Medicaid Program; Methods for Assuring Access to Covered Medicaid Services, 67575-67612 [2015-27697]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 80, Number 211 (Monday, November 2, 2015)]
[Rules and Regulations]
[Pages 67575-67612]
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

[[Page 67576]]


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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 https://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: https://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

[[Page 67580]]

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

[[Page 67592]]

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 https://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 https://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/Paperwork@cms.hhs.gov">www.cms.hhs.gov/Paperwork@cms.hhs.gov, 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: OIRA_submission@omb.eop.gov.
    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