80_FR_78372 80 FR 78131 - Waivers for State Innovation

80 FR 78131 - Waivers for State Innovation

DEPARTMENT OF THE TREASURY
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 241 (December 16, 2015)

Page Range78131-78135
FR Document2015-31563

This guidance relates to Section 1332 of the Patient Protection and Affordable Care Act (ACA) and its implementing regulations. Section 1332 provides the Secretary of Health and Human Services and the Secretary of the Treasury with the discretion to approve a state's proposal to waive specific provisions of the ACA (a State Innovation Waiver), provided the proposal meets certain requirements. In particular, the Secretaries can only exercise their discretion to approve a waiver if they find that the waiver would provide coverage to a comparable number of residents of the state as would be provided coverage absent the waiver, would provide coverage that is at least as comprehensive and affordable as would be provided absent the waiver, and would not increase the Federal deficit. If the waiver is approved, the state may receive funding equal to the amount of forgone Federal financial assistance that would have been provided to its residents pursuant to specified ACA programs, known as pass- through funding. State Innovation Waivers are available for effective dates beginning on or after January 1, 2017. They may be approved for periods up to 5 years and can be renewed. The Departments promulgated implementing regulations in 2012. This document provides additional information about the requirements that must be met, the Secretaries' application review procedures, the amount of pass-through funding, certain analytical requirements, and operational considerations.

Federal Register, Volume 80 Issue 241 (Wednesday, December 16, 2015)
[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Rules and Regulations]
[Pages 78131-78135]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31563]


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DEPARTMENT OF THE TREASURY

31 CFR Part 33

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 155

[CMS-9936-N]


Waivers for State Innovation

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS; Department 
of the Treasury.

ACTION: Guidance.

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SUMMARY: This guidance relates to Section 1332 of the Patient 
Protection and Affordable Care Act (ACA) and its implementing 
regulations. Section 1332 provides the Secretary of Health and Human 
Services and the Secretary of the Treasury with the discretion to 
approve a state's proposal to waive specific provisions of the ACA (a 
State Innovation Waiver), provided the proposal meets certain 
requirements. In particular, the Secretaries can only exercise their 
discretion to approve a waiver if they find that the waiver would 
provide coverage to a comparable number of residents of the state as 
would be provided coverage absent the waiver, would provide coverage 
that is at least as comprehensive and affordable as would be provided 
absent the waiver, and would not increase the Federal deficit. If the 
waiver is approved, the state may receive funding equal to the amount 
of forgone Federal financial assistance that would have been provided 
to its residents pursuant to specified ACA programs, known as pass-
through funding. State Innovation Waivers are available for effective 
dates beginning on or after January 1, 2017. They may be approved for 
periods up to 5 years and can be renewed. The Departments promulgated 
implementing regulations in 2012. This document provides additional 
information about the requirements that must be met, the Secretaries' 
application review procedures, the amount of pass-through funding, 
certain analytical requirements, and operational considerations.

DATES: Comment Date: Comments may be submitted at any time.

ADDRESSES: In commenting, please refer to file code CMS-9936-N. 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 
document to http://www.regulations.gov. Follow the ``Submit a comment'' 
instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-9936-N, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    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-9936-N, 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:
    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) 786-9994 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.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Centers for Medicare & Medicaid 
Services: Tricia Beckmann, 301-492-4328, or Robert Yates, 301-492-5151.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received 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 on the following 
Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received will also be 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.

I. Statutory Requirements

    Under Section 1332 of the Affordable Care Act (ACA), the 
Secretaries of Health and Human Services (HHS) and the Treasury as 
appropriate may

[[Page 78132]]

exercise their discretion to approve a request for a State Innovation 
Waiver only if the Secretaries determine that the proposal meets the 
following four requirements: (1) The proposal will provide coverage to 
at least a comparable number of the state's residents as would be 
provided absent the waiver; (2) the proposal will provide coverage and 
cost-sharing protections against excessive out-of-pocket spending that 
are at least as affordable for the state's residents as would be 
provided absent the waiver; (3) the proposal will provide coverage that 
is at least as comprehensive for the state's residents as would be 
provided absent the waiver; and, (4) the proposal will not increase the 
Federal deficit. The Secretaries retain their discretionary authority 
under Section 1332 to deny waivers when appropriate given consideration 
of the application as whole, including the four requirements. As under 
similar waiver authorities, the Secretaries reserve the right to 
suspend or terminate a waiver, in whole or in part, any time before the 
date of expiration, if the Secretaries determine that the state 
materially failed to comply with the terms and conditions of the 
waiver, including any of the requirements discussed in this guidance.
    Final regulations at 31 CFR part 33 and 45 CFR part 155, subpart N 
require a state to provide actuarial analyses and actuarial 
certifications, economic analyses, data and assumptions, targets, an 
implementation timeline, and other necessary information to support the 
state's estimates that the proposed waiver will comply with these 
requirements.\1\
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    \1\ ``Application, Review, and Reporting Process for Waivers for 
State Innovation Final Rule.'' February 27, 2012. Available at: 
http://www.thefederalregister.org/fdsys/pkg/FR-2012-02-27/pdf/2012-4395.pdf.
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A. Coverage

    To meet the coverage requirement, a comparable number of state 
residents must be forecast to have coverage under the waiver as would 
have coverage absent the waiver.
    Coverage refers to minimum essential coverage (or, if the 
individual shared responsibility provision is waived under a State 
Innovation Waiver, to something that would qualify as minimum essential 
coverage but for the waiver). For this purpose, ``comparable'' means 
that the forecast of the number of covered individuals is no less than 
the forecast of the number of covered individuals absent the waiver. 
This condition generally must be forecast to be met in each year that 
the waiver would be in effect.
    The impact on all state residents is considered, regardless of the 
type of coverage they would have absent the waiver. (For example, while 
a State Innovation Waiver may not change the terms of a state's 
Medicaid coverage or change existing Medicaid demonstration authority, 
changes in Medicaid enrollment that result from a State Innovation 
Waiver, holding the state's Medicaid policies constant, are considered 
in evaluating the number of residents with coverage under a waiver.)
    Assessment of whether the proposal covers a comparable number of 
individuals also takes into account the effects across different groups 
of state residents, and, in particular, vulnerable residents, including 
low-income individuals, elderly individuals, and those with serious 
health issues or who have a greater risk of developing serious health 
issues. Reducing coverage for these types of vulnerable groups would 
cause a waiver application to fail this requirement, even if the waiver 
would provide coverage to a comparable number of residents overall. 
Finally, analysis under the coverage requirement takes into account 
whether the proposal sufficiently prevents gaps in or discontinuations 
of coverage.
    As provided in 31 CFR part 33 and 45 CFR part 155, subpart N, the 
waiver application must include analysis and supporting data that 
establishes that the waiver satisfies this requirement, including 
information on the number of individuals covered by income, health 
status, and age groups, under current law and under the waiver, 
including year-by-year estimates. The application should identify any 
types of individuals who are less likely to be covered under the waiver 
than under current law.
    The state should also provide a description of the model used to 
produce these estimates, including data sources and quality, key 
assumptions, and parameters. The state may be required to provide micro 
data and other information to inform the Secretaries' analysis.

B. Affordability

    To meet the affordability requirement, health care coverage under 
the waiver must be forecast to be as affordable overall for state 
residents as coverage absent the waiver.
    Affordability refers to state residents' ability to pay for health 
care and may generally be measured by comparing residents' net out-of-
pocket spending for health coverage and services to their incomes. Out-
of-pocket expenses include both premium contributions (or equivalent 
costs for enrolling in coverage), and any cost sharing, such as 
deductibles, co-pays, and co-insurance, associated with the coverage. 
Spending on health care services that are not covered by a plan may 
also be taken into account if they are affected by the waiver proposal. 
The impact on all state residents is considered, regardless of the type 
of coverage they would have absent the waiver. This condition generally 
must be forecast to be met in each year that the waiver would be in 
effect.
    Waivers are evaluated not only based on how they affect 
affordability on average, but also on how they affect the number of 
individuals with large health care spending burdens relative to their 
incomes. Increasing the number of state residents with large health 
care spending burdens would cause a waiver to fail the affordability 
requirement, even if the waiver would increase affordability for many 
other state residents. Assessment of whether the proposal meets the 
affordability requirement also takes into account the effects across 
different groups of state residents, and, in particular, vulnerable 
residents, including low-income individuals, elderly individuals, and 
those with serious health issues or who have a greater risk of 
developing serious health issues. Reducing affordability for these 
types of vulnerable groups would cause a waiver to fail this 
requirement, even if the waiver maintained affordability in the 
aggregate.
    In addition, a waiver would fail the affordability requirement if 
it would reduce the number of individuals with coverage that provides a 
minimal level of protection against excessive cost sharing. In 
particular, waivers that reduce the number of people with insurance 
coverage that provides both an actuarial value equal to or greater than 
60 percent and an out-of-pocket maximum that complies with section 
1302(c)(1) of the ACA, would fail this requirement. So too would 
waivers that reduce the number of people with coverage that meets the 
affordability requirements set forth in sections 1916 and 1916A of the 
Social Security Act, as codified in 42 CFR part 447, subpart A, while 
holding the state's Medicaid policies constant.
    As provided in 31 CFR part 33 and 45 CFR part 155, subpart N, the 
waiver application must include analysis and supporting data that 
establishes that the waiver satisfies this requirement. This includes 
information on estimated individual out-of-pocket costs by income, 
health status, and age groups, absent the waiver and with the waiver. 
The expected changes in premium contributions and other out-of-pocket

[[Page 78133]]

costs and the combined impact of changes in these components should be 
identified separately. The application should also describe any changes 
in employer contributions to health coverage or in wages expected under 
the waiver. The application should identify any types of individuals 
for whom affordability of coverage would be reduced by the waiver.
    The state should also provide a description of the model used to 
produce these estimates, including data sources and quality, key 
assumptions, and parameters. The state may be required to provide micro 
data and other information to inform the Secretaries' analysis.

C. Comprehensiveness

    To meet the comprehensiveness requirement, health care coverage 
under the waiver must be forecast to be at least as comprehensive 
overall for residents of the state as coverage absent the waiver.
    Comprehensiveness refers to the scope of benefits provided by the 
coverage as measured by the extent to which coverage meets the 
requirements for essential health benefits (EHBs) as defined in section 
1302(b) of the ACA, or, as appropriate, Medicaid and/or CHIP standards. 
The impact on all state residents is considered, regardless of the type 
of coverage they would have absent the waiver.
    Comprehensiveness is evaluated by comparing coverage under the 
waiver to the state's EHB benchmark, selected by the state (or if the 
state does not select a benchmark, the default base-benchmark plan) 
pursuant to 45 CFR 156.100, as well as to, in certain cases, the 
coverage provided under the state's Medicaid and/or CHIP programs. A 
waiver cannot satisfy the comprehensiveness requirement if the waiver 
decreases: (1) The number of residents with coverage that is at least 
as comprehensive as the benchmark in all ten EHB categories; (2) for 
any of the ten EHB categories, the number of residents with coverage 
that is at least as comprehensive as the benchmark in that category; or 
(3) the number of residents whose coverage includes the full set of 
services that would be covered under the state's Medicaid and/or CHIP 
programs, holding the state's Medicaid and CHIP policies constant. That 
is, the waiver must not decrease the number of individuals with 
coverage that satisfies EHB requirements, the number of individuals 
with coverage of any particular category of EHB, or the number of 
individuals with coverage that includes the services covered under the 
state's Medicaid and/or CHIP programs.
    Assessment of whether the proposal meets the comprehensiveness 
requirement also takes into account the effects across different groups 
of state residents, and, in particular, vulnerable residents, including 
low-income individuals, elderly individuals, and those with serious 
health issues or who have a greater risk of developing serious health 
issues. A waiver would fail the comprehensiveness requirement if it 
would reduce the comprehensiveness of coverage provided to these types 
of vulnerable groups, even if the waiver maintained comprehensiveness 
in the aggregate. This condition generally must be forecast to be met 
in each year that the waiver would be in effect.
    As provided in the final regulations at 31 CFR part 33 and 45 CFR 
part 155, subpart N, the waiver application must include analysis and 
supporting data that establishes that the waiver satisfies this 
requirement. This includes an explanation of how the benefits offered 
under the waiver differ from the benefits provided absent the waiver 
(if the benefits differ at all) and how the state determined the 
benefits to be as comprehensive.
    The state should also provide a description of the model used to 
produce these estimates, including data sources and quality, key 
assumptions, and parameters. The state may be required to provide micro 
data and other information to inform the Secretaries' analysis.

D. Deficit Neutrality

    Under the deficit neutrality requirement, the projected Federal 
spending net of Federal revenues under the State Innovation Waiver must 
be equal to or lower than projected Federal spending net of Federal 
revenues in the absence of the waiver.
    The estimated effect on Federal revenue includes all changes in 
income, payroll, or excise tax revenue, as well as any other forms of 
revenue (including user fees), that would result from the proposed 
waiver. Estimated effects would include, for example, changes in: The 
premium tax credit and health coverage tax credit, individual shared 
responsibility payments, employer shared responsibility payments, the 
excise tax on high-cost employer-sponsored plans, the credit for small 
businesses offering health insurance, and changes in income and payroll 
taxes resulting from changes in tax exclusions for employer-sponsored 
insurance and in deductions for medical expenses.
    The effect on Federal spending includes all changes in Exchange 
financial assistance and other direct spending, such as changes in 
Medicaid spending (while holding the state's Medicaid policies 
constant) that result from the changes made through the State 
Innovation Waiver. Projected Federal spending under the waiver proposal 
also includes all administrative costs to the Federal government, 
including any changes in Internal Revenue Service administrative costs, 
Federal Exchange administrative costs, or other administrative costs 
associated with the waiver.
    Waivers must not increase the Federal deficit over the period of 
the waiver (which may not exceed 5 years unless renewed) or in total 
over the ten-year budget plan submitted by the state as part of the 
State Innovation Waiver application. The ten-year budget plan must 
describe for both the period of the waiver and for the ten-year budget 
the projected Federal spending net of Federal revenues under the State 
Innovation Waiver and the projected Federal spending net of Federal 
revenues in the absence of the waiver.
    The ten-year budget plan should assume the waiver would continue 
permanently, but should not include Federal spending or savings 
attributable to any period outside of the ten-year budget window. A 
variety of factors, including the likelihood and accuracy of projected 
spending and revenue effects and the timing of these effects, are 
considered when evaluating the effect of the waiver on the Federal 
deficit. A waiver that increases the deficit in any given year is less 
likely to meet the deficit neutrality requirement.
    The state should also provide a description of the model used to 
produce these estimates, including data sources and quality, key 
assumptions, and parameters. The state may be required to provide micro 
data and other information to inform the Secretaries' analysis.
    As provided in 31 CFR part 33 and 45 CFR part 155, subpart N, a 
state must submit evidence to demonstrate deficit neutrality, including 
a description of the analysis used to produce its estimate of the 
impact of the waiver on the Federal deficit. The description must 
include detailed information about the model, data sources and quality, 
key assumptions, and parameters. The state may be required to provide 
micro data and other information to support actuarial and economic 
analyses, so that the Secretaries can independently verify that the 
waiver meets the deficit neutrality requirement.

[[Page 78134]]

II. Impact of Other Program Changes on Assessment of a Waiver Proposal

    The assessment of whether a State Innovation Waiver proposal 
satisfies the statutory criteria set forth in Section 1332 takes into 
consideration the impact of changes to ACA provisions made pursuant to 
the State Innovation Waiver. The assessment also considers related 
changes to the state's health care system that, under state law, are 
contingent only on the approval of the State Innovation Waiver. For 
example, the assessment would take into account the impact of a new 
state-run health benefits program that, under legislation enacted by 
the state, would be implemented if the State Innovation Waiver were 
approved.
    The assessment does not consider the impact of policy changes that 
are contingent on further state action, such as state legislation that 
is proposed but not yet enacted. It also does not include the impact of 
changes contingent on other Federal determinations, including approval 
of Federal waivers pursuant to statutory provisions other than Section 
1332. Therefore, the assessment would not take into account changes to 
Medicaid or CHIP that require separate Federal approval, such as 
changes in coverage or Federal Medicaid or CHIP spending that would 
result from a proposed Section 1115 demonstration, regardless of 
whether the Section 1115 demonstration proposal is submitted as part of 
a coordinated waiver application with a State Innovation Waiver. 
Savings accrued under either proposed or current Section 1115 Medicaid 
or CHIP demonstrations are not factored into the assessment of whether 
a proposed State Innovation Waiver meets the deficit neutrality 
requirement. The assessment also does not take into account any changes 
to the Medicaid or CHIP state plan that are subject to Federal 
approval.
    The assessment does take into account changes in Medicaid and/or 
CHIP coverage or in Federal spending on Medicaid and/or CHIP that would 
result directly from the proposed waiver of provisions pursuant to 
Section 1332, holding state Medicaid and CHIP policies constant.
    As the Departments receive and review waiver proposals, we will 
continue to examine the types of changes that will be considered in 
assessing State Innovation Waivers.
    Nothing in this guidance alters a state's authority to make changes 
to its Medicaid and CHIP policies consistent with applicable law. This 
guidance does not alter the Secretary of Health and Human Services' 
authority or CMS' policy regarding review and approval of Section 1115 
demonstrations, and states should continue to work with CMS' Center for 
Medicaid and CHIP Services on issues relating to Section 1115 
demonstrations. A state may submit a coordinated waiver application as 
provided in 31 CFR 33.102 and 45 CFR 155.1302; in such a case, each 
waiver will be evaluated independently according to applicable Federal 
laws.

III. Federal Pass-Through Funding

    The amount of Federal pass-through funding equals the Secretaries' 
annual estimate of the Federal cost (including outlays and forgone 
revenue) for Exchange financial assistance provided pursuant to the ACA 
that would be claimed by participants in the Exchange in the state in 
the calendar year in the absence of the waiver, but will not be claimed 
as a result of the waiver. The calculation of the amount of pass-
through funding does not account for any other changes in Federal 
spending or revenues as a result of the waiver, including Federal 
administrative expenses for making the payments (note, however that 
changes to Federal spending on administrative expenses is considered in 
determining whether a waiver proposal meets the deficit neutrality 
requirement). The estimates take into account experience in the 
relevant state and similar states. The amount is calculated annually.
    The waiver application must provide analysis and supporting data to 
inform the estimate of the pass-through funding amount. For states that 
do not utilize a Federally-facilitated or state Partnership Exchange 
this includes information about enrollment, premiums, and Exchange 
financial assistance in the state's Exchange by age, income, and type 
of policy, and other information as may be required by the Secretaries.
    For further information on the demographic and economic assumptions 
to be used in determining the pass-through amount, see Section IV 
below.

IV. Economic Assumptions and Methodological Guidelines

    The determination of whether a waiver meets the requirements under 
Section 1332 and the calculation of the pass-through funding amount are 
made using generally accepted actuarial and economic analytic methods 
such as micro-simulation. The analysis relies on assumptions and 
methodologies that are similar to those used to produce the baseline 
and policy projections included in the most recent President's Budget 
(or Mid-Session Review), but adapted as appropriate to reflect state-
specific conditions.
    The analysis is based on state-specific estimates of the current 
level and distribution of population by the relevant economic and 
demographic characteristics, including income and source of health 
coverage. It generally uses Federal estimates of population growth, 
economic growth as published in the Analytical Perspectives volume 
released as part of the President's Budget (https://www.whitehouse.gov/omb/budget/Analytical_Perspectives) and health care cost growth 
(https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/index.html?redirect=/NationalHealthExpendData/.) to project the initial state variables 
through the ten-year Budget plan window. However, in limited 
circumstances where it is expected that a state will experience 
substantially different trends than the nation as a whole in the 
absence of a waiver, the Secretaries may determine that state-specific 
assumptions will be used.
    Estimates of the effect of the waiver assume, in accordance with 
standard estimating conventions, that macroeconomic variables like 
population, output, and labor supply are not affected by the waiver. 
However, estimates take into account, as appropriate, other changes in 
the behavior of individuals, employers, and other relevant entities 
induced by the waiver, including employer decisions regarding what 
coverage (and other compensation) they offer and individual decisions 
regarding whether to take up coverage. The same state-specific and 
Federal data, assumptions, and model are used to calculate 
comprehensiveness, affordability, and coverage, and relevant state 
components of Federal taxes and spending under the waiver and under 
current law.
    The analysis and information submitted by the state as part of the 
application must conform to these standards. The application must 
describe all modeling assumptions used, sources of state-specific data, 
and the rationale for any deviation from Federal forecasts. A state may 
be required to provide to the Secretaries copies of any data used for 
their waiver analyses that are not publicly available so that the 
Secretaries can independently verify the analysis produced by the 
state.

V. Operational Considerations

A. Federally-Facilitated Exchanges

    The Centers for Medicare & Medicaid Services (CMS) operates the 
Federally-

[[Page 78135]]

facilitated Exchange (FFE) platform. Certain changes that affect FFE 
processes may make a waiver proposal not feasible to implement at this 
time. Until further guidance is issued, the Federal platform cannot 
accommodate different rules for different states. For example, waivers 
that would require changes to the calculation of Exchange financial 
assistance, non-standard enrollment period determinations, customized 
plan management review options, or changes to the design used to 
display plan options are generally not feasible at this time due to 
operational limitations. In addition, the Federal platform cannot 
accommodate changes to its plan management templates in the near term. 
States contemplating a waiver that requires such changes may consider 
establishing their own platform administered by the state.
    As noted in Section I.D. of this guidance, costs associated with 
changes to Federal administrative processes are taken into account in 
determining whether a waiver application satisfies the deficit 
neutrality requirement. Regulations at 31 CFR part 33 and 45 CFR part 
155, subpart N require that such costs be included in the 10-year 
budget plan submitted by the state.

B. Internal Revenue Service

    Certain changes that affect Internal Revenue Service (IRS) 
administrative processes may make a waiver proposal not feasible to 
implement. At this time, the IRS is not generally able to administer 
different sets of rules in different states. As a result, while a state 
may propose to entirely waive the application of one or more of the tax 
provisions listed in Section 1332 to taxpayers in the state, it is 
generally not feasible to design a waiver that would require the IRS to 
administer an alteration to these provisions for taxpayers in the 
state. For example, it is generally not feasible to have the IRS 
administer a different set of eligibility rules for the premium tax 
credit for residents of a particular state. States contemplating a 
waiver proposal that includes a modified version of a Federal tax 
provision may consider waiving the provision entirely and relying on a 
tax program administered by the state.
    In addition, a waiver proposal that completely waives one or more 
tax provisions in a state may create administrative costs for the IRS. 
As noted in Section I.D. above, costs associated with changes to 
Federal administrative processes are taken into account in determining 
whether a waiver application satisfies the deficit neutrality 
requirement. Regulations at 31 CFR part 33 and 45 CFR part 155, subpart 
N require that such costs be included in the 10-year budget plan 
submitted by the state.

VI. Public Input on Waiver Proposals

    Consistent with the statutory provisions of Section 1332, 
regulations at 31 CFR 33.112 and 45 CFR 155.1312 require states to 
provide a public notice and comment period for a waiver application 
sufficient to ensure a meaningful level of public input prior to 
submitting an application. As part of the public notice and comment 
period, a state with one or more Federally-recognized tribes must 
conduct a separate process for meaningful consultation with such 
tribes. Because State Innovation Waiver applications may vary 
significantly in their complexity and breadth, the regulations provide 
states with flexibility in determining the length of the comment period 
required to allow for meaningful and robust public engagement. The 
comment period must be sufficient to ensure a meaningful level of 
public input and in no case can be less than 30 days.
    Consistent with HHS regulations, waiver applications must be posted 
online in a manner that meets national standards to assure access to 
individuals with disabilities. Such standards are issued by the 
Architectural and Transportation Barriers Compliance Board, and are 
referred to as ``section 508'' standards. Alternatively, the World Wide 
Web Consortium's Web Content Accessibility Guidelines (WCAG) 2.0 Level 
AA standards would also be considered as acceptable national standard 
for Web site accessibility. For more information, see the WCAG Web site 
at http://www.w3.org/TR/WCAG20/.
    Section 1332 and its implementing regulations also require the 
Federal Government to provide a public notice and comment period, once 
the Secretaries receive an application. The period must be sufficient 
to ensure a meaningful level of public input and must not impose 
requirements that are in addition to, or duplicative of, requirements 
imposed under the Administrative Procedures Act, or requirements that 
are unreasonable or unnecessarily burdensome with respect to state 
compliance. As with the comment period described above, the length of 
the comment period should reflect the complexity of the proposal and in 
no case can be less than 30 days.

    Dated: December 8, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: December 11, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
    Approved: December 10, 2015.
Mark J. Mazur,
Assistant Secretary of the Treasury (Tax Policy).
[FR Doc. 2015-31563 Filed 12-11-15; 4:15 pm]
 BILLING CODE 4150-28-P



                                                         Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations                                         78131

                                            ■ 2. In § 121.1, under Category XI, revise               Treasury with the discretion to approve                  a. For delivery in Washington, DC—
                                            paragraph (b), effective December 29,                    a state’s proposal to waive specific                  Centers for Medicare & Medicaid
                                            2015 to read as follows:                                 provisions of the ACA (a State                        Services, Department of Health and
                                                                                                     Innovation Waiver), provided the                      Human Services, Room 445–G, Hubert
                                            § 121.1    The United States Munitions List.             proposal meets certain requirements. In               H. Humphrey Building, 200
                                            *      *      *       *      *                           particular, the Secretaries can only                  Independence Avenue SW.,
                                            Category XI—Military Electronics                         exercise their discretion to approve a                Washington, DC 20201.
                                                                                                     waiver if they find that the waiver                      (Because access to the interior of the
                                            *     *     *     *     *                                would provide coverage to a comparable                Hubert H. Humphrey Building is not
                                               *(b) Electronic systems, equipment or                 number of residents of the state as                   readily available to persons without
                                            software, not elsewhere enumerated in                    would be provided coverage absent the                 Federal government identification,
                                            this sub-chapter, specially designed for                 waiver, would provide coverage that is                commenters are encouraged to leave
                                            intelligence purposes that collect,                      at least as comprehensive and affordable              their comments in the CMS drop slots
                                            survey, monitor, or exploit, or analyze                  as would be provided absent the waiver,               located in the main lobby of the
                                            and produce information from, the                        and would not increase the Federal                    building. A stamp-in clock is available
                                            electromagnetic spectrum (regardless of                  deficit. If the waiver is approved, the               for persons wishing to retain a proof of
                                            transmission medium), or for                             state may receive funding equal to the                filing by stamping in and retaining an
                                            counteracting such activities.                           amount of forgone Federal financial                   extra copy of the comments being filed.)
                                            *     *     *     *     *                                assistance that would have been                          b. For delivery in Baltimore, MD—
                                            ■ 3. In § 121.1, under Category XI, revise               provided to its residents pursuant to                 Centers for Medicare & Medicaid
                                            paragraph (b), effective August 30, 2017,                specified ACA programs, known as                      Services, Department of Health and
                                            to read as follows:                                      pass-through funding. State Innovation                Human Services, 7500 Security
                                                                                                     Waivers are available for effective dates             Boulevard, Baltimore, MD 21244–1850.
                                            § 121.1    The United States Munitions List.             beginning on or after January 1, 2017.                   If you intend to deliver your
                                            *      *      *       *      *                           They may be approved for periods up to                comments to the Baltimore address, call
                                            Category XI—Military Electronics                         5 years and can be renewed. The                       telephone number (410) 786–9994 in
                                                                                                     Departments promulgated implementing                  advance to schedule your arrival with
                                            *     *     *     *     *                                regulations in 2012. This document                    one of our staff members. Comments
                                               *(b) Electronic systems or equipment,                 provides additional information about                 erroneously mailed to the addresses
                                            not elsewhere enumerated in this sub-                    the requirements that must be met, the                indicated as appropriate for hand or
                                            chapter, specially designed for                          Secretaries’ application review                       courier delivery may be delayed.
                                            intelligence purposes that collect,                      procedures, the amount of pass-through                   For information on viewing public
                                            survey, monitor, or exploit the                          funding, certain analytical                           comments, see the beginning of the
                                            electromagnetic spectrum (regardless of                  requirements, and operational                         SUPPLEMENTARY INFORMATION section.
                                            transmission medium), or for                             considerations.                                       FOR FURTHER INFORMATION CONTACT:
                                            counteracting such activities.                                                                                 Centers for Medicare & Medicaid
                                                                                                     DATES: Comment Date: Comments may
                                            *     *     *     *     *                                be submitted at any time.                             Services: Tricia Beckmann, 301–492–
                                            Brian H. Nilsson,                                        ADDRESSES: In commenting, please refer                4328, or Robert Yates, 301–492–5151.
                                            Deputy Assistant Secretary for Defense Trade             to file code CMS–9936–N. Because of                   SUPPLEMENTARY INFORMATION: Inspection
                                            Controls, Bureau of Political-Military Affairs,          staff and resource limitations, we cannot             of Public Comments: All comments
                                            U.S. Department of State.                                accept comments by facsimile (FAX)                    received are available for viewing by the
                                            [FR Doc. 2015–31528 Filed 12–15–15; 8:45 am]             transmission.                                         public, including any personally
                                            BILLING CODE 4710–25–P                                      You may submit comments in one of                  identifiable or confidential business
                                                                                                     four ways (please choose only one of the              information that is included in a
                                                                                                     ways listed):                                         comment. We post all comments
                                            DEPARTMENT OF THE TREASURY                                  1. Electronically. You may submit                  received on the following Web site as
                                                                                                     electronic comments on this document                  soon as possible after they have been
                                            31 CFR Part 33                                           to http://www.regulations.gov. Follow                 received: http://www.regulations.gov.
                                                                                                     the ‘‘Submit a comment’’ instructions.                Follow the search instructions on that
                                            DEPARTMENT OF HEALTH AND                                    2. By regular mail. You may mail                   Web site to view public comments.
                                            HUMAN SERVICES                                           written comments to the following                        Comments received will also be
                                                                                                     address ONLY: Centers for Medicare &                  available for public inspection as they
                                            45 CFR Part 155                                          Medicaid Services, Department of                      are received, generally beginning
                                                                                                     Health and Human Services, Attention:                 approximately 3 weeks after publication
                                            [CMS–9936–N]                                             CMS–9936–N, P.O. Box 8016,                            of a document, at the headquarters of
                                            Waivers for State Innovation                             Baltimore, MD 21244–8016.                             the Centers for Medicare & Medicaid
                                                                                                        3. By express or overnight mail. You               Services, 7500 Security Boulevard,
                                            AGENCY: Centers for Medicare &                           may send written comments to the                      Baltimore, Maryland 21244, Monday
                                            Medicaid Services (CMS), HHS;                            following address ONLY: Centers for                   through Friday of each week from 8:30
                                            Department of the Treasury.                              Medicare & Medicaid Services,                         a.m. to 4 p.m. To schedule an
                                            ACTION: Guidance.                                        Department of Health and Human                        appointment to view public comments,
                                                                                                     Services, Attention: CMS–9936–N, Mail                 phone 1–800–743–3951.
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                                            SUMMARY:  This guidance relates to                       Stop C4–26–05, 7500 Security
                                            Section 1332 of the Patient Protection                   Boulevard, Baltimore, MD 21244–1850.                  I. Statutory Requirements
                                            and Affordable Care Act (ACA) and its                       4. By hand or courier. Alternatively,                Under Section 1332 of the Affordable
                                            implementing regulations. Section 1332                   you may deliver (by hand or courier)                  Care Act (ACA), the Secretaries of
                                            provides the Secretary of Health and                     your written comments ONLY to the                     Health and Human Services (HHS) and
                                            Human Services and the Secretary of the                  following addresses:                                  the Treasury as appropriate may


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                                            78132         Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations

                                            exercise their discretion to approve a                  be met in each year that the waiver                   equivalent costs for enrolling in
                                            request for a State Innovation Waiver                   would be in effect.                                   coverage), and any cost sharing, such as
                                            only if the Secretaries determine that                     The impact on all state residents is               deductibles, co-pays, and co-insurance,
                                            the proposal meets the following four                   considered, regardless of the type of                 associated with the coverage. Spending
                                            requirements: (1) The proposal will                     coverage they would have absent the                   on health care services that are not
                                            provide coverage to at least a                          waiver. (For example, while a State                   covered by a plan may also be taken into
                                            comparable number of the state’s                        Innovation Waiver may not change the                  account if they are affected by the
                                            residents as would be provided absent                   terms of a state’s Medicaid coverage or               waiver proposal. The impact on all state
                                            the waiver; (2) the proposal will provide               change existing Medicaid demonstration                residents is considered, regardless of the
                                            coverage and cost-sharing protections                   authority, changes in Medicaid                        type of coverage they would have absent
                                            against excessive out-of-pocket                         enrollment that result from a State                   the waiver. This condition generally
                                            spending that are at least as affordable                Innovation Waiver, holding the state’s                must be forecast to be met in each year
                                            for the state’s residents as would be                   Medicaid policies constant, are                       that the waiver would be in effect.
                                            provided absent the waiver; (3) the                     considered in evaluating the number of                   Waivers are evaluated not only based
                                            proposal will provide coverage that is at               residents with coverage under a waiver.)              on how they affect affordability on
                                            least as comprehensive for the state’s                     Assessment of whether the proposal                 average, but also on how they affect the
                                            residents as would be provided absent                   covers a comparable number of                         number of individuals with large health
                                            the waiver; and, (4) the proposal will                  individuals also takes into account the               care spending burdens relative to their
                                            not increase the Federal deficit. The                   effects across different groups of state              incomes. Increasing the number of state
                                            Secretaries retain their discretionary                  residents, and, in particular, vulnerable             residents with large health care
                                            authority under Section 1332 to deny                    residents, including low-income                       spending burdens would cause a waiver
                                            waivers when appropriate given                          individuals, elderly individuals, and                 to fail the affordability requirement,
                                            consideration of the application as                     those with serious health issues or who               even if the waiver would increase
                                            whole, including the four requirements.                 have a greater risk of developing serious             affordability for many other state
                                            As under similar waiver authorities, the                health issues. Reducing coverage for                  residents. Assessment of whether the
                                            Secretaries reserve the right to suspend                these types of vulnerable groups would                proposal meets the affordability
                                            or terminate a waiver, in whole or in                   cause a waiver application to fail this               requirement also takes into account the
                                            part, any time before the date of                       requirement, even if the waiver would                 effects across different groups of state
                                            expiration, if the Secretaries determine                provide coverage to a comparable                      residents, and, in particular, vulnerable
                                            that the state materially failed to comply              number of residents overall. Finally,                 residents, including low-income
                                            with the terms and conditions of the                    analysis under the coverage requirement               individuals, elderly individuals, and
                                            waiver, including any of the                            takes into account whether the proposal               those with serious health issues or who
                                            requirements discussed in this                          sufficiently prevents gaps in or                      have a greater risk of developing serious
                                            guidance.                                               discontinuations of coverage.                         health issues. Reducing affordability for
                                                                                                       As provided in 31 CFR part 33 and 45               these types of vulnerable groups would
                                               Final regulations at 31 CFR part 33                  CFR part 155, subpart N, the waiver                   cause a waiver to fail this requirement,
                                            and 45 CFR part 155, subpart N require                  application must include analysis and                 even if the waiver maintained
                                            a state to provide actuarial analyses and               supporting data that establishes that the             affordability in the aggregate.
                                            actuarial certifications, economic                      waiver satisfies this requirement,                       In addition, a waiver would fail the
                                            analyses, data and assumptions, targets,                including information on the number of                affordability requirement if it would
                                            an implementation timeline, and other                   individuals covered by income, health                 reduce the number of individuals with
                                            necessary information to support the                    status, and age groups, under current                 coverage that provides a minimal level
                                            state’s estimates that the proposed                     law and under the waiver, including                   of protection against excessive cost
                                            waiver will comply with these                           year-by-year estimates. The application               sharing. In particular, waivers that
                                            requirements.1                                          should identify any types of individuals              reduce the number of people with
                                            A. Coverage                                             who are less likely to be covered under               insurance coverage that provides both
                                                                                                    the waiver than under current law.                    an actuarial value equal to or greater
                                              To meet the coverage requirement, a                      The state should also provide a                    than 60 percent and an out-of-pocket
                                            comparable number of state residents                    description of the model used to                      maximum that complies with section
                                            must be forecast to have coverage under                 produce these estimates, including data               1302(c)(1) of the ACA, would fail this
                                            the waiver as would have coverage                       sources and quality, key assumptions,                 requirement. So too would waivers that
                                            absent the waiver.                                      and parameters. The state may be                      reduce the number of people with
                                              Coverage refers to minimum essential                  required to provide micro data and                    coverage that meets the affordability
                                            coverage (or, if the individual shared                  other information to inform the                       requirements set forth in sections 1916
                                            responsibility provision is waived under                Secretaries’ analysis.                                and 1916A of the Social Security Act, as
                                            a State Innovation Waiver, to something                                                                       codified in 42 CFR part 447, subpart A,
                                                                                                    B. Affordability                                      while holding the state’s Medicaid
                                            that would qualify as minimum
                                            essential coverage but for the waiver).                   To meet the affordability requirement,              policies constant.
                                                                                                    health care coverage under the waiver                    As provided in 31 CFR part 33 and 45
                                            For this purpose, ‘‘comparable’’ means
                                                                                                    must be forecast to be as affordable                  CFR part 155, subpart N, the waiver
                                            that the forecast of the number of
                                                                                                    overall for state residents as coverage               application must include analysis and
                                            covered individuals is no less than the
                                                                                                    absent the waiver.                                    supporting data that establishes that the
                                            forecast of the number of covered
                                                                                                      Affordability refers to state residents’            waiver satisfies this requirement. This
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                                            individuals absent the waiver. This
                                                                                                    ability to pay for health care and may                includes information on estimated
                                            condition generally must be forecast to
                                                                                                    generally be measured by comparing                    individual out-of-pocket costs by
                                              1 ‘‘Application, Review, and Reporting Process for
                                                                                                    residents’ net out-of-pocket spending for             income, health status, and age groups,
                                            Waivers for State Innovation Final Rule.’’ February
                                                                                                    health coverage and services to their                 absent the waiver and with the waiver.
                                            27, 2012. Available at: http://www.gpo.gov/fdsys/       incomes. Out-of-pocket expenses                       The expected changes in premium
                                            pkg/FR-2012-02-27/pdf/2012-4395.pdf.                    include both premium contributions (or                contributions and other out-of-pocket


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                                                         Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations                                         78133

                                            costs and the combined impact of                        the state’s Medicaid and/or CHIP                         The effect on Federal spending
                                            changes in these components should be                   programs.                                             includes all changes in Exchange
                                            identified separately. The application                     Assessment of whether the proposal                 financial assistance and other direct
                                            should also describe any changes in                     meets the comprehensiveness                           spending, such as changes in Medicaid
                                            employer contributions to health                        requirement also takes into account the               spending (while holding the state’s
                                            coverage or in wages expected under the                 effects across different groups of state              Medicaid policies constant) that result
                                            waiver. The application should identify                 residents, and, in particular, vulnerable             from the changes made through the
                                            any types of individuals for whom                       residents, including low-income                       State Innovation Waiver. Projected
                                            affordability of coverage would be                      individuals, elderly individuals, and                 Federal spending under the waiver
                                            reduced by the waiver.                                  those with serious health issues or who               proposal also includes all
                                               The state should also provide a                      have a greater risk of developing serious             administrative costs to the Federal
                                            description of the model used to                        health issues. A waiver would fail the                government, including any changes in
                                            produce these estimates, including data                 comprehensiveness requirement if it                   Internal Revenue Service administrative
                                            sources and quality, key assumptions,                   would reduce the comprehensiveness of                 costs, Federal Exchange administrative
                                            and parameters. The state may be                        coverage provided to these types of                   costs, or other administrative costs
                                            required to provide micro data and                      vulnerable groups, even if the waiver                 associated with the waiver.
                                            other information to inform the                         maintained comprehensiveness in the                      Waivers must not increase the Federal
                                            Secretaries’ analysis.                                  aggregate. This condition generally must              deficit over the period of the waiver
                                                                                                    be forecast to be met in each year that               (which may not exceed 5 years unless
                                            C. Comprehensiveness
                                                                                                    the waiver would be in effect.                        renewed) or in total over the ten-year
                                               To meet the comprehensiveness                           As provided in the final regulations at            budget plan submitted by the state as
                                            requirement, health care coverage under                 31 CFR part 33 and 45 CFR part 155,                   part of the State Innovation Waiver
                                            the waiver must be forecast to be at least              subpart N, the waiver application must                application. The ten-year budget plan
                                            as comprehensive overall for residents                  include analysis and supporting data                  must describe for both the period of the
                                            of the state as coverage absent the                     that establishes that the waiver satisfies            waiver and for the ten-year budget the
                                            waiver.                                                 this requirement. This includes an                    projected Federal spending net of
                                               Comprehensiveness refers to the                      explanation of how the benefits offered               Federal revenues under the State
                                            scope of benefits provided by the                       under the waiver differ from the benefits             Innovation Waiver and the projected
                                            coverage as measured by the extent to                   provided absent the waiver (if the                    Federal spending net of Federal
                                            which coverage meets the requirements                   benefits differ at all) and how the state             revenues in the absence of the waiver.
                                            for essential health benefits (EHBs) as                 determined the benefits to be as                         The ten-year budget plan should
                                            defined in section 1302(b) of the ACA,                  comprehensive.                                        assume the waiver would continue
                                            or, as appropriate, Medicaid and/or                        The state should also provide a                    permanently, but should not include
                                            CHIP standards. The impact on all state                 description of the model used to                      Federal spending or savings attributable
                                            residents is considered, regardless of the              produce these estimates, including data               to any period outside of the ten-year
                                            type of coverage they would have absent                 sources and quality, key assumptions,                 budget window. A variety of factors,
                                            the waiver.                                             and parameters. The state may be                      including the likelihood and accuracy of
                                               Comprehensiveness is evaluated by                    required to provide micro data and                    projected spending and revenue effects
                                            comparing coverage under the waiver to                  other information to inform the                       and the timing of these effects, are
                                            the state’s EHB benchmark, selected by                  Secretaries’ analysis.                                considered when evaluating the effect of
                                            the state (or if the state does not select                                                                    the waiver on the Federal deficit. A
                                                                                                    D. Deficit Neutrality                                 waiver that increases the deficit in any
                                            a benchmark, the default base-
                                            benchmark plan) pursuant to 45 CFR                        Under the deficit neutrality                        given year is less likely to meet the
                                            156.100, as well as to, in certain cases,               requirement, the projected Federal                    deficit neutrality requirement.
                                            the coverage provided under the state’s                 spending net of Federal revenues under                   The state should also provide a
                                            Medicaid and/or CHIP programs. A                        the State Innovation Waiver must be                   description of the model used to
                                            waiver cannot satisfy the                               equal to or lower than projected Federal              produce these estimates, including data
                                            comprehensiveness requirement if the                    spending net of Federal revenues in the               sources and quality, key assumptions,
                                            waiver decreases: (1) The number of                     absence of the waiver.                                and parameters. The state may be
                                            residents with coverage that is at least                  The estimated effect on Federal                     required to provide micro data and
                                            as comprehensive as the benchmark in                    revenue includes all changes in income,               other information to inform the
                                            all ten EHB categories; (2) for any of the              payroll, or excise tax revenue, as well as            Secretaries’ analysis.
                                            ten EHB categories, the number of                       any other forms of revenue (including                    As provided in 31 CFR part 33 and 45
                                            residents with coverage that is at least                user fees), that would result from the                CFR part 155, subpart N, a state must
                                            as comprehensive as the benchmark in                    proposed waiver. Estimated effects                    submit evidence to demonstrate deficit
                                            that category; or (3) the number of                     would include, for example, changes in:               neutrality, including a description of the
                                            residents whose coverage includes the                   The premium tax credit and health                     analysis used to produce its estimate of
                                            full set of services that would be                      coverage tax credit, individual shared                the impact of the waiver on the Federal
                                            covered under the state’s Medicaid and/                 responsibility payments, employer                     deficit. The description must include
                                            or CHIP programs, holding the state’s                   shared responsibility payments, the                   detailed information about the model,
                                            Medicaid and CHIP policies constant.                    excise tax on high-cost employer-                     data sources and quality, key
                                            That is, the waiver must not decrease                   sponsored plans, the credit for small                 assumptions, and parameters. The state
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                                            the number of individuals with coverage                 businesses offering health insurance,                 may be required to provide micro data
                                            that satisfies EHB requirements, the                    and changes in income and payroll                     and other information to support
                                            number of individuals with coverage of                  taxes resulting from changes in tax                   actuarial and economic analyses, so that
                                            any particular category of EHB, or the                  exclusions for employer-sponsored                     the Secretaries can independently verify
                                            number of individuals with coverage                     insurance and in deductions for medical               that the waiver meets the deficit
                                            that includes the services covered under                expenses.                                             neutrality requirement.


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                                            78134        Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations

                                            II. Impact of Other Program Changes on                  policy regarding review and approval of               adapted as appropriate to reflect state-
                                            Assessment of a Waiver Proposal                         Section 1115 demonstrations, and states               specific conditions.
                                              The assessment of whether a State                     should continue to work with CMS’                       The analysis is based on state-specific
                                            Innovation Waiver proposal satisfies the                Center for Medicaid and CHIP Services                 estimates of the current level and
                                            statutory criteria set forth in Section                 on issues relating to Section 1115                    distribution of population by the
                                            1332 takes into consideration the impact                demonstrations. A state may submit a                  relevant economic and demographic
                                            of changes to ACA provisions made                       coordinated waiver application as                     characteristics, including income and
                                            pursuant to the State Innovation Waiver.                provided in 31 CFR 33.102 and 45 CFR                  source of health coverage. It generally
                                            The assessment also considers related                   155.1302; in such a case, each waiver                 uses Federal estimates of population
                                            changes to the state’s health care system               will be evaluated independently                       growth, economic growth as published
                                            that, under state law, are contingent                   according to applicable Federal laws.                 in the Analytical Perspectives volume
                                            only on the approval of the State                                                                             released as part of the President’s
                                                                                                    III. Federal Pass-Through Funding                     Budget (https://www.whitehouse.gov/
                                            Innovation Waiver. For example, the
                                            assessment would take into account the                    The amount of Federal pass-through                  omb/budget/Analytical_Perspectives)
                                            impact of a new state-run health                        funding equals the Secretaries’ annual                and health care cost growth (https://
                                            benefits program that, under legislation                estimate of the Federal cost (including               www.cms.gov/Research-Statistics-Data-
                                            enacted by the state, would be                          outlays and forgone revenue) for                      and-Systems/Statistics-Trends-and-
                                            implemented if the State Innovation                     Exchange financial assistance provided                Reports/NationalHealthExpendData/
                                            Waiver were approved.                                   pursuant to the ACA that would be                     index.html?redirect=/
                                              The assessment does not consider the                  claimed by participants in the Exchange               NationalHealthExpendData/.) to project
                                            impact of policy changes that are                       in the state in the calendar year in the              the initial state variables through the
                                            contingent on further state action, such                absence of the waiver, but will not be                ten-year Budget plan window. However,
                                            as state legislation that is proposed but               claimed as a result of the waiver. The                in limited circumstances where it is
                                            not yet enacted. It also does not include               calculation of the amount of pass-                    expected that a state will experience
                                            the impact of changes contingent on                     through funding does not account for                  substantially different trends than the
                                            other Federal determinations, including                 any other changes in Federal spending                 nation as a whole in the absence of a
                                            approval of Federal waivers pursuant to                 or revenues as a result of the waiver,                waiver, the Secretaries may determine
                                            statutory provisions other than Section                 including Federal administrative                      that state-specific assumptions will be
                                            1332. Therefore, the assessment would                   expenses for making the payments                      used.
                                            not take into account changes to                        (note, however that changes to Federal                  Estimates of the effect of the waiver
                                            Medicaid or CHIP that require separate                  spending on administrative expenses is                assume, in accordance with standard
                                            Federal approval, such as changes in                    considered in determining whether a                   estimating conventions, that
                                            coverage or Federal Medicaid or CHIP                    waiver proposal meets the deficit                     macroeconomic variables like
                                            spending that would result from a                       neutrality requirement). The estimates                population, output, and labor supply are
                                            proposed Section 1115 demonstration,                    take into account experience in the                   not affected by the waiver. However,
                                            regardless of whether the Section 1115                  relevant state and similar states. The                estimates take into account, as
                                            demonstration proposal is submitted as                  amount is calculated annually.                        appropriate, other changes in the
                                            part of a coordinated waiver application                  The waiver application must provide                 behavior of individuals, employers, and
                                            with a State Innovation Waiver. Savings                 analysis and supporting data to inform                other relevant entities induced by the
                                            accrued under either proposed or                        the estimate of the pass-through funding              waiver, including employer decisions
                                            current Section 1115 Medicaid or CHIP                   amount. For states that do not utilize a              regarding what coverage (and other
                                            demonstrations are not factored into the                Federally-facilitated or state Partnership            compensation) they offer and individual
                                            assessment of whether a proposed State                  Exchange this includes information                    decisions regarding whether to take up
                                            Innovation Waiver meets the deficit                     about enrollment, premiums, and                       coverage. The same state-specific and
                                            neutrality requirement. The assessment                  Exchange financial assistance in the                  Federal data, assumptions, and model
                                            also does not take into account any                     state’s Exchange by age, income, and                  are used to calculate
                                            changes to the Medicaid or CHIP state                   type of policy, and other information as              comprehensiveness, affordability, and
                                            plan that are subject to Federal                        may be required by the Secretaries.                   coverage, and relevant state components
                                            approval.                                                 For further information on the                      of Federal taxes and spending under the
                                              The assessment does take into                         demographic and economic                              waiver and under current law.
                                            account changes in Medicaid and/or                      assumptions to be used in determining                   The analysis and information
                                            CHIP coverage or in Federal spending                    the pass-through amount, see Section IV               submitted by the state as part of the
                                            on Medicaid and/or CHIP that would                      below.                                                application must conform to these
                                            result directly from the proposed waiver                                                                      standards. The application must
                                                                                                    IV. Economic Assumptions and                          describe all modeling assumptions used,
                                            of provisions pursuant to Section 1332,                 Methodological Guidelines
                                            holding state Medicaid and CHIP                                                                               sources of state-specific data, and the
                                            policies constant.                                        The determination of whether a                      rationale for any deviation from Federal
                                              As the Departments receive and                        waiver meets the requirements under                   forecasts. A state may be required to
                                            review waiver proposals, we will                        Section 1332 and the calculation of the               provide to the Secretaries copies of any
                                            continue to examine the types of                        pass-through funding amount are made                  data used for their waiver analyses that
                                            changes that will be considered in                      using generally accepted actuarial and                are not publicly available so that the
                                            assessing State Innovation Waivers.                     economic analytic methods such as                     Secretaries can independently verify the
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                                              Nothing in this guidance alters a                     micro-simulation. The analysis relies on              analysis produced by the state.
                                            state’s authority to make changes to its                assumptions and methodologies that are                V. Operational Considerations
                                            Medicaid and CHIP policies consistent                   similar to those used to produce the
                                            with applicable law. This guidance does                 baseline and policy projections                       A. Federally-Facilitated Exchanges
                                            not alter the Secretary of Health and                   included in the most recent President’s                 The Centers for Medicare & Medicaid
                                            Human Services’ authority or CMS’                       Budget (or Mid-Session Review), but                   Services (CMS) operates the Federally-


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                                                         Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations                                              78135

                                            facilitated Exchange (FFE) platform.                    subpart N require that such costs be                    Dated: December 8, 2015.
                                            Certain changes that affect FFE                         included in the 10-year budget plan                   Andrew M. Slavitt,
                                            processes may make a waiver proposal                    submitted by the state.                               Acting Administrator, Centers for Medicare
                                            not feasible to implement at this time.                                                                       & Medicaid Services.
                                            Until further guidance is issued, the                   VI. Public Input on Waiver Proposals                    Dated: December 11, 2015.
                                            Federal platform cannot accommodate                        Consistent with the statutory                      Sylvia M. Burwell,
                                            different rules for different states. For                                                                     Secretary, Department of Health and Human
                                                                                                    provisions of Section 1332, regulations
                                            example, waivers that would require                                                                           Services.
                                                                                                    at 31 CFR 33.112 and 45 CFR 155.1312
                                            changes to the calculation of Exchange                                                                          Approved: December 10, 2015.
                                            financial assistance, non-standard                      require states to provide a public notice
                                                                                                    and comment period for a waiver                       Mark J. Mazur,
                                            enrollment period determinations,
                                            customized plan management review                       application sufficient to ensure a                    Assistant Secretary of the Treasury (Tax
                                                                                                    meaningful level of public input prior to             Policy).
                                            options, or changes to the design used
                                                                                                    submitting an application. As part of the             [FR Doc. 2015–31563 Filed 12–11–15; 4:15 pm]
                                            to display plan options are generally not
                                            feasible at this time due to operational                public notice and comment period, a                   BILLING CODE 4150–28–P

                                            limitations. In addition, the Federal                   state with one or more Federally-
                                            platform cannot accommodate changes                     recognized tribes must conduct a
                                            to its plan management templates in the                 separate process for meaningful                       ENVIRONMENTAL PROTECTION
                                            near term. States contemplating a                       consultation with such tribes. Because                AGENCY
                                            waiver that requires such changes may                   State Innovation Waiver applications
                                            consider establishing their own platform                may vary significantly in their                       40 CFR Part 52
                                            administered by the state.                              complexity and breadth, the regulations
                                               As noted in Section I.D. of this                     provide states with flexibility in                    [EPA–R01–OAR–2012–0950; A–1–FRL–
                                            guidance, costs associated with changes                 determining the length of the comment                 9940–15–Region 1]
                                            to Federal administrative processes are                 period required to allow for meaningful
                                            taken into account in determining                                                                             Air Plan Approval; NH; Infrastructure
                                                                                                    and robust public engagement. The                     State Implementation Plan
                                            whether a waiver application satisfies
                                                                                                    comment period must be sufficient to                  Requirements for Ozone, Lead, and
                                            the deficit neutrality requirement.
                                            Regulations at 31 CFR part 33 and 45                    ensure a meaningful level of public                   Nitrogen Dioxide
                                            CFR part 155, subpart N require that                    input and in no case can be less than 30
                                                                                                    days.                                                 AGENCY:  Environmental Protection
                                            such costs be included in the 10-year                                                                         Agency (EPA).
                                            budget plan submitted by the state.                        Consistent with HHS regulations,
                                                                                                                                                          ACTION: Final rule.
                                            B. Internal Revenue Service                             waiver applications must be posted
                                                                                                    online in a manner that meets national                SUMMARY:    The Environmental Protection
                                               Certain changes that affect Internal                 standards to assure access to individuals
                                            Revenue Service (IRS) administrative                                                                          Agency (EPA) is approving elements of
                                                                                                    with disabilities. Such standards are                 State Implementation Plan (SIP)
                                            processes may make a waiver proposal                    issued by the Architectural and
                                            not feasible to implement. At this time,                                                                      submissions from New Hampshire
                                                                                                    Transportation Barriers Compliance                    regarding the infrastructure
                                            the IRS is not generally able to
                                                                                                    Board, and are referred to as ‘‘section               requirements of the Clean Air Act (CAA
                                            administer different sets of rules in
                                            different states. As a result, while a state            508’’ standards. Alternatively, the                   or Act) for the 2008 lead, 2008 ozone,
                                            may propose to entirely waive the                       World Wide Web Consortium’s Web                       and 2010 nitrogen dioxide National
                                            application of one or more of the tax                   Content Accessibility Guidelines                      Ambient Air Quality Standards
                                            provisions listed in Section 1332 to                    (WCAG) 2.0 Level AA standards would                   (NAAQS). EPA is also converting
                                            taxpayers in the state, it is generally not             also be considered as acceptable                      conditional approvals for several
                                            feasible to design a waiver that would                  national standard for Web site                        infrastructure requirements for the 1997
                                            require the IRS to administer an                        accessibility. For more information, see              and 2006 fine particle (PM2.5) NAAQS to
                                            alteration to these provisions for                      the WCAG Web site at http://                          full approval under the CAA.
                                            taxpayers in the state. For example, it is              www.w3.org/TR/WCAG20/.                                Furthermore, we are updating the
                                            generally not feasible to have the IRS                                                                        classification for one of New
                                                                                                       Section 1332 and its implementing                  Hampshire’s air quality control regions
                                            administer a different set of eligibility               regulations also require the Federal
                                            rules for the premium tax credit for                                                                          for ozone based on recent air quality
                                                                                                    Government to provide a public notice                 monitoring data collected by the state,
                                            residents of a particular state. States                 and comment period, once the
                                            contemplating a waiver proposal that                                                                          and are granting the state’s request for
                                                                                                    Secretaries receive an application. The               an exemption from the infrastructure
                                            includes a modified version of a Federal
                                                                                                    period must be sufficient to ensure a                 SIP contingency plan obligation for
                                            tax provision may consider waiving the
                                            provision entirely and relying on a tax                 meaningful level of public input and                  ozone. Last, we are conditionally
                                            program administered by the state.                      must not impose requirements that are                 approving certain elements of New
                                               In addition, a waiver proposal that                  in addition to, or duplicative of,                    Hampshire’s submittal relating to
                                            completely waives one or more tax                       requirements imposed under the                        prevention of significant deterioration
                                            provisions in a state may create                        Administrative Procedures Act, or                     requirements.
                                            administrative costs for the IRS. As                    requirements that are unreasonable or                   The infrastructure requirements are
                                            noted in Section I.D. above, costs                      unnecessarily burdensome with respect                 designed to ensure that the structural
tkelley on DSK3SPTVN1PROD with RULES




                                            associated with changes to Federal                      to state compliance. As with the                      components of each state’s air quality
                                            administrative processes are taken into                 comment period described above, the                   management program are adequate to
                                            account in determining whether a                        length of the comment period should                   meet the state’s responsibilities under
                                            waiver application satisfies the deficit                reflect the complexity of the proposal                the CAA.
                                            neutrality requirement. Regulations at                  and in no case can be less than 30 days.              DATES: This rule is effective on January
                                            31 CFR part 33 and 45 CFR part 155,                                                                           15, 2016.


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Document Created: 2015-12-16 01:01:35
Document Modified: 2015-12-16 01:01:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionGuidance.
ContactCenters for Medicare & Medicaid Services: Tricia Beckmann, 301-492-4328, or Robert Yates, 301-492-5151.
FR Citation80 FR 78131 
CFR Citation31 CFR 33
45 CFR 155

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