals, and also requires that such coverage
include certain minimum benefits. States may elect to cover other
populations and benefits. To give meaning to coverage requirements and
options, beneficiaries must have meaningful access to the health care
items and services that are within the scope of the covered benefits.
This is consistent with the requirements of section 1902(a)(30)(A) of
the Act, which provides that states must have methods and procedures to
assure that payments to providers are ``sufficient to enlist enough
providers so that care and services are available under the plan at
least to the same extent that such care and services are available to
the general population in the geographic area,'' which we refer to as
the ``access requirement.'' Many factors affect whether beneficiaries
have access to Medicaid services, including but not limited to: The
beneficiaries' health care needs and characteristics; state or local
service delivery models; procedures for enrolling and reimbursing
qualified providers; the availability of providers in the community;
the capacity of Medicaid participating providers; and Medicaid service
payment rates to providers. To align with the statutory requirements,
states may employ any number of strategies to ensure or improve access
to care that are targeted toward one or more of these factors.
We have not previously defined through federal regulation an
approach to guide states in meeting the statutory access requirement at
section 1902(a)(30)(A) of the Act. In the absence of federal guidance
and a clear process for monitoring and ensuring access, at times
budget-driven payment changes in state Medicaid programs led to
confusion and litigation for states and to possible access problems for
beneficiaries. CMS's review of state payment rate methodologies for
compliance with this requirement was on a case-by-case basis and was
hampered by the lack of consistent information related to beneficiary
access. We historically relied on state certifications and available
supporting information to conclude that Medicaid payment rates met the
statutory standards.
In the May 6, 2011 proposed rule, we proposed to adopt an approach
for states to analyze access to care for Medicaid services through data
and information from beneficiaries and providers. The approach
specifically focused on: (1) The extent to which enrollee needs are
met; (2) the availability of care and providers; and (3) changes in
beneficiary utilization. The purpose of the proposed regulation was not
to create an access standard or rate thresholds that each state must
meet, but to develop a standard process for each state to follow in
documenting access to care. The regulation proposed to require that
states conduct regular reviews of Medicaid access to care that rely
upon: Payment data, trends in utilization, provider enrollment,
feedback from providers and beneficiaries, and other pertinent
information that describes access to Medicaid services. The access data
reviews would be used to inform state payment changes as well as our
approval decisions when states proposed provider payment reductions. In
addition, the proposed rule specified that states must conduct a public
process when reducing Medicaid payment rates and monitor changes in
access to care after payment reductions are approved by us and go into
effect.
Earlier this year, the Supreme Court decided in Armstrong v.
Exceptional Child Center, Inc., 135 S. Ct. 1378 (2015) that the
Medicaid statute does not provide a private right of action to
providers to enforce state compliance with section 1902(a)(30)(A) of
the Act in

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federal court. As a result, provider and beneficiary legal challenges
are not available to supplement CMS review and enforcement to ensure
beneficiary access to covered services. To strengthen CMS review and
enforcement capabilities, this final rule with comment period provides
for the development of needed information to monitor and measure
Medicaid access to care. The final rule with comment period will
provide more transparency on access in Medicaid fee-for-service (FFS)
systems than ever before and allow us to make informed data-driven
decisions and document our decisions when considering proposed rate
reductions and other methodology changes that may reduce beneficiaries'
abilities to receive needed care. In addition, because the proposed
rule was issued several years prior to the Armstrong decision and
therefore does not address CMS' or states' role in light of Armstrong's
limits on providers' and beneficiaries' ability to take legal action
regarding access, CMS is also issuing a Request for Information to
obtain public input into additional approaches to Medicaid's statutory
access requirements for CMS to consider.
While states will continue to have the discretion to set program
rates and improve access to care through a variety of strategies, this
final rule, and any additional measures we adopt, will increase the
information available to CMS, to ensure that rates meet the
requirements of section 1902(a)(30)(A) of the Act and that access
improvement strategies work to improve care delivery when there are
deficiencies. We are also developing internal standard operating
procedures to bolster the administrative record that is used to
document compliance with the final rule for individual SPAs and ensure
that there is consistent national application of these policies.

C. Medicaid Service Delivery Systems and Provider Payment Methodologies

States have broad flexibility under the Act to establish service
delivery systems for covered health care items and services, to design
the procedures for enrolling providers of such care, and to set the
methods for establishing provider payment rates. For instance, many
states provide medical assistance primarily through capitated managed
care arrangements, while others use FFS payment arrangements (with or
without primary care case management). Increasingly, states are
developing service delivery models that emphasize medical homes, health
homes, or broader integrated care models to provide and coordinate
medical services. The delivery system design and accompanying payment
methodologies can significantly shape beneficiaries' abilities to
access needed care by facilitating the availability of such care. In
addition, the delivery system model and payment methodologies can
improve access to care by making available care management teams,
physician assistants, community care coordinators, telemedicine and
telehealth, nurse help lines, health information technology and other
methods for providing coordinated care and services and support in a
setting and timeframe that meet beneficiary needs.
We have issued a series of State Medicaid Directors (SMD) letters
to promote and provide guidance on pathways to implementing integrated
care models which can provide higher quality care at lower cost. We
have also worked with states to explore innovative approaches to
improving care and lowering cost through the Innovation Accelerator
Program, the Medicaid Value-Based Learning Collaborative series, group
workshop sessions, and one-to-one technical assistance discussions. All
of these efforts seek to drive systemic changes in the Medicaid program
that manage program costs consistent with the economy and efficiency
provisions of section 1902(a)(30)(A) of the Act while also promoting
the quality of care.
As state delivery system models have evolved, so have their
provider payment systems. For most services, states develop rates based
on the costs of providing the service, a review of the amount paid by
commercial payers in the private market, or as a percentage of rates
paid under the Medicare program for equivalent services. Often, rates
are updated based on specific trending factors such as the Medicare
Economic Index or a Medicaid trend factor that incorporates a state-
determined inflation adjustment rate. Rates may include incentive
payments that encourage providers to serve Medicaid populations and
improve care. For instance, some states have authorized Medicaid
providers to receive separate payments for treatment services and for
care coordination and care management. Some states have increased
provider payments based on achievement of certain specified quality or
health outcome measures.
We have worked with states to design payment and service delivery
systems to ensure program savings are aligned with better care quality
and promote rather than reduce access to services. Although states may
experience reductions in service utilization or overall provider
payments for high cost services as a result of program innovations that
emphasize preventive care and divert individuals into more appropriate
treatment modalities, including serving them in the most integrated
setting appropriate to the needs of the individual consistent with
Olmstead v. L.C. 527 S.Ct. 581 (1999), we do not see those reductions
as being at odds with the statutory requirements or provisions
described in this final rule with comment period. The provisions of the
final rule with comment period allow states the opportunity to
transparently discuss the methods and analyses that they use to
demonstrate compliance with section 1902(a)(30)(A) of the Act. The
analysis and the follow-up monitoring data should clarify whether and
how changes in care and payment data result from delivery and payment
systems reform rather than reductions in access to care.
The flexibility in designing service delivery systems and provider
payment methodologies, as described above, is consistent with the
requirement in section 1902(a)(30)(A) of the Act that state Medicaid
plans must provide: Such methods and procedures relating to the
utilization of, and the payment for, care and services available under
the plan as may be necessary to safeguard against unnecessary
utilization of such care and services. As well, states must assure that
payments are consistent with efficiency, economy, and quality of care
and are sufficient to enlist enough providers so that care and services
are available under the plan at least to the same extent that such care
and services are available to the general population in the geographic
area.
Consistent with the requirement in section 1902(a)(30)(A) of the
Act to provide payment for quality care in an effective and efficient
manner, states can use their ratesetting policies to seek the best
value. Achieving best value has been a key strategy for some states
that have attempted to reduce costs in the Medicaid program in these
difficult fiscal times. We do not intend to impair states' abilities to
pursue that goal, or to impair states' abilities to explore innovative
approaches to providing services and lowering costs for other reasons.
In this final rule with comment period, we hope to clarify that,
although states must demonstrate that beneficiaries have access to
covered services at least comparable to others in the geographic area,
this access can be through service delivery networks, using payment
methodologies different from other individuals in the geographic area.
Comparable access does not

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necessarily require that beneficiaries obtain services from the same
providers, or the same number of providers, as other individuals in the
geographic area.

D. Modifications to State Payment Rates

Payment rates should be neither too low nor too high to ensure
access to care for Medicaid beneficiaries and to ensure the economy and
efficiency of Medicaid services and spending. Setting total payments
too high does not necessarily improve beneficiary access. This is
particularly true when higher payments are targeted to select providers
and do not necessarily translate into improved access to services.
Payment reductions or other adjustments to payment rates can help to
manage Medicaid program costs and ensure efficiency of service
provision, without necessarily violating requirements to ensure access
to care. For example, a state may amend its program to use a selective
contract to provide incontinence supplies which results in lower
payment rates for those supplies while maintaining statewide access to
those supplies. Or a state may reduce payments for hospital
readmissions to encourage the hospital to collaborate with a primary
care case management provider in the community. A state may also
rebalance its long term services and supports spending consistent with
Olmstead v. L.C. 527 S. Ct. 581 (1999) to ensure that older adults and
individuals with disabilities can receive high quality community-based
services.
However, payment reductions or other adjustments can, in some
circumstances, compromise beneficiary access to services. Consequently,
we affirm in this final rule with comment period that such payment rate
changes be made only with consideration of the potential impact on
access to care for Medicaid beneficiaries and with effective processes
for assuring access. Payment rate changes do not comply with the
Medicaid access requirements if they result in a denial of sufficient
access to covered care and services. Non-compliant changes could
adversely affect beneficiaries' abilities to obtain needed, cost-
effective preventive care, create stress on safety-net providers, and
counteract state delivery reform efforts that seek to reduce cost and
increase quality.
At times, budget-driven payment changes have led to confusion among
states and providers about the analysis required to demonstrate
compliance with Medicaid access requirements at section 1902(a)(30)(A)
of the Act. States attempting to reduce Medicaid costs through payment
rate changes have increasingly been faced with litigation challenging
payment rate reductions as inconsistent with the statutory access
provision. Further, resulting court decisions have not offered
consistent approaches to compliance. These decisions have at times left
states, providers, and beneficiaries without clear and consistent
guidelines and resulted in uncertainty in moving forward in designing
service delivery systems and payment methodologies. For instance,
several federal Courts of Appeals have addressed access and payment
issues, but there has been no consensus concerning the data or
standards that would be relevant in determining compliance with the
Medicaid statute. More recently, in March 2015, the Supreme Court ruled
in Armstrong v. Exceptional Child Center, Inc., 135 S. Ct. 1378 (2015)
that the Medicaid statute does not provide a private right of action
for providers and beneficiaries to challenge payment rates in federal
court. The lack of a private right of action underscores the need for
stronger non-judicial processes to ensure access, including stronger
processes at both the state and federal levels for developing data on
beneficiary access and reviewing the effect on beneficiary access of
changes to payment methodologies. In issuing this final rule with
comment period, we have reviewed options to ensure that states are
adhering to the statute in light of the absence of a private right of
action for noncompliance in federal court following the Armstrong
decision.
In the May 6, 2011 proposed rule, we intended to establish
consistent procedures that all states would follow in reviewing and
understanding Medicaid access to care on an ongoing basis and
monitoring access after reducing or restructuring rates. Specifically,
we proposed that states conduct ongoing access reviews for all Medicaid
services over 5-year periods that evaluate: The extent to which
enrollee needs are met; the availability of care and providers; and
changes in beneficiary utilization of covered services. We proposed
that within the reviews, states would need to include information about
access gathered through ongoing beneficiary feedback mechanisms and
comparisons of Medicaid payments to Medicare, commercials rates, or
Medicaid service costs. We proposed that when states reduce or
restructure rates in ways that could harm access to care, they consider
concerns raised by beneficiaries and stakeholders and develop and
monitor indices to ensure sustained access after implementing the rate
changes. States would have the discretion to choose the data used to
measure and analyze access to care and mechanisms to receive
information from beneficiaries and other stakeholders.
This final rule with comment period recognizes the importance of
stronger processes and data to ensure access to care while supporting
state flexibility to design the appropriate measures to demonstrate and
monitor access to care, which reflect the unique and evolving state
service delivery models and service rate structures. A uniform approach
to meeting the statutory requirement under section 1902(a)(30)(A) of
the Act could prove challenging at this time, given local variations in
service delivery, beneficiary needs, provider practice roles, and
limitations on data. At this time, we are issuing this final rule with
comment period to establish approaches for states to demonstrate
consistency with the access requirement using a consistent, transparent
process, rather than setting nationwide standards. These approaches
will also strengthen our ability to make sound and data-driven
decisions about the adequacy of state payment rates.
This final rule with comment period will not directly require
states to adjust payment rates; nor will it require states to adopt
policies that are inconsistent with efficiency, economy, and quality of
care. Even if access issues are discovered as a result of the analysis
that is required under this rule, states may be able to resolve those
issues through means other than increasing payment rates. This rule
requires that beneficiary access must be considered in setting and
adjusting payment methodologies for Medicaid services. If a problem is
identified, any number of steps, including payment increases, might be
appropriate to address the problem, such as: Redesigning service
delivery strategies or improving provider enrollment and retention
efforts. This final rule with comment period provides that we will
review these access issues in making SPA approval decisions, and
describes a more consistent and transparent way for states to collect
and analyze the necessary information to support such reviews.
We consider the requirements of this final rule with comment period
as a component of a broader strategy to ensure access in the Medicaid
program. However, the 2011 proposed rule did not anticipate the Supreme
Court decision: Armstrong v. Exceptional Child Center, Inc., 135 S. Ct.
1378 (2015), which underscored the primacy of CMS's role in ensuring
access. For this reason, CMS may consider

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additional approaches to promote access to care. We will, for example,
examine the feasibility of establishing a core set of access metrics
and thresholds that can be universally applied across all states and
services, as well as appropriate ways to gather that information.
Additionally, we will assess the feasibility of processes that target
and resolve access to care issues at an individual level, such as
robust complaint resolution or formal hearings processes.
Specifically, as we issue this final rule with comment period, we
are concurrently issuing a request for information (RFI) that solicits
feedback from stakeholders on whether and which core access measures,
thresholds, and appeals processes would provide additional information
or approaches that would be useful to us and states in ensuring access
to care for Medicaid beneficiaries. We are interested in access
measures that would apply regardless of the service delivery approach
adopted by the state, and would include access measures applicable for
populations enrolled in managed care. Ultimately, our RFI-related goals
are to better measure, monitor, and ensure Medicaid access across state
program and delivery systems and understand the economic and policy
factors that affect access to care. The RFI is published elsewhere in
this Federal Register along with information on where respondents can
send their responses.
In addition to issuing this final rule with comment period and the
RFI, we also will improve our administrative processes associated with
documenting the basis for approval and disapprovals when states propose
SPAs that reduce rates or restructure payments in ways that may affect
access to care. The information that is gathered by states through the
processes described in this final rule with comment, as well as through
additional state and CMS processes for ensuring Medicaid access to
care, will be the basis for our approval decisions and we will build
our administrative SPA records with this information.

II. Summary of Proposed Provisions

We proposed to address state processes for setting payment rates by
amending existing regulations at Sec. 447.203, Sec. 447.204, and
Sec. 447.205. The following is a summary of our proposals.

A. Documentation of Access to Care and Service Payment Rates

We proposed to revise Sec. 447.203(b) to require state Medicaid
agencies to demonstrate access to care by documenting in an access
monitoring review plan their consideration of: Enrollee needs; the
availability of care and providers; and the utilization of services.
The experiences of beneficiaries should be a primary determinant of
whether access is sufficient. We solicited comments that would serve to
help states narrow the focus of the data review to core elements that
would demonstrate sufficient access to care. We received, through
public comments, many suggested elements that states could incorporate
into access reviews, but there was no consensus among commenters as to
measures that could be universally applied across all services. We will
continue to study whether a core set of measures and thresholds should
be applied to Medicaid access to care and are soliciting more
information from stakeholders on this question through the RFI process.
Proposed Sec. 447.203(b)(1)(i) through (iii) would have required
states to review and make publically available data trends and factors
that measure: Enrollee needs; availability of care and providers; and
utilization of services. Consistent with the statutory requirement, we
proposed that states review this data by state designated geographic
location.
We proposed revisions to Sec. 447.203(b)(1)(iii)(B) to require
that the review must include: (1) An estimate of the percentile which
Medicaid payment represents of the estimated average customary provider
charges; (2) an estimate of the percentile which Medicaid payment
represents of one, or more, of the following: Medicare payment rates,
the average commercial payment rates, or the applicable Medicaid
allowable cost of the services; and (3) an estimate of the composite
average percentage increase or decrease resulting from any proposed
revision in payment rates.
We proposed in Sec. 447.203(b)(1)(iii)(B)(3) that the Medicaid
payment rates must include both base and supplemental payments for
Medicaid services. Since states often reimburse service providers
according to different payment schedules based on governmental status,
we proposed at Sec. 447.203(b)(1)(iii)(C) that states stratify the
access review data by state government owned or operated, non-state
government owned or operated and private providers.
In Sec. 447.203(b)(1)(iii)(D), we proposed to describe the minimum
content that must be in included in the rate review. Specifically, we
proposed to require that states describe the measures that were used to
conduct the review and their relationship to enrollee needs, the
availability of care and providers, service utilization and Medicaid
payment rates as compared to other payment structures.
Proposed Sec. 447.203(b)(2) described the timeframe for states to
conduct the data review and make the information available to the
public through accessible public records or Web sites on an on-going
basis for all covered services. We proposed that the annual reviews
begin no later than 2013, so states would have the discretion to
determine a timeframe to review each covered Medicaid service, as long
as the state reviewed a subset of services each year and each covered
service is reviewed at least once every 5 years. We provided states
this 5-year cycle to reduce the burden while accommodating the need for
review to assure compliance with section 1902(a)(30)(A) of the Act.
Because of the need to demonstrate service access in the context of
a payment rate reduction, we proposed in Sec. 447.203(b)(3)(i) that
states would need to conduct the review relevant to the affected
service prior to submission of a SPA implementing a reduction. If the
state had already reviewed access relating to the types of services
that are subject to the rate reduction within 12 months prior to the
proposed rate reduction, and maintained an ongoing monitoring mechanism
for beneficiary complaints, its review relative to the rate reduction
could be referenced in the previous review. To ensure sustained access
to care, we included provisions at Sec. 447.203(b)(3)(ii) that would
require states to develop ongoing monitoring procedures through which
they periodically review indices to measure sustained access to care.
We also proposed at Sec. 447.203(b)(4) to require states to have a
mechanism for beneficiary input on access to care, such as hotlines,
surveys, ombudsman or other equivalent mechanisms. Additionally, we
proposed at Sec. 447.203(b)(5) a corrective action procedure requiring
states to submit a remediation plan should access issues be discovered
through the access review or monitoring processes. These requirements
were proposed to ensure that states would oversee and address future
access concerns.

B. Medicaid Provider Participation and Public Process To Inform Access
to Care

In Sec. 447.204, we proposed to implement the statutory
requirement that Medicaid payment rates must be consistent with
efficiency, economy,

[[Page 67581]]

and quality and are sufficient to enlist enough providers so that
services under the plan are available to beneficiaries at least to the
extent that those services are available to the general population. We
proposed to revise Sec. 447.204(a)(1) through (a)(2) to require that
states consider, when proposing to reduce or restructure Medicaid
payment rates, the data collected through the proposed requirement at
Sec. 447.203 and undertake a public process that solicits input on the
potential impact of the proposed reduction of Medicaid service payment
rates on beneficiary access to care. In Sec. 447.204(b), we also
proposed to clarify that we may disapprove a proposed rate reduction or
restructuring SPA that does not include or consider the data review and
a public process. Disapproving the SPA means that a state would not
have authority to implement the proposed rate reduction or
restructuring and would continue to pay providers according to the rate
methodology described in the state plan.

C. Public Notice of Changes in Statewide Methods and Standards for
Setting Payment Rates

We proposed to clarify and modernize changes to the public notice
requirement at Sec. 447.205. We also solicited comments on whether it
is advisable to delete the term ``significant'' from Sec. 447.205(a)
and explicitly state that notice is required for any change in rates.
Alternatively, we solicited comments on whether to adopt a threshold
for significance and what that threshold might be.
Further, we proposed to recognize electronic publication as an
optional means of publishing payment notice. To do so, we proposed
adding Sec. 447.205(d)(iv), which would allow notice to be published
on a Web site developed and maintained by the single state Medicaid
agency or other responsible state agency that is accessible to the
general public on the Internet.

III. Analysis of and Responses to Public Comments

We received at total of 181 comments from states, advocacy groups,
providers, provider organizations and individuals on the May 6, 2011
proposed rule. The comments ranged from support for the proposal to
specific questions or comments regarding the proposed changes. We
received some comments that were outside of the scope of the proposed
rule, and therefore, not addressed in this final rule with comment
period.
The following are brief summaries of the public comments received,
and our responses to those public comments:

A. General Comments

We received many comments that were general in nature and were not
specific to any of the provisions of the May 6, 2011 proposed rule. We
have summarized and responded to those comments below.
Comment: Several commenters urged CMS to delay implementation of
the final rule and work with states to find alternative approaches to
measuring access. Commenters also recommended that CMS convene a
workgroup with state Medicaid agencies to develop access thresholds.
One commenter wrote that CMS and states would be better served to work
together to identify reasonable criteria under which state legislatures
could make timely and meaningful adjustments to provider rates and
states could document the potential impact to access.
Response: We have worked with states and federal partners to
identify appropriate access measures and a manageable process for state
Medicaid agencies to meet the statutory requirements of section
1902(a)(30)(A) of the Act. This included listening sessions with the
National Association of Medicaid Directors to hear state concerns
regarding Medicaid access to care and how states were working to
address access issues. We worked with many states and providers
individually to understand state-specific access issues and the types
of information that states and providers rely upon to discuss access to
care. Finally, we worked with HHS' Assistant Secretary for Planning and
Evaluation (ASPE) to investigate if there are national access measures
that may be applied across all states and services for compliance with
section 1902(a)(30)(A) of the Act. The policies reflected in this final
rule with comment period are consistent with these efforts and the
public comments we received. This final rule with comment period is
being published after extensive consultation, 4 years after we issued
the proposed rule. Further delaying this rule could result in confusion
as to the application of the access requirements of section
1902(a)(30)(A) of the Act, especially given the Supreme Court's
decision in Armstrong v. Exceptional Child Center, Inc., 135 S. Ct.
1378 (2015), which specifically stated that providers do not have a
private right of action to enforce section 1902(a)(30)(A) of the Act
and that CMS is ultimately responsible for enforcing the statutory
requirements. This final rule with comment provides a more systematic
approach than currently exists in the Medicaid program for states and
us to evaluate beneficiary access to services. The regulatory framework
also seeks to ensure that states will have the information necessary to
consider and evaluate access issues. We will continue to work closely
with states and other partners to appropriately review access to care
and address access issues, while remaining cognizant that states need
to make program adjustments and operate within budgets. In addition,
the RFI will solicit further information on whether and which core
access measures, thresholds and appeals processes would provide
additional information or approaches that would be useful to us and
states in ensuring access to care to Medicaid beneficiaries.
Comment: A number of commenters requested that CMS provide an
incentive mechanism to encourage states to address access issues in a
timely manner. Commenters specifically suggested that an enhanced
administrative matching rate be made available for costs associated
with the final rule.
Response: To receive federal financial participation (FFP) for
Medicaid services, states must comply with the applicable statutory and
regulatory requirements. To the extent that state activities described
in this final rule with comment period are for the proper and efficient
administration of the Medicaid state plan, the administrative match
rate is available to states. We do not have the statutory authority to
provide an enhanced administrative match rate for these activities.
Comment: Several commenters requested that CMS clarify what
constitutes a payment change. A commenter noted that providers often
view years when rates do not increase as payment reductions. Another
noted that the preamble of the May 6, 2011 proposed rule refers to
``payments'' and ``rates'' interchangeably but that courts have defined
payments to include all Medicaid provider revenues rather than only
Medicaid FFS rates. The commenter stated that if the final rule
considers all Medicaid revenues received by providers, states may be
challenged to make any change to the Medicaid program that might reduce
provider revenues. The commenter also suggested that the final rule
clarify that the statute refers to specific service rates under the
Medicaid state plan or waiver rather than all Medicaid provider
payments.
Response: The statute requires that states have methods and
procedures relating to Medicaid payment rates so

[[Page 67582]]

that such rates are sufficient to enlist enough providers to ensure
access to care. The final rule refers to actions to reduce or
restructure rates which may result in less access to care. While the
final rule applies only to Medicaid fee-for-service rates for state
plan covered services, which may not include all Medicaid revenues
received by a provider, the rule does contemplate broader payment
changes that may affect access, such as reductions to supplemental
provider payments. In addition, reviewing additional data will enable
CMS to better identify and work with states to address access
deficiencies that may arise if rates are not updated for many years,
and if necessary to address them through compliance action. At this
time, we generally do not review individual Medicaid payment rates as
part of the SPA process, but we review the methodologies that states
apply to set their provider rates or payments.
This final rule with comment period requires states to review
access information on an ongoing basis for primary care services,
including physician, federally qualified health centers (FQHC), clinic,
dental care, etc.; physician specialist services (for example,
cardiology, urology, radiology); behavioral health services, including
mental health and substance abuse disorder treatment; pre- and post-
natal obstetric services including labor and delivery; and home health
services (as defined in Sec. 440.70), whether or not the payment
methodologies change. States may also choose to select additional
services to review through the access monitoring review plan. In
addition, when changes to payment methodologies are made through the
SPA process, the state must be able to support that change with
documentation that access to care will not be adversely affected, and
must monitor access after the change is made. If, for example, a state
removes an annual inflation adjustment and therefore freezes rates from
1 year to the next when an increase in inflation was anticipated, a
current access review will be required to support approval of a SPA,
and the state will also need to continue to monitor access. In
addition, whether or not the state changes payment methodologies
(including for services outside of the ongoing monitoring and review
requirements), required ongoing mechanisms to receive beneficiary and
provider feedback would indicate to states and CMS access issues that
arise for any Medicaid service.
Comment: Several commenters suggested the final rule clarify that
all state actions pertaining to provider payment rate setting,
including legislatively mandated rate reductions, are subject to the
access analysis and public process requirements and that legislatively
mandated rate cuts cannot be implemented retroactively.
Response: We agree with the commenters that it is important for
states to evaluate access any time the state proposes a change to its
Medicaid reimbursement methodologies that will result in a reduction or
restructuring of provider rates. This final rule with comment period
does not provide for exceptions to this requirement to review access
when there is a state legislative requirement. But nothing in this rule
changes the longstanding policies that permit a state to submit a SPA
with an effective date as early as the first day of the quarter in
which a plan is submitted (but only after public notice of the new
rates have been issued). This policy permits states flexibility to
implement approvable rate changes without delay while it undergoes
federal review. Thus, states may continue to implement rate reductions
retroactively to the first day of the quarter in which an approvable
SPA is submitted to CMS.
Comment: Several commenters requested that we make the following
data public for all providers, beneficiaries, and stakeholders to
review and comment upon: (1) Data analysis and any supporting
documentation; (2) SPA submissions and supporting documentation; and
(3) all communication between CMS and states pertaining to data
analysis and SPAs.
Response: In this rule, we require states to make the data analysis
and supporting documentation available both to the public and to CMS.
While publication of specific information related to SPA submissions
and disposition is not required under this final rule with comment
period, these materials may be available through Freedom of Information
Act (FOIA) requests. We recommend that states publish the access
monitoring review plans and subsequent data collected through those
plans on their Web sites for full transparency. Furthermore, we
continue to post approved SPAs on the www.Medicaid.gov Web site and
will post state access review plans so that they are publicly
available. Issuing all of the communications and documentation
associated with the SPA review process as it is ongoing would add
burden without adding significant relevant information, and would
significantly slow the process for CMS to review and approve state
submissions, many of which are time sensitive.
Comment: Many commenters requested that we broaden the proposed
regulatory framework to apply to provider payment rates beyond those
authorized under the Medicaid state plan. Commenters specifically
requested that the regulation apply to rates paid by Medicaid managed
care organizations and rates paid under Medicaid waiver programs. Many
commenters were concerned that a proposal to address access issues
under managed care delivery systems is needed. Some commenters called
for specific revisions to managed care regulations to set forth clearer
standards for managed care rate reviews. One commenter suggested that
CMS should incorporate into the actuarial soundness review, standards
for transparency in rate setting for managed care organizations and
require states to evaluate the impact of managed care rate cuts on
access. Another commenter offered that the rule should be extended to
apply to children enrolled in managed care.
Response: As stated in the May 6, 2011 proposed rule, section
1902(a)(30)(A) of the Act specifically applies to payment for care and
services available under the state plan, which we interpret to refer to
payments to providers and not to capitated payments to managed care
entities. While Medicaid access to services under managed care
arrangements is an important issue, that issue is addressed through
reviews of network sufficiency and managed care quality review
processes. As a result, we are not addressing access to care under
managed care arrangements in this rulemaking effort. Similarly, methods
to assure access to care, including payment methodologies, are reviewed
in the approval process for Medicaid waiver and demonstration programs
(and, when appropriate, may be monitored in the evaluation of a
demonstration program). As a result, we did not specifically address
those programs within the context of this rulemaking process. Separate
recent CMS initiatives have addressed the framework for Medicaid
managed care and home and community based service programs, including
access and quality review methods. In January 16, 2014, we issued the
``Home and Community-Based State Plan Services Program, Waivers, and
Provider Payment Reassignments'' final rule (79 FR 2947-3039), and on
June 1, 2015, we published the ``Medicaid Managed Care, CHIP Delivered
in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies,
and Revisions related to Third Party Liability'' proposed rule (80 FR
31097-

[[Page 67583]]

31297) which proposed to align the rules governing Medicaid managed
care with those of other major sources of coverage, including coverage
through Qualified Health Plans and Medicare Advantage plans. The
Medicaid managed care proposed rule specifically discusses requirements
for network adequacy.
Comment: A commenter requested that the regulation explicitly state
that all Medicaid long-term services and supports options must be
included in these reviews.
Response: All Medicaid services covered under the state plan are
included within the scope of the regulatory requirements of this final
rule with comment period. We will require an access analysis to support
a request for approval of any rate reduction or restructuring for any
service in the state plan. As a baseline, the final rule with comment
period will require that states review and publish access studies for
primary care services; physician specialist services; behavioral health
services, including mental health and substance abuse disorder
treatment; pre- and post-natal obstetric services including labor and
delivery; and home health services on an ongoing basis. States may also
select additional services to add to this list. In addition, access
studies and continued monitoring will be required for covered services
when payment rates have been reduced or restructured, or when the state
receives a significant volume of public input raising access to care
issues. We are requesting public comment on the service categories
selected for inclusion in baseline access analysis. Additional services
will need to be reviewed as reductions to payment rates or as access
issues become apparent. These additional services must be monitored
periodically for a minimum of 3 years following the initial rate
reduction.
Comment: One commenter stated that providers can practice cost-
shifting by overcharging some patients to make up for low Medicaid
rates. The commenter noted that cost-shifting permits equal access even
if Medicaid rates are not consistent with economy and efficiency.
Response: The focus of this rule is to provide a reasonable
approach for states to document access to care for Medicaid services
under the state plan. While we agree with the commenter that the
adequacy of payment rates in meeting provider costs are not necessarily
the only or the decisive factor in ensuring access to care, in this
final rule with comment period, we do not require that states establish
access by reviewing the relationship of payment rates to provider
costs. Ultimately Medicaid payment rates must sufficient to ensure
beneficiary access to care, whether or not providers are shifting costs
to other payers.
Comment: A commenter suggested that CMS exempt the effects of care
coordination initiatives from access documentation requirements. Other
commenters more specifically suggested that CMS should exempt from
access documentation requirements services to which beneficiary access
is limited by coordination of care activities of home and community
based providers, especially when these activities may result in loss of
access to care in medically underserved or rural areas.
Response: Care coordination is an important aspect of a well-
designed health care system and this regulation does not intend to
discourage states from implementing care coordination programs or other
efforts that seek to lower cost and improve the quality of care. Such
activities should enhance access to care by arranging for individuals
to receive appropriate care when needed. Therefore, we do not agree
that exemptions to the requirements of this final rule with comment
period should be applied to states that offer care coordination.
Comment: Commenters requested specific exceptions to the procedures
described in the final rule based on state Medicaid program features.
As examples, commenters requested exceptions for states with a majority
of individuals enrolled in managed Medicaid and relatively few enrolled
in FFS systems, states with all payer payment systems, states that pay
Medicare rates, and for services where Medicaid is the only or primary
payer of care. The commenters stated that requiring states with these
program features to follow the procedures described in the rule would
be inefficient.
Response: This final rule with comment period applies to all
covered services under the state plan for which payment is made on a
FFS basis. However we are soliciting comments through the final rule
with comment period on whether we should consider further rulemaking or
guidance, as appropriate, to allow for such exemptions to the scope of
required access reviews required under Sec. 447.203(b)(5), including
whether to permit streamlined approaches to measuring access to care
based on specific circumstances within states. For instance, we are
particularly interested in whether states with higher percentages of
beneficiaries enrolled with managed care organizations should be exempt
from conducting the ongoing access data reviews and/or the rate
reduction monitoring procedures and what threshold for such exemptions
would be appropriate. We understand that many states carve out certain
services from managed care capitation rates and continue to pay for
those services through FFS. We also understand that many of the
individuals who remain in state FFS systems may have complex care
needs. We note that states already have significant flexibility within
the final provisions of the rule to choose measures within their access
monitoring review plans that are tailored to state delivery systems.
This could allow, for instance, a state with high levels of managed
care enrollment to focus on specific care needs of the populations that
remain in FFS after a managed care transition.
Comment: A number of commenters offered that the rule inhibits a
state's ability to make adjustments to payment rates that may be
necessary to deal with state economic and fiscal crisis. Commenters
also noted that CMS should acknowledge that states cannot dismiss local
budgetary issues or casually increase revenue to address perceived
access to care issues. Other commenters stated that the rule will
infringe on states' abilities to make budget decisions. Some commenters
raised concerns that the timing of a state legislative session makes it
difficult for states to comply with the due dates of the access
monitoring review plans.
Response: The final rule with comment period does not prohibit
states from implementing (through a SPA) payment rate reductions, as
long as beneficiaries will maintain sufficient access to care. In the
May 6, 2011 proposed rule, we acknowledged the reality that state
budgets often play a role in Medicaid rate-setting. This final rule
with comment period requires that states have a process in place to
review and monitor access to care to determine the impact various
program changes have on beneficiary access. The rule does not prescribe
specific state actions to address access to care issues. The rule
instead requires procedures that will inform states and CMS of access
concerns before SPA approval and on an ongoing basis. This information
should be useful to state legislators as they make budgetary decisions
and is not intended to hamper the legislative process.
Comment: A commenter requested that we clarify how CMS would handle
access issues that arise due to events that are not within the state's
control, such as through competitive bidding programs for certain
Durable Medical

[[Page 67584]]

Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS).
Response: There may be any number of issues that contribute to
inadequate service access within state Medicaid programs. Though some
causes of access issues may be out of a state's control, the statutory
requirements still apply and a state must implement appropriate
remediation measures in an effort to address access issues. The
strategies for remediation are not limited to increases in payments and
states may employ any number of approaches to assuring better access to
Medicaid state plan services. To competitively bid for medical devices
and supplies, states are currently required to waive ``freedom of
choice'' through the exception provided under section 1915(a)(1)(B) of
the Act and federal regulation at 42 CFR 431.54(d). Section
1915(a)(1)(B)(i) and the regulation at Sec. 431.54(d) expressly
require that adequate services or devices must be available to
recipients under a competitive bidding program. States should consider
this requirement in structuring their competitive bidding programs and
drafting requests for bids. If a state's competitive bidding program
does not meet this standard, than it is not in compliance with Sec.
431.54(d) and section 1915(a)(1)(B) of the Act.
Comment: One commenter requested that CMS clarify whether states
would need to have CMS approval for a change to payment rates or
methodologies prior to implementing a change. The commenter noted that
a SPA should be necessary any time a state proposes to implement
changes in law, policy, or practice that may result in reduction of
payment, regardless of whether it requires modification of existing
plan language. Similarly, commenters urged that state Medicaid programs
cannot implement provider payment reductions until they have complied
with the proposed regulatory process for assuring access to care and
CMS has approved the state's SPA to reduce provider payments.
Response: Without exception, our policy, as set forth in Sec.
447.201(b), is that states must receive approval through the SPA
process to modify Medicaid payment methodologies. CMS approval ensures
that the changes in service payment methodologies comply with all
applicable regulatory and statutory requirements and are eligible for
FFP. SPAs may be effective no earlier than the first day of the quarter
in which a state submits an amendment. While there is no specific
regulatory or statutory requirement that a state wait until SPA
approval to implement a reduction in payment rates, the state must
reimburse providers at approved state plan rates, and thus would need
to make corrective payments if the amendment is disapproved.
Comment: Many commenters offered that CMS should require higher
standards for services with known access issues. Many providers and
provider groups highlighted access challenges unique to the services
that they provide. These providers noted access challenges specific to
many services, including, but not limited to: Primary care services;
mental health services; maternity services; long term care and
supports; family planning and contraception; pharmacy; specialty care;
dental care; hospital services; End Stage Renal Disease (ESRD)
services; physical therapy; transplants for essential body organs; and
community and ambulatory care. Similarly, commenters wrote that state
access reviews should be segmented to identify the needs of children
and individuals with particular health care needs that may go unmet.
Response: We agree that there are unique qualities in service
categories, delivery systems, and populations that require independent
analysis and that certain categories of service are known to be more
prone to access to care issues in the Medicaid program. This is one of
the challenges that CMS and states face in selecting access data and
measures that are appropriate and also addressing concerns on the part
of states regarding administrative burden. Based on the public comments
we received, the final rule with comment period requires that ongoing
access reviews focus on the following categories of services: Primary
care services; physician specialist services (for example, cardiology,
urology, radiology); behavioral health services, including mental
health and substance abuse disorder treatment; pre- and post-natal
obstetric services including labor and delivery; and home health
services. We believe these services are both in high demand and
commonly utilized by Medicaid beneficiaries (see: The Kaiser Commission
on Medicaid and the Uninsured. Medicaid Moving Forward. Julia Paradise.
March 2015). States may also select additional services to add to this
list. This final rule with comment period also requires that all
services that are subject to reduced rates or restructured rates and
that could impact access will also need to be reviewed and monitored as
part of a state's access monitoring review plan.
We will work with states to identify, based on feedback from
beneficiaries and providers and other available information and data,
additional services that may require more regular review based on data
analysis or known concerns. We are soliciting comments in this final
rule with comment period on whether additional categories of service
should be added to the list of required ongoing reviews included in the
rule.
Comment: Commenters suggested that as part of the final rule, CMS
should recognize that some states are entirely or in part Health
Professional Shortage Areas (HPSA) or Medically Underserved Areas (MUA)
which makes increasing access a more difficult challenge, particularly
in a 12-month frame.
Response: We appreciate that some states or geographic areas within
states are in HPSAs or MUAs, which present challenges in improving
access to care. We are restating that this final rule with comment
period does not require specific improvements or timeframes for
improvement in access to care when Medicaid access is consistent with
the statute and the availability of care for the general population in
a geographic area. We recognize that some areas within states may face
particular challenges in meeting the health needs of the individuals
residing in those areas, and states should describe the challenges
within their access reviews and discuss how they affect the Medicaid
program in particular.
Comment: Some commenters stated that the proposed rule did not
provide an appropriate balance between economy and efficiency and
access by allowing states to invoke cost as a constraint only when they
can address access issues in some way other than an increase in payment
rates. Other commenters noted that emphasizing access to care over
economy and efficiency is at odds with many state innovation strategies
that aim to lower cost and improve care.
Response: The rule does not limit a state's ability to reduce or
restructure rates based on information that the rates are not economic
and efficient; rather, it ensures that states take appropriate measures
to document access to care consistent with section 1902(a)(30)(A) of
the Act. Under the Act, rates are neither economic nor efficient if
they do not also ensure that individuals have appropriate access to
covered services. We interpret section 1902(a)(30)(A) of the Act as a
balanced approach to Medicaid rate-setting and we encourage states to
utilize appropriate information and program experience to develop rates
to meet all of its requirements. Further, we expect states to document
that Medicaid rates are economic and efficient when the state submits
changes to payment methodologies through a SPA. We will continue to
document as part of our SPA review process why the methodology is in
line with statutory

[[Page 67585]]

requirements. We will continue to work with state leaders and
stakeholders and will consider issuing policy guidance on standards for
economy and efficiency through future rulemaking efforts. We are
actively working with states toward innovative delivery system designs
that promote economy and efficiency through person centered coordinated
care and value-based purchasing. We do not view the requirements
described in this final rule with comment period or the access
provisions under section 1902(a)(30)(A) of the Act in conflict with
these efforts.
Comment: A commenter noted that by using only access metrics, it
would be very unlikely that state access reviews would ever show that
emergency room rates violate the statute because hospitals, in
practice, usually do not opt out of serving Medicaid patients. The
commenter further stated that rates to Medicaid hospitals could sustain
equal access to emergency room services, but could simultaneously be
entirely inconsistent with efficiency, economy, and quality of care.
Response: This final rule with comment period focuses specifically
on documenting compliance with the access to care requirements of
section 1902(a)(30)(A) of the Act. This rule includes a multi-faceted
approach to reviewing access data, soliciting feedback from
beneficiaries, providers and other stakeholders, and public processes
to raise issues specific to state rate actions that may impact access
to care. We do not disagree that providers that have a requirement or
mission to provide care could still receive Medicaid payment that falls
short of their full cost of providing the care furnished. This is an
issue that is relevant to the state's rate-setting process, but not
necessarily an access issue. These issues could be raised by hospitals
in the rate-setting procedures required under section 1902(a)(13)(A) of
the Act, but we agree that there could be additional opportunities for
public input. We are including in the final rule with comment period,
requirements that states develop mechanisms for ongoing provider
feedback, which should allow hospitals and other providers who seek
higher rates to raise concerns to states.
Comment: A commenter stated that the proposed rule does not provide
sufficient discretion to consider market considerations and expressed
concern that the proposed rule should require states to implement a
process to evaluate access regardless of whether a state is seeking
changes to rates. Further, the commenter expressed concern regarding
the establishment of a price floor for Medicaid services.
Response: The statute requires Medicaid payment rates to be
sufficient to ensure access to care and services for beneficiaries, and
this final rule with comment provides considerable flexibility to
consider relevant factors including market rates. The requirement to
assure access to services is not limited in scope to when a state is
proposing a change to its payment rate methodology, but rather, applies
to current rates as well. If a state has not changed its Medicaid
payment methodology for many years, we believe it is just as important
to assess those rates to determine if the rates are still sufficient to
ensure access as it is to evaluate the effect of proposed changes to
rate methodologies. The provisions of the final rule with comment
period allow for state flexibility to take into account market
conditions in carrying out their access monitoring review plans. We
have considered state concerns with the burden associated with the rule
and have focused the ongoing access reviews on: primary care services;
physician specialist services (for example, cardiology, urology,
radiology); behavioral health services, including mental health and
substance abuse disorder treatment; pre- and post-natal obstetric
services including labor and delivery; and home health services. Access
to these services should be indicators that beneficiaries have ongoing
access to primary sources of care. States may also select additional
services to add to this list. Ongoing access concerns with other
services can be addressed through public input processes also required
under this final rule with comment period. We note that the final rule
with comment period does not require a payment floor for any Medicaid
service.
Comment: One commenter recommended that CMS clearly explain in the
rule that the statute includes strong policy against over-utilization
of medical services, and it is both appropriate and desirable that
states adopt rate policies that will discourage unnecessary utilization
of services and embody incentives for more efficient use of health care
resources. Commenters wrote that measuring utilization of covered
services to determine appropriate access is in conflict with and
ignores many states' efforts to ensure appropriate utilization. To
remedy this conflict, commenters suggested that CMS clarify the law
requires states to enroll enough providers to ensure access rather than
ensure that people are actively seeking treatment. These commenters
also objected to measuring enrollee needs and the comparison of
Medicaid rates to other payer systems.
Response: We agree that state oversight efforts and rate setting
policies should discourage over-utilization. We support state efforts
to identify utilization associated with inappropriate care through
processes that can include prior authorization, claims review, and care
management initiatives. Regulations at 42 CFR part 456 specifically
discuss the requirements concerning control of the utilization of
Medicaid services in certain settings, or for certain services. The
regulatory framework presented in this final rule with comment period
describes several data points that may be indicators of access within a
given state; however, we recognize that no one measure offers a precise
indication of sufficient or insufficient access to care. If a state
experiences a severe decline in service utilization without a plausible
explanation, there may be an access concern worthy of investigation.
The same is true of beneficiary needs. If a state experiences a spike
in beneficiaries who experience difficulty receiving a particular
service in a geographic region, this could indicate access issues and
should be investigated. Because the statutory provisions at section
1902(a)(30)(A) of the Act refer to payment rates and comparisons to the
general population, it is necessary for states to compare Medicaid
payment rates to the rates of Medicare or private payers. We expect
that states will evaluate access in consideration of outcome-based care
as new approaches to payment and deliver systems take form. The final
rule with comment period allows states broad flexibility to consider
the impact of new types of payments and care delivery in the access
monitoring review plans.
Comment: One commenter requested that CMS specifically examine out-
of-state Medicaid payments, particularly in states with historically
high-volume, out-of-state use of services.
Response: We have not set out specific requirements for out-of-
state providers in this final rule with comment period. To the extent
that individuals in the state obtain access to a particular type of
service through out-of-state providers, including through telemedicine
or telehealth, or to the extent that individuals in a geographic area
generally obtain services through out-of-state providers, the state
will need to consider such providers in reviewing access to care.
Comment: One commenter stated that the regulatory effort should be
expanded to address section 1902(a)(30)(A) of the Act's quality of care
requirements.

[[Page 67586]]

Response: We currently have several initiatives in place to improve
upon quality within Medicaid delivery systems and strengthen quality
measures. We are actively engaged with states and other stakeholders in
developing quality guidelines, for example the Child and Adult Core
Health Care Quality Measurement Sets developed in conjunction with the
National Quality Forum. While the focus of this final regulation is
limited in scope to access to care, we will continue our work to
promote quality improvement within state Medicaid programs and may, in
the future, develop regulatory or subregulatory guidance on quality
standards. We also recognize that access and quality can be related and
beneficiaries may provide beneficial input to states on this
relationship through the processes states develop in accordance with
this rule.
Comment: Several commenters stated that the requirements of the
notice of proposed rule-making create a stricter standard than what is
required under the statute. Some commenters offered that the
requirement will be difficult to meet and would effectively preclude a
state from making program changes.
Response: Prior to the issuance of this final rule with comment
period, several states implemented a number of the regulatory
provisions we proposed in the May 6, 2011 proposed rule. These states
recognized the need to review and monitor data and to work with
stakeholders to address potential access issues in light of cuts to
Medicaid payment rates. Based on the work of these states, we consider
the requirements of the final rule with comment period to be reasonable
and achievable. As discussed in the May 6, 2011 proposed rule and in
this final rule with comment period, the requirements of the rule do
not limit state flexibility in program operation. Nor do the regulatory
requirements go beyond the scope of what is necessary to reasonably
document beneficiary access to care. Instead, the rule provides states
with procedures to document compliance with the statutory requirement
to ensure access to care. These procedures permit states considerable
flexibility in the analysis of data reflecting access, and in the
measures that a state must take to respond to access concerns.
Comment: One commenter stated that Medicare and Social Security
have not experienced the same challenges facing Medicaid, likely
because their beneficiaries have considerable political clout. The
commenter stated that policymakers must factor in this reality when
reviewing the proposed rule comments and provide special consideration
to comments from those who advocate on behalf Medicaid beneficiaries.
Response: The public comment period is a unique opportunity for the
public to contribute to the regulatory process. All comments are
considered in the development of final regulations. Input from
beneficiaries and their advocates is essential because that input most
directly reflects the success or failure to obtain beneficiary access
to care. And the importance of that input is not limited to the
rulemaking process. This is why this final rule with comment period
requires that states maintain ongoing systems to collect and analyze
beneficiary comments and complaints concerning access to care. The
importance of beneficiary needs and ongoing feedback are highlighted in
the framework described in the proposed and final rules.

B. Documentation of Access to Care and Service Payment Rates (Sec.
447.203)

Comment: Many commenters agreed that it is important for states to
conduct access reviews to examine access and related data in different
geographic regions throughout the state.
Response: We appreciate support for the proposed data analysis
requirements. We have adopted without change many of the proposed
requirements in this final rule with comment period.
Comment: Many commenters suggested that we modify the access review
procedures to require baseline access analysis prior to taking action
to approve provider rate reductions, ongoing monitoring to detect
problems, and corrective action when problems are detected. Some
commenters offered that CMS should suspend the rate reduction until
corrective measures are taken.
Response: Consistent with the commenters' suggestion, this final
rule with comment period requires that states conduct baseline reviews
of the core services defined in this regulation and monitor access data
to ensure compliance with section 1902(a)(30)(A) of the Act. States are
also required to review and submit access data when states submit rate
proposals that may have a negative impact on access to care and
continue monitoring for 3 years afterwards through the process outlined
in the access monitoring review plan. In addition, we have revised the
ongoing access monitoring review plan activities to require a review of
primary care services; physician specialist services; behavioral health
services, including mental health and substance abuse disorder
treatment; pre- and post-natal obstetric services including labor and
delivery; and home health services. We have made this change in
consideration of state burden and to focus ongoing access monitoring on
highly needed and utilized services. States may also select additional
services to add to this list. While the suspension of a rate reduction
may be an appropriate corrective action, we are not requiring a
specific approach to addressing access issues within the final rule
with comment period and we will work with states on appropriate
remedies.
Comment: A commenter requested that CMS provide a list of the
covered services and benefits that fall under the 5-year access review
cycles described in the May 6, 2011 proposed rule to ensure that all
services are included.
Response: We proposed that states review all services covered in
the Medicaid state plan over 5-year cycles. Medicaid allows states the
option to cover certain services and the list of services that
individual states would have been required to review would vary. The
scope of services proposed for review are described in regulation at 42
CFR part 440. Based on public comments, we have revised the access
review requirements in this final rule with comment period to be more
targeted so as to only require measurement of a discrete set of
services, which provides additional data on access while reducing
administrative burden on states. States must conduct access monitoring
reviews every 3 years for the following categories of service: Primary
care services; physician specialist services (for example, cardiology,
urology, radiology); behavioral health services, including mental
health and substance abuse disorder treatment; pre- and post-natal
obstetric services including labor and delivery; and home health
services. States may also need to add additional services to the access
monitoring review plan based on access to care concerns that arise out
of the information received by states through the public input
processes described in this final rule with comment period. We note
that states may have additional alternative processes to identify
access to care issues for services in addition to those required under
the final rule. This rule is not intended to preclude states from
continuing to use those processes and does not intend to limit
additional state access to care review activities for Medicaid services
that are already effective.
Comment: We received several comments that requested additional
guidance on how states should review access to consider geography.

[[Page 67587]]

Commenters recommended that CMS define the relevant ``geographic area''
that states should use for access comparisons, while others
specifically suggested that CMS should require states to assess
Medicaid beneficiary access in designated rural geographic locations of
a state. One commenter suggested that we require states to review
trends and factors as they vary by state geography and to emphasize the
importance of geographic variation through specific changes to the
regulatory text.
Response: To clarify, states must assure that access is available
to Medicaid beneficiaries to the extent that care is available to the
general population in a geographic area. The actual definition of
geographic area may vary by state and the extent and need to which
states review and monitor access based on geographic area may depend on
the data and other information that states are required to review as
part of the framework of this final rule with comment period. For
instance, states may receive information that access to care is an
issue in one specific region within the state and focus monitoring and
remediation strategies on that region. Other states may have more
statewide access concerns that require a county-by-county analysis and
strategy to address access on a statewide basis. At this time, we are
not defining state geographic areas or the specific geographic
considerations that states must include in access reviews. CMS will
rely on states and the processes described in this final rule with
comment period, including the public processes that allow stakeholders
to comment on the access monitoring review plans, to determine
appropriate geographic considerations.
Comment: Commenters requested that we clarify the difference
between a ``comparable population'' to Medicaid and statutory
designation of ``the general population in a geographic area.'' A few
commenters wrote that the regulations need to acknowledge that the law
requires Medicaid to be compared to the general population. Some
commenters stated that the appropriate comparison is between Medicaid
and those in the general population regardless of insurance status,
while others stated that the comparison to the general population is
unrealistic and should be removed from consideration.
Response: The regulation adopts the statutory standard of ``the
general population'' and we have applied this in this final rule with
comment period. States are allowed to analyze access issues within
broad parameters in a manner that appropriately reflects the local
health care delivery system of each state, as outlined in this final
rule with comment period. A state's rate of insured and uninsured may
not be directly related to the ability of an individual on Medicaid to
access a covered Medicaid benefit since the ability to access care is
different from having the means to pay for care. While the final rule
with comment period does not specify how states should make such
comparisons to the general population, we note that a state's analysis
should be robust and consider both demands for care and whether
individuals have an ability to pay for such care if individuals without
coverage are included in the analysis.
Comment: Several commenters noted that courts have determined that
the term ``general population'' only means people who have private
insurance and not the uninsured and requiring Medicaid to compare its
coverage to private plans without accounting for the access of the
uninsured is an artificial standard.
Response: The final rule does not define standards for measuring
medical services available to the general population in a geographic
area. States are instead allowed to analyze access issues within broad
parameters in a manner that appropriately reflects the local health
care delivery system of each state, as outlined in this final rule with
comment period.
Comment: Several commenters requested clarification as to how the
agency will evaluate the data from access reviews. The commenters also
sought clarification as to how CMS would apply or evaluate the data
when deciding to approve or disapprove a SPA.
Response: Under this final rule with comment period, states will
follow specific procedures to review and monitor access to care and to
solicit feedback from stakeholders through ongoing public processes. We
also require a public review timeframe for the access monitoring review
plan which will allow interested parties to review and comment on
states' access monitoring review plans for a period no less than 30
days before the monitoring plan is finalized and submitted to CMS. We
will review this information in total when reviewing SPAs but have not,
at this time, required any specific thresholds that would determine an
amendment to be approved or disapproved. We will document as part of
our SPA review process that states are following the process described
in this final rule with comment period, that access to care is
consistent with the statutory requirements, and the reasons for our
determination. We continue to consider whether core measures and access
thresholds would help states and CMS assure access to care in the
Medicaid program and we are accordingly issuing a RFI, as well as this
final rule with comment period, to gather additional information on
this topic.
Comment: Commenters requested that we clarify scenarios when
restructuring rate methodologies would result in access issues and
trigger the requirements of this rule.
Response: There may be any number of payment methodology changes
that could harm access to care and we cannot set forth an exhaustive
list. One common type of restructuring is a change in the targeting of
supplemental payments. States may alter payments in ways that are
budget neutral as a whole for the amendment action, but would reduce
payments for some providers. For instance, some states make up for low
base payment rates through lump sum supplemental provider payments. The
supplemental payments are often targeted to certain providers and may
be dependent upon the availability of local governments to fund the
nonfederal share of payments. A change in supplemental payments that
reduces the total amounts that providers receive or shifts funds from
one provider to another could result in access to care issues and is
one example of a potential payment restructuring that could negatively
impact access to care. Where there is uncertainty, we will work with
states to help identify other situations where the processes described
in this final rule with comment period should apply.
Comment: Several commenters requested that CMS mandate that states
make the annual data reviews publically available. Commenters further
requested that CMS require states to disclose the reports with a
sufficient amount of time to review the data and provide comments prior
to the state's submission of a SPA.
Response: We are finalizing the provision to require that states
make access data reviews available to the public and to CMS for review.
In addition, prior to submitting a SPA that reduces or restructures
Medicaid payment rates or otherwise have a negative impact on access to
care, states are required to conduct a public process that solicits
feedback from stakeholders in consideration of the access reviews
conducted by the states. Access monitoring review plans will be
published and made available to the public for review and comment for a

[[Page 67588]]

period of no less than 30 days, prior to being finalized and furnished
to CMS for review.
Comment: We received many comments that requested more detail on
how a state can sufficiently demonstrate access to care, including
thresholds for sufficient access. Some commenters raised concerns that
without mandatory thresholds states would never know CMS' expectations
for meeting the requirements of the statute. Other commenters
recommended that we provide states with the flexibility to determine
the elements most appropriate for review of access to care that are
meaningful for their specific populations and programs.
Response: Currently, there are no national standards to demonstrate
access for each Medicaid covered service that would take into account
differences in state geographic locations. Since the issuance of the
May 6, 2011 proposed rule, we have worked with many states to review
state data sources and develop monitoring plans to demonstrate
compliance with the statute. That experience and the public comments
received through this rulemaking process have further suggested that
particular measures may be specific to individual services and systems
and that states should have some flexibility and discretion in
determining the measures and thresholds, to allow states to take into
account varying circumstances. We requested comments on specific
thresholds that states could use to measure access within their
Medicaid programs. While we received some comments with suggestions of
thresholds, we did not receive suggestions for metrics that could be
applied across all states without additional consideration or
compelling evidence that the standards offered in comments would
necessarily ensure consistency with section 1902(a)(30)(A) of the Act.
We will continue to study whether a core set of measures or thresholds
should be applied to the Medicaid program and are soliciting more
information from stakeholders through the RFI process described
earlier.
Therefore, while we continue to study this issue, in this final
rule with comment period we are adopting the proposed multi-faceted
approach to reviewing access to care that includes data analysis and
feedback from beneficiaries, providers and stakeholders rather than
national thresholds. The analysis of this information must also weigh
relevant state-specific circumstances. As a result, we are requiring
states to have a public review timeframe for the access monitoring
review plan which will allow interested parties to review and comment
on the state's monitoring plans for a period of no less than 30 days
before the monitoring plan is finalized and submitted to CMS.
Comment: Commenters requested that the ongoing access reviews
include the agency's summary of the views of beneficiaries and of
providers of the covered service obtained through the input of medical
care advisory committee under Sec. 431.12(e).
Response: We agree that feedback from beneficiaries and providers
on access to care is important and should be considered by states in
evaluating access and as they make decisions about Medicaid rates. This
final rule with comment period requires that states have a mechanism
for ongoing beneficiary input and that states log the volume and nature
of responses to beneficiary input. In addition, we have added a
requirement that states establish and maintain a similar provider
feedback mechanism. Both feedback mechanisms are incorporated into
state access monitoring review plans within the final rule with comment
period. CMS will rely on information from the beneficiary and provider
feedback mechanisms to understand real-time access to care concerns and
may require states add services to their access monitoring review plans
based on this information. Depending on the nature of the concerns,
states may need to take actions to address more immediate needs though,
as the concerns may vary, CMS is not specifying actions or timeframes
that states must take at this time.
States are expected to solicit feedback during the development of
the access monitoring review plan and corrective action plans and could
also use the existing Medical Care Advisory Committees for input into
the process.
Comment: Several commenters suggested that CMS should develop a
template for access monitoring review plans that includes the Medicaid
payment rate comparisons, stakeholder feedback, and provider feedback.
Response: Each state Medicaid program is unique, and as such, this
final rule with comment period allows states the flexibility to design
and implement access measures specific to the characteristics of their
state. At this time, we are not issuing a template or specific format
for states to conduct their access monitoring review plans. However,
CMS will identify model plans for states to consider as they develop
their own plans.
Comment: Several comments suggested that the scope of access
reviews should be limited to mandatory services. Other comments urged
that access reviews only be required where there is considerable
empirical evidence of an access problem such as: Primary care; and
physician specialist services; and dental services for children.
Additional commenters suggested state access reviews should focus on
access to specialists, especially pediatric subspecialists.
Response: After careful consideration of all the comments received,
we are revising this final rule with comment period to eliminate the
requirement that states review all covered services within a 5-year
period, and instead will require that states review a discrete set of
services provided by various provider types and site of service that
are related to particular types of beneficiary needs every 3 years.
These are: Primary care services; physician specialist services (for
example, cardiology, urology, radiology); behavioral health services
(including both mental health and substance abuse disorder treatment
services); pre- and post-natal obstetric services including labor and
delivery; and home health services. These categories represent
frequently used services in Medicaid and can serve as indicators that
beneficiaries are receiving access to care. States may at their
discretion add additional services to their access review monitoring
plans. In addition, we have included a requirement for states to review
additional service categories as determined necessary based on the
public input processes described in this rule. We note that states may
have alternative processes to identify access to care issues for
services in addition to those required under the final rule. This rule
is not intended to preclude states from continuing to use those
processes and does not intend to limit additional state access to care
review activities for Medicaid services that are already effective.
Comment: One commenter suggested that FQHC reimbursement rates be
given a separate category in the access review process as they receive
an advantageous Medicaid reimbursement rate which could skew the lower
rates for many Medicaid family planning services.
Response: The final rule requires states to identify payment rate
comparisons for service by provide type and site of service. This
should address the commenters concerns. We recognize the important role
FQHCs play in delivering health care services to Medicaid
beneficiaries. We expect that states would include them, as

[[Page 67589]]

appropriate, in the ongoing access to care reviews for the types of
services that they provide. The statute requires that states pay an
all-inclusive prospective payment system (PPS) rate to FQHC providers
or an alternative payment methodology that results in payment at least
at the PPS rate. The PPS rate recognizes costs associated with all of
the Medicaid services that FQHCs provide and is not specific to
particular service. So, while services furnished by FQHCs may increase
beneficiary access to certain categories of care, payments made to
FQHCs are not going to be relevant to the payments made to other types
of providers.
Comment: Several commenters suggested that state-level reviews of
beneficiary access to specialty pharmacies are critically important for
assisting states in determining whether Medicaid beneficiaries' access
to specialty pharmacy services under the state plan is at least
equivalent to that available to the general population is the
geographic area. Commenters also noted that access issues may already
exist in most states due to the combination of low dispensing fee rates
and insufficient reimbursement for specialty products.
Response: As discussed, this final rule with comment period will
require states to review a certain subset of services every 3 years,
including primary care services; physician specialist services;
behavioral health services, including mental health and substance abuse
disorder treatment; pre- and post-natal obstetric services including
labor and delivery; and home health services. While we have not
included specialty pharmacies, we have included the requirement for
states to review access for additional services based on a
significantly higher than usual level of beneficiary or provider access
complaints. States may also select additional services to add to
reviews at their discretion.
Comment: Another commenter expressed concern that states will
attempt to satisfy pharmacy access requirements simply by demonstrating
or offering the availability of mail order pharmacy, which may not be
adequate for certain Medicaid beneficiaries.
Response: Access requirements are not met by the ``availability''
of provider types if the Medicaid population cannot obtain needed
services from those provider types. To the extent that mail order
pharmacies are not adequate or appropriate for some Medicaid
beneficiaries, availability of mail order pharmacies would not
constitute access to pharmacy services.
Comment: Several commenters requested that CMS clarify the
anticipated approach for reviewing access when a state adds a new
service or benefit.
Response: This final rule with comment period clarifies that states
must conduct a baseline access review for new services within 3 years
of the effective date of the SPAs that authorizes the service for FFP
if the service falls under a certain subset of service categories
defined in this regulation. All other new services will fall under the
rate reduction or payment restructuring protocol outlined in this final
rule with comment period whereby SPAs reducing or restructuring payment
rates for the services are submitted with an analysis of access to care
and are monitored periodically for a minimum period of 3 years.
Comment: Some commenters suggested that CMS allow independent third
parties to conduct the access reviews, stating that access reviews
should be objective and conducted by an organization/academic
institution that is impartial.
Response: Ultimately, states are responsible for ensuring
compliance with statutory and regulatory requirements. States have
flexibility in determining the available resources to meet the
regulatory requirement described in this final rule with comment
period. While we are not requiring use of an independent third party to
conduct access reviews, the option is certainly available to states.
Additionally, we will consider alternative approaches to addressing
Medicaid access issues that beneficiaries face through a hearing or
complaint driven process. We intend to solicit feedback on the
feasibility and implementation options for such an approach through an
RFI process.
1. Access Review Data Requirements
Comment: Several commenters suggested that CMS should require
states to disclose payment and other claims data states use to conduct
their access reviews.
Response: Section 447.203(b)(1) will require states to review and
make publically available data trends and factors that measure access,
as represented by beneficiary needs, availability of care and
providers, utilization of services, and service payment information.
These publically available measures will support the SPA submission.
Comment: Comments suggested provider and service specific metrics,
threshold, and considerations should be incorporated into the final
rule. For instance, one commenter suggested that CMS require an impact
analysis of rate cuts on the ability of high Medicaid volume providers
to meet staffing requirements and quality and safety standards. Other
commenters recommended that the numbers of providers willing to care
for Medicaid patients be compared to some measure of patient need to
provide an indication of whether access is adequate. Commenters
lamented that the rule did not specifically address circumstances
related to care in hospitals, family planning centers, long term
services and supports and many additional benefit categories.
Response: While we are not adopting any specific metrics at this
time, we are continuing to evaluate the feasibility of establishing a
set of core metrics and thresholds and are soliciting input from
stakeholders on these approaches through the RFI. We considered these
comments in developing this final rule with comment period, and hope
that the information provided through the public comment process
informs state access monitoring review plans. We included examples of a
number of metrics that states should consider within the regulatory
text. These measures represent the type and scope of information that
states should review through the access monitoring review process. As
we review state access monitoring review plans, our expectation will be
that the plans are robust and are carefully designed to indicate access
to care issues as they develop. We also anticipate that stakeholders
will provide feedback on state access monitoring review plans,
including on proposed, baselines, metrics and thresholds, and that
states will review the feedback and make appropriate changes to their
monitoring plans.
Comment: Some commenters suggested that the proposed regulations
should be revised to allow for some metrics that establish a prima
facie assurance that care and services for Medicaid enrollees are
available at least to the extent that they are available to the general
population in the geographic area. For instance, if at least 80 percent
or more of the service providers for a particular service such as
hospitals, physicians, labs, etc. in a geographic area are enrolled in
the Medicaid program, the commenter offered that would reasonably mean
access is available.
Response: As we discussed in the preamble of the May 6, 2011
proposed rule, CMS is not currently proposing national standards to be
applied across all service categories or uniformly for all

[[Page 67590]]

states. We also think it is important to note that enrollment alone in
the Medicaid program does not mean sufficient access is available.
There are other factors that must be considered. However, we are
continuing to study whether a core set of measures or thresholds should
be applied to Medicaid, and, if so, what those specific measures would
be, and are soliciting input through the RFI process.
Comment: Several commenters suggested that specific information for
specific populations be required data elements within the access
reviews. In particular, one commenter suggested children and young
adults with ESRD should have specific consideration in access reviews
since they have complex care needs. Other commenters suggested that
states should examine the needs of adolescents ages 12 to 21 as a
distinct subgroup in the pediatric population due to their significant
unmet health needs. Others requested that CMS articulate that child and
adolescent mental health services are a high priority for monitoring
access in recognition of the severe shortages of child and adolescent
mental health professionals.
Response: We do not dispute the importance of these types of
services and we understand the commenters' concerns. To the extent that
states understand that there are specific access issues for certain
populations, it would be prudent to develop remediation plans that
focus on improving access for those populations. States will be
required to review, at a minimum, primary care services; physician
specialist services; behavioral health services, including mental
health and substance abuse disorder treatment; pre- and post-natal
obstetric services including labor and delivery, home health services,
and other service categories when the state or CMS has received a
significantly higher than usual volume of beneficiary or provider
access complaints for a geographic area. States may also select
additional services to add to this list. We are requesting comments on
the selected categories of services outlined above.
Comment: One commenter suggested that CMS should require that
Medicaid payment analyses determine the degree to which Medicaid
payments are sufficient by, at a minimum, following the same set of
analyses that MedPAC undertakes when assessing the adequacy of Medicare
Payments.
Response: States have significant discretion in establishing
payment methods across services, providers, and states, whereas
Medicare uses national rates adjusted for geography for all services.
While some states pay for services through rates based on Medicare fee
structures, many services are reimbursed through cost reconciliation or
other methodologies that do not follow Medicare approaches. Therefore,
it would be difficult to standardize an analysis similar to the MedPAC
approach for assessing adequate Medicare payments. As previously
discussed, this final rule with comment period allows states
considerable discretion to review access based on a state's program and
local considerations as long as the review is consistent with the
standardized and transparent process described in this final rule with
comment period.
Comment: Some commenters suggested that the framework described in
the rule relies heavily on Medicaid provider reimbursement rates,
beneficiary surveys, and provider engagement, with the latter two
considerations being subjective and potentially at odds with one
another.
Response: This final rule with comment period requires that states
review access information focused on: the availability of care and
providers, enrollee needs, and service utilization. In addition, states
must consider information from beneficiaries and providers, as well as
provider payments. We do not view this information as conflicting, but
instead a comprehensive review of access to care that considers a
number of factors that may indicate compliance with the statute.
Comment: We received many comments that were critical of the
framework of the May 6, 2011 proposed rule which focused on the
availability of care and providers, enrollee needs and service
utilization. One commenter suggested that CMS should incorporate
measures through future rulemaking and guidance, but only after
Medicaid and CHIP Payment and Access Commission (MACPAC) completes its
process of identifying a set of measures to determine and track access
levels. The commenter further suggested that for purposes of the final
rule, CMS should identify existing data and measures based on its
experience and existing resources rather than the framework described
in the proposed rule.
Response: While we appreciate the comment and intend to continue to
work with states to identify appropriate access measures, the
components of the broad framework that are described in this final rule
with comment period are viewed by industry experts as good indicators
of access to health care services. We are considering providing states
with additional guidance through future rulemaking or subregulatory
guidance and are reviewing ways to standardize access monitoring and
remediation efforts. In this rule, we require that states review data
that considers enrollee needs, the availability of care and providers,
and service utilization. Within the framework, this final rule with
comment period continues to provide states with significant flexibility
in reviewing data to demonstrate and monitor access to care which
reflects their local healthcare delivery systems. States also have the
ability to add to the framework to better represent access to services
within the state.
Comment: Several commenters recommended that CMS consider
identifying a set of uniform measures that states must collect data on
or that CMS weighs more heavily in its analysis, based on CMS
experience and existing studies. While some commenters suggested such
uniform data elements would enable access comparisons across states and
facilitate best practices, other commenters suggested that CMS provide
flexibility to states by permitting the use of other measures based on
the strength of the alternatives.
Response: We appreciate the value of common data sets to help
compare access across states; however, we also recognize the importance
of allowing states flexibility in designing and implementing
appropriate access measures which reflect each state Medicaid program.
Because each state Medicaid program faces unique challenges and it is
difficult to create data sets that uniformly apply across all service
categories, we are not at this time requiring specific access measures
in the final rule with comment period. As discussed, we will continue
to study and solicit feedback on standard data sets through a RFI
process.
Comment: Several commenters suggested that consideration be given
to race, ethnicity, rural, and urban, primary language spoken,
eligibility subgroup, geography, age and income of Medicaid
beneficiaries.
Response: We appreciate these suggestions. We have not specified
the level of detail at which states are required to investigate access
to care. States have the option to add the above elements to their
access monitoring efforts and we hope that the access monitoring review
plans become more sophisticated over time.
2. Beneficiary Information
Comment: Most commenters expressed support for the provisions
requiring a mechanism to solicit

[[Page 67591]]

feedback from beneficiaries on access issues. In addition to the
feedback mechanisms for beneficiaries, many commenters also suggested
mechanisms to gain feedback from service providers, caregivers, and
advocates. A few commenters urged that we target feedback on specific
issues (for example, mental health, and women's health) and mandate
types of feedback mechanisms, while other commenters urged CMS to allow
states flexibility to determine the best tools to obtain feedback.
Commenters also requested clarification regarding the types of feedback
mechanisms CMS would consider acceptable and the standards that CMS
would use when reviewing beneficiary input.
Response: We appreciate the commenters' support for this provision
and we are finalizing Sec. 447.203(b)(4) that requires states to have
mechanisms for obtaining ongoing beneficiary feedback through hotlines,
surveys, ombudsman, or other equivalent mechanisms. We continue to
offer states the ability to implement feedback mechanisms tailored to
their program characteristics and to use feedback mechanisms that are
already in place and working to meet the objectives of this final rule
with comment period. In consideration of comments from providers and
provider groups, we are adding a requirement within the final rule with
comment period that states have a mechanism for ongoing provider
feedback. While CMS will not formally approve state feedback
mechanisms, states are required in this final rule with comment period
to maintain a record of the volume and nature of responses to
beneficiary feedback.
Comment: One commenter suggested that CMS establish a mechanism for
beneficiaries and stakeholders to raise concerns about access issues
directly to CMS.
Response: Because each state designs and administers its own
Medicaid program within the federal framework, we believe it is most
appropriate for beneficiaries and stakeholders to raise access concerns
with the state directly, rather than to CMS. To the extent that a
beneficiary or stakeholder's access concerns are not addressed by the
state adequately, those concerns may be raised to CMS although we are
not establishing a formal process at the federal level. As part of the
final rule with comment period, states will be required to promptly
respond to specific access problems, with an appropriate investigation,
analysis, and response. In addition, we are exploring the feasibility
of requiring a state level formal hearings process where access to care
concerns will be independently heard by a hearings officer. We may
propose this process through future rulemaking, which will include
notice and opportunity for public comment.
Comment: One commenter encouraged CMS to work with state Medicaid
agencies to collect Consumer Assessment of Healthcare Providers and
Systems (CAHPS) data for FFS beneficiaries in a similar manner to what
is collected for Medicare FFS beneficiaries.
Response: We are currently working with state Medicaid agencies to
collect and use the CAHPS survey data for institutional and primary
care settings and we will continue to assist states in collecting this
or similar data in the future. To the extent possible, we will work
with states to use the CAHPS survey data to support the analysis and
oversight procedures described in this final rule with comment period.
Comment: Commenters suggested that states should also obtain
provider and beneficiary feedback during the development of corrective
action plans so that beneficiary and provider experience may better
inform the state's actions.
Response: We are finalizing Sec. 447.203(b)(4), which requires
states to have a mechanism for obtaining ongoing beneficiary feedback
through hotlines, surveys, ombudsman, or other equivalent mechanisms.
We are also adding a provision that requires states to have similar
mechanisms in place for provider feedback. One mechanism that states
could use is the Medical Care Advisory Committees that are already
required in federal regulations. We believe that states should solicit
feedback during the development of corrective action plans or use the
existing Medical Care Advisory Committees for input into the process.
3. Access Review Medicaid Payment Data
Comment: We received numerous comments regarding which factors
should or should not be included in the payment rate analysis. Many
commenters requested CMS exclude Disproportionate Share Hospital (DSH)
payments in the analysis, while other commenters stated these payments
should be included. Commenters also suggested that uncompensated care
pool payments, Health Information Technology (HIT) payments and other
types of supplemental payments be excluded from the rate analysis. One
commenter suggested that states should separately show percentiles with
and without supplemental payments. Additional commenters stated the
payment rate analysis should only include the net amount of payments,
including supplemental payments, to the provider, and that payment data
should appropriately deduct, or account for any taxes or assessments
that are required to be paid by Medicaid providers. Some commenters
even suggested a separate payment rate metric to reflect public
hospitals and providers that pay the non-federal share of the Medicaid
payments.
Response: Section 1902(a)(30)(A) of the Act describes payment rates
for Medicaid care and services. Our regulatory purview is to review all
state payment rate methodologies through the SPA process to ensure the
payment rates are economic, efficient, and sufficient to assure access.
The requirements contained in this final rule with comment period set
forth a framework for states to use to demonstrate their payment rate
methodologies are sufficient to ensure access. To the extent that
payments are made to providers outside of a state plan rate methodology
(for example, uncompensated care pool payments, Medicaid DSH, or HIT
payments), such payments would not be directly included in the state's
rate analysis. But rate analysis is only one part of an overall access
analysis, and these other payments may affect provider's participation
rates in Medicaid by providing additional incentive to serve Medicaid
patients.
Comment: We received a significant number of comments regarding the
proposed requirement to compare Medicaid rates to the rates of other
payers; some commenters supported the proposed requirement while other
commenters opposed it. One commenter suggested that the only way CMS
could demonstrate that Medicaid access is at least comparable to that
of the general population is through a comparison to commercial rates.
Another commenter contended that it is difficult to determine actual
commercial rates because often this information is considered
proprietary. One state expressed concern about not being able to meet
this requirement because there are no large commercial plans within the
state. Other commenters suggested that it is ineffective to base rate
comparisons on other payers' rates alone and some states may be relying
on unsound data for comparisons. A few commenters cautioned against
using Medicare rates as a comparison, citing that Medicare does not
offer the same benefits as Medicaid (for example, comprehensive dental
and pediatric) and that the Medicare payment rates do not reflect the
costs incurred by the Medicare provider to provide the

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services. One commenter sought clarification on whether the review must
include all three proposed comparisons or could be limited to at least
one.
Response: The framework in the final rule with comment period
recognizes that access to covered services may be affected by multiple
factors. One such factor is the Medicaid payment rates in comparison to
other payers. We maintain that a comparison can be a useful tool for
states in determining the adequacy of their rates; however, it should
not be relied upon without taking into account other factors that
impact access. To the extent a state has issues making comparisons to
private or public health payer rates because the data is not available
for a particular service, we would expect the state to explain this as
part of its analysis and conduct other appropriate reviews of Medicaid
rates.
Comment: Some commenters expressed support for a two-pronged
review: One comparing Medicaid FFS payments in relation to Medicare
payment rates; and Medicaid FFS payments in relation to the payment
rates used by Medicaid managed care organizations within the state.
Response: The final rule with comment period requires that states
include percentage comparisons of Medicaid payment rates to other
public and private health coverage rates within the state for all
services reviewed under the access monitoring review plan by provider
type and site of service (e.g. primary care providers within office
settings). We would expect the state to include Medicaid managed care
payment rates in these comparisons to the extent practical.
Comment: Some commenters suggested CMS specify that children's
access to primary care, specialty care and oral health services must be
included in the first reviews conducted by states. Additionally, other
commenters suggested that CMS should specify that children's access to
dental services must be included in the first review conducted by
states, as HHS has placed considerable emphasis on this issue and 5
years is an eternity in the lifetime of a child.
Response: This final rule with comment period requires that the
access monitoring review plan include a review of primary care
services; physician specialist services; behavioral health services,
including mental health and substance abuse disorder treatment; pre-
and post-natal obstetric services including labor and delivery, home
health services, and for services where either payment rates have been
reduced or restructured or where a significantly higher than usual
volume of beneficiary, provider, or stakeholder access complaints.
Within primary care services, we are including dental care as one of
the service categories states must review as part of the access
monitoring review plan. We also agree that access needs may vary
between pediatric and adult populations and we are requiring states to
describe within their plans, the characteristics of the beneficiary
populations, including considerations for care, services, and payment
variations for pediatric and adult populations, as well as individuals
with disabilities.
Comment: One commenter urged CMS not to require the publication of
all payers' rates.
Response: This final rule with comment period does not require a
state to publish the rates used by other payers. Although we are
finalizing the requirement for states to conduct a percentage
comparison of Medicaid payment rates to other payers within the state,
this is not intended to require the publication of other payers'
specific rates.
Comment: Commenters offered that the May 6, 2011 proposed rule does
not clarify that access reviews of Medicaid payment data should be
collected and provided for each individual item or service rather than
in the aggregate. Commenters requested that CMS require transparency of
the state's analysis of provider rates and access determination for
stakeholders to provide meaningful input of the changes to the state
and CMS. The commenters noted that aggregate numbers would not allow an
adequate review of potential access issues and would lack the
specificity to identify any needed corrective action for individual
types of Medicaid services. Some commenters suggested that CMS analyze
rates for each code and that committees be established to determine if
rates for each code are sufficient. Additionally, commenters stressed
the importance that states gather and compare similar data sets from
commercial insurers, Medicare, and other payers within their state.
Response: We approve states' rate methodologies for compliance with
regulation and statute, but generally do not approve individual service
rates unless a state presents a final rate, or a fee schedule, as the
output of a rate methodology. This final rule with comment period does
not change that policy or imply that CMS will review individual rates
for sufficiency. Reviewing individual rates within a fee schedule would
not necessarily provide a better determination of whether the rates are
sufficient to enlist providers into the Medicaid program or not, since
generally providers do not determine whether to provide care to an
individual based on the rate for a single service. This final rule with
comment period requires states to provide an analysis to compare
Medicaid rates to other private and public health payer rates. This
analysis will only serve as an indicator of whether low rates may be a
source of access issues. A better determination of whether the rates
are sufficient to enlist providers into the Medicaid program will be
the analysis of enrollee needs, the availability of providers and
utilization trends, as well as beneficiary and stakeholder feedback
that will be received through the processes described in this rule.
Comment: A commenter noted an error in the proposed regulatory
text. Specifically, the May 6, 2011 proposed rule would have required
that states calculate the ``percentile'' estimate which Medicaid
payment represents of one, or more, of the following: Medicare payment
rates, the average commercial rates, or the applicable Medicaid
allowable cost of the service. The commenter notes that CMS likely
intended states to calculate the ``percentage'' of which Medicaid
payment represents the other payer or cost amounts.
Response: We agree with the commenter and we have corrected this in
this final rule with comment period. We also note that, based on
comments, we revised the payment analysis so that states are required
to determine the percentage of which Medicaid payments represent other
public or private payer rates for the services subject to the access
monitoring review plan requirements by provider type and site of
service.
Comment: Some commenters agreed that the proposed use of fee
percentiles as an effective way of representing the distribution of
fees charged by providers in a particular area.
Response: We are revising the regulations to require that states
review percentage comparisons of Medicaid payment rates to other public
or private health coverage rates within geographic areas of the state.
Comment: Many commenters suggested that CMS require states to
compare Medicaid payment rates to the provider's actual cost as part of
the access review. Some commenters stated CMS should specifically
clarify that provider rates need not be tied to, or based on provider
costs, while others suggested CMS should mandate that rates meet a
certain percentage of provider cost. One commenter suggested

[[Page 67593]]

that CMS should require the access reviews to account for average
customary provider charges and also the extent to which providers in
the geographic area are requiring these charges to be paid in full.
Still other commenters stated that healthcare charges have virtually no
relationship to the true cost of procuring services, and therefore, are
not a valid reference for comparison.
Response: The framework described in this final rule with comment
period addresses how states can demonstrate and monitor sufficient
access to care as required by section 1902(a)(30)(A) of the Act.
Neither provider cost nor charges is a required review element in
meeting the requirements of the final rule with comment period. We
acknowledge and support states' efforts in working toward delivery
system reforms that promote more effective care and lower cost. We have
issued several guidance letters on reform models that can be supported
under the Medicaid program and, within those letters, have cautioned
that access to care should be considered as part of a reform model.
Comment: Commenters suggested that the regulations be revised to
address ``payment'' as referring to both individual health care service
rates, as well as payments for care and services on an aggregate basis
such as total payments for all care and services or total payments for
all acute hospital care and services.
Response: This rule only addresses how states can demonstrate and
monitor sufficient access to care as required by section 1902(a)(30)(A)
of the Act, which describes payment rates for Medicaid care and
services. The requirements contained in this final rule with comment
period set forth a framework for states to use to demonstrate their
payment rate methodologies are sufficient to ensure access. We
appreciate the comment but, as previously discussed, we are not
requiring states to review access for each individual item, service, or
procedure payment rate.
Comment: One commenter expressed concern that the proposed
requirement in Sec. 447.203(b)(3) is unreasonable and impedes the
efficient operation of the Medicaid program because all changes in
payment policy can be considered ``significant''.
Response: Reviews of access to care are necessary to ensure the
state Medicaid program is providing sufficient services to its
beneficiaries. We discussed the reasons for issuing this regulation at
length in the May 6, 2011 proposed rule. Although there is some burden
associated with the proposed requirements, we considered comments
related to burden in developing this final rule with comment period.
The requirements of the final rule with comment period are not
predicated upon a significant change in payment policy, but whether the
proposed changes could negatively impact access. Where there is
confusion over whether a change may cause harm to access to care, we
will work with states to make a determination.
Comment: Some commenters stated that Medicaid payment rates should
be reviewed and analyzed as new technology is introduced into the
medical community to determine whether access to the new technology is
limited. Commenters also suggested that medical conditions affecting
Medicaid populations may develop that substantially affect the need for
certain covered items and services, such as the rise in HIV infection
in the early 1980s. The commenters concluded that any similar health-
related changes should require review of provider payments rates to
ensure continued access to necessary items and services; this is not
reflected in the proposed 5-year review structure.
Response: Our intent is to define a process by which states can
effectively and consistently measure beneficiary access to medical
services in the Medicaid program. To the extent that advances in
technology and/or unforeseen challenges arise that have an impact on
the delivery of care in the Medicaid program, we expect these types of
changes to be considered when reviewing access to care but only to the
extent that it increases or decreases access to services as established
in section 1902(a)(30)(A) of the Act. As such, this final rule with
comment period offers flexibility to states to demonstrate access
within the context of each state's local health care delivery system.
Comment: We received some comments indicating that establishing a
standard equivalent to commercial insurance would need to be
established by the Congress and doing so through the proposed rule is
an administrative expansion of the Medicaid entitlement, one that may
or may not be achievable even if substantial increases in state and
federal program funding were possible.
Response: We did not propose to establish a standard equivalent to
commercial insurance. Rather, this rule will require states to make
comparisons of Medicaid service rates to private or public health payer
rates. We are aware that a number of states already perform these types
of calculations for varying administrative purposes.
4. Stratification Requirements
Comment: Some commenters supported the proposed stratification
requirement for the access review, while other commenters opposed such
a requirement.
Response: After careful consideration, we are not finalizing this
requirement. Section 1902(a)(30)(A) of the Act does not specify that
beneficiaries have access to care within specific provider ownership
categories, but rather that access be viewed within the service
categories as a whole and within associated geographic areas. We
understand that payments do vary based on provider ownership status and
we intend to review those differences outside of the scope of this
final rule with comment period.
5. Access Review Timeframe
Comment: Several commenters addressed the timeframe of the on-going
reviews and offered alternatives to the timeframe in the May 6, 2011
proposed rule. One commenter suggested requiring that each state
complete a full program access review by the end of the second full
calendar year following the effective date of the regulations, request
that all services be reviewed every 3 years, and that one-third of all
services be reviewed each year. Other commenters suggested that rates
be reviewed more frequently than every 5 years and suggested various
alternative for more frequent review. While other commenters suggested
that yearly reviews are excessive without a change in payments and that
it is more appropriate to monitor access after implementation of rate
changes to determine the impact of the change.
Response: The timeframe outlined in the May 6, 2011 proposed rule
was designed to ensure a timely review of access, while accommodating
the time, manpower, and data constraints of state Medicaid agencies.
After considering the public comments, we have determined that a full
program review over 5 years is too burdensome. Therefore, we have
revised this requirement to include a review of: Primary care services;
physician specialist services; behavioral health services (including
mental health and substance abuse disorder treatment); pre- and post-
natal obstetric services including labor and delivery; and home health
services; services where either payment rates have been reduced or
restructured; and services for which a higher than usual volume of
beneficiaries, providers, or stakeholders have raised access to care
issues. The ongoing reviews will be conducted

[[Page 67594]]

every 3 years and intend to measure the current status of access to
services within the state. We chose to require that states conduct the
ongoing reviews every 3 years based on comments indicating that the 5
year proposed review periods were too infrequent to adequately capture
changes in access to care. In addition, SPAs reducing payment rates for
the services other than those mentioned above must be submitted with an
analysis of access to care and then reviewed for a minimum period of 3
years. States may also select additional services to review at their
discretion.
Comment: Some commenters requested that CMS require states to post
their access review online by January 15th each year since access
reviews are to be completed by January 1st.
Response: We consider the completion date to be synonymous with the
date the access monitoring review plan should be published or readily
made available upon request. We have revised the final rule with
comment period to require that states issue the access monitoring
review plan by July 1 of each review year. This coincides with the
beginning of most state fiscal years and allows states sufficient time
after the issuance of this final rule with comment period to conduct
the first review for service categories subject to ongoing review.
Comment: Many commenters suggested revisions to the timeline for
review that would require states to conduct access studies and monitor
program changes on an annual basis. For example, commenters suggested
CMS require states to conduct annual reviews and compare information
from year-to-year and analyze trends, averages, and notations of
changes in access to care over time.
Response: We agree that comprehensive studies of access are
important. However, we have also considered concerns from states over
the burden associated with the data requirements discussed in the May
6, 2011 proposed rule and the resources that states estimate would be
required to collect and analyze access information for all covered
Medicaid services. Therefore, to comply with section 1902(a)(30)(A) of
the Act, we focus access review requirements on ongoing reviews of
primary care services, physician specialist services, mental health
services, pre- and post-natal obstetric services including labor and
delivery, and home health services and to focus state efforts on review
and monitoring access to care for all other Medicaid services specific
to rate methodology changes made through SPAs, as well as ongoing
feedback from beneficiaries, providers and other stakeholders.
Comment: Some commenters suggested as an alternative to the
proposed timeline, that states should be required to conduct a
comprehensive and public access review within 180 days prior to
submission of the proposed payment rate change.
Response: We believe that the changes in access to care that occur
within 180 days between a review and SPA submission and a year between
review and submission would be negligible. Furthermore, states are
required to monitor access ongoing for 3 years once a rate reduction
goes into effect so any access to care issues that arise between the
initial review and SPA submission will be detected through state
monitoring procedures.
Comment: We received some comments suggesting that the regulation
carve out a separate effective date of January 1, 2013 for the first
rate review required under the regulation and the subsequent rate
reviews be conducted every 5 years thereafter. Other commenters stated
that CMS should require states to begin the access reviews as soon as
possible. Some commenters stated that CMS could require states to begin
reviews on the sooner of the first day of the state fiscal year or the
first day of the calendar year after the final rule with comment period
becomes effective.
Response: We had proposed that states make available the first
access data reviews beginning January 1 of the year beginning no sooner
than 12 months after the effective date of the final rule with comment
period. Based on comments regarding the delay in access review
information, we are revising the proposed timeframe and will require
states to publish the access monitoring review plans by July 1 after
the effective date of this final rule with comment period. The access
monitoring review plans must be updated by July 1st every 3 years
thereafter. As discussed, this timeframe corresponds with the start of
state fiscal years for the majority of states and provides states with
time to gather the necessary data and resources to perform accurate and
detailed access reviews.
Comment: Several commenters suggested that priority be given to
certain services for which access problems have been documented. The
list of services included physician services, dental services, mental
health services, and many specialty care services.
Response: We agree with the commenters though the list of services
that commenters suggested that states prioritize would have required
levels of state effort similar to what we proposed. For the reasons
discussed in more detail above, we will require that the access
monitoring review plan include a review of primary care services;
physician specialist services; behavioral health services, including
mental health and substance abuse disorder treatment; pre- and post-
natal obstetric services including labor and delivery; home health
services, and for services where either payment rates have been reduced
or restructured or where a significantly higher than usual level of
beneficiary, provider or stakeholder access complaints have been
received. States may also select additional services to review at their
discretion.
6. Special Provisions for Proposed Provider Rate Reductions
Comment: We received many comments on the requirement that access
monitoring review plans accompany SPAs that proposed rate reductions.
Many commenters suggested that we modify the access review procedures
to require baseline access analysis prior to taking action to reduce
provider rates, ongoing monitoring processes to detect problems, and
corrective action when problems are detected. Some of the commenters
stated that CMS should suspend the rate reduction until corrective
measures are taken. Other commenters requested that CMS eliminate the
requirement that proposed rate changes be accompanied by an analysis of
access or face disapproval.
Response: In the May 6, 2011 proposed rule, we discussed the basis
and reasoning behind requiring access information in making SPA
decisions. This final rule with comment period requires that states
conduct baseline reviews and monitoring procedures when implementing
rate reductions or restructuring rates in ways that may negatively
affect access to care. Consistent with commenters' suggestions, this
rule requires that states conduct baseline reviews and ongoing
monitoring of access data to ensure compliance with section
1902(a)(30)(A) of the Act.
Based on feedback from states that ongoing 5-year access reviews
for all services would overly burden state agencies, we determined a
process similar to the commenters' to be the appropriate regulatory
framework. Such a process will include a review of primary care
services, physician specialist services, behavioral health

[[Page 67595]]

services including mental health, pre- and post-natal obstetric
services including labor and delivery, home health services and for
services where either payment rates have been reduced or restructured
or for which a significantly higher than usual level of beneficiary,
provider or stakeholder complaints have been received. While the
suspension of a rate reduction may be an appropriate corrective action,
we will not require a specific approach to addressing access issues
within this rule, and we will work with states on appropriate remedies
given the facts and nuances of particular situations. We intend to work
with states to monitor access data and determine an appropriate course
of action should access issues arise.
7. Compliance With Access Requirements
Comment: Some commenters suggested that CMS approve an access
review within 90 days of receipt and if the review is deemed
unacceptable, that CMS disapprove a SPA submittal or take corrective
action to address inadequate access to care.
Response: While we will not formally approve or disapprove access
reviews, all reviews must include the elements described in the
regulations and we will review the plans using this standard. We will
not approve SPAs that are unsupported by data and the processes
described in this final rule with comment period, and will pursue
compliance action should a state fail to conduct the baseline access
data reviews.
8. Monitoring Procedures
Comment: Some commenters suggested that we revise the access
demonstration to state that states must ``consider'' the access impact
and commit to ongoing monitoring when appropriate.
Response: We agree that states should conduct ongoing monitoring
efforts on access to care and included oversight and monitoring
procedures within this final rule with comment period. To the extent
that states find access to care issues as part of the access monitoring
review plan processes that are ongoing or associated with specific rate
actions, we expect the state to take actions to remediate those issues.
If a state does not take remediation actions, the state would not be in
compliance with the statute and would be at risk of losing FFP.
Comment: Commenters requested that CMS define access issues and
action plans as system-wide rather than case-by-case as identified by
beneficiaries or providers, and that the requirement be comparability
to the private sector.
Response: Section 1902(a)(30)(A) of the Act requires that payments
be sufficient to enlist enough providers so that care and services are
available under the plan at least to the extent that such care and
services are available to the general population in the geographic
area. We expect states to address access issues, whether through a
formal corrective action plan, or if more appropriate, on a case by
case basis.
Comment: Some commentators requested more specific requirements for
monitoring access after a rate reduction is implemented, including the
request that CMS set specific timeframes for the required monitoring
procedures.
Response: Section 447.203(b)(6)(ii) allows the state flexibility to
develop access monitoring strategies. While monitoring procedures are
required of states, each state may develop the monitoring plan that
best accommodates its data and other resources, while still adequately
monitoring access to services. This final rule with comment period
incorporates a specified time period of 3 years for monitoring
following the implementation of a SPA that reduces or restructures
payment rates.
Comment: Some commenters suggested that we provide clear and broad
discretion to states in managing rates, and a clear path toward
expedient approval of a rate reduction, provided that the states have
mechanisms in place to monitor and correct adverse impacts to access.
Response: This final rule with comment period continues to offer
states broad discretion to manage rates and includes procedures to
ensure that proposed changes in the program do not violate section
1902(a)(30)(A) of the Act.
Comment: Some commenters suggested that CMS should define in the
regulation its role in post-implementation monitoring.
Response: We will review access to care data each time a state
submits a rate reduction or restructuring of payment SPA or any time
the agency is made aware of access to care issues. The monitoring
procedures in the regulation are intended to be used to inform the
state and federal government of the overall status of access to care in
their program. In addition, CMS may use the access to care data to
monitor the adequacy of rates over time, and may use it to address
areas in which access is insufficient.
Comment: One commenter requested that CMS clarify if the monitoring
requirements apply to all payment methodology restructuring or only
those that result in rate reductions.
Response: A state must develop procedures to monitor continued
access to care after implementation of state plan service rate
reduction or payment restructuring that may reduce access to care. The
procedures must define a periodic review of state determined indices
that will serve to demonstrate sustained service access, consistent
with efficiency, economy, and quality of care.
Comment: One commenter requested that CMS clarify how a state would
demonstrate sustained access after implementation of a SPA that reduces
or restructures rates.
Response: The monitoring procedures required in Sec.
447.203(b)(6)(ii) require that a state develop procedures to monitor
access after implementation of a SPA that results in rate reduction or
payment restructuring. Such monitoring should include enrollee needs,
availability of care and providers, utilization of services, and
service payment information. States must conduct reviews periodically
over a minimum 3-year period following implementation of a SPA that
reduces or restructures rates.
Comment: Several commenters recommended changes to the review and
monitoring requirements of the proposed rule. Some commenters requested
that CMS provide additional flexibility to states in establishing
appropriate methods for measuring and monitoring beneficiary access to
services. Other commenters suggested that states should periodically
review and monitor access and states determine the measures of access
and beneficiary information included in such reviews allowing states to
take a more balanced approach to evaluating access.
Response: This final rule with comment period offers states
significant flexibility in determining the measures of access and
beneficiary information included in the review as the commenter
suggests. However, we believe that a defined time period for completion
of the access to care reviews allows the collected data to serve as an
acceptable comparative analytical tool over a number of years whenever
states proposes to restructure or reduce rates or when beneficiaries
alert the agency to access to care issues. Timely reviews also allow
states to demonstrate ongoing compliance with the section
1902(a)(30)(A) of the Act. Section 447.203(b)(6)(ii) will require
states to develop ongoing monitoring procedures through which they
periodically review indices to measure sustained access to care. Our
goal is to provide a consistent path for all states to document access
to

[[Page 67596]]

care consistent with the Act but to also allow states flexibility to
measure and monitor access within state means.
Comment: Some commenters stated that states should be required to
use the same methodology to measure access once a rate reduction is put
into place so that a fair comparison of the impact of the rate
reduction may be made.
Response: We generally agree that consistency in a state's
methodology may allow for better comparisons of access over a period of
time; however, states may need to make adjustments and changes to the
analysis based on modifications of service delivery systems, payment
rates or other program changes that may affect access to care. States
and CMS may also determine that an analysis is not feasible to conduct
or does not accurately demonstrate access after conducting a review For
these reasons, we are not restricting states from making modifications
to their methodology when the changes intend to improve the analysis or
present reasonable alternative approaches to reviewing access to care.
Comment: Some commenters suggested, as part of monitoring
identified access issues, an annual review and public town hall
meetings should be implemented.
Response: We considered requiring that states conduct a public
process for monitoring activities similar to that which is described
for the submission of SPA that reduce rate or restructure payment in
circumstances when the changes could result in access issues. This
final rule with comment period requires states to have mechanisms for
ongoing beneficiary, provider, and other stakeholder feedback and those
mechanisms should ensure that state monitoring activities are effective
and were properly developed.
9. Mechanisms for Ongoing Input
Comment: Many commenters supported the requirement that states have
ongoing mechanisms (hotlines, surveys, ombudsman, etc.) for beneficiary
input on access to care. Some of the commenters suggested that we add a
specific mechanism for feedback from tribes, tribal organizations, and
Indian Health Providers.
Response: We appreciate the support for the requirement that states
have an ongoing mechanism for beneficiary feedback. We have also
considered comments from providers and provider organizations and will
require that states have a similar mechanism for provider feedback.
Tribes and Indian Health providers are an important part of the
Medicaid community and both the beneficiary and provider feedback
mechanisms must be available to Tribes and Indian Health providers. In
addition, consistent with Executive Order 13175, HHS Policy, and the
CMS Tribal Consultation Policy, states are required to consult with
tribes to receive their input. We also encourage states to develop
specialized mechanisms that would be responsive to input from
beneficiaries from other populations that have particular access
concerns.
Comment: Several commenters requested that states or CMS establish
advisory groups to help determine whether state payment rates
sufficiently provide for access to care. Commenters suggested that the
groups be comprised of a variety of stakeholders, such as
beneficiaries, beneficiary advocacy groups, clinicians, and provider
trade organizations.
Response: Current Sec. 431.12 requires that state Medicaid
agencies establish Medical care advisory committees that include
provider and beneficiary participation. We are finalizing the
requirement that states have a mechanism for ongoing provider feedback,
similar to the process for ongoing beneficiary feedback. This could
include the Medical care advisory committee required at Sec. 431.12.
Comment: Commenters requested that we clarify the decision to
require ongoing beneficiary feedback when other requirements of the
proposed rule, such as the public process, involve providers and other
stakeholders. In addition, commenters requested that CMS clarify the
standard against which we would require states to consider input from
beneficiaries and other stakeholders. A commenter noted that the level
of input and magnitude of proposed SPA changes are not always
correlated.
Response: After considering the comments received, we are including
in this final rule with comment period the requirement that states
consider provider feedback similar to the requirement for ongoing
beneficiary feedback. This could be accomplished through state Medical
care advisory committees, logging of issues raised by providers, or
other means. States must incorporate feedback from beneficiaries and
providers are part of the access monitoring review plan procedures.
There is no threshold or standard that we will apply to stakeholder
feedback; rather, the requirements will assure that states understand
access to care concerns from the community as they arise and consider
that information as they make changes to their Medicaid program.
Comment: Some commenters suggested advocate groups should also have
an opportunity for ongoing input which should be differentiated from
the mechanism provided for public input.
Response: We understand that advocate groups currently have many
opportunities to provide feedback to states on Medicaid issues and
offer important insights for state consideration. This final rule with
comment period offers advocates and other stakeholders an opportunity
to provide feedback on specific state rate actions through the public
process procedures. In addition, we would expect that individuals
advocating on behalf of a Medicaid beneficiary would have access to the
mechanism for ongoing beneficiary feedback described in this rule.
10. Addressing Access Questions and Remediation of Access Issues
Comment: We received several comments regarding the subsequent
actions if an access issue is identified. Many commenters were in
support of the requirement for states to submit a corrective action
plan, while many commenters were opposed to such a requirement.
Commenters stated opposition and expressed concern about the lack of
``threshold'' for the scope or severity of an access issue that would
require the submission of a corrective action plan. While some
commenters sought clarification from CMS, others implied that the state
should be able to define such threshold, especially in instances that
are clearly compliant with the statutory standard. Some commenters
suggested that CMS should not approve a SPA or permit a payment
reduction to be imposed until corrective action measures are taken.
Other commenters suggested that CMS should affirmatively require states
to suspend or reverse a payment reduction if an access issue is
identified. A few commenters urged CMS to impose sanctions on states
that fail to remedy access issues timely. Still other commenters
requested that CMS remove any references to remedies for access issues
that do not involve increasing payment rates. Commenters also discussed
the 90-day timeframe to submit corrective action plan after discovery.
Some concerns were raised that the 90-day timeframe was overly hasty,
while others thought it appropriate.
Response: After careful consideration of all of the comments
received, we are finalizing Sec. 447.203(b)(8) requiring a state to
develop and submit a corrective action plan to CMS within 90 days of
discovery of an access deficiency. The

[[Page 67597]]

submitted action plan must aim to remediate the access deficiency
within 12 months. This requirement ensures that the access deficiency
is addressed in a timely manner while allowing the state time to
address underlying causes of the access issue, be it payment rates,
provider participation, etc. Section 447.203(b)(8) clarifies that
states have a number of options to address access to care issues. These
remediation efforts can include but are not limited to: increasing
payment rates; improving outreach to providers; reducing barriers to
provider enrollment; providing additional transportation to services;
or improving care coordination. This is an acknowledgement that access
to care is not always about payment rates but rather that when enough
providers are enlisted in the program, states may need to find ways to
connect beneficiaries with the care and services they need.
Comment: Some commenters stated that states need more than 12
months to implement corrective action when access issues are
discovered, whereas other commenters believed that allowing states 12
months to resolve the issue was too long. Commenters stated concerns
that that the 12-month time frame attached to the corrective action
plan could encourage longer-term measures, which may have an adverse
effect on provider participation. One commenter stated the final rule
should recognize the potential need for state legislative action to
address identified access issues and the 12-month timeframe could
potentially be too short for a state to make these changes, especially
in states with biennial legislative sessions.
Response: We are finalizing Sec. 447.203(b)(8) that requires a
state to develop and submit a corrective action plan to CMS within 90
days of discovery of an access issue. The submitted action plan must
aim to remediate the access deficiency within 12 months. This timeframe
has been developed to minimize the length of time beneficiaries may
experience decreased access while realistically accommodating a state's
resources and allowing sufficient time to address the underlying causes
of identified access issues. Although longer-term measures may be
needed to fully address the underlying causes of an access issue, it is
imperative that a corrective action plan aim to resolve the access
issue within 12 months, in the interest of preserving adequate
beneficiary access.
Comment: Commenters suggested that we require states to publicly
report and address any decline in access to services following rate
reductions.
Response: We are finalizing Sec. 447.203 that will require states
to publish, or promptly make available upon request, the access
monitoring review plan. Within the access monitoring review plan, a
state must monitor continued access to care following rate reduction or
payment restructuring.
Comment: A commenter suggested that CMS should implement a
mechanism to fast-track any substantive access concerns that are
uncovered during state-level review; states should not be permitted to
wait until the start of the next calendar year to fix a substantive
problem.
Response: Once access issues are identified, the state will have 90
days to submit to CMS for review a corrective action plan; the goal of
this plan must be to resolve the identified access issues within 12
months. This timeframe has been developed to minimize the length of
time beneficiaries may experience decreased access while realistically
accommodating a state's resources, allowing sufficient time to address
the underlying causes of identified access issues.
Comment: Commenters raised concerns that the remediation process
could result in a SPA backlog because states would need to address
access issues before moving forward with state plan changes.
Response: State plan changes must comply with statutory and
regulatory requirements. To the extent a state identifies areas of
inadequate access to Medicaid services, we could not approve any SPA
that could potentially impede access further. We will work with states
to address these issues on an as needed basis.
Comment: One commenter stated that the final rule should remove the
requirement for data gathering and focus on monitoring and corrective
action. The commenter further suggested that if, and when, access
issues are found, a state should develop and implement a corrective
action plan. These activities would be supplemented through ongoing
mechanisms for obtaining beneficiary input, using hotlines, surveys and
other tools.
Response: We have revised the requirements of this final rule with
comment period to have a greater focus on monitoring and corrective
action. Data gathering is essential to these activities and, as
previously discussed, we are focusing the data review efforts in
consideration of state burden.
Comment: A commenter noted that the May 6, 2011 proposed rule
states that CMS may disapprove a SPA if a rate is ``modified'' without
an access review; however, the term ``modified'' is not defined in the
rule.
Response: We believe that in the context of the regulatory language
and we are confirming here that modified means to reduce or restructure
Medicaid service payment rates in circumstances when the changes could
result in access issues. To the extent that states are unsure whether a
change could result in access issues, we will work with states
individually to make a determination.
Comment: One commenter suggested that CMS outline the remedies that
beneficiaries and providers will have if access issues are discovered
and the state proceeds with implementing a SPA without regard to the
issues.
Response: This final rule with comment period requires that states
monitor access to care after implementing Medicaid payment rate
reductions and identify and remediate issues that are found as a result
of the access review and monitoring efforts. The rule also requires an
ongoing mechanism for beneficiaries, providers, and other stakeholders
to raise concerns over access to care. States are required to maintain
a record of the volume and nature of the response to those concerns. We
expect that the monitoring procedures and mechanisms for ongoing input
will work together to raise ongoing access concerns.

C. Medicaid Provider Participation and Public Process To Inform Access
to Care (Sec. 447.204)

We received several comments that discussed concerns over the
proposed changes to the public process requirements.
Comment: One commenter stated that the public process requirements
are not enforceable because they are not a specific requirement in
statute.
Response: The purpose of this final rule with comment period is to
provide states with standard processes that consider and document
access to care in the Medicaid program consistent with section
1902(a)(30)(A) of the Act. We respectfully disagree that the proposed
changes to the public process are not contemplated within the
requirements of that section. The regulatory guidance within this rule
relies upon public interaction to, in part, gauge and document whether
beneficiaries and stakeholders raise concerns that proposed rate
changes will have a meaningful effect on beneficiary needs and the
availability of care and providers. We maintain that such information
is necessary to understand state rate proposals and inform CMS approval
actions.

[[Page 67598]]

Comment: Commenters noted that the May 6, 2011 proposed rule may
create a timing problem for states by requiring the public process to
occur prior to the submission of a SPA. Commenters anticipate that the
public process does not allow sufficient time for states to prepare and
submit SPAs. Commenters also stated that the public process requirement
increases the time it takes to submit a SPA by at least 30 days. As an
alternative, some commenters suggested that the public process occur
prior to the effective date of the SPA consistent with the public
notice requirement.
Response: Under the processes required by this final rule with
comment period, to the extent that a state wishes to change payment
rates that may affect access, the state will need to be up to date in
following the access review procedures and public input mechanisms. If
the state does not have the required access review data, or has not
recently prepared an access analysis, there could be a delay in its
ability to submit an approvable SPA submission. We note that this rule
does not affect the timing provisions for SPA effective dates. States
may make SPAs effective as early as the first day within the quarter in
which the SPA is submitted so even a 30-day delay should rarely change
the proposed effective date of a state's SPA action. Furthermore, we
also note that states are already subject to a similar process related
to conducting notice prior to SPA submissions through the Tribal
Notification processes established under section 1916 of the Act.
Comment: Commenters stated that the proposed changes were overly
prescriptive and that CMS should allow individual states to determine
how to interact with stakeholders on changes to Medicaid payment
methodologies.
Response: We provided states with the flexibility to determine the
appropriate mechanism to solicit input from beneficiaries and affected
stakeholders. States that have these mechanisms in place are under no
requirement to change their approach. This final rule with comment
period requires that a state document beneficiary and stakeholder
feedback and use that information to inform how they evaluate access to
care to meet the statutory requirement. This information will both
inform CMS's approval actions and serve as the state's public record
for compliance with section 1902(a)(30)(A) of the Act.
Comment: We received many comments that requested states provide
specific information as part of the public process. Commenters stated
that public process should include: the proposed SPA; material
submitted by the state Medicaid agency in connection with the proposed
SPA; the information that CMS reviews to approve a SPA; and information
on how interested parties may promptly obtain such materials.
Commenters also requested that all state plans and proposed SPAs should
be posted on state Web sites or the CMS Web site.
Response: This final rule with comment period does not address the
public process under section 1902(a)(13)(A) of the Act that is required
for institutional rate setting. This rule addresses only the procedures
necessary to document compliance with section 1902(a)(30)(A) of the Act
to assure that provider payment rates are sufficient for beneficiary
access to care. Those procedures must include a public input mechanism
for comments on access to care. This final rule with comment period
provides states with considerable flexibility to determine appropriate
public input mechanisms. We suggest that interested parties work with
states to ensure that these mechanisms are effective.
Comment: Commenters suggested that CMS be more prescriptive in how
states should conduct the public process based upon a proven
methodology. One commenter suggested a formal ``Listserv'' for comments
similar to the federal proposed rule listserv for public access to
comments. A commenter requested that families, caregivers, and
providers be able to represent their concerns to the Medicaid agencies
and have processes in place that allow them to represent the voice of
Medicaid beneficiaries where appropriate.
Response: While we continue to allow for states to determine exact
procedures for soliciting input from beneficiaries and stakeholders, we
appreciate the suggestion that states could use a listserv to reach its
intended audience. The mechanisms for ongoing beneficiary feedback
required in this final rule with comment period will allow
beneficiaries and stakeholders to voice concerns related to access to
care in multiple forums, such as hotlines and ombudsman programs. We
agree that beneficiary and stakeholder feedback is vital to
understanding access to care both as it pertains to specific rate
proposals and on an ongoing basis.
Comment: Some commenters offered concerns that the specific
requirements of public input is an unclear process and that it is
difficult for states to obtain stakeholder input on all services.
Commenters further stated that public process creates a substantial
administrative burden for the state to implement on an ongoing basis.
To overcome these issues, commenters wrote that the final rule should
clarify that states have flexibility in monitoring access to care and
recommend that we remove the requirements of ongoing ``beneficiary
input'' since the public process and ongoing beneficiary feedback
mechanisms are duplicative.
Response: This final rule with comment period does not require a
particular mechanism for states to receive feedback from beneficiaries
and other stakeholders that are affected by Medicaid rate-setting. The
preamble to the May 6, 2011 proposed rule specifically discussed state
flexibilities and the ability of states to rely on current processes to
demonstrate access to care to the extent that states already have such
processes in place. In this rule, we are implementing a standard set of
procedures, including feedback from stakeholders, that all states must
follow to document access to care consistent with section
1902(a)(30)(A) of the Act. States develop the particular mechanisms to
enact the procedures either consistent with current practices or in
other ways that meet beneficiary needs and address access concerns
within each state. The public process requirements for institutional
rates and the ongoing public input mechanisms serve different purposes.
The ongoing public input mechanisms apply to all services, are not
limited to input regarding proposed changes in rates, and includes a
clear opportunity for beneficiary feedback on access. The beneficiary
feedback mechanism allows states to understand any access to care
concerns in real time as they occur. We respectfully disagree that
those efforts are duplicative.
Comment: Several commenters recommended that CMS strengthen the
regulation to state that any SPAs submitted without having completed
the public process requirement would be disapproved. A commenter
specifically proposed that the regulatory text be modified so that CMS
``must'' disapprove a SPA if submitted without a state meeting the
public process requirements described at Sec. 447.204(b).
Response: The regulations require that states provide a mechanism
for public input when reducing or restructuring Medicaid payment rates
in circumstances that could result in access issues. We retain the
authority to consider the circumstances of and content of a SPA
submittal to determine its compliance with statutory and regulatory
requirements before making approval decisions.
Comment: One commenter wrote that discretionary language in Sec.
447.204(b)

[[Page 67599]]

``the agency may disapprove a proposed SPA using the authority . . . or
may take a compliance action'' could enjoin a rate alteration or
reduction based solely on the fact that the SPA is not yet CMS-
approved.
Response: As we indicated above, we do not intend in this
rulemaking to change the requirements relating to the effective date of
approvable SPAs. How these requirements are applied and interpreted in
judicial review in the federal courts is an issue that is beyond the
scope of this rulemaking.
Comment: Several commenters suggested requiring states to implement
an ongoing input process for every change, regardless of the scope.
Other commenters noted the rule creates a significant administrative
burden for states and stated it would be an inefficient use of limited
resources in situations where states are making minor changes. The
commenters requested that CMS work with states to define a threshold
that would trigger the need for beneficiary input. The commenters also
recommended that CMS adopt language for such a process similar to that
contained in the proposed ``Monitoring Access'' provisions whereby the
state is able to define the procedures and process.
Response: The requirements in this final rule with comment period
for public input allow states flexibility to design public input
mechanisms that are appropriate for state-specific circumstances.
Considering that there is so much variability in the Medicaid program
and the delivery of Medicaid services, CMS is concerned that defining
the significance of a rate reduction or payment restructuring before a
state institutes a beneficiary feedback mechanism would undermine the
inclusion of the process in this regulation. Many states have indicated
to CMS through other venues that the feedback mechanism is a primary
indicator of access to care.

D. Public Notice of Changes in Statewide Methods and Standards for
Setting Payment Rates (Sec. 447.205)

Comment: We received comments that suggested various thresholds for
significant changes and removal of the term significant from the public
notice requirement. Some commenters requested that states be allowed to
define the term ``significant'' in the regulations, while others
requested that CMS define both the terms ``significant'' and ``change''
in the final rule. A number of commenters suggested thresholds for
issuing public notice, including: any reduction in payment; a reduction
of 5 percent or more; a reduction of 10 percent or more, a CMS-defined
threshold; or any rate reduction or alteration in reimbursement
methods. Many commenters also suggested that CMS should delete the term
``significant'' altogether.
Response: The public notice requirement informs providers of
changes in state plan methods and standards that have either a positive
or negative impact on rate-setting. As discussed in the May 6, 2011
proposed rule, it is difficult to determine a threshold of a
significant change in payment methods and standards since the
determination to participate or continue to participate in Medicaid is
provider specific. This final rule with comment period should reduce
the administrative and financial burden of issuing notice by allowing
states to publish on state agency Web site. In consideration of this
and comments from providers requesting the removal of the term
``significant'' and the past ambiguity in interpreting whether notice
is required, we are removing the term ``significant'' in this final
rule with comment period. Aside from the specific exceptions described
in the regulation, notice will be required for all changes in state
plan methods and standards with the effective date of this final rule
with comment period.
Comment: A commenter suggested that the public notice regulation
describe requirements specific to tribal consultation.
Response: While the May 6, 2011 proposed rule did not address
tribal consultation, the CMS tribal consultation requirements were
detailed in policy in the November 17, 2011 document entitled ``CMS
Tribal Consultation Policy.'' The policy incorporates provision in the
American Recovery and Reinvestment Act of 2009 (Recovery Act) and the
Children's Health Insurance Program Reauthorization Act of 2009
(CHIPRA). Additional information regarding the CMS Tribal Consultation
Policy is available at http://www.cms.gov/Outreach-and-Education/American-Indian-Alaska-Native/AIAN/Consultation.html. CMS will continue
to consult with Tribal leaders on the delivery of health care for
American Indians/Alaska Natives (AI/AN) served by the Marketplace,
Medicare, Medicaid, Children's Health Insurance Program (CHIP), or any
other health care program funded by CMS and make updates to the policy
as necessary.
Comment: One commenter offered that the public notice requirement
should be expanded so that a ``change'' includes both a change in
payment rates and/or a change in the scope or definition of Medicaid
benefits.
Response: We did not propose an expansion of the public notice
requirement to include changes in coverage policy and the public notice
regulation discusses notice of changes in statewide methods and
standards for setting payment rates. Since this rule addresses policies
related to section 1902(a)(30)(A) of the Act, which is specific to
state plan service rates and access to care, we are not addressing
changes to coverage policies at this time.
Comment: One commenter offered that the public notice requirement
should be amended to tie in with the public process requirement
described in the May 6, 2011 proposed rule. The commenter offered that
since the new public process is required prior to a state submitting a
SPA, the process should tie in with the requirements set forth in Sec.
447.205 as to how notice should be given.
Response: The public process and public notice requirements serve
different purposes. The public notice applies to any changes in state
plan methods and standards, and is published 1 day prior to the
effective date of a Medicaid SPA. The public notice informs the public
of a proposed change in Medicaid rate-setting or policy without
necessarily considering public feedback as part of the policymaking
process. The public process requirement provides opportunity for the
public to provide input into determining beneficiary access to care.
Comment: A few commenters objected to the use of web-based
publications as an option to issue public notice. One commenter cited a
number of reasons for the opposition, including: The benefit of printed
notice over Internet notice; the fact that state Web sites do not have
strong readership when compared to newspapers; limited access to the
Internet in many poor and rural communities; potential problems that
individuals with disabilities or illness may have with using the
Internet; lack of assurance that states will maintain Internet sites
sufficiently; and difficulty in archiving web-based publications for
courts, historians, researchers and archivists. The commenter stated
that the proposal would leave the public with large gaps in public
information.
Response: We have addressed many of the issues raised in the
comment in this final rule with comment period. For instance, the rule
provides that a state's electronic publication must be regular and
known. This offers significant

[[Page 67600]]

advantages over paper-based publications that may appear on any day in
the calendar year and should alleviate some concerns over access to the
state Web sites. We agree that these Web sites must meet national
standard to assure access to individuals with disabilities, and we are
including this requirement in the final rule with comment period. Such
standards are issued by the Architectural and Transportation Barriers
Compliance Board, and are referred to as ``section 508'' standards.
Alternatively, the World Wide Web Consortium's Web Content
Accessibility Guidelines (WCAG) 2.0 Level AA standards would also be
considered as acceptable national standard for Web site accessibility.
For more information, see the WCAG Web site at http://www.w3.org/TR/WCAG20/. We also note that states currently have the option to publish
notice in a state register that is similar to the Federal Register.
Like the Federal Register, many state registers are web-based and
states already routinely use them to publish notice as an alternative
to paper-based publication. Therefore, we do not view the proposed
flexibility as a significant departure from the current available
options. Furthermore, we believe that web-based publication will be as
accessible to poor and rural communities as publication in a state
register.
Comment: A commenter suggested that CMS reconsider the statement in
Sec. 447.205(b) which allows states to change reimbursement as long as
the change is made to conform to Medicare without public notice. The
commenter stated that Medicare serves a significantly different
population than Medicaid, has different conditions of participation,
and may be a relative low payer of professional services in some
locations.
Response: The May 6, 2011 proposed rule did not contemplate
modifying the exception to public notice in instances where the change
in Medicaid rates is consistent with Medicare. At this time we are not
adopting the commenter's suggestion.

IV. Provisions of the Final Regulations

This final rule with comment period incorporates many of the
provisions of the May 6, 2011 proposed rule but also makes substantial
modifications based on responses to the public comments. Those
provisions of this final rule with comment period that differ from the
proposed rule are as follows:
The term ``access review'' is replaced throughout by the
term ``access monitoring review plan'' to emphasize that the regulation
is intended to establish a process by which states monitor and measure
access, rather than just the requirement that data is due to CMS.
Section 447.203(b) is revised to clarify that the states'
access monitoring review plans must be developed in consultation with
the state's medical care advisory committee and submitted to CMS, and
will be reviewed by CMS. This section has been revised to also indicate
that the plans must be made available for public review and comment for
a period of no less than 30 days prior to the finalization of the plan
and submission to CMS. This allows stakeholders time to comment on the
appropriateness of the specific measures the state will use to
determine that there is adequate access to Medicaid services.
Section 447.203(b)(1) is revised to state that the access
monitoring review plan must include the items specified under the
access review procedures, as well as data sources, methodologies,
assumptions, trends and factors, and thresholds so that it is clear
that measurable data and analysis are essential components of the
access monitoring review plans.
Section 447.203(b)(1) is revised by replacing the term
``access review'' with ``access monitoring review plan'' for the
reasons described above. We made clarifying changes to the monitoring
plan framework, specifying that reviews must measure whether
beneficiary needs are fully met, that the providers analyzed as part of
the review are enrolled in the program, and that the access analysis
must demonstrate access to care within state specified geographic
areas. This is consistent with the statutory requirements. We also
added a requirement that the analysis describe the characteristics of
the beneficiary population (including considerations for care, service,
and payment variations for pediatric and adult populations and for
individuals with disabilities). This is important to understand
specific access needs within geographic areas.
Section 447.203(b)(2) is revised to specify that
beneficiary and provider input must be considered within the access
monitoring review plans. We have also indicated potential sources of
this information, such as the public rate-setting process, medical care
advisory committees, and letters to state and federal officials. In
addition to the data the state will review, ongoing input from
beneficiaries and providers will help states understand access issues
(and suggestions to improve access) on a real-time basis and
potentially target access improvements and remediation strategies.
Section 447.203(b)(3) changes the analysis of payments to
compare Medicaid payments as a percentage of other public and private
health payment rates within geographic areas of the state. We proposed
that states compare Medicaid rates to provider charges and Medicare
payments rates, the average commercial payment rates or the applicable
allowable cost of Medicaid services. We also proposed that states
stratify this information based on provider ownership status. The final
rule with comment period modified the requirement to streamline the
information and allow states flexibility in demonstrating the
comparative analysis of the Medicaid payment rates as now defined in
Sec. 447.203(b)(1)(C). The analysis required in the final rule with
comment reduces administrative burden associated with the proposed
requirements while continuing to provide a basis to understand how
Medicaid service payments compared to other health payer payments. The
statute discusses the sufficiency of rates in ensuring access to
services; however, as we have stated, rates may not be the only or most
important determinant of access in the Medicaid program.
Section 447.203(b)(4) provides details on the review plan
standards and methodologies. To provide additional clarity on types of
information that states can use for these reviews, we have described
suggested data elements for state consideration including, but not
limited to: time and distance standards, providers participating in the
Medicaid program, providers with open panels, providers accepting new
Medicaid beneficiaries, service utilization patterns, identified
beneficiary needs, logs of beneficiary and provider feedback and
suggestions for improvement, etc. While not specifically required,
these data elements may be used by states to address the framework
described in the final rule with comment and represents the scope of
the analysis that states should conduct when reviewing access to care.
This responds to state and provider concerns that the data reviews in
the May 6, 2011 proposed rule lacked clear direction and standards for
how CMS will evaluate the sufficiency of a state's access analysis.
Section 447.203(b)(5) regarding the ``Access Review
Timeline'' has been modified to clarify that states will need to comply
with the provision of this final rule with comment period. We received
many comments on the timing associated with the access data reviews. In
the final rule with comment, states will be required to conduct the
first review for the specified subset of

[[Page 67601]]

ongoing services by July 1 after the effective date of the final rule
with comment period and update the analysis every 3 years by July 1 of
each review year. This corresponds with the start of the fiscal year
for most states and provides sufficient time to develop the baseline
monitoring plan.
Section 447.203(b)(5)(ii) was revised to change the
requirement that states review all covered services within a 5-year
period to require that states review a subset of service categories at
least once every 3 years. Language has also been added to this section
to clarify that the states are required to ``complete a full review of
the data collected through the monitoring plan methodology.''
Paragraphs (b)(5)(ii)A, (ii)(B), (ii)(C), (ii)(D), and (ii)(E) were
added to define the specific categories of services that must be
included in the access monitoring review plan. Paragraph (b)(5)(ii)(A)
adds primary care services which includes physician, FQHC, clinic,
dental care, etc. Paragraph (b)(5)(ii)(B) adds physician specialist
services which includes services which are provided via a referral from
a primary care provider, for example, cardiology, urology and
radiology. Paragraph (b)(5)(ii)(C) adds behavioral health services
which includes mental health, substance use disorder, etc. Paragraphs
(b)(5)(ii)(D) adds pre- and post-natal obstetric services including
labor and delivery. Paragraph (b)(5)(ii)(E) adds home health services.
These categories were added because they are frequently used services
in Medicaid, and access to these services indicates that an individual
has primary sources of care, which may increase the likelihood of
having their care needs met. Paragraph (b)(5)(ii)(F) has been added
clarify that additional services are to be added to the access
monitoring review plan when states reduce or restructure rates.
Paragraph (b)(5)(ii)(G) was added to require states to review access
for additional services based on a significantly higher than usual
level of beneficiary, provider, or stakeholder access complaints.
Paragraph (b)(5)(ii)(H) was added to allow additional types of services
selected by the state. These modifications remove some burden from the
states, particularly those that have continuously monitored Medicaid
access to care and do not have widespread access issues. We are
requesting comment on the revisions to paragraphs (b)(5)(ii)(A) through
(ii)(E).
Section 447.203(b)(6)(i) was revised to clarify that
access monitoring review plans shall be updated to incorporate an
access review as described under paragraph (b)(1) of this section when
a state submits a SPA to reduce payment or restructure payment in
circumstances when the changes could result in diminished access for
the service or services affected by the SPA. We have further clarified
in this paragraph that a state must update the access monitoring review
plan within 12 months of the effective date of the submitted SPA.
Section 447.203(b)(6)(ii) which describes monitoring
procedures, has been retitled ``Monitoring procedures.'' The monitoring
process has been modified to require incorporation of access monitoring
review plans and procedures, including period review protocols and
clearly defined measures and thresholds, into the Medicaid state plan
reimbursement methodology and to require the first monitoring review to
occur within a year after the effective date of a SPA rate change and
continue periodically for a period of at least 3 years after the
effective date of the SPA authorizing the payment reduction or
restructuring.
Section 447.203(b)(7) describes that states must have
mechanisms for ongoing beneficiary input on access to care (through
hotlines, surveys, ombudsman, or another equivalent mechanism). In
response to concerns over individual access issues, we revised the
provision to require states to promptly respond to public input with an
appropriate investigation, analysis, and response. The state is also
required to maintain records of the input and the nature of the state's
responses. While CMS recognizes that services provided through home and
community-based waivers or 1115 demonstrations are not bound by the
procedural requirements of this rule, states may understand through
these feedback mechanisms access issues that may also arise for
individuals receiving services through those delivery systems.
Section 447.203(b)(8) is revised to clarify that states
have a number of options to address access to care issues that are
identified through the access monitoring review plans. These
remediation efforts can include but are not limited to: modifying
payment rates; improving outreach to providers; reducing barriers to
provider enrollment; providing additional transportation to services;
improving care coordination; or changing provider licensing or scope of
practice polices. This is an acknowledgement that access to care is not
determined by payment rates alone but rather that when enough providers
are enlisted in the program states may need to find ways to connect
beneficiaries with the care and services that they need.
In Sec. 447.204(a), the term ``recipients'' is changed to
``beneficiaries.''
Section 447.204(a)(1) is revised to incorporate the
baseline data review requirement and as part of the information that
states consider prior to the submission of a SPA that proposes to
reduce or restructure Medicaid service payment rates. The results of
the baseline data should inform states on compliance with section
1902(a)(30)(A) of the Act and project the potential impact of rate
policies on access to care.
Section 447.204(a)(2) is revised to indicate that prior to
the submission of a SPA that proposes to reduce or restructure Medicaid
service payment rates, states must consider input from providers, as
well as input from beneficiaries and other affected stakeholders. This
change was added based on public comments that requested that feedback
from providers be considered in addition to beneficiaries as part of
the public process.
Section 447.204(b) is modified to more clearly state that
with any proposed SPA affecting payment rates, states must provide the
most recent access monitoring review plan, if any, together with an
analysis of the effect of the change in payment rates on access, and a
specific analysis of the information and concerns expressed in input
from affected stakeholders. With this change, is more clearly
delineated that states must furnish the information gathered under the
procedures of the final rule with comment to CMS as part of the SPA
submission process. We will use this information to inform our SPA
approval decisions.
Section 447.204(c) and (d) were edited to more clearly
describe CMS's enforcement process if a state does not submit the
supporting documentation described in the final rule with comment
period along with SPAs. If a state does not submit the supporting
documentation, then the SPA would be disapproved. Likewise, if a state
submits a SPA and the access analysis does not demonstrate adequate
access, the SPA would be disapproved. To address access deficiencies,
CMS may also take a compliance action using the procedures described at
Sec. 430.35 of this chapter which is specified at 447.204(d). These
edits were made for clarity and did not alter the agency's proposed
approach to enforcing the provisions of the final rule with comment
period.
Section 447.205(iv) was proposed to allow states to issue
public notice on Web sites maintained by the single state agency. We
revised this section to provide some additional parameters

[[Page 67602]]

around notice publications, requiring that publication Web site must be
easily reached from a hyperlink that provides general information to
beneficiaries and providers and the state specific page on the federal
Medicaid Web site and that the state ensures compliance with national
standards to ensure access to individuals with disabilities (that is,
section 508 standards). Further, we clarified that the notice must be
issued as part of regular and known provider bulletin updates and
maintained on the state's Web site for no less than 3 years. These
changes are necessary to ensure that notices are easily accessible to
the public (and CMS) and will remain available for a sufficient period
of time.

V. 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. 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.
In the May 6, 2011, proposed rule (76 FR 26352-26359), we solicited
public comments on each of the section 3506(c)(2)(A) required issues
for the following information collection requirements (ICRs). PRA-
related comments were received as indicated below in section C under
``Comments Associated with the Collection of Information
Requirements.''

A. Wages

To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2014 National Occupational Employment and Wage
Estimates for all salary estimates (www.bls.gov/oes/current/oes_nat.htm). In this regard, the following table presents the mean
hourly wage, the cost of fringe benefits (calculated at 100 percent of
salary), and the adjusted hourly wage.

National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Mean hourly wage Fringe benefit ($/ Adjusted hourly
Occupation title Occupation code ($/hr) hr) wage ($/hr)
----------------------------------------------------------------------------------------------------------------
Business Operations Specialist...... 13-1000 33.69 33.69 67.38
Computer and Information Analyst.... 15-1120 42.25 42.25 84.50
General and Operations Manager...... 11-1021 56.35 56.35 112.70
Management Analyst.................. 13-1111 43.68 43.68 87.36
Social Science Research Assistant... 19-4061 20.71 20.71 41.42
----------------------------------------------------------------------------------------------------------------

As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is necessarily a rough adjustment,
both because fringe benefits and overhead costs vary significantly from
employer to employer, and because methods of estimating these costs
vary widely from study to study. Nonetheless, there is no practical
alternative and we believe that doubling the hourly wage to estimate
total cost is a reasonably accurate estimation method.

B. ICRs Carried Over From the Proposed Rule (May 6, 2011; 76 FR 26352-
26359)

1. ICRs Regarding Access Monitoring Review Plans (Sec. 447.203(b))
Section 447.203(b) requires that states develop and make public an
access monitoring review plan that considers, at a minimum: Beneficiary
needs, the availability of care and providers, utilization of services,
characteristics of the beneficiary population, and provider payment
rates. States are also required under this provision to monitor data
and beneficiary and provider input on an ongoing basis and address
known access issues through corrective action.
This final rule with comment period provides states with the
discretion to determine appropriate data sources that will be used to
conduct the review. We believe most of the data that will be used to
inform access is available to states and may already be collected by
states as part of Medicaid program reviews and payment rate-setting
procedures. We also note that states have flexibility to compare
Medicaid rates to one or more of Medicare rates, commercial rates, or
Medicaid cost, as may be appropriate to the service under review. The
burden associated with these requirements is the time and effort
associated with analyzing this information, making it available to the
public, and periodically updating the information relative to
activities states are already undertaking. We have attempted to
mitigate any new burden by identifying data that states are likely to
currently possess, identifying other data sources that might be
informative to state access reviews, and limiting the categories of
services states will be required to review.
a. Access Monitoring Review Plan Timeline
Section 1902(a)(30)(A) of the Act requires states to ensure that
Medicaid beneficiaries have access to care and services that is
equivalent to care provided to the general population within a
geographic area. Based on public comments received we are revising the
requirements of Sec. 447.203(b) to limit the scope of Medicaid
services that states must review on an ongoing basis. This final rule
with comment period stipulates that states must develop an access
monitoring review plan for the specified service categories and update
the plan every 3 years. States will also be required to develop an
access monitoring review plan when a state submits a SPA to reduce or
restructure payment rates in circumstances where the changes could
result in access issues for the service or services affected by the
SPA. In this way, states would consider the impact that such proposals
may have on access to care and demonstrate compliance with section
1902(a)(30)(A) of the Act. States may complete this review within the
prior 12 months of the SPA submission.
b. Access Monitoring Review Plan Framework
The data analysis activities described in this final rule with
comment period are claimable as administrative claiming activities and
are reimbursable at the general 50 percent FFP rate for

[[Page 67603]]

administrative expenditures, insofar as they are necessary for the
proper and efficient administration of the Medicaid state plan as
described at section 1903(a)(7) of the Act. More specifically,
utilization review is identified as an allowable Medicaid
administrative activity in guidance that was issued in the form of a
SMD letter dated December 20, 1994 (www.medicaid.gov/Federal-Policy-Guidance/downloads/SMD122094.pdf). We also believe that states may be
collecting some of this information as part of current review efforts
for various purposes, including program administration and oversight,
quality activities, integrity and payment, and as part of other
performance standards and measures required under the Affordable Care
Act.
The provisions at Sec. 447.203(b)(1) through (3) require that
states develop and make publically available an access monitoring
review plan using data trends and factors that considers: Beneficiary
needs, availability of care and providers, and changes in beneficiary
utilization of covered services. Consistent with the statutory
requirement, we have clarified that states demonstrate access to care
within specific geographic regions. After careful consideration of the
comments received, we are finalizing the review framework with some
modifications in an effort to minimize the administrative burden
associated with the requirement. Though we recognize that no
methodology to gauge access to care is flawless, we believe that the
framework, as supported by state data sources, is appropriate to inform
whether the Medicaid access requirements are met.
Section 447.203(b)(1) and (2) describes the minimum factors that
states must considered when developing an access monitoring review
plan. Specifically, we require the review to include feedback from both
Medicaid beneficiaries and Medicaid providers, an analysis of Medicaid
payment data, and a description of the specific measures the state will
use to analyze access to care. We recommend that states use existing
provider feedback mechanism such as medical care advisory committees
described in Sec. 431.12 to ease burden on states rather than create
new requirements.
Section 447.203(b)(3) requires that states include percentage
comparisons of Medicaid payment rates to other public (including, as
practical, Medicaid managed care rates) or private health coverage
rates within geographic areas of the state. This requirement was
modified based on comments received to allow states maximum flexibility
in comparing Medicaid payment rates to the rates of other payers.
Section 447.203(b)(4) describes the minimum content that must be in
included in the monitoring plan. States are required to describe: The
measures the state uses to analyze access to care issues, how the
measures relate to the overarching framework, access issues that are
discovered as a result of the review, and the state Medicaid agency's
recommendations on the sufficiency of access to care based on the
review.
Section 447.203(b)(5) describes the timeframe for states to develop
and complete its access monitoring review plan the data review and make
the information available to the public through accessible public
records or Web sites on an on-going basis for the following categories
of services: Primary care, physician specialist services, behavioral
health, pre- and post-natal obstetric services including labor and
delivery, home health services and additional services as determined
necessary by the state or CMS. The initial access monitoring review
plans are to be completed by July 1 after the effective date of this
final rule with comment period. The plan must be updated at least every
3 years, but no later than July 1 of the update year. We estimate that
the requirements to develop and make the access monitoring review plans
publically available under Sec. 447.203(b)(1) through (4) will affect
all states. We have defined specific categories of services that states
must develop access monitoring review plans for, while allowing states
to include additional service categories as necessary. We assume states
will conduct reviews in the context of rate reductions or restructuring
payment rates and we consider the burden associated with rate reduction
or restructuring reviews as part of the ongoing estimated burden.
The one-time burden associated with the requirements under Sec.
447.203(b)(1) through (5) is the time and effort it would take, on
average, each of the 50 state Medicaid programs and the District of
Columbia (51 total respondents) to develop and make publically
available an access monitoring review plan for the specific categories
of Medicaid services. The uniform nature of the initial menu of
services required for the access monitoring review plans are the reason
we present average impacts.
We estimate that it will take 5,100 hr to develop the access
monitoring review plan, 8,160 hr to collect and analyze the data, and
2,040 to publish the plan and 510 hr for a manager to review and
approve the plan (15,810 total hours). We also estimate a cost of
$22,631,80 per state and a total of $1,154,221.80.
In deriving these figures we used the following hourly labor rates
and time to complete each task: 80 hr at $41.42/hr for a research
assistant staff to gather data, 80 hr at $84.50/hr for an information
analyst staff to analyze the data, 100 hr at $87.36/hr for management
analyst staff to develop the content of the access monitoring review
plan, 40 hr at $67.38/hr for business operations specialist staff to
publish the access monitoring review plan, and 10 hr at $112.70/hr for
managerial staff to review and approve the access monitoring review
plan.

Table 1--Access Monitoring Review Plan--One-Time Burden Per State
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per
Requirement Occupation title Burden hours hourly wage ($/ monitoring
hr) plan ($/State)
----------------------------------------------------------------------------------------------------------------
Gathering Data........................ Social Science Research 80 41.42 3,313.60
Assistant.
Analyzing Data........................ Computer and Information 80 84.50 6,760
Analyst.
Developing Content of Access Management Analyst...... 100 87.36 8,736
Monitoring Review Plan.
Publishing Access Monitoring Review Business Operations 40 67.38 2,695.20
Plan. Specialist.
Reviewing and Approving Access General and Operations 10 112.70 1,127.00
Monitoring Review Plan. Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 310 .............. 22,631.80
----------------------------------------------------------------------------------------------------------------

[[Page 67604]]

Table 2--Access Monitoring Review Plan--One-Time Total Burden
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
51 15,810 22,631.80 1,154,221.80
----------------------------------------------------------------------------------------------------------------

The ongoing burden associated with the requirements under Sec.
447.203(b)(1) through (5) is the time and effort it would take each of
the 50 state Medicaid programs and the District of Columbia (51 total
respondents) to develop and make publically available an access
monitoring review plan for the specific categories of Medicaid
services. The access monitoring review plans must be updated at least
every 3 years.
We anticipate that the average initial and ongoing burden is likely
to be the same since states will need to re-run the data, determine
whether to add or drop measures, consider public feedback, and write-up
new conclusions based on the information they review. In this regard,
we estimate it will take 5,100 hr to develop the access monitoring
review plan, 8,160 hr to collect and analyze the data, and 2,040 to
publish the plan, and 510 hr for a manager to review and approve the
plan (15,810 total hours). We also estimate a cost of $22,631,80 per
state and a total of $1,154,221.80.
In deriving these figures we used the following hourly labor rates
and time to complete each task: 80 hr at $41.42/hr for a research
assistant staff to gather data, 80 hr at $84.50/hr for an information
analyst staff to analyze the data, 100 hr at $87.36/hr for management
analyst staff to update the content of the access monitoring review
plan, 40 hr at $67.38/hr for business operations specialist staff to
publish the access monitoring review plan, and 10 hr at $112.70/hr for
managerial staff to review and approve the access monitoring review
plan.

Table 3--Access Monitoring Review Plan-Ongoing Burden Per State (Annual)
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per
Requirement Occupation title Burden hours hourly wage ($/ monitoring
hr) plan ($/State)
----------------------------------------------------------------------------------------------------------------
Gathering Data........................ Social Science Research 80 41.42 3,313.60
Assistant.
Analyzing Data........................ Computer and Information 80 84.50 6,760
Analyst.
Updating Content of Access Monitoring Management Analyst...... 100 87.36 8,736
Review Plan.
Publishing Access Monitoring Review Business Operations 40 67.38 2,695.20
Plan. Specialist.
Reviewing and Approving Access General and Operations 10 112.70 1,127.00
Monitoring Review Plan. Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 310 .............. 22,631.80
----------------------------------------------------------------------------------------------------------------

Table 4--Access Monitoring Review Plan--Ongoing Total Burden (Annual)
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
51 15,810 22,631.80 1,154,221.80
----------------------------------------------------------------------------------------------------------------

The requirements and burden will be submitted to OMB under control
number 0938-1134 (CMS-10391). Annualized over the three-year reporting
period, we estimate 17 responses, 5,270 hr, $7,543.93 (per state), and
$384,740.60 (aggregate).
2. ICRs Regarding Monitoring Procedures (Sec. 447.203(b)(6)(ii))
Section 447.203(b)(6)(ii) requires states to have procedures within
the access monitoring review plan to monitor continued access after
implementation of a SPA that reduces or restructures payment rates. The
monitoring procedures must be in place for at least 3 years following
the effective date of a SPA that reduces or restructures payment rates.
The ongoing burden associated with the requirements under Sec.
447.203(b)(6)(ii) is the time and effort it would take each of the 50
state Medicaid programs and the District of Columbia to monitor
continued access following the implementation of a SPA that reduces or
restructures payment rates. The requirements will affect all states
that implement a rate reduction or restructure payment rates. We
estimate that in each SPA submission cycle, 22 states will implement
these rate changes based on the number of states that proposed such
reductions in FY 2010. Please note that we are using FY 2010 as the
basis for our estimate because of the unusual high volume of rate
reduction SPAs that states submitted during this period. By basing our
estimate on FY 2010 data, we anticipate the highest potential for
burden associated with this final rule with comment period.
We estimate that it will take, on average, 880 hr to develop the
monitoring procedures, 528 hr to periodically review the monitoring
results, and 66 hr for review and approval of the monitoring procedures
(1,474 total hours). We also estimate an average cost of $5,929.14 per
state and a total of $130,441.08.
In deriving these figures we used the following hourly labor rates
and time to complete each task: 40 hr at $87.36/hr for management
analyst staff to develop the monitoring procedures, 24 hr at $87.36/hr
for management analyst staff to periodically review the monitoring
results, and 3 hr at $112.70/hr for management staff to review and
approve the monitoring procedures.

[[Page 67605]]

Table 5--Access Monitoring Procedures Following Rate Reduction SPA--Burden Per State (Annual)
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per data
Requirement Occupation title Burden hours hourly wage review ($/
($/hr) State)
----------------------------------------------------------------------------------------------------------------
Develop Monitoring Procedures......... Management Analyst...... 40 87.36 3,494.40
Periodically Review Monitoring Results Management Analyst...... 24 87.36 2,096.64
Approve Monitoring Procedures......... General and Operations 3 112.70 338.10
Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 67 .............. 5,929.14
----------------------------------------------------------------------------------------------------------------

Table 6--Access Monitoring Procedures Following Rate Reduction SPA--Total Burden (Annual)
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
22 1,474 5,929.14 130,441.08
----------------------------------------------------------------------------------------------------------------

The requirements and burden will be submitted to OMB under control
number 0938-1134 (CMS-10391).
3. ICRs Regarding Ongoing Input (Sec. 447.203(b)(7))
Section 447.203(b)(7) requires that states have a mechanism for
obtaining ongoing beneficiary, provider and stakeholder input on access
to care issues, such as hotlines, surveys, ombudsman, or other
equivalent mechanisms. States must promptly respond to public input
with an appropriate investigation, analysis, and response. They must
also maintain records of the beneficiary input and the nature of the
state response.
We estimate that the requirement will affect all states that do not
currently have a means of beneficiary feedback. Since we currently do
not know which states have implemented these mechanisms, we are
assuming in our estimate that all states will need to develop new
mechanisms. The one-time burden associated with the requirements under
Sec. 447.203(b)(7) is the time and effort it would take, on average,
for each of the 50 state Medicaid programs and the District of Columbia
(51 total respondents) to develop and implement beneficiary feedback
mechanisms.
We estimate that it will take an average 5,100 hr to develop the
feedback effort and 255 hr to approve the feedback effort (5,355 total
hours). We also estimate an average cost of $9,299.50 per state and a
total of $474,274.50.
In deriving these figures we used the following hourly labor rates
and time to complete each task: 100 hr at $87.36/hr for management
analyst staff to develop the feedback effort and 5 hr at $112.70/hr for
managerial staff to review and approve the feedback effort.

Table 7--Beneficiary Feedback Mechanism--One-Time Burden Per State
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per data
Requirement Occupation title Burden hours hourly wage ($/ review ($/
hr) State)
----------------------------------------------------------------------------------------------------------------
Developing Feedback Effort............ Management Analyst...... 100 87.36 8,736
Approve Feedback Effort............... General and Operations 5 112.70 563.50
Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 105 .............. 9,299.50
----------------------------------------------------------------------------------------------------------------

Table 8--Beneficiary Feedback Mechanism--One-Time Total Burden
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
51 5,355 9,299.50 474,274.50
----------------------------------------------------------------------------------------------------------------

The ongoing burden associated with the requirements under Sec.
447.203(b)(7) is the time and effort it would take each of the 50 state
Medicaid programs and the District of Columbia (51 total respondents)
to monitor beneficiary feedback mechanisms.
The overall effort associated with monitoring the feedback will
primarily be incurred by analysts who will gather, review and make
recommendations for and conduct follow-up on the feedback. We do not
estimate that the approval of the recommendations will not require as
significant effort from managers. We estimate that it will take an
average of 3,825 hr to monitor the feedback results, and 255 hr to
approve the feedback effort (4,080 total hours). We also estimate an
average cost of $7,115.50 per state and a total of $362,890.50.
In deriving these figures we used the following hourly labor rates
and time to complete each task: 75 hr at $87.36/hr for management
analyst staff to monitor feedback results and 5 hr at $112.70/hr for
managerial staff to review and approve the feedback effort.

[[Page 67606]]

Table 9--Beneficiary Feedback Mechanism--Ongoing Burden Per State (Annual)
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per data
Requirement Occupation title Burden hours hourly wage review ($/
($/hr) State)
----------------------------------------------------------------------------------------------------------------
Monitoring Feedback Results........... Management Analyst...... 75 87.36 6,552.00
Oversee Feedback Effort............... General and Operations 5 112.70 563.50
Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 80 .............. 7,115.50
----------------------------------------------------------------------------------------------------------------

Table 10--Beneficiary Feedback Mechanism--Ongoing Total Burden (Annual)
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
51 4,080 7,115.50 362,890.50
----------------------------------------------------------------------------------------------------------------

The requirements and burden will be submitted to OMB under control
number 0938-1134 (CMS-10391).
4. ICRs Regarding Corrective Action Plan (Sec. 447.203(b)(8))
Section 447.203(b)(8) institutes a corrective action procedure that
requires states to submit to CMS a corrective action plan should access
issues be discovered through the access monitoring processes. The
requirement is intended to ensure that states will oversee and address
any future access concerns.
This is a new requirement and thus we have no past data to use to
determine how many states will identify access issues as they conduct
their data reviews and monitoring activities. We assume that many
states currently have mechanisms in place to monitor access to care and
identify issues. While we are careful not to under-estimate the burden
associated with this provision, we believe that a maximum of 10 states
may identify access issues per year. The on-time burden associated with
the requirements under Sec. 447.203(b)(7) is the time and effort it
would take 10 state Medicaid programs to develop and implement
corrective action plans.
We estimate that it will take an average of 200 hr to identify
issues requiring corrective action, 400 hr to develop the corrective
action plans, and 30 hr to review and approve the corrective action
plans (630 total hours). We also estimate an average cost of $5,579.70
per state and a total of $55,797.00.
In deriving these figures we used the following hourly labor rates
and time to complete each task: 20 hr at $87.36/hr for management
analyst staff to identify issues requiring corrective action, 40 hr at
$87.36/hr for management analyst staff to develop the corrective action
plans, and 3 hr at $112.70/hr for managerial staff to review and
approve the corrective action plans.

Table 11--Corrective Action Plan--Burden Per State
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per data
Requirement Occupation title Burden hours hourly wage ($/ review ($/
hr) State)
----------------------------------------------------------------------------------------------------------------
Identifying Issues for Action......... Management Analyst...... 20 87.36 1,747.20
Developing the Corrective Plan........ Management Analyst...... 40 87.36 3,494.40
Approve Corrective Plan............... General and Operations 3 112.70 338.10
Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 63 .............. 5,579.70
----------------------------------------------------------------------------------------------------------------

Table 12--Corrective Action Plan--Total Burden
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
10 630 5,579.70 55,797.00
----------------------------------------------------------------------------------------------------------------

The requirements and burden will be submitted to OMB under control
number 0938-1134 (CMS-10391).
5. ICRs Regarding Public Process to Engage Stakeholders (Sec. 447.204)
Sections 447.204(a)(1) and (a)(2) require that states consider
(when proposing to reduce or restructure Medicaid payment rates) the
data collected through Sec. 447.203 and undertake a public process
that solicits input on the potential impact of the proposed reduction
or restructuring of Medicaid service payment rates on beneficiary
access to care. In Sec. 447.204(b), we have also clarified that we may
disapprove a proposed rate reduction or restructuring if the SPA does
not include or consider the data review and a public process. As an
alternative, or additionally, we may take a compliance action in
accordance with Sec. 430.35.
We are estimating, annually, that for each SPA revision
approximately 22 states will develop and implement these rate changes
that would require a public process based on the number of states that
proposed such reductions in FY 2010. Again, we are using FY 2010 as the
estimate due to the high number of rate reduction proposals submitted
by states in that year.
We estimate that it will take an average of 440 hr to develop the
public process and 66 hr for review and approval of the public process
(506 total hours). We also estimate an average cost

[[Page 67607]]

of $2,085.30 per state and a total of $45,876.60.
In deriving these figures we used the following hourly labor rates
and time to complete each task: 20 hr at $87.36/hr for management
analyst staff to develop the public process and 3 hr at $112.70/hr for
managerial staff to review and approve the public process.

Table 13--Public Process--One-Time Burden Per State Per SPA
----------------------------------------------------------------------------------------------------------------
Adjusted
Requirement Occupation title Burden hours hourly wage Cost per SPA
($/hr) ($)
----------------------------------------------------------------------------------------------------------------
Develop the Public Process............ Management Analyst...... 20 87.36 1,747.20
Approve Public Process................ General and Operations 3 112.70 338.10
Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 23 .............. 2,085.30
----------------------------------------------------------------------------------------------------------------

Table 14--Public Process--One-Time Total Burden
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
22 506 2,085.30 45,876.60
----------------------------------------------------------------------------------------------------------------

The ongoing burden associated with the requirements under Sec.
447.204 is the time and effort it would take 22 state Medicaid programs
to oversee a public process.
The overall effort associated with developing the public process
will primarily be incurred by analysts who develop and initiate public
process activities. We do not estimate that efforts associated with
review and approval of the activities will increase for overseeing
managers. We estimate it will take an average of 880 hr to oversee the
public process and 66 hr for review and approval of the public process
(946 total hours). We also estimate an average cost of $3,832.50 per
state and a total of $84,315.00
In deriving these figures we used the following hourly labor rates
and time to complete each task: 40 hr at $87.36/hr for management
analyst staff to oversee the public process and 3 hr at $112.70/hr for
managerial staff to review and approve the public process.

Table 15--Public Process--Ongoing Burden Per State
----------------------------------------------------------------------------------------------------------------
Adjusted
Requirement Occupation title Burden hours hourly wage ($/ Cost per SPA
hr) ($)
----------------------------------------------------------------------------------------------------------------
Oversee the Public Process............ Management Analyst...... 40 87.36 3,494.40
Approve Public Process................ General and Operations 3 112.70 338.10
Manager.
-----------------------------------------------
Total Burden Per State............ ........................ 43 .............. 3,832.50
----------------------------------------------------------------------------------------------------------------

Table 16--Public Process--Ongoing Total Burden (Annual)
----------------------------------------------------------------------------------------------------------------
Anticipated number of Cost of review per state
state reviews Total hours ($) Total cost estimate ($)
----------------------------------------------------------------------------------------------------------------
22 946 3,832.50 84,315.00
----------------------------------------------------------------------------------------------------------------

The requirements and burden will be submitted to OMB under control
number 0938-1134 (CMS-10391).
6. ICRs Regarding Public Notice of Changes in Statewide Methods and
Standards for Setting Payment Rates (Sec. 447.205)
The provisions at Sec. 447.205 clarify when states must issue
public notice to providers and allow for the electronic publication of
those notices. Section 447.205(d)(2)(iv)(A) through (D) allow those
notices to be published on the single state Medicaid agency or other
state-developed and maintained Web site that is accessible to the
general public via the Internet. The burden associated with developing
and issuing public notice at Sec. 447.205 is not affected by this
requirement since the revision would simply address an additional (in
this case, electronic) means of notification. Consequently, we do not
include the electronic notice activity in our burden analysis.

C. Comments Associated With the Collection of Information Requirements

Comment: Several commenters noted that it could take a state up to
6 months and consume many resources to conduct ongoing access reviews
(in conjunction with a SPA) and have the documentation, including rate
reduction SPA documents ready to submit to CMS. These commenters were
concerned that the efforts would create a significant backlog of SPAs.
Response: As previously discussed, we have considered concerns
related to the proposed burden and have modified the ongoing regulatory
requirements to reduce the burden. We also note that the challenges
presented by initial access reviews, including time constraints, were
considered in the finalizing this rule. Though initial access reviews,
either triggered by the routine, rotating review process, or by
submission of a SPA, will require a significant time

[[Page 67608]]

investment, subsequent reviews are expected to be more manageable, due
to pre-established metrics and review mechanisms. We have conducted a
regulatory impact analysis as part of this final rule with comment
period. We do not believe that there is potential for this regulation
to surpass the threshold for economic significance.

D. Summary of Annual Burden Estimates

Table 17--Annual Recordkeeping and Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hourly
OMB Burden per Total labor cost Total labor Total
Regulation section(s) Control Number of Number of response annual of cost of capital/ Total cost ($)
No. respondents responses (hours) burden reporting reporting ($) maintenance
(hours) ($/hr) costs ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
447.203(b)(1)-(4) (one-time 0938-1134 51 17 80 1,360 41.42 56,331.20 0 56,331.20
requirement).................
80 1,360 84.50 114,920.00 0 114,920.00
100 1,700 87.36 148,512.00 0 148,512.00
40 680 67.38 45,818.40 0 45,818.40
10 170 112.70 19,159.00 0 19,159.00
-------------------------------------------------------------------------------------------------------------
Subtotal.................. .......... 51 17 310 5,270 ........... 384,740.60 0 384,740.60
447.203(b)(1)-(4) (on-going 0938-1134 51 51 80 4,080 41.42 168,993.60 0 168,993.60
requirement).................
80 4,080 84.50 344,760.00 0 344,760.00
100 5,100 87.36 445,536.00 0 445,536.00
40 2,040 67.38 137,455.20 0 137,455.20
10 510 112.70 54,477.00 0 54,477.00
-------------------------------------------------------------------------------------------------------------
Subtotal.................. .......... 51 51 310 15,810 ........... 1,154,221.80 0 1,154,221.80
447.203(b)(6)(ii)............. 0938-1134 22 22 64 1,408 87.36 123,002.88 0 123,002.88
3 66 112.70 7,438.20 0 7,438.20
-------------------------------------------------------------------------------------------------------------
Subtotal.................. .......... 22 22 67 1,474 ........... 130,441.08 0 130,441.08
447.203(b)(7) (one-time 0938-1134 51 17 100 1,700 87.36 148,512.00 0
requirement).................
5 85 112.70 9,579.50 0
-------------------------------------------------------------------------------------------------------------
Subtotal.................. .......... 51 17 105 1,785 ........... 158,091.50 0 158,091.50
447.203(b)(7) (on-going 0938-1134 51 51 75 3,825 87.36 334,152.00 0 334,152.00
requirement).................
5 255 112.70 28,738.50 0 28,738.50
-------------------------------------------------------------------------------------------------------------
Subtotal.................. .......... 51 51 80 4,080 ........... 362,890.50 0 362,890.50
447.203(b)(8) (one-time 0938-1134 10 3.3 60 198 87.36 17,297.28 0 17,297.28
requirement).................
3 9.9 112.70 1,115.73 0 1,115.73
-------------------------------------------------------------------------------------------------------------
Subtotal.................. .......... 10 3.3 63 207.9 ........... 18,413.01 0 18,413.01
447.204(a)(1) and (2) (one- 0938-1134 22 7.3 20 146 87.36 12,754.56 0 12,754.56
time requirement)............
3 21.9 112.70 2,468.13 0 2,468.13
Subtotal.................. .......... 22 7.3 23 167.9 ........... 15,222.69 ........... 15,222.69
447.204(a)(1) and (2) (on- 0938-1134 22 22 40 880 87.36 76,876.80 0 76,876.80
going requirement)...........
3 66 112.70 7,438.20 0 7,438.20
-------------------------------------------------------------------------------------------------------------
Subtotal.................. .......... 22 22 43 946 ........... 84,315.00 0 84,315.00
-------------------------------------------------------------------------------------------------------------
SUB-TOTAL (One Time .......... ........... 44.6 568 8,905 ........... 706,908.88 0 706,908.88
Requirements)................
-------------------------------------------------------------------------------------------------------------
SUB-TOTAL (On-Going .......... ........... 146 433 20,836 ........... 1,601,427.30 0 1,601,427.30
Requirements)............
-------------------------------------------------------------------------------------------------------------
TOTAL................. .......... ........... 381.2 896 27,956 ........... 2,150,244.68 0 2,150,244.68
--------------------------------------------------------------------------------------------------------------------------------------------------------

E. Submission of PRA-Related Comments

We submitted a copy of this final rule to OMB for its review of the
rule's information collection and recordkeeping requirements. The
requirements are not effective until they have been approved by the
OMB.
To obtain copies of the supporting statement and any related forms
for the proposed collections discussed above, please visit CMS' Web
site at www.cms.hhs.gov/[email protected]">www.cms.hhs.gov/[email protected], or call the Reports
Clearance Office at 410-786-1326.
We invite public comments on these potential information collection
requirements. If you wish to comment, please identify the rule (CMS-
2328-FC) and submit your comments to the OMB desk officer via one of
the following transmissions:
Mail: OMB, Office of Information and Regulatory Affairs, Attention:
CMS Desk Officer.
Fax Number: 202-395-5806, OR
Email: [email protected].
ICR-related comments are due December 2, 2015.

VI. Response to Comments

Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of

[[Page 67609]]

this preamble, and, when we proceed with a subsequent document, we will
respond to the comments in the preamble to that document.

VII. Regulatory Impact Statement

A. Statement of Need

This final rule with comment period revises regulatory provisions
in Sec. 447.203 and Sec. 447.204 to create a standardized,
transparent process for states to follow as part of their broader
efforts to assure that payments are consistent with efficiency,
economy, and quality of care and are sufficient to enlist enough
providers so that care and services are available to the general
population in the geographic area, as required by section
1902(a)(30)(A) of the Act. This rule also clarifies and amends Sec.
447.205, which require states to issue public notice to their providers
when changing Medicaid payment methods and standards. The changes to
the public notice requirement will alleviate confusion on when states
must issue notice to providers and recognize electronic media as a
means to issue the notices.

B. Overall Impact

We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA)) (September
19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security 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 Order 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). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). We do not
believe that there is potential for this provision to surpass the
threshold for economic significance because the proposed data analysis
effort is generally consistent with current state oversight and review
activities and states have flexibility within the reviews to use their
existing data or build upon that data when reviewing access to care.
In fact, the guidance provided under this rule intends to focus
disparate state efforts in monitoring and overseeing data and
beneficiary concerns, which offers a clear framework to comply with
section 1902(a)(30)(A) of the Act. In the absence of federal guidance,
states have likely misspent resources in efforts to interpret and
comply with section 1902(a)(30)(A) of the Act. We will also make every
effort, in collaboration with state and federal partners, to identify
resources and tools that states may use to review and monitor access to
care within their state Medicaid programs. In this final rule with
comment period, we are soliciting public comments to begin identifying
data sources and will continue to provide assistance as states develop
their reviews and monitoring procedures.
Based on our analysis above, we estimate that even if these data
collection efforts were totally new to a state and each state were to
either bid a contract to gather and publish the data collection effort
and public process required under this rule or conduct the collection
and public process with state agency resources, the economic effects
would not surpass $100 million or more in any 1 year.
Further, we are not requiring states to directly adjust payment
rates as a result of the provisions of this final rule with comment
period, nor to take any steps that would not be consistent with
efficiency, economy, and quality of care. Rather, these rules propose
to clarify that beneficiary access must be considered in setting and
adjusting payment methodology for Medicaid services. If a problem is
identified, any number of steps might be appropriate, such as
redesigning service delivery strategies, or improving provider
enrollment and retention efforts. It has historically been within our
regulatory authority to make SPA approval decisions based on
sufficiency of beneficiary service access and this rule merely provides
a more consistent and transparent way to gather and analyze the
necessary information to support such reviews.
The RFA requires agencies to analyze options for regulatory relief
for small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small government
jurisdictions. For details, see the Small Business Administration's Web
site at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf. Individuals and states are not included in
the definition of a small entity. We are not preparing an analysis for
the RFA because we and the Secretary have determined that this final
rule with comment period will not have a significant economic impact on
a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area for Medicare payment regulations and has fewer than
100 beds. We are not preparing an analysis for section 1102(b) of the
Act because we and the Secretary have determined that this final rule
with comment period will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2015, that
threshold is approximately $144 million. This final rule with comment
period will not impose a mandate that will result in the expenditure by
state, local, and tribal governments, in the aggregate, or by the
private sector, of more than $144 million in any one year.
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. Since the estimated total cost associated with the
provisions in this final rule with comment period is around $2.3
million annually, it will not impose significant costs on state or
local governments, the requirements of E.O. 13132 are not applicable.
We also note that the costs associated with this final rule with
comment are allocated across 51 state governments. To the extent that
costs are for the proper and efficient administration of the Medicaid
state plan, many of the activities required under this final rule are
likely available at the Medicaid matching rate for administrative
expenditures.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.

[[Page 67610]]

C. Regulatory Alternatives Considered

This section provides an overview of regulatory alternatives that
CMS considered for this final rule with comment period. In determining
the appropriate approach to guide states in their efforts to meet the
requirements of section 1902(a)(30)(A) of the Act and demonstrate
sufficient access to Medicaid services, we consulted with SMDs, federal
agency policy officials and the MACPAC. Based, in part, on these
discussions we arrived at the provisions discussed in this rule, which
seek to balance state obligations to meet the statutory requirement of
section 1902(a)(30)(A) of the Act and potential new burden associated
with the proposal. To achieve this balance, we have set forth a process
that provides a framework for states to demonstrate access to Medicaid
services using available data resources and in consideration of unique
and evolving health care delivery systems. We have also emphasized the
importance of considering beneficiary input in determining and
monitoring access to Medicaid services throughout the process as
discussed in this final rule with comment period.
1. Access Monitoring Review Plan
The process for documenting access to care and service payment
rates described at Sec. 447.203 will require states to develop and
make publically available access monitoring review plans that address
the extent to which beneficiary needs are met, the availability of care
and providers, and changes in beneficiary utilization of covered
services and other factors. The access monitoring review plan would
also include percentage comparisons of Medicaid payment rates to other
public or private health coverage rates within geographic areas of the
state. The access monitoring review plans are to be developed for a
subset of Medicaid service categories and updated at least every 3
years or, in the context of a SPA proposal to reduce provider rates or
restructure provider rates in circumstance that may negatively impact
access to care, within 12 months of implementing the SPA.
As an alternative to the proposed framework for reviewing access to
care, we considered requiring states to report standard data measures
to demonstrate sufficient access to care and section 1902(a)(30)(A) of
the Act. We also considered setting national access thresholds or
requiring states to establish and demonstrate access thresholds. As we
have highlighted throughout this final rule with comment period, there
are no standardized, transparent methodologies for demonstrating access
to care that would be appropriate to adopt at this time.
Rather than prescribe data measures that may not align with all
services or set threshold standards, we have adopted a general
framework, which sets forth a three-part review that applies across
services and delivery systems and will allow states the flexibility to
determine, through current or new data sources, appropriate measures of
access to care. As states analyze their existing data sources and those
that we identify through work with MACPAC and our federal partners, we
believe that states may arrive at best practices for determining
sufficient Medicaid access to care which could be replicated across
state delivery systems and will evolve with new approaches to
delivering health care to Medicaid beneficiaries. In addition, we are
issuing an RFI to solicit feedback from stakeholders on whether data
exists to develop core access measures and thresholds would provide
additional information or approaches that would be useful to us and
states in ensuring access to care to Medicaid beneficiaries.
2. Access Review Timeframe and Monitoring Procedures
States will be required to develop access monitoring review plans
for the following service categories: Primary care; physician
specialist services; behavioral health; pre- and post-natal obstetric
services, including labor and delivery; home health services and other
service categories as determined necessary based on beneficiary,
provider or stakeholder complaints; the access monitoring review plans
must be reviewed and updated at least every 3 years. States must also
submit an access review, completed within the 12 months prior, with any
SPA that proposes to reduce or restructure provider payments for each
of the impacted services. We have arrived at this subset of service
categories because they are frequently used services in Medicaid and
they are considered gateway services, meaning if a beneficiary has
access to these services, it is likely that the majority of the
beneficiary's needs are being met.
We considered requiring the review for all services on an annual
basis or a review period that is more frequent than 5 years. After
careful consideration of the burden associated with annual reviews,
which were a foremost concern for some commenters, we determined 3 year
ongoing reviews as an appropriate frequency period. The final rule with
comment period provides for more frequent reviews for fewer high demand
services and requires additional review and monitoring over three years
for services subject to rate reductions or restructuring of payments or
when the Medicaid agency receives a significantly higher than usual
level of complaints about access to care from beneficiaries, providers,
or other stakeholders. In this way, the final rule with comment period
ensures that access to care reviews for most services will be conducted
as potential issues arise or circumstances change. We believe that,
absent rate reductions or restructuring of payments, the 3-year review
and monitoring periods combined with ongoing solicitation of
information about access from beneficiaries are sufficient to identify
access issues that may occur over time.
This final rule with comment period will require states to develop
monitoring procedures after implementing provider rate reductions or
restructuring rates in ways that may negatively impact access to care.
We require these monitoring procedures because the impact of rate
changes on access to care may not be apparent at the time the changes
are adopted. We considered not requiring states to monitor access after
implementing the changes and to continue to rely on the 5-year reviews
to ensure that access is maintained. However, we believe that it is
important for states to identify and address access issues that arise
from specific SPA actions, such as reimbursement rate reductions or
restructuring.
3. Beneficiary Input on Access to Care
The requirements of Sec. 447.203 and Sec. 447.204 emphasize the
importance of involving beneficiaries in determining access issues and
the impact that state rate changes will have on access to care.
Specifically, we require that states implement an ongoing mechanism for
beneficiary input on access to care (through hotlines, surveys,
ombudsman, or another equivalent mechanism) and receive input from
beneficiaries (and affected stakeholders) on the impact that proposed
rates changes will have through a public process. We believe that
beneficiaries' experiences in accessing Medicaid services is the most
important indicator of whether access is sufficient and beneficiary
input will be particularly informative in identifying access issues.
We also considered a requirement that states consult with
beneficiaries when developing their corrective action plans in
instances when the access data reviews or monitoring procedures
identify access issues. While we encourage states to solicit
beneficiary

[[Page 67611]]

input on corrective action plans, we did not make this a specific
regulatory requirement and we leave it to the states' discretion to
develop the corrective action plans as part of their current policy
development methods.

List of Subjects in 42 CFR Part 447

Accounting, Administrative practice and procedure, Drugs, Grant
programs-health, Health facilities, Health professions, Medicaid,
Reporting and recordkeeping requirements, and Rural areas.

For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 447--PAYMENTS FOR SERVICES

0
1. The authority citation for part 447 continues to read as follows:

Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).

0
2. Section 447.203 is amended by revising the section heading and
paragraph (b) to read as follows:

Sec. 447.203 Documentation of access to care and service payment
rates.

* * * * *
(b) In consultation with the medical care advisory committee under
Sec. 431.12 of this chapter, the agency must develop a medical
assistance access monitoring review plan and update it, in accordance
with the timeline established in paragraph (b)(5) of this section. The
plan must be published and made available to the public for review and
comment for a period of no less than 30 days, prior to being finalized
and submitted to CMS for review.
(1) Access monitoring review plan data requirements. The access
monitoring review plan must include an access monitoring analysis that
includes: Data sources, methodologies, baselines, assumptions, trends
and factors, and thresholds that analyze and inform determinations of
the sufficiency of access to care which may vary by geographic location
within the state and will be used to inform state policies affecting
access to Medicaid services such as provider payment rates, as well as
the items specified in this section. The access monitoring review plan
must specify data elements that will support the state's analysis of
whether beneficiaries have sufficient access to care. The plan and
monitoring analysis will consider:
(i) The extent to which beneficiary needs are fully met;
(ii) The availability of care through enrolled providers to
beneficiaries in each geographic area, by provider type and site of
service;
(iii) Changes in beneficiary utilization of covered services in
each geographic area.
(iv) The characteristics of the beneficiary population (including
considerations for care, service and payment variations for pediatric
and adult populations and for individuals with disabilities); and
(v) Actual or estimated levels of provider payment available from
other payers, including other public and private payers, by provider
type and site of service.
(2) Access monitoring review plan beneficiary and provider input.
The access monitoring review plan must include an analysis of data and
the state's conclusion of the sufficiency of access to care that will
consider relevant provider and beneficiary information, including
information obtained through public rate-setting processes, the medical
care advisory committees established under Sec. 431.12 of this
chapter, the processes described in paragraph (b)(7) of this section,
and other mechanisms (such as letters from providers and beneficiaries
to State or Federal officials), which describe access to care concerns
or suggestions for improvement in access to care.
(3) Access monitoring review plan comparative payment rate review.
For each of the services reviewed, by the provider types and sites of
service (e.g. primary care physicians in office settings) described
within the access monitoring analysis, the access monitoring review
plan must include an analysis of the percentage comparison of Medicaid
payment rates to other public (including, as practical, Medicaid
managed care rates) and private health insurer payment rates within
geographic areas of the state.
(4) Access monitoring review plan standards and methodologies. The
access monitoring review plan and analysis must, at a minimum, include:
The specific measures that the state uses to analyze access to care
(such as, but not limited to: Time and distance standards, providers
participating in the Medicaid program, providers with open panels,
providers accepting new Medicaid beneficiaries, service utilization
patterns, identified beneficiary needs, data on beneficiary and
provider feedback and suggestions for improvement, the availability of
telemedicine and telehealth, and other similar measures), how the
measures relate to the access monitoring review plan described in
paragraph (b)(1) of this section, baseline and updated data associated
with the measures, any issues with access that are discovered as a
result of the review, and the state agency's recommendations on the
sufficiency of access to care based on the review. In addition, the
access monitoring review plan must include procedures to periodically
monitor access for at least 3 years after the implementation of a
provider rate reduction or restructuring, as discussed in paragraph
(b)(6)(ii) of this section.
(5) Access monitoring review plan timeframe. Beginning July 1, 2016
the State agency must:
(i) Develop its access monitoring review plan by July 1 of the
first review year, and update this plan by July 1 of each subsequent
review period;
(ii) For all of the following, complete an analysis of the data
collected using the methodology specified in the access monitoring
review plan in paragraphs (b)(1) through (4) of this section, with a
separate analysis for each provider type and site of service furnishing
the type of service at least once every 3 years:
(A) Primary care services (including those provided by a physician,
FQHC, clinic, or dental care).
(B) Physician specialist services (for example, cardiology,
urology, radiology).
(C) Behavioral health services (including mental health and
substance use disorder).
(D) Pre- and post-natal obstetric services including labor and
delivery.
(E) Home health services.
(F) Any additional types of services for which a review is required
under paragraph (b)(6) of this section;
(G) Additional types of services for which the state or CMS has
received a significantly higher than usual volume of beneficiary,
provider or other stakeholder access complaints for a geographic area,
including complaints received through the mechanisms for beneficiary
input consistent with paragraph (b)(7) of this section; and
(H) Additional types of services selected by the state.
(6) Special provisions for proposed provider rate reductions or
restructuring--(i) Compliance with access requirements. The State shall
submit with any State plan amendment that proposes to reduce provider
payment rates or restructure provider payments in circumstances when
the changes could result in diminished access, an access review, in
accordance with the access monitoring review plan, for each service
affected by the State plan amendments as described under paragraph
(b)(1) of this section completed within the prior 12 months.

[[Page 67612]]

That access review must demonstrate sufficient access for any service
for which the state agency proposes to reduce payment rates or
restructure provider payments to demonstrate compliance with the access
requirements at section 1902(a)(30)(A) of the Act.
(ii) Monitoring procedures. In addition to the analysis conducted
through paragraphs (b)(1) through (4) of this section that demonstrates
access to care is sufficient as of the effective date of the State plan
amendment, a state must establish procedures in its access monitoring
review plan to monitor continued access to care after implementation of
state plan service rate reduction or payment restructuring. The
frequency of monitoring should be informed by the public review
described in paragraph (b) of this section and should be conducted no
less frequently than annually.
(A) The procedures must provide for a periodic review of state
determined and clearly defined measures, baseline data, and thresholds
that will serve to demonstrate continued sustained service access,
consistent with efficiency, economy, and quality of care.
(B) The monitoring procedures must be in place for a period of at
least 3 years after the effective date of the state plan amendment that
authorizes the payment reductions or restructuring.
(7) Mechanisms for ongoing beneficiary and provider input. (i)
States must have ongoing mechanisms for beneficiary and provider input
on access to care (through hotlines, surveys, ombudsman, review of
grievance and appeals data, or another equivalent mechanisms),
consistent with the access requirements and public process described in
Sec. 447.204.
(ii) States should promptly respond to public input through these
mechanisms citing specific access problems, with an appropriate
investigation, analysis, and response.
(iii) States must maintain a record of data on public input and how
the state responded to this input. This record will be made available
to CMS upon request.
(8) Addressing access questions and remediation of inadequate
access to care. When access deficiencies are identified, the state
must, within 90 days after discovery, submit a corrective action plan
with specific steps and timelines to address those issues. While the
corrective action plan may include longer-term objectives, remediation
of the access deficiency should take place within 12 months.
(i) The state's corrective actions may address the access
deficiencies through a variety of approaches, including, but not
limited to: Increasing payment rates, improving outreach to providers,
reducing barriers to provider enrollment, proving additional
transportation to services, providing for telemedicine delivery and
telehealth, or improving care coordination.
(ii) The resulting improvements in access must be measured and
sustainable.

0
3. Section 447.204 is revised to read as follows:

Sec. 447.204 Medicaid provider participation and public process to
inform access to care.

(a) The agency's payments must be consistent with efficiency,
economy, and quality of care and sufficient to enlist enough providers
so that services under the plan are available to beneficiaries at least
to the extent that those services are available to the general
population. In reviewing payment sufficiency, states are required to
consider, prior to the submission of any state plan amendment that
proposes to reduce or restructure Medicaid service payment rates:
(1) The data collected, and the analysis performed, under Sec.
447.203.
(2) Input from beneficiaries, providers and other affected
stakeholders on beneficiary access to the affected services and the
impact that the proposed rate change will have, if any, on continued
service access. The state should maintain a record of the public input
and how it responded to such input.
(b) The state must submit to CMS with any such proposed state plan
amendment affecting payment rates:
(1) Its most recent access monitoring review plan performed under
Sec. 447.203(b)(6) for the services at issue;
(2) An analysis of the effect of the change in payment rates on
access; and
(3) A specific analysis of the information and concerns expressed
in input from affected stakeholders.
(c) CMS may disapprove a proposed state plan amendment affecting
payment rates if the state does not include in its submission the
supporting documentation described in paragraph (b) of this section,
for failure to document compliance with statutory access requirements.
Any such disapproval would follow the procedures described at part 430
Subpart B of this title.
(d) To remedy an access deficiency, CMS may take a compliance
action using the procedures described at Sec. 430.35 of this chapter.

0
4. Section 447.205 is amended by adding paragraph (d)(2)(iv) to read as
follows:

Sec. 447.205 Public notice of changes in Statewide methods and
standards for setting payment rates.

* * * * *
(d) * * *
(2) * * *
(iv) A Web site developed and maintained by the single State agency
or other responsible State agency that is accessible to the general
public, provided that the Web site:
(A) Is clearly titled and can be easily reached from a hyperlink
included on Web sites that provide general information to beneficiaries
and providers, and included on the State-specific page on the Federal
Medicaid Web site.
(B) Is updated for bulletins on a regular and known basis (for
example, the first day of each month), and the public notice is issued
as part of the regular update;
(C) Includes the actual date it was released to the public on the
Web site; or
(D) Complies with national standards to ensure access to
individuals with disabilities; and
(E) Includes protections to ensure that the content of the issued
notice is not modified after the initial publication and is maintained
on the Web site for no less than a 3-year period.

Dated: September 17, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: October 22. 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-27697 Filed 10-29-15; 11:15 am]
BILLING CODE 4120-01-P