Catastrophic Health Emergency Fund, 45867-45872 [2023-14849]
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Federal Register / Vol. 88, No. 136 / Tuesday, July 18, 2023 / Proposed Rules
mortgages, respectively. A mortgagee or
lender approved under this paragraph is
not required to meet a net worth
requirement. A lender or mortgagee
shall maintain fidelity bond coverage
and errors and omissions insurance
acceptable to the Secretary and in an
amount required by the Secretary, or
alternative insurance coverage approved
by the Secretary, that assures the
faithful performance of the
responsibilities of the mortgagee. There
are no additional requirements beyond
the general approval requirements in
§ 202.5 or as provided under paragraph
(c) of this section.
(b) Government-Sponsored
Enterprises. The Government-Sponsored
Enterprises are the Federal Home Loan
Banks, Federal Home Loan Mortgage
Corporation, and Federal National
Mortgage Association. A GovernmentSponsored Enterprise may be an
approved lender or mortgagee. A lender
or mortgagee approved under this
paragraph may purchase, service, or sell
Title I loans and insured mortgages,
respectively. A mortgagee or lender
approved under this paragraph is not
required to meet a net worth
requirement. There are no additional
requirements beyond the general
approval requirements in § 202.5.
*
*
*
*
*
(d) Audit requirements. The insuring
of loans and mortgages under the Act
constitutes ‘‘Federal financial
assistance’’ (as defined in 2 CFR 200.1)
for purposes of audit requirements set
out in 2 CFR part 200, subpart F. NonFederal entities (as defined in 2 CFR
200.1) that receive insurance as lenders
and mortgagees shall conduct audits in
accordance with 2 CFR part 200, subpart
F.
Julia R. Gordon,
Assistant Secretary for Housing—Federal
Housing Commissioner.
[FR Doc. 2023–15033 Filed 7–17–23; 8:45 am]
BILLING CODE 4210–67–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
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42 CFR Part 136
RIN 0917–AA10
Catastrophic Health Emergency Fund
Indian Health Service, HHS.
Proposed rule.
AGENCY:
ACTION:
The Indian Health Service
(IHS or Service) administers the
Catastrophic Health Emergency Fund
SUMMARY:
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(CHEF) pursuant to section 202 of the
Indian Health Care Improvement Act
(IHCIA). The purpose of the CHEF is to
meet the extraordinary medical costs
associated with the treatment of victims
of disasters or catastrophic illnesses
who are within the responsibility of the
Service. This notice proposes
regulations governing the
administration of the CHEF.
DATES: Send comments on or before
September 18, 2023.
ADDRESSES: You may submit comments
by the following method:
Electronically: Go to the Federal
eRulemaking Portal: https://
www.regulations.gov. In the Search box,
enter the Regulation Identifier Number
(RIN) (presented above in the document
headings). For best results, do not copy
and paste the number; instead, type the
RIN into the Search box using hyphens.
Then, click on the Search button. On the
resulting page, in the panel on the left
side of the screen, under the Document
Type heading, check the Proposed Rule
box to locate this document. You may
submit a comment by clicking on
‘‘Comment.’’
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered by the IHS. All comments
received are a part of the public record
and will generally be posted for public
viewing on www.regulations.gov
without change. All submissions are
voluntary, and such voluntary
submission of personal identifying
information (e.g., name, address, etc.),
confidential business information, or
otherwise sensitive information
constitutes permission for IHS to make
the information publicly accessible. The
IHS will accept anonymous comments
(enter ‘‘N/A’’ in the required fields if
you wish to remain anonymous).
FOR FURTHER INFORMATION CONTACT: For
technical questions concerning this rule
contact: Carl Mitchell, Director, Division
of Regulatory and Policy Coordination
(DRPC), Office of Management Services
(OMS), Indian Health Service, 301–443–
6384, carl.mitchell@ihs.gov; or CAPT
John Rael, Director, Office of Resource
Access and Partnerships (ORAP), Indian
Health Service, 301–443–0969,
john.rael@ihs.gov.
SUPPLEMENTARY INFORMATION: The CHEF
was established by section 202 of the
IHCIA, Public Law 94–437 (25 U.S.C.
1621a). The Patient Protection and
Affordable Care Act, Public Law 111–
148 as amended by the Health Care and
Education Reconciliation Act of 2010,
Public Law 111–152 (collectively, the
Affordable Care Act or ‘‘the ACA’’),
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reauthorized the IHCIA and amended
the CHEF, directing the Secretary to
promulgate regulations governing the
administration of the CHEF.
I. Background
The purpose of the CHEF is to meet
the extraordinary medical costs
associated with the treatment of victims
of disasters or catastrophic illnesses
who are within the responsibility of the
Service. The IHS administers the CHEF
to reimburse certain IHS and Tribal
purchased/referred care (PRC) costs that
exceed the cost threshold. Although the
CHEF was first established in 1988, a
similar fund was authorized by Public
Law 99–591, a Joint Resolution
continuing appropriations for fiscal year
(FY) 1987. The IHS developed operating
guidelines for the management of the
CHEF in August of 1987, which were
approved by the Office of Management
and Budget (OMB). Those guidelines
were developed with input from Tribal
Organizations and the IHS personnel
who work with the daily processing and
management of Contract Health Services
(CHS), now known as the Purchased/
Referred Care (PRC) Program. Congress
passed the Indian Health Care
Improvement Reauthorization and
Extension Act of 2009, S. 1790, 111th
Cong. (2010) (IHCIREA), as section
10221(a) of the Patient Protection and
Affordable Care Act, Public Law 111–
148. Through IHCIREA, Congress
permanently reauthorized and amended
the IHCIA, Public Law 94–437. Section
202 of the IHCIA (25 U.S.C. 1621a)
establishes the CHEF and directs the
IHS to promulgate regulations for its
administration. The operating
guidelines and twenty-eight (28) years
of experience (FYs 1987–2015)
contributed to the design of the
proposed rule published January 26,
2016, (81 FR 4239). Following
additional consultation and additional
years of experience, the IHS is issuing
this new notice of proposed rulemaking
(NPRM). This NPRM supersedes and
replaces the proposed rule published
January 26, 2016, (81 FR 4239); as such,
the 2016 NPRM is hereby rescinded.
II. Provisions of This Proposed
Regulation
This regulation proposes to (1)
establish definitions governing the
CHEF, including definitions of disasters
and catastrophic illnesses; (2) establish
that a Service Unit shall not be eligible
for reimbursement for the cost of
treatment from the CHEF until its cost
of treating any victim of such
catastrophic illness or disaster has
reached a certain threshold cost; (3)
establish a procedure for reimbursement
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of the portion of the costs for authorized
services that exceed such threshold
costs; (4) establish a procedure for
payment from the CHEF for cases in
which the exigencies of the medical
circumstances warrant treatment prior
to the authorization of such treatment;
and, (5) establish a procedure that will
ensure no payment will be made from
the CHEF to a Service Unit to the extent
the provider of services is eligible to
receive payment for the treatment from
any other Federal, state, local, or private
source of reimbursement for which the
patient is eligible.
No part of the CHEF, or its
administration, shall be subject to
contract or grant under any law,
including the Indian Self-Determination
and Education Assistance Act
(ISDEAA), Public Law 93–638 (25
U.S.C. 5301 et seq.) and may not be
allocated, apportioned, or delegated to a
Service Unit, Area Office, or any other
IHS organizational unit. Accordingly,
the IHS Division of Contract Care within
ORAP, IHS, shall remain responsible for
administration of the CHEF.
The proposed regulation also
incorporates provisions on severability.
Congress has specifically directed the
promulgation of these rules for the
administration of the CHEF, which is
administered by the Secretary,
Department of Health and Human
Services (HHS) (‘‘the Secretary’’) acting
through the Headquarters of the Indian
Health Service (IHS) (‘‘the Service’’).
The sole purpose of the CHEF is
meeting extraordinary medical costs
associated with treatment of victims of
disasters or catastrophic illnesses who
are within the responsibility of the
Service. In the event that any portion of
the proposed regulation is declared
invalid, the Secretary, acting through
the IHS, will continue to be responsible
for the administration of the CHEF. The
IHS anticipates that the remainder of the
regulation could function sensibly and
continue to govern the administration of
the CHEF. For these reasons, if any
portion of the proposed regulation is
declared invalid, the IHS intends that
the remaining provisions be severable.
A. Definitions
The IHS proposes establishing the
following definitions for governing the
CHEF, including definitions of disasters
and catastrophic illnesses:
1. Alternate Resources—health care
resources other than those of the IHS.
Such resources include health care
providers and institutions and health
care programs for the payment of health
services including but not limited to
programs under titles XVIII or XIX of
the Social Security Act (i.e., Medicare,
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Medicaid), state or local health care
programs, and private insurance.
2. Catastrophic Health Emergency
Fund (CHEF)—the fund established by
Congress to reimburse extraordinary
medical expenses incurred for
catastrophic illnesses and disasters paid
by a PRC program of the IHS, whether
such program is carried out by the IHS
or an Indian Tribe or Tribal
Organization under the ISDEAA.
3. Catastrophic Illness—a medical
condition that is costly by virtue of the
intensity and/or duration of its
treatment. Examples of conditions that
frequently require multiple hospital
stays and extensive treatment are
cancer, burns, premature births, cardiac
disease, end-stage renal disease, strokes,
trauma-related cases such as automobile
accidents and gunshot wounds, and
certain mental disorders. The CHEF is
intended to insulate the IHS and Tribal
PRC operations from financial
disruption caused by the intensity of
expenses incurred as a result of high
cost illnesses and/or disasters.
4. Disasters—situations that pose a
significant level of threat to life or
health or cause loss of life or health
stemming from events such as
tornadoes, earthquakes, floods,
catastrophic accidents, epidemics, fires,
and explosions. The CHEF is intended
to insulate the IHS and Tribal PRC
operations from financial disruption
caused by the intensity of expenses
incurred as a result of high cost illnesses
and/or disasters.
5. Episode of Care—the period of
consecutive days for a discrete health
condition during which reasonable and
necessary medical services related to the
condition occur.
6. Purchased/Referred Care (PRC)—
any health service that is—
(a) delivered based on a referral by, or
at the expense of, an Indian health
program; and
(b) provided by a public or private
medical provider or hospital that is not
a provider or hospital of the IHS health
program.
7. Service Unit—an administrative
entity of the Service or a Tribal health
program through which services are
provided, directly or by contract, to
eligible Indians within a defined
geographic area.
8. Threshold Cost—the annual
designated amount above which
incurred medical costs will be
considered for the CHEF reimbursement
after a review of the authorized
expenses and diagnosis.
B. Threshold Cost
The IHCIA section 202 provides that
a Service Unit shall not be eligible for
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reimbursement from the CHEF until its
cost of treating any victim of a
catastrophic illness or event has reached
a certain threshold cost. The Secretary
is directed to establish the initial CHEF
threshold at—
(1) the FY 2000 level of $19,000; and
(2) for any subsequent year, the
threshold will not be less than the
threshold cost of the previous year
increased by the percentage increase in
the medical care expenditure category of
the Consumer Price Index (CPI) for all
urban consumers (United States city
average) for the 12-month period ending
with December of the previous year.
The IHS intends to set the initial
threshold governed by this rule at
$19,000 for FY 2023. In reaching this
determination, the IHS adopted the
recommendation of the IHS Director’s
Workgroup on Improving PRC
(Workgroup). The Workgroup,
composed of Tribal leaders and Tribal
and Federal representatives, voted 18–2
to recommend $19,000 as the initial
threshold. For this recommendation, the
Workgroup considered several factors,
including (1) Tribal concerns regarding
the lower threshold and the potential to
exhaust the CHEF earlier in the fiscal
year leaving PRC programs without the
ability to recover costs for treating
victims of catastrophic illnesses or
disasters; and, (2) Tribal concerns about
setting the threshold at the FY 2000
level and then applying the CPI–U
Medical for each year since FY 2000,
which would have resulted in a $30,000
plus threshold requirement by FY 2013.
At this higher level, PRC programs with
limited budgets would be unable to
access the CHEF to seek recovery for
extraordinary medical costs.
Accordingly, the IHS intends to set the
initial threshold at $19,000 for FY 2023,
with increases in subsequent years
based on the annual CPI–U Medical
factor. The IHS will publish the revised
threshold costs yearly in the Federal
Register.
C. Compliance With PRC Regulations
The IHS proposes to follow PRC
regulations 42 Code of Federal
Regulations (CFR) part 136 for payment
from the CHEF. For example, payment
or reimbursement from the CHEF may
be made for the costs of treating persons
eligible for PRC in accordance with 42
CFR 136.23 and authorized for PRC in
accordance with 42 CFR 136.24. In cases
where the exigencies of the medical
circumstances warrant treatment prior
to the authorization of such treatment
by the Service Unit, authorization must
be obtained in accordance with 42 CFR
136.24(c). For example, claims for
reimbursement of services provided that
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do not meet the 72 hour emergency
notification requirements found at 42
CFR 136.24(c) will be denied. The
applicable Area PRC program shall
review the CHEF requests for CHEF
reimbursement to ensure consistency
with PRC regulations. The IHS seeks
comment on whether payments by PRC
programs to patients, or other
individuals/entities that are not PRC
providers, should be included as
eligible for CHEF reimbursement under
these regulations and if so, under what
circumstances.
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D. Alternate Resources
In accordance with section 202(d)(5)
of the IHCIA [25 U.S.C. 1621a (d)(5)],
alternate resources must be exhausted
before reimbursement is made from the
CHEF. No reimbursement shall be made
from the CHEF to any Service Unit to
the extent that the provider of treatment
is eligible to receive payment for the
treatment from any other Federal, state,
local, or private source of
reimbursement for which the patient is
eligible. Medical expenses incurred for
catastrophic illnesses and events will
not be considered eligible for
reimbursement if they are payable by
alternate resources, as determined by
the IHS. The IHS is the payor of last
resort and, if the provider of services is
eligible to receive payment from other
resources, the medical expenses are
only payable by PRC and reimbursable
by the CHEF to the extent the IHS
would not consider the other resources
to be ‘‘alternate resources’’ under the
applicable regulations and the IHS
policy. Expenses paid by alternate
resources are not eligible for payment by
PRC or reimbursement by the CHEF.
However, if the patient is found to have
been eligible for alternate resources at
the time of service, the Service Unit
shall promptly return all funds
reimbursed from the CHEF to the
Headquarters CHEF account.
E. Reimbursement Procedure
A patient must be eligible for PRC
services and the Service Unit must
adhere to regulations (42 CFR 136.23(a)
through (f)) governing the PRC program
to be reimbursed for catastrophic cases
from the CHEF. Once the catastrophic
case meets the threshold requirement
and the Service Unit has authorized
PRC resources exceeding the threshold
requirement, the Service Unit may
qualify for reimbursement from the
CHEF. Reimbursable costs are those
costs that exceed the threshold
requirement after payment has been
made by all alternate resources such as
Federal, state, local, private insurance,
and other resources. Reimbursement of
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PRC expenditures incurred by the
Service Unit and approved by the PRC
program at Headquarters will be
processed through the respective IHS
Area Office. Reimbursement from the
CHEF shall be subject to availability of
funds.
F. Recovery of the CHEF Reimbursement
Funds
In the event a PRC program has been
reimbursed from the CHEF for an
episode of care and that same episode
of care becomes eligible for and is paid
by any Federal, state, local, or private
source (including third party insurance),
the PRC program shall return all the
CHEF funds received for that episode of
care to the CHEF at the IHS
Headquarters. These recovered CHEF
funds will be used to reimburse other
approved CHEF requests.
III. Collection of Information
Requirements
Prior to implementing the rule, the
IHS may be required to develop new
information collection forms that would
require approval from the Office of
Management and Budget in accordance
with the Paperwork Reduction Act of
1995, 44 United States Code 3507(d).
IV. Response to Comments
Because of the large number of public
comments normally received on Federal
Register documents, we are not able to
acknowledge or respond to them
individually. We will consider all
comments received by the date and time
specified in the DATES section of the
preamble of this proposed rule, and,
when we proceed with a final rule, we
will respond to the comments in the
preamble to that rule.
V. Regulatory Impact Analysis
We have examined the impacts of this
rule as required by Executive Order
(E.O.) 12866 on Regulatory Planning
and Review (September 30, 1993);
section 603 of the Regulatory Flexibility
Act (RFA), Public Law 96–354 [5 U.S.C.
601–612], as amended by subtitle D of
the Small Business Regulatory Fairness
Act of 1996, Public Law 104–121; the
Unfunded Mandates Reform Act
(UMRA) of 1995, Public Law 104–4;
E.O. 13132 on Federalism (August 4,
1999); and E.O. 13175 Consultation and
Coordination with Indian Tribal
Governments.
A. Executive Order 12866
Executive Order 12866, as amended
by Executive Order 14094, directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
if regulation is necessary, to select
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regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects, distributive impacts,
and equity). Section 3(f) of Executive
Order 12866, as amended, defines a
‘‘significant regulatory action’’ as one
that is likely to result in a rule that may:
(1) have an annual effect on the
economy of $200 million or more in any
one year (adjusted every three years by
the Administrator of OIRA for changes
in gross domestic product), or adversely
affect in a material way a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, territorial, or tribal
governments or communities (2) create
a serious inconsistency or otherwise
interfering with an action taken or
planned by another agency; (3)
materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) raise legal or
policy issues for which centralized
review would meaningfully further the
President’s priorities or the principles
set forth in Executive Order 12866.
While the Office of Information and
Regulatory Affairs has determined that
this is a significant regulatory action as
defined by Executive Order 12866, they
have also determined that it does not
confer significant costs and does not
warrant a regulatory impact analysis.
B. Regulatory Flexibility Act (RFA)
RFA requires analysis of regulatory
options that minimize any significant
economic impact of a rule on small
entities, unless it is certified that the
proposed rule is not expected to have a
significant economic impact on small
entities. This rule is not expected to
have a significant economic impact on
small entities, because the rule only
governs reimbursements of certain
expenditures made by Service Units
under Purchased/Referred Care (PRC)
authorities. Many PRC programs are
operated by the Federal Government,
through the Indian Health Service (IHS).
The remaining PRC programs are
operated by Tribes and tribal
organizations under Indian SelfDetermination and Education
Assistance Act (ISDEAA) agreements
with the IHS. Presently, there are 62
federally operated PRC programs and
188 tribally operated PRC programs.
Some of the entities operating PRC
programs may be small entities, but the
rule does not directly impact a
substantial number of small entities and
the rule is not expected to reduce their
revenues or raise their costs.
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C. Unfunded Mandates Reform Act
(UMRA)
Section 202 of UMRA (Pub. L. 104–4)
requires an assessment of anticipated
costs and benefits before proposing any
rule that may result in expenditure by
state, local, and Tribal Governments, in
aggregate, or by the private sector of
$100 million or more (adjusted annually
for inflation) in any one year. The
current threshold after adjustment for
inflation is $165 million, using the most
current (2021) Implicit Price Deflator for
the Gross Domestic Product. We have
determined that this rule is consistent
with the principles set forth in the
executive orders and in these statutes
and find that this rule will not have an
effect on the economy that exceeds the
UMRA threshold in any one year. The
IHS FY 2022 annual appropriation for
the CHEF was $53 million. This final
rule is not anticipated to have an effect
on state, local, or Tribal Governments in
the aggregate, or by the private sector of
$165 million or more. This rule does not
impose any new costs on small entities,
and it will not result in a significant
economic impact on a substantial
number of small entities. Thus, no
further analysis is required.
D. Federalism
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E.O. 13132 establishes certain
requirements that an agency must meet
when it promulgates a proposed rule
(and subsequent final rule) that imposes
substantial direct requirement costs on
State and local Governments, preempts
state law, or otherwise has federalism
implications. We have reviewed this
proposed rule under the threshold
criteria of E.O. 13132 and have
determined that this proposed rule
would not have substantial direct effect
on the states, on the relationship
between the Federal Government and
the states, or on the distribution of
power and governmental
responsibilities among the various
levels of the Government(s). As this rule
has no Federal implications, a
federalism summary impact statement is
not required.
the daily processing and management of
PRC resources. Specifically, the IHS
Director’s Workgroup on Improving PRC
met and discussed the CHEF guidelines
on October 12–13, 2010, and June 1–2,
2011, in Denver, Colorado, and on
January 11–12, 2012, in Albuquerque,
New Mexico. In addition, the IHS issued
‘‘Dear Tribal Leader’’ letters related to
the development of these regulations on
February 9, 2011, and May 6, 2013.
The IHS has sought additional Tribal
input throughout the development of
this new proposed rule. Specifically,
Tribal consultation sessions were held
in the fall of 2016. At meetings of the
Workgroup in 2015 and 2018, the
Workgroup recommended establishing a
$19,000 CHEF threshold. Moreover, in
November 2020, the Workgroup
recommended that the IHS promulgate
new regulations based on Workgroup
input. Based on the recommendation of
the Workgroup, the threshold amount of
$19,000 is proposed to be established
for the current fiscal year. This
proposed rule serves as additional
Tribal consultation with affected Tribes
by giving interested Tribes the
opportunity to comment on the
regulation before it is finalized. The IHS
intends to consult as fully as possible
with Tribes prior to the publication of
a final rule.
List of Subjects in 42 CFR Part 136
Alaska Natives, Purchased/Referred
Care (formerly Contract Health
Services), Health, Health facilities,
Indians.
For the reasons set out in the
preamble, the IHS proposes to amend 42
CFR chapter I as set forth below:
PART 136—INDIAN HEALTH
1. The authority citation for part 136
is revised to read as follows:
■
Authority: 42 U.S.C. 2001 and 2003; 25
U.S.C. 13; and 25 U.S.C. 1621a.
2. Add new subpart L consisting of
§§ 136.501–136.510 to read as follows:
■
E. E.O. 13175 Consultation and
Coordination With Indian Tribal
Governments
Subpart L—Indian Catastrophic Health
Emergency Fund
This rule has Tribal implications
under E.O. 13175, Consultation and
Coordination with Indian Tribal
Governments, because it would have a
substantial direct and positive effect on
one or more Indian Tribes.
The first proposed CHEF rule,
published in January 2016 (81 FR 4239),
was developed with input from Tribes
and the IHS personnel who work with
Sec.
136.501
136.502
136.503
136.504
136.505
136.506
136.507
136.508
136.509
136.510
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Definitions.
Purpose of the regulations.
Threshold cost.
Reimbursement procedure.
Reimbursable services.
Alternate resources.
Program integrity.
Recovery of reimbursement funds.
Reconsideration and appeals.
Severability.
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§ 136.501
Definitions.
Alternate Resources means health
care resources other than those of the
Indian Health Service. Such resources
include health care providers and
institutions and health care programs
for the payment of health services
including but not limited to programs
under titles XVIII or XIX of the Social
Security Act (i.e., Medicare, Medicaid),
state or local health care programs, and
private insurance.
Catastrophic Health Emergency Fund
(CHEF) means the fund established by
Congress to reimburse extraordinary
medical expenses incurred for
catastrophic illnesses and disasters paid
by a PRC program of the IHS, whether
such program is carried out by the IHS
or an Indian Tribe or Tribal
Organization under the ISDEAA.
Catastrophic Illness refers to a
medical condition that is costly by
virtue of the intensity and/or duration of
its treatment. Examples of conditions
that frequently require multiple hospital
stays and extensive treatment are
cancer, burns, premature births, cardiac
disease, end-stage renal disease, strokes,
trauma-related cases such as automobile
accidents, and gunshot wounds, and
some mental disorders. The CHEF is
intended to insulate the IHS and Tribal
PRC operations from financial
disruption caused by the intensity of
expenses incurred as a result of high
cost illnesses and/or disasters.
Disaster means a situation that poses
a significant level of threat to life or
health or causes loss of life or health
stemming from events such as
tornadoes, earthquakes, floods,
catastrophic accidents, epidemics, fires,
and explosions. The CHEF is intended
to insulate the IHS and Tribal PRC
operations from financial disruption
caused by the intensity of expenses
incurred as a result of high cost illnesses
and/or disasters.
Episode of Care means the period of
consecutive days for a discrete health
condition during which reasonable and
necessary medical services related to the
condition occur.
Purchased/Referred Care means any
health service that is—
(1) delivered based on a referral by, or
at the expense of, an Indian health
program; and
(2) provided by a public or private
medical provider or hospital which is
not a provider or hospital of the Indian
health program.
Service Unit means an administrative
entity of the Service or a Tribal Health
Program through which services are
provided, directly or by contract, to
eligible Indians within a defined
geographic area.
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Threshold Cost means the annual
designated amount above which
incurred medical costs will be
considered for the CHEF reimbursement
after a review of the authorized
expenses and diagnosis.
§ 136.502
Purpose of the regulations.
The Indian Catastrophic Health
Emergency Fund (hereafter referred to
as ‘‘CHEF’’) is authorized by section 202
of the Indian Health Care Improvement
Act (IHCIA) [25 U.S.C. 1621a]. The
CHEF is administered by the Secretary,
Department of Health and Human
Services (HHS) (‘‘the Secretary’’) acting
through the Headquarters of the Indian
Health Service (IHS) (‘‘the Service’’),
solely for the purpose of meeting
extraordinary medical costs associated
with treatment of victims of disasters or
catastrophic illnesses who are within
the responsibility of the Service.
These regulations:
(a) establish definitions of terms
governing the CHEF, including
definitions of disasters and catastrophic
illnesses for which the cost of treatment
provided under contract would qualify
for payment from the CHEF;
(b) establish a threshold level for
reimbursement for the cost of treatment;
(c) establish procedures for
reimbursement of the portion of the
costs incurred by Service Units that
exceeds such threshold costs, including
procedures for when the exigencies of
the medical circumstances warrant
treatment prior to the authorization of
such treatment by the Service; and
(d) establish procedures for
reimbursements pending the outcome or
payment by alternate resources.
ddrumheller on DSK120RN23PROD with PROPOSALS1
§ 136.503
Threshold cost.
A Service Unit shall not be eligible for
reimbursement from the CHEF until its
cost of treating any victim of a
catastrophic illness or disaster for an
episode of care has reached a certain
threshold cost.
(a) The threshold cost shall be
established at the level of $19,000.
(b) The threshold cost in subsequent
years shall be calculated from the
threshold cost of the previous year,
increased by the percentage increase in
the medical care expenditure category of
the Consumer Price Index for all urban
consumers (United States city average)
for the 12-month period ending with
December of the previous year. The
revised threshold costs shall be
published yearly in the Federal
Register.
§ 136.504
Reimbursement procedure.
Service Units whose scope of work
and funding include the purchase of
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medical services from private or public
vendors under PRC are eligible to
participate. The CHEF payments shall
be based only on valid PRC
expenditures, including expenditures
for exigent medical circumstances
without prior PRC authorization.
Reimbursement from the CHEF will not
be made if applicable PRC requirements
are not followed.
(a) Claim Submission: Requests for
reimbursement from the CHEF must be
submitted to the appropriate IHS Area
Office. Area PRC programs will review
requests for reimbursement to ensure
compliance with PRC requirements,
including but not limited to: patient
eligibility, medical necessity,
notification requirements for emergent
and non-emergent care, medical
priorities, allowable expenditures, and
eligibility for alternate resources.
Following this review, Area PRC
programs may provide Service Units an
opportunity to submit missing
information or to resubmit documents
that are indecipherable. Area PRC
programs will then forward all requests
to the Division of Contract Care, along
with any recommendations or
observations from the Area PRC
program regarding compliance with PRC
or other CHEF requirements. The
Division of Contract Care will
adjudicate the claim based upon an
independent review of the claim
documentation, but it may consider any
recommendations or observations from
the Area PRC program.
(b) Content of Claims: All claims
submitted for reimbursement may be
submitted electronically utilizing the
secure IHS system(s) established for this
purpose or may be submitted in paper
form but must include:
(1) A fully completed Catastrophic
Health Emergency Fund Reimbursement
Request Form.
(2) A statement of the provider’s
charges on a form that complies with
the format required for the submission
of claims under title XVIII of the Social
Security Act. For example, charges may
be printed on forms such as the Centers
for Medicare & Medicaid Services (CMS)
1500, UB–04 (formerly CMS–1450),
American Dental Association (ADA)
dental claim form, or National Council
for Prescription Drug Program (NCPDP)
universal claim forms. The forms
submitted for review must include
specific appropriate diagnostic and
procedure codes.
(3) An explanation of benefits or
statement of payment identifying how
much was paid to the provider by the
Service Unit for the Catastrophic Illness
or Disaster. Payments to the patient or
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45871
any other entity are ineligible for the
CHEF reimbursement.
(4) The Division of Contract Care may
request additional medical
documentation describing the medical
treatment or service provided, including
but not limited to discharge summaries
and/or medical progress notes. Cases
may be submitted for 50%
reimbursement of eligible expenses
pending discharge summaries. Medical
documentation must be received to
close the CHEF case.
(c) Limitation of Funds and
Reimbursement Procedure: Because of
the limitations of funds, full
reimbursement cannot be guaranteed on
all requests and will be based on the
availability of funds at the time the IHS
processes the claim. To the extent funds
are available, the CHEF funds may not
be used to cover the cost of services or
treatment for which the funds were not
approved. Unused funds, including but
not limited to, funds unused due to
overestimates, alternate resources, and
cancellations must be returned to the
CHEF.
§ 136.505
Reimbursable services.
The costs of catastrophic illnesses and
disasters for distinct episodes of care are
eligible for reimbursement from the
CHEF in accordance with the medical
priorities of the Service. Only services
that are related to a distinct episode of
care will be eligible for reimbursement.
(a) Some of the services that may
qualify for reimbursement from the fund
are:
(1) Emergency treatment.
(2) Emergent and acute inpatient
hospitalization.
(3) Ambulance services; air and
ground (including patient escort travel
costs).
(4) Attending and consultant
physician.
(5) Functionally required
reconstructive surgery.
(6) Prostheses and other related items.
(7) Reasonable rehabilitative therapy
exclusive of custodial care not to exceed
30 days after discharge.
(8) Skilled nursing care when the
patient is discharged from the acute
process to a skilled nursing facility.
(b) [Reserved]
§ 136.506
Alternate resources.
(a) Expenses paid by alternate
resources are not eligible for payment by
PRC or reimbursement by the CHEF. No
payment shall be made from the CHEF
to any Service Unit to the extent that the
provider of services is eligible to receive
payment for the treatment from any
other Federal, state, local, or private
source of reimbursement for which the
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patient is eligible. A patient shall be
considered eligible for such resources
and no payment shall be made from the
CHEF if:
(1) The patient is eligible for alternate
resources, or
(2) The patient would be eligible for
alternate resources if he or she were to
apply for them, or
(3) The patient would be eligible for
alternate resources under Federal, state,
or local law or regulation but for the
patient’s eligibility for PRC, or other
health services, from the Indian Health
Service or Indian Health Service funded
programs.
(b) The determination of whether a
resource constitutes an alternate
resource for the purpose of the CHEF
reimbursement shall be made by the
Headquarters of the Indian Health
Service, irrespective of whether the
resource was determined to be an
alternate resource at the time of PRC
payment.
§ 136.507
Program integrity.
All the CHEF records and documents
will be subject to review by the
respective Area and by Headquarters.
Internal audits and administrative
reviews may be conducted as necessary
to ensure compliance with PRC
regulations and the CHEF policies.
§ 136.508
funds.
Recovery of reimbursement
In the event a Service Unit has been
reimbursed from the CHEF for an
episode of care and that same episode
of care becomes eligible for and is paid
by any Federal, state, local, or private
source (including third party insurance)
the Service Unit shall return all the
CHEF funds received for that episode of
care to the CHEF at the IHS
Headquarters. These recovered CHEF
funds will be used to reimburse other
valid CHEF requests.
ddrumheller on DSK120RN23PROD with PROPOSALS1
§ 136.509
Reconsideration and appeals.
(a) Any Service Unit to whom
payment from the CHEF is denied will
be notified of the denial in writing
together with a statement of the reason
for the denial within 130 business days
from receipt.
(b) If a decision on the CHEF case is
not made by the CHEF Program Manager
within 180 calendar days from receipt,
the Service Unit that submitted the
claim may choose to appeal it as a
deemed denial.
(c) In order to seek review of a denial
decision or deemed denial, the Service
Unit must follow the procedures set
forth in paragraphs (c)(1) and (c)(2) of
this section.
(1) Within 40 business days from the
receipt of the denial provided in
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paragraph (a) of this section, the Service
Unit may submit a request in writing for
reconsideration of the original denial to
the Division of Contract Care. The
request for reconsideration must
include, as applicable, corrections to the
original claim submission necessary to
overcome the denial; or a statement and
supporting documentation establishing
that the original denial was in error. If
no additional information is submitted
the original denial will stand. The
Service Unit may also request a
telephone conference with the Division
of Contract Care, to further explain the
materials submitted, which shall be
scheduled within 40 business days from
receipt of the request for review. A
decision by the Division of Contract
Care shall be made within 130 business
days of the request for review. The
Division of Contract Care Director, or
designee, shall review the application
de novo with no deference to the
original decision maker or to the
applicant.
(2) If the original decision is affirmed
on reconsideration, the Service Unit
will be notified in writing and advised
that an appeal may be taken to the
Director, Indian Health Service, within
40 business days of receipt of the denial.
The appeal shall be in writing and shall
set forth the grounds supporting the
appeal. The Service Unit may also
request a telephone conference through
the Division of Contract Care, which
shall be scheduled with the Director or
a representative designated by the
Director, to further explain the grounds
supporting the appeal. A decision by the
Director shall be made within 180
calendar days of the request for
reconsideration. The decision of the
Director, Indian Health Service or
designee, shall constitute the final
administrative action.
§ 136.510
Severability.
If any provision of this subpart is held
to be invalid or unenforceable by its
terms, as applied to any person or
circumstance, or stayed pending further
agency action, the provision shall be
construed to continue to give the
maximum effect to the provision
permitted by law, including as applied
to those not similarly situated or to
dissimilar circumstances. However, if
such holding is that the provision of this
subpart is invalid and unenforceable in
all circumstances, the provision shall be
severable from the remainder of this
subpart and shall not affect the
remainder thereof.
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Dated: July 10, 2023.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–14849 Filed 7–17–23; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Chapter IV
[CMS–5540–NC]
RIN 0938–AV19
Request for Information; EpisodeBased Payment Model
Centers for Medicare &
Medicaid Services (CMS), Department
of Health of Human Services (HHS).
ACTION: Request for information.
AGENCY:
This request for information
seeks input from the public regarding
the design of a future episode-based
payment model. Responses to this
request for information may be used to
inform potential future rulemaking or
other policy development.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, by
August 17, 2023.
ADDRESSES: In commenting, refer to file
code CMS–5540–NC.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–5540–NC, P.O. Box 8013,
Baltimore, MD 21244–8013.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–5540–NC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
SUMMARY:
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Agencies
[Federal Register Volume 88, Number 136 (Tuesday, July 18, 2023)]
[Proposed Rules]
[Pages 45867-45872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14849]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
42 CFR Part 136
RIN 0917-AA10
Catastrophic Health Emergency Fund
AGENCY: Indian Health Service, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Indian Health Service (IHS or Service) administers the
Catastrophic Health Emergency Fund (CHEF) pursuant to section 202 of
the Indian Health Care Improvement Act (IHCIA). The purpose of the CHEF
is to meet the extraordinary medical costs associated with the
treatment of victims of disasters or catastrophic illnesses who are
within the responsibility of the Service. This notice proposes
regulations governing the administration of the CHEF.
DATES: Send comments on or before September 18, 2023.
ADDRESSES: You may submit comments by the following method:
Electronically: Go to the Federal eRulemaking Portal: https://www.regulations.gov. In the Search box, enter the Regulation Identifier
Number (RIN) (presented above in the document headings). For best
results, do not copy and paste the number; instead, type the RIN into
the Search box using hyphens. Then, click on the Search button. On the
resulting page, in the panel on the left side of the screen, under the
Document Type heading, check the Proposed Rule box to locate this
document. You may submit a comment by clicking on ``Comment.''
Instructions: Comments sent by any other method, to any other
address or individual, or received after the end of the comment period,
may not be considered by the IHS. All comments received are a part of
the public record and will generally be posted for public viewing on
www.regulations.gov without change. All submissions are voluntary, and
such voluntary submission of personal identifying information (e.g.,
name, address, etc.), confidential business information, or otherwise
sensitive information constitutes permission for IHS to make the
information publicly accessible. The IHS will accept anonymous comments
(enter ``N/A'' in the required fields if you wish to remain anonymous).
FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this rule contact: Carl Mitchell, Director, Division of Regulatory and
Policy Coordination (DRPC), Office of Management Services (OMS), Indian
Health Service, 301-443-6384, [email protected]; or CAPT John Rael,
Director, Office of Resource Access and Partnerships (ORAP), Indian
Health Service, 301-443-0969, [email protected].
SUPPLEMENTARY INFORMATION: The CHEF was established by section 202 of
the IHCIA, Public Law 94-437 (25 U.S.C. 1621a). The Patient Protection
and Affordable Care Act, Public Law 111-148 as amended by the Health
Care and Education Reconciliation Act of 2010, Public Law 111-152
(collectively, the Affordable Care Act or ``the ACA''), reauthorized
the IHCIA and amended the CHEF, directing the Secretary to promulgate
regulations governing the administration of the CHEF.
I. Background
The purpose of the CHEF is to meet the extraordinary medical costs
associated with the treatment of victims of disasters or catastrophic
illnesses who are within the responsibility of the Service. The IHS
administers the CHEF to reimburse certain IHS and Tribal purchased/
referred care (PRC) costs that exceed the cost threshold. Although the
CHEF was first established in 1988, a similar fund was authorized by
Public Law 99-591, a Joint Resolution continuing appropriations for
fiscal year (FY) 1987. The IHS developed operating guidelines for the
management of the CHEF in August of 1987, which were approved by the
Office of Management and Budget (OMB). Those guidelines were developed
with input from Tribal Organizations and the IHS personnel who work
with the daily processing and management of Contract Health Services
(CHS), now known as the Purchased/Referred Care (PRC) Program. Congress
passed the Indian Health Care Improvement Reauthorization and Extension
Act of 2009, S. 1790, 111th Cong. (2010) (IHCIREA), as section 10221(a)
of the Patient Protection and Affordable Care Act, Public Law 111-148.
Through IHCIREA, Congress permanently reauthorized and amended the
IHCIA, Public Law 94-437. Section 202 of the IHCIA (25 U.S.C. 1621a)
establishes the CHEF and directs the IHS to promulgate regulations for
its administration. The operating guidelines and twenty-eight (28)
years of experience (FYs 1987-2015) contributed to the design of the
proposed rule published January 26, 2016, (81 FR 4239). Following
additional consultation and additional years of experience, the IHS is
issuing this new notice of proposed rulemaking (NPRM). This NPRM
supersedes and replaces the proposed rule published January 26, 2016,
(81 FR 4239); as such, the 2016 NPRM is hereby rescinded.
II. Provisions of This Proposed Regulation
This regulation proposes to (1) establish definitions governing the
CHEF, including definitions of disasters and catastrophic illnesses;
(2) establish that a Service Unit shall not be eligible for
reimbursement for the cost of treatment from the CHEF until its cost of
treating any victim of such catastrophic illness or disaster has
reached a certain threshold cost; (3) establish a procedure for
reimbursement
[[Page 45868]]
of the portion of the costs for authorized services that exceed such
threshold costs; (4) establish a procedure for payment from the CHEF
for cases in which the exigencies of the medical circumstances warrant
treatment prior to the authorization of such treatment; and, (5)
establish a procedure that will ensure no payment will be made from the
CHEF to a Service Unit to the extent the provider of services is
eligible to receive payment for the treatment from any other Federal,
state, local, or private source of reimbursement for which the patient
is eligible.
No part of the CHEF, or its administration, shall be subject to
contract or grant under any law, including the Indian Self-
Determination and Education Assistance Act (ISDEAA), Public Law 93-638
(25 U.S.C. 5301 et seq.) and may not be allocated, apportioned, or
delegated to a Service Unit, Area Office, or any other IHS
organizational unit. Accordingly, the IHS Division of Contract Care
within ORAP, IHS, shall remain responsible for administration of the
CHEF.
The proposed regulation also incorporates provisions on
severability. Congress has specifically directed the promulgation of
these rules for the administration of the CHEF, which is administered
by the Secretary, Department of Health and Human Services (HHS) (``the
Secretary'') acting through the Headquarters of the Indian Health
Service (IHS) (``the Service''). The sole purpose of the CHEF is
meeting extraordinary medical costs associated with treatment of
victims of disasters or catastrophic illnesses who are within the
responsibility of the Service. In the event that any portion of the
proposed regulation is declared invalid, the Secretary, acting through
the IHS, will continue to be responsible for the administration of the
CHEF. The IHS anticipates that the remainder of the regulation could
function sensibly and continue to govern the administration of the
CHEF. For these reasons, if any portion of the proposed regulation is
declared invalid, the IHS intends that the remaining provisions be
severable.
A. Definitions
The IHS proposes establishing the following definitions for
governing the CHEF, including definitions of disasters and catastrophic
illnesses:
1. Alternate Resources--health care resources other than those of
the IHS. Such resources include health care providers and institutions
and health care programs for the payment of health services including
but not limited to programs under titles XVIII or XIX of the Social
Security Act (i.e., Medicare, Medicaid), state or local health care
programs, and private insurance.
2. Catastrophic Health Emergency Fund (CHEF)--the fund established
by Congress to reimburse extraordinary medical expenses incurred for
catastrophic illnesses and disasters paid by a PRC program of the IHS,
whether such program is carried out by the IHS or an Indian Tribe or
Tribal Organization under the ISDEAA.
3. Catastrophic Illness--a medical condition that is costly by
virtue of the intensity and/or duration of its treatment. Examples of
conditions that frequently require multiple hospital stays and
extensive treatment are cancer, burns, premature births, cardiac
disease, end-stage renal disease, strokes, trauma-related cases such as
automobile accidents and gunshot wounds, and certain mental disorders.
The CHEF is intended to insulate the IHS and Tribal PRC operations from
financial disruption caused by the intensity of expenses incurred as a
result of high cost illnesses and/or disasters.
4. Disasters--situations that pose a significant level of threat to
life or health or cause loss of life or health stemming from events
such as tornadoes, earthquakes, floods, catastrophic accidents,
epidemics, fires, and explosions. The CHEF is intended to insulate the
IHS and Tribal PRC operations from financial disruption caused by the
intensity of expenses incurred as a result of high cost illnesses and/
or disasters.
5. Episode of Care--the period of consecutive days for a discrete
health condition during which reasonable and necessary medical services
related to the condition occur.
6. Purchased/Referred Care (PRC)--any health service that is--
(a) delivered based on a referral by, or at the expense of, an
Indian health program; and
(b) provided by a public or private medical provider or hospital
that is not a provider or hospital of the IHS health program.
7. Service Unit--an administrative entity of the Service or a
Tribal health program through which services are provided, directly or
by contract, to eligible Indians within a defined geographic area.
8. Threshold Cost--the annual designated amount above which
incurred medical costs will be considered for the CHEF reimbursement
after a review of the authorized expenses and diagnosis.
B. Threshold Cost
The IHCIA section 202 provides that a Service Unit shall not be
eligible for reimbursement from the CHEF until its cost of treating any
victim of a catastrophic illness or event has reached a certain
threshold cost. The Secretary is directed to establish the initial CHEF
threshold at--
(1) the FY 2000 level of $19,000; and
(2) for any subsequent year, the threshold will not be less than
the threshold cost of the previous year increased by the percentage
increase in the medical care expenditure category of the Consumer Price
Index (CPI) for all urban consumers (United States city average) for
the 12-month period ending with December of the previous year.
The IHS intends to set the initial threshold governed by this rule
at $19,000 for FY 2023. In reaching this determination, the IHS adopted
the recommendation of the IHS Director's Workgroup on Improving PRC
(Workgroup). The Workgroup, composed of Tribal leaders and Tribal and
Federal representatives, voted 18-2 to recommend $19,000 as the initial
threshold. For this recommendation, the Workgroup considered several
factors, including (1) Tribal concerns regarding the lower threshold
and the potential to exhaust the CHEF earlier in the fiscal year
leaving PRC programs without the ability to recover costs for treating
victims of catastrophic illnesses or disasters; and, (2) Tribal
concerns about setting the threshold at the FY 2000 level and then
applying the CPI-U Medical for each year since FY 2000, which would
have resulted in a $30,000 plus threshold requirement by FY 2013. At
this higher level, PRC programs with limited budgets would be unable to
access the CHEF to seek recovery for extraordinary medical costs.
Accordingly, the IHS intends to set the initial threshold at $19,000
for FY 2023, with increases in subsequent years based on the annual
CPI-U Medical factor. The IHS will publish the revised threshold costs
yearly in the Federal Register.
C. Compliance With PRC Regulations
The IHS proposes to follow PRC regulations 42 Code of Federal
Regulations (CFR) part 136 for payment from the CHEF. For example,
payment or reimbursement from the CHEF may be made for the costs of
treating persons eligible for PRC in accordance with 42 CFR 136.23 and
authorized for PRC in accordance with 42 CFR 136.24. In cases where the
exigencies of the medical circumstances warrant treatment prior to the
authorization of such treatment by the Service Unit, authorization must
be obtained in accordance with 42 CFR 136.24(c). For example, claims
for reimbursement of services provided that
[[Page 45869]]
do not meet the 72 hour emergency notification requirements found at 42
CFR 136.24(c) will be denied. The applicable Area PRC program shall
review the CHEF requests for CHEF reimbursement to ensure consistency
with PRC regulations. The IHS seeks comment on whether payments by PRC
programs to patients, or other individuals/entities that are not PRC
providers, should be included as eligible for CHEF reimbursement under
these regulations and if so, under what circumstances.
D. Alternate Resources
In accordance with section 202(d)(5) of the IHCIA [25 U.S.C. 1621a
(d)(5)], alternate resources must be exhausted before reimbursement is
made from the CHEF. No reimbursement shall be made from the CHEF to any
Service Unit to the extent that the provider of treatment is eligible
to receive payment for the treatment from any other Federal, state,
local, or private source of reimbursement for which the patient is
eligible. Medical expenses incurred for catastrophic illnesses and
events will not be considered eligible for reimbursement if they are
payable by alternate resources, as determined by the IHS. The IHS is
the payor of last resort and, if the provider of services is eligible
to receive payment from other resources, the medical expenses are only
payable by PRC and reimbursable by the CHEF to the extent the IHS would
not consider the other resources to be ``alternate resources'' under
the applicable regulations and the IHS policy. Expenses paid by
alternate resources are not eligible for payment by PRC or
reimbursement by the CHEF. However, if the patient is found to have
been eligible for alternate resources at the time of service, the
Service Unit shall promptly return all funds reimbursed from the CHEF
to the Headquarters CHEF account.
E. Reimbursement Procedure
A patient must be eligible for PRC services and the Service Unit
must adhere to regulations (42 CFR 136.23(a) through (f)) governing the
PRC program to be reimbursed for catastrophic cases from the CHEF. Once
the catastrophic case meets the threshold requirement and the Service
Unit has authorized PRC resources exceeding the threshold requirement,
the Service Unit may qualify for reimbursement from the CHEF.
Reimbursable costs are those costs that exceed the threshold
requirement after payment has been made by all alternate resources such
as Federal, state, local, private insurance, and other resources.
Reimbursement of PRC expenditures incurred by the Service Unit and
approved by the PRC program at Headquarters will be processed through
the respective IHS Area Office. Reimbursement from the CHEF shall be
subject to availability of funds.
F. Recovery of the CHEF Reimbursement Funds
In the event a PRC program has been reimbursed from the CHEF for an
episode of care and that same episode of care becomes eligible for and
is paid by any Federal, state, local, or private source (including
third party insurance), the PRC program shall return all the CHEF funds
received for that episode of care to the CHEF at the IHS Headquarters.
These recovered CHEF funds will be used to reimburse other approved
CHEF requests.
III. Collection of Information Requirements
Prior to implementing the rule, the IHS may be required to develop
new information collection forms that would require approval from the
Office of Management and Budget in accordance with the Paperwork
Reduction Act of 1995, 44 United States Code 3507(d).
IV. Response to Comments
Because of the large number of public comments normally received on
Federal Register documents, we are not able to acknowledge or respond
to them individually. We will consider all comments received by the
date and time specified in the DATES section of the preamble of this
proposed rule, and, when we proceed with a final rule, we will respond
to the comments in the preamble to that rule.
V. Regulatory Impact Analysis
We have examined the impacts of this rule as required by Executive
Order (E.O.) 12866 on Regulatory Planning and Review (September 30,
1993); section 603 of the Regulatory Flexibility Act (RFA), Public Law
96-354 [5 U.S.C. 601-612], as amended by subtitle D of the Small
Business Regulatory Fairness Act of 1996, Public Law 104-121; the
Unfunded Mandates Reform Act (UMRA) of 1995, Public Law 104-4; E.O.
13132 on Federalism (August 4, 1999); and E.O. 13175 Consultation and
Coordination with Indian Tribal Governments.
A. Executive Order 12866
Executive Order 12866, as amended by Executive Order 14094, directs
agencies to assess all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, distributive impacts,
and equity). Section 3(f) of Executive Order 12866, as amended, defines
a ``significant regulatory action'' as one that is likely to result in
a rule that may: (1) have an annual effect on the economy of $200
million or more in any one year (adjusted every three years by the
Administrator of OIRA for changes in gross domestic product), or
adversely affect in a material way a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities (2) create a serious inconsistency or otherwise interfering
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise legal or policy issues for which centralized review would
meaningfully further the President's priorities or the principles set
forth in Executive Order 12866. While the Office of Information and
Regulatory Affairs has determined that this is a significant regulatory
action as defined by Executive Order 12866, they have also determined
that it does not confer significant costs and does not warrant a
regulatory impact analysis.
B. Regulatory Flexibility Act (RFA)
RFA requires analysis of regulatory options that minimize any
significant economic impact of a rule on small entities, unless it is
certified that the proposed rule is not expected to have a significant
economic impact on small entities. This rule is not expected to have a
significant economic impact on small entities, because the rule only
governs reimbursements of certain expenditures made by Service Units
under Purchased/Referred Care (PRC) authorities. Many PRC programs are
operated by the Federal Government, through the Indian Health Service
(IHS). The remaining PRC programs are operated by Tribes and tribal
organizations under Indian Self-Determination and Education Assistance
Act (ISDEAA) agreements with the IHS. Presently, there are 62 federally
operated PRC programs and 188 tribally operated PRC programs. Some of
the entities operating PRC programs may be small entities, but the rule
does not directly impact a substantial number of small entities and the
rule is not expected to reduce their revenues or raise their costs.
[[Page 45870]]
C. Unfunded Mandates Reform Act (UMRA)
Section 202 of UMRA (Pub. L. 104-4) requires an assessment of
anticipated costs and benefits before proposing any rule that may
result in expenditure by state, local, and Tribal Governments, in
aggregate, or by the private sector of $100 million or more (adjusted
annually for inflation) in any one year. The current threshold after
adjustment for inflation is $165 million, using the most current (2021)
Implicit Price Deflator for the Gross Domestic Product. We have
determined that this rule is consistent with the principles set forth
in the executive orders and in these statutes and find that this rule
will not have an effect on the economy that exceeds the UMRA threshold
in any one year. The IHS FY 2022 annual appropriation for the CHEF was
$53 million. This final rule is not anticipated to have an effect on
state, local, or Tribal Governments in the aggregate, or by the private
sector of $165 million or more. This rule does not impose any new costs
on small entities, and it will not result in a significant economic
impact on a substantial number of small entities. Thus, no further
analysis is required.
D. Federalism
E.O. 13132 establishes certain requirements that an agency must
meet when it promulgates a proposed rule (and subsequent final rule)
that imposes substantial direct requirement costs on State and local
Governments, preempts state law, or otherwise has federalism
implications. We have reviewed this proposed rule under the threshold
criteria of E.O. 13132 and have determined that this proposed rule
would not have substantial direct effect on the states, on the
relationship between the Federal Government and the states, or on the
distribution of power and governmental responsibilities among the
various levels of the Government(s). As this rule has no Federal
implications, a federalism summary impact statement is not required.
E. E.O. 13175 Consultation and Coordination With Indian Tribal
Governments
This rule has Tribal implications under E.O. 13175, Consultation
and Coordination with Indian Tribal Governments, because it would have
a substantial direct and positive effect on one or more Indian Tribes.
The first proposed CHEF rule, published in January 2016 (81 FR
4239), was developed with input from Tribes and the IHS personnel who
work with the daily processing and management of PRC resources.
Specifically, the IHS Director's Workgroup on Improving PRC met and
discussed the CHEF guidelines on October 12-13, 2010, and June 1-2,
2011, in Denver, Colorado, and on January 11-12, 2012, in Albuquerque,
New Mexico. In addition, the IHS issued ``Dear Tribal Leader'' letters
related to the development of these regulations on February 9, 2011,
and May 6, 2013.
The IHS has sought additional Tribal input throughout the
development of this new proposed rule. Specifically, Tribal
consultation sessions were held in the fall of 2016. At meetings of the
Workgroup in 2015 and 2018, the Workgroup recommended establishing a
$19,000 CHEF threshold. Moreover, in November 2020, the Workgroup
recommended that the IHS promulgate new regulations based on Workgroup
input. Based on the recommendation of the Workgroup, the threshold
amount of $19,000 is proposed to be established for the current fiscal
year. This proposed rule serves as additional Tribal consultation with
affected Tribes by giving interested Tribes the opportunity to comment
on the regulation before it is finalized. The IHS intends to consult as
fully as possible with Tribes prior to the publication of a final rule.
List of Subjects in 42 CFR Part 136
Alaska Natives, Purchased/Referred Care (formerly Contract Health
Services), Health, Health facilities, Indians.
For the reasons set out in the preamble, the IHS proposes to amend
42 CFR chapter I as set forth below:
PART 136--INDIAN HEALTH
0
1. The authority citation for part 136 is revised to read as follows:
Authority: 42 U.S.C. 2001 and 2003; 25 U.S.C. 13; and 25 U.S.C.
1621a.
0
2. Add new subpart L consisting of Sec. Sec. 136.501-136.510 to read
as follows:
Subpart L--Indian Catastrophic Health Emergency Fund
Sec.
136.501 Definitions.
136.502 Purpose of the regulations.
136.503 Threshold cost.
136.504 Reimbursement procedure.
136.505 Reimbursable services.
136.506 Alternate resources.
136.507 Program integrity.
136.508 Recovery of reimbursement funds.
136.509 Reconsideration and appeals.
136.510 Severability.
Sec. 136.501 Definitions.
Alternate Resources means health care resources other than those of
the Indian Health Service. Such resources include health care providers
and institutions and health care programs for the payment of health
services including but not limited to programs under titles XVIII or
XIX of the Social Security Act (i.e., Medicare, Medicaid), state or
local health care programs, and private insurance.
Catastrophic Health Emergency Fund (CHEF) means the fund
established by Congress to reimburse extraordinary medical expenses
incurred for catastrophic illnesses and disasters paid by a PRC program
of the IHS, whether such program is carried out by the IHS or an Indian
Tribe or Tribal Organization under the ISDEAA.
Catastrophic Illness refers to a medical condition that is costly
by virtue of the intensity and/or duration of its treatment. Examples
of conditions that frequently require multiple hospital stays and
extensive treatment are cancer, burns, premature births, cardiac
disease, end-stage renal disease, strokes, trauma-related cases such as
automobile accidents, and gunshot wounds, and some mental disorders.
The CHEF is intended to insulate the IHS and Tribal PRC operations from
financial disruption caused by the intensity of expenses incurred as a
result of high cost illnesses and/or disasters.
Disaster means a situation that poses a significant level of threat
to life or health or causes loss of life or health stemming from events
such as tornadoes, earthquakes, floods, catastrophic accidents,
epidemics, fires, and explosions. The CHEF is intended to insulate the
IHS and Tribal PRC operations from financial disruption caused by the
intensity of expenses incurred as a result of high cost illnesses and/
or disasters.
Episode of Care means the period of consecutive days for a discrete
health condition during which reasonable and necessary medical services
related to the condition occur.
Purchased/Referred Care means any health service that is--
(1) delivered based on a referral by, or at the expense of, an
Indian health program; and
(2) provided by a public or private medical provider or hospital
which is not a provider or hospital of the Indian health program.
Service Unit means an administrative entity of the Service or a
Tribal Health Program through which services are provided, directly or
by contract, to eligible Indians within a defined geographic area.
[[Page 45871]]
Threshold Cost means the annual designated amount above which
incurred medical costs will be considered for the CHEF reimbursement
after a review of the authorized expenses and diagnosis.
Sec. 136.502 Purpose of the regulations.
The Indian Catastrophic Health Emergency Fund (hereafter referred
to as ``CHEF'') is authorized by section 202 of the Indian Health Care
Improvement Act (IHCIA) [25 U.S.C. 1621a]. The CHEF is administered by
the Secretary, Department of Health and Human Services (HHS) (``the
Secretary'') acting through the Headquarters of the Indian Health
Service (IHS) (``the Service''), solely for the purpose of meeting
extraordinary medical costs associated with treatment of victims of
disasters or catastrophic illnesses who are within the responsibility
of the Service.
These regulations:
(a) establish definitions of terms governing the CHEF, including
definitions of disasters and catastrophic illnesses for which the cost
of treatment provided under contract would qualify for payment from the
CHEF;
(b) establish a threshold level for reimbursement for the cost of
treatment;
(c) establish procedures for reimbursement of the portion of the
costs incurred by Service Units that exceeds such threshold costs,
including procedures for when the exigencies of the medical
circumstances warrant treatment prior to the authorization of such
treatment by the Service; and
(d) establish procedures for reimbursements pending the outcome or
payment by alternate resources.
Sec. 136.503 Threshold cost.
A Service Unit shall not be eligible for reimbursement from the
CHEF until its cost of treating any victim of a catastrophic illness or
disaster for an episode of care has reached a certain threshold cost.
(a) The threshold cost shall be established at the level of
$19,000.
(b) The threshold cost in subsequent years shall be calculated from
the threshold cost of the previous year, increased by the percentage
increase in the medical care expenditure category of the Consumer Price
Index for all urban consumers (United States city average) for the 12-
month period ending with December of the previous year. The revised
threshold costs shall be published yearly in the Federal Register.
Sec. 136.504 Reimbursement procedure.
Service Units whose scope of work and funding include the purchase
of medical services from private or public vendors under PRC are
eligible to participate. The CHEF payments shall be based only on valid
PRC expenditures, including expenditures for exigent medical
circumstances without prior PRC authorization. Reimbursement from the
CHEF will not be made if applicable PRC requirements are not followed.
(a) Claim Submission: Requests for reimbursement from the CHEF must
be submitted to the appropriate IHS Area Office. Area PRC programs will
review requests for reimbursement to ensure compliance with PRC
requirements, including but not limited to: patient eligibility,
medical necessity, notification requirements for emergent and non-
emergent care, medical priorities, allowable expenditures, and
eligibility for alternate resources. Following this review, Area PRC
programs may provide Service Units an opportunity to submit missing
information or to resubmit documents that are indecipherable. Area PRC
programs will then forward all requests to the Division of Contract
Care, along with any recommendations or observations from the Area PRC
program regarding compliance with PRC or other CHEF requirements. The
Division of Contract Care will adjudicate the claim based upon an
independent review of the claim documentation, but it may consider any
recommendations or observations from the Area PRC program.
(b) Content of Claims: All claims submitted for reimbursement may
be submitted electronically utilizing the secure IHS system(s)
established for this purpose or may be submitted in paper form but must
include:
(1) A fully completed Catastrophic Health Emergency Fund
Reimbursement Request Form.
(2) A statement of the provider's charges on a form that complies
with the format required for the submission of claims under title XVIII
of the Social Security Act. For example, charges may be printed on
forms such as the Centers for Medicare & Medicaid Services (CMS) 1500,
UB-04 (formerly CMS-1450), American Dental Association (ADA) dental
claim form, or National Council for Prescription Drug Program (NCPDP)
universal claim forms. The forms submitted for review must include
specific appropriate diagnostic and procedure codes.
(3) An explanation of benefits or statement of payment identifying
how much was paid to the provider by the Service Unit for the
Catastrophic Illness or Disaster. Payments to the patient or any other
entity are ineligible for the CHEF reimbursement.
(4) The Division of Contract Care may request additional medical
documentation describing the medical treatment or service provided,
including but not limited to discharge summaries and/or medical
progress notes. Cases may be submitted for 50% reimbursement of
eligible expenses pending discharge summaries. Medical documentation
must be received to close the CHEF case.
(c) Limitation of Funds and Reimbursement Procedure: Because of the
limitations of funds, full reimbursement cannot be guaranteed on all
requests and will be based on the availability of funds at the time the
IHS processes the claim. To the extent funds are available, the CHEF
funds may not be used to cover the cost of services or treatment for
which the funds were not approved. Unused funds, including but not
limited to, funds unused due to overestimates, alternate resources, and
cancellations must be returned to the CHEF.
Sec. 136.505 Reimbursable services.
The costs of catastrophic illnesses and disasters for distinct
episodes of care are eligible for reimbursement from the CHEF in
accordance with the medical priorities of the Service. Only services
that are related to a distinct episode of care will be eligible for
reimbursement.
(a) Some of the services that may qualify for reimbursement from
the fund are:
(1) Emergency treatment.
(2) Emergent and acute inpatient hospitalization.
(3) Ambulance services; air and ground (including patient escort
travel costs).
(4) Attending and consultant physician.
(5) Functionally required reconstructive surgery.
(6) Prostheses and other related items.
(7) Reasonable rehabilitative therapy exclusive of custodial care
not to exceed 30 days after discharge.
(8) Skilled nursing care when the patient is discharged from the
acute process to a skilled nursing facility.
(b) [Reserved]
Sec. 136.506 Alternate resources.
(a) Expenses paid by alternate resources are not eligible for
payment by PRC or reimbursement by the CHEF. No payment shall be made
from the CHEF to any Service Unit to the extent that the provider of
services is eligible to receive payment for the treatment from any
other Federal, state, local, or private source of reimbursement for
which the
[[Page 45872]]
patient is eligible. A patient shall be considered eligible for such
resources and no payment shall be made from the CHEF if:
(1) The patient is eligible for alternate resources, or
(2) The patient would be eligible for alternate resources if he or
she were to apply for them, or
(3) The patient would be eligible for alternate resources under
Federal, state, or local law or regulation but for the patient's
eligibility for PRC, or other health services, from the Indian Health
Service or Indian Health Service funded programs.
(b) The determination of whether a resource constitutes an
alternate resource for the purpose of the CHEF reimbursement shall be
made by the Headquarters of the Indian Health Service, irrespective of
whether the resource was determined to be an alternate resource at the
time of PRC payment.
Sec. 136.507 Program integrity.
All the CHEF records and documents will be subject to review by the
respective Area and by Headquarters. Internal audits and administrative
reviews may be conducted as necessary to ensure compliance with PRC
regulations and the CHEF policies.
Sec. 136.508 Recovery of reimbursement funds.
In the event a Service Unit has been reimbursed from the CHEF for
an episode of care and that same episode of care becomes eligible for
and is paid by any Federal, state, local, or private source (including
third party insurance) the Service Unit shall return all the CHEF funds
received for that episode of care to the CHEF at the IHS Headquarters.
These recovered CHEF funds will be used to reimburse other valid CHEF
requests.
Sec. 136.509 Reconsideration and appeals.
(a) Any Service Unit to whom payment from the CHEF is denied will
be notified of the denial in writing together with a statement of the
reason for the denial within 130 business days from receipt.
(b) If a decision on the CHEF case is not made by the CHEF Program
Manager within 180 calendar days from receipt, the Service Unit that
submitted the claim may choose to appeal it as a deemed denial.
(c) In order to seek review of a denial decision or deemed denial,
the Service Unit must follow the procedures set forth in paragraphs
(c)(1) and (c)(2) of this section.
(1) Within 40 business days from the receipt of the denial provided
in paragraph (a) of this section, the Service Unit may submit a request
in writing for reconsideration of the original denial to the Division
of Contract Care. The request for reconsideration must include, as
applicable, corrections to the original claim submission necessary to
overcome the denial; or a statement and supporting documentation
establishing that the original denial was in error. If no additional
information is submitted the original denial will stand. The Service
Unit may also request a telephone conference with the Division of
Contract Care, to further explain the materials submitted, which shall
be scheduled within 40 business days from receipt of the request for
review. A decision by the Division of Contract Care shall be made
within 130 business days of the request for review. The Division of
Contract Care Director, or designee, shall review the application de
novo with no deference to the original decision maker or to the
applicant.
(2) If the original decision is affirmed on reconsideration, the
Service Unit will be notified in writing and advised that an appeal may
be taken to the Director, Indian Health Service, within 40 business
days of receipt of the denial. The appeal shall be in writing and shall
set forth the grounds supporting the appeal. The Service Unit may also
request a telephone conference through the Division of Contract Care,
which shall be scheduled with the Director or a representative
designated by the Director, to further explain the grounds supporting
the appeal. A decision by the Director shall be made within 180
calendar days of the request for reconsideration. The decision of the
Director, Indian Health Service or designee, shall constitute the final
administrative action.
Sec. 136.510 Severability.
If any provision of this subpart is held to be invalid or
unenforceable by its terms, as applied to any person or circumstance,
or stayed pending further agency action, the provision shall be
construed to continue to give the maximum effect to the provision
permitted by law, including as applied to those not similarly situated
or to dissimilar circumstances. However, if such holding is that the
provision of this subpart is invalid and unenforceable in all
circumstances, the provision shall be severable from the remainder of
this subpart and shall not affect the remainder thereof.
Dated: July 10, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-14849 Filed 7-17-23; 8:45 am]
BILLING CODE 4165-16-P