Catastrophic Health Emergency Fund, 4239-4244 [2016-01138]
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Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Proposed Rules
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, Aug. 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and,
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, Feb. 16, 1994).
The SIP is not approved to apply on
any Indian reservation land or in any
other area where EPA or an Indian tribe
has demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations,
Greenhouse gases, Lead, Nitrogen
dioxide, Ozone, Particulate matter,
Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: January 12, 2016.
Shaun L. McGrath,
Regional Administrator, Region 8.
[FR Doc. 2016–01403 Filed 1–25–16; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2015–0747; FRL–9941–59–
OAR]
RIN 2060–AS13
Oil and Natural Gas Sector: National
Emission Standards for Hazardous Air
Pollutants; Extension of Comment
Period
Environmental Protection
Agency (EPA).
ACTION: Request for information;
extension of comment period.
AGENCY:
On November 27, 2015, the
Environmental Protection Agency (EPA)
requested information related to
hazardous air pollutant emissions from
sources in the oil and natural gas
production and natural gas transmission
and storage segments of the oil and
natural gas sector. The deadline to
respond to our request was January 26,
2016. In response to requests from
several stakeholders, the EPA is
extending the period to respond to our
request for information to March 11,
2016.
SUMMARY:
The public comment period for
the request for information published in
the Federal Register on November 27,
2015 (80 CFR 74068), is being extended.
Written comments must be received on
or before March 11, 2016.
ADDRESSES: Comments. Submit your
comments, identified by Docket ID No.
EPA–HQ–OAR–2015–0747, to the
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or withdrawn. The EPA may
publish any comment received to its
public docket. Do not submit
electronically any information you
consider to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Multimedia submissions (audio, video,
etc.) must be accompanied by a written
comment. The written comment is
considered the official comment and
should include discussion of all points
you wish to make. The EPA will
generally not consider comments or
comment contents located outside of the
primary submission (i.e., on the web,
cloud, or other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
DATES:
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https://www2.epa.gov/dockets/
commenting-epa-dockets.
Docket. Publicly available documents
relevant to this action are available for
public inspection either electronically at
https://www.regulations.gov or in hard
copy at the EPA Docket Center, Room
3334, 1301 Constitution Avenue NW.,
Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. A reasonable fee may be
charged for copying. The official public
docket for this rulemaking is Docket ID
No. EPA–HQ–OAR–2015–0747.
World Wide Web. The EPA Web site
for this rulemaking is at https://www3.
epa.gov/airquality/oilandgas/
actions.html.
FOR FURTHER INFORMATION CONTACT: For
further information about this action,
contact Mr. Matthew Witosky, Sector
Policies and Programs Division (E143–
05), Office of Air Quality Planning and
Standards, Environmental Protection
Agency, Research Triangle Park, North
Carolina 27711, telephone number:
(919) 541–2865; facsimile number: (919)
541–3740; email address:
witosky.matthew@epa.gov.
SUPPLEMENTARY INFORMATION:
Comment Period
After considering the requests to
extend the public comment period, the
EPA has decided to extend the public
comment period until March 11, 2016.
This extension will provide the
additional time requested by the public
to review the request and gather data to
respond.
Dated: January 14, 2016.
Stephen D. Page,
Director, Office of Air Quality Planning and
Standards.
[FR Doc. 2016–01508 Filed 1–25–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
42 CFR Part 136
RIN 0905AC97
Catastrophic Health Emergency Fund
Indian Health Service, HHS.
Proposed rule.
AGENCY:
ACTION:
The Indian Health Service
(IHS) administers the Catastrophic
Health Emergency Fund, The purpose of
CHEF is to meet the extraordinary
medical costs associated with the
treatment of victims of disasters or
SUMMARY:
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catastrophic illnesses who are within
the responsibility of the Service. This
proposed rule: Proposes definitions
governing the CHEF; establishes that a
Service Unit shall not be eligible for
reimbursement for the cost of treatment
until the episode of care’s cost has
reached a certain threshold; establishes
a procedure for reimbursement for
certain services exceeding a threshold
cost; establishes a procedure for
payment for certain cases; and,
establishes a procedure to ensure
payment will not be made from CHEF
if other sources of payment (Federal,
state, local, private) are available.
DATES: To be assured consideration,
written comments must be received at
the address below, no later than 5 p.m.
on March 11, 2016. The IHS Area and
program offices will send copies of this
notice to each Tribe within their
jurisdiction.
In commenting, please refer
to file code 0905AC97. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission. You may submit
comments in one of four ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a Comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address only: Betty Gould, Regulations
Officer, Indian Health Service, Office of
Management Services, Division of
Regulatory Affairs, 5600 Fishers Lane,
Mailstop: 09E70, Rockville, Maryland
20857.
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
above address.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to the address
above.
If you intend to deliver your
comments to the Rockville address,
please call telephone number (301) 443–
1116 in advance to schedule your
arrival with one of our staff members.
Comments will be made available for
public inspection at the Rockville
address from 8:30 a.m. to 5:00 p.m.,
Monday–Friday, two weeks after
publication of this notice.
FOR FURTHER INFORMATION CONTACT: Carl
Harper, Director, Office of Resource
Access and Partnerships, Indian Health
Service, 5600 Fishers Lane, Mailstop:
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ADDRESSES:
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10E85C, Rockville, Maryland 20857,
Telephone (301) 443–1553.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments as
soon as possible after they have been
received to the following Web site:
https://www.regulations.gov. Follow the
search instructions on the Web site to
view public comments.
I. Background
The purpose of 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. IHS administers CHEF to
reimburse certain IHS and Tribal
purchased/referred care (PRC) costs that
exceed the cost threshold. Although
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. IHS developed operating
guidelines in August of 1987, which
were approved by the Office of
Management and Budget (OMB) for the
management of CHEF. Those guidelines
were developed with input from Tribal
organizations and 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 Indian Health Care Improvement
Act (IHCIA), Public Law 94–437.
Section 202 of IHCIA [25 U.S.C. 1621a]
establishes 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 this
regulation.
II. Provisions of This Proposed
Regulation
This regulation proposes to (1)
establish definitions governing 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 CHEF until its cost of treating any
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victim of such catastrophic illness or
disaster has reached a certain threshold
cost; (3) establish a procedure for
reimbursement of the portion of the
costs for authorized services that exceed
such threshold costs; (4) establish a
procedure for payment from 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 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 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. 450 et seq.] and may not be
allocated, apportioned, or delegated to a
Service Unit, Area Office, or any other
organizational unit. Accordingly, the
IHS Division of Contract Care within the
Office of Resource Access and
Partnerships at Headquarters shall
remain responsible for administration of
CHEF.
A. Definitions
IHS proposes establishing the
following definitions for governing
CHEF, including definitions of disasters
and catastrophic illnesses:
1. Alternate Resources—any Federal,
State, Tribal, local, or private source of
coverage for which the patient is
eligible. 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 and Medicaid), other Federal
health care programs, State, Tribal or
local health care programs, Veterans
Health Administration, and private
insurance, including Tribal selfinsurance.
2. Catastrophic Health Emergency
Fund (CHEF)—the fund established by
Congress to reimburse extraordinary
medical expenses incurred for
catastrophic illnesses and disasters
covered by a PRC program of the IHS,
whether such program is carried out by
IHS or an Indian Tribe or Tribal
organization under the Indian SelfDetermination and Education
Assistance Act.
3. Catastrophic Illness—a medical
condition that is costly by virtue of the
intensity and/or duration of its
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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. CHEF is
intended to shield IHS and Tribal PRC
operations from financial disruption
caused by the intensity of high cost
illnesses and/or events.
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.
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 which 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 designated
amount above which incurred medical
costs will be considered for CHEF
reimbursement after a review of the
authorized expenses and diagnosis.
B. Threshold Cost
IHCIA section 202 provides that a
Service Unit shall not be eligible for
reimbursement from 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.
IHS intends to set the initial threshold
governed by this rule at $19,000 for FY
2016. In reaching this determination,
IHS adopted the recommendation of the
IHS Director’s Workgroup on Improving
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PRC. 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 CHEF earlier in the FY 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 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, IHS intends to set
the initial threshold at $19,000 for FY
2016, with increases in subsequent
years based on the annual Consumer
Price Index.
C. Compliance With PRC Regulations
IHS proposes to follow PRC
regulations 42 CFR part 136 for payment
from CHEF. For example, payment or
reimbursement from 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
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 CHEF requests for CHEF
reimbursement to ensure consistency
with PRC regulations.
D. Alternate Resources
In accordance with section 202(d)(5)
of IHCIA [25 U.S.C. 1621a (d)(5)],
alternate resources must be exhausted
before reimbursement is made from
CHEF. No reimbursement shall be made
from CHEF to any Service Unit to the
extent the patient is eligible to receive
payment for treatment from any other
Federal, State, Tribal, local, or private
source of reimbursement. 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 IHS, whether or not
such resources actually make payment.
IHS is the payor of last resort and, if the
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provider of services is eligible to receive
payment from other resources, the
medical expenses are only payable by
PRC and reimbursable by CHEF to the
extent IHS would not consider the other
resources to be ‘‘alternate resources’’
under the applicable regulations and
IHS policy. Expenses paid by alternate
resources are not eligible for payment by
PRC or reimbursement by CHEF.
However, if the patient becomes eligible
for alternate resources, the Service Unit
shall return all funds reimbursed from
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 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 CHEF.
Reimbursable costs are those costs that
exceed the threshold requirement after
payment has been made by all alternate
resources such as Federal, State, Tribal,
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 CHEF shall be
subject to availability of funds.
F. Recovery of CHEF Reimbursement
Funds
In the event a PRC program has been
reimbursed from CHEF for an episode of
care and that same episode of care
becomes eligible for and is paid by any
Federal, State, Tribal, local, or private
source (including third party insurance),
the PRC program shall return all CHEF
funds received for that episode of care
to the CHEF at IHS Headquarters. These
recovered CHEF funds will be used to
reimburse other valid CHEF requests.
III. Collection of Information
Requirements
Prior to implementing the rule, 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 we normally receive on
Federal Register documents, we are not
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C. Unfunded Mandates Reform Act
(UMRA)
Telecommunications Act of 1996 and
the amendments made by that Act.
F. E.O. 13175 Consultation and
Coordination With Indian Tribal
Governments
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); the Congressional Review Act [5
U.S.C. 804(2)]; and E.O. 13175
Consultation and Coordination with
Indian Tribal Governments.
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 in any one year. 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 $100
million in any one year. The IHS FY
2015 annual appropriation for CHEF
was $51.5 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
$100 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.
A. E.O. 12866
D. Federalism
E.O. 12866 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). In accordance with E.O. 12866,
Agencies must submit a regulatory
impact analysis for those regulatory
actions that are ‘‘significant’’ within the
meaning of ‘‘economically significant.’’
A regulatory action is economically
significant if it is anticipated to ‘‘(1)
have an annual effect on the economy
of $100 million or more’’ or (2) to
‘‘adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or Tribal governments or
communities.’’ This rule is not being
treated as a ‘‘significant regulatory
action’’ under section 3(f) of E.O. 12866.
Accordingly, the rule has not been
reviewed by the Office of Management
and Budget.
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.
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 this
preamble, and, when we proceed with
a final rule, we will respond to the
comments in the preamble to that rule.
V. Regulatory Impact Analysis
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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.
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E. Congressional Review Act
This rule is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2)—it does not
or is not likely to result in:
(1) An annual effect on the economy
of $100,000,000 or more;
(2) a major increase in costs or prices
for consumers, individual industries,
Federal, State, or local government
agencies, or geographic regions; or
(3) significant adverse effects on
competition, employment, investment,
productivity, innovation, or on the
ability of United States-based
enterprises to compete with foreignbased enterprises in domestic and
export markets. The term does not
include any rule promulgated under the
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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.
These guidelines were developed
with input from Tribes and IHS
personnel who work with the daily
processing and management of PRC
resources. The IHS Director’s
Workgroup on Improving PRC met and
discussed these guidelines on October
12–13, 2010, and June 1–2, 2011, in
Denver, Colorado, and on January 11–
12, 2012, in Albuquerque, New Mexico.
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 Tribal
consultation with affected Tribes by
giving interested Tribes the opportunity
to comment on the regulation before it
is finalized. In addition, IHS issued
‘‘Dear Tribal Leader’’ letters related to
the development of these regulations on
February 9, 2011, and May 6, 2013. 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, Contract Health
Services, Health, Health facilities,
Health service delivery areas, Indians.
Dated: November 10, 2015.
Robert G. McSwain,
Principal Deputy Director, Indian Health
Service.
Dated: January 11, 2016.
Sylvia M. Burwell,
Secretary, Health and Human Services.
For the reasons set out in the
preamble, the Indian Health Service
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
§§ 136.501–136.509 to read as follows:
■
Subpart L—Indian Catastrophic Health
Emergency Fund
Sec.
136.501 Definitions.
136.502 Purpose of the regulations.
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136.503
136.504
136.505
136.506
136.507
136.508
136.509
Threshold cost.
Reimbursement procedure.
Reimbursable services.
Alternate resources.
Program integrity.
Recovery of reimbursement funds.
Reconsideration and appeals.
Subpart L—Indian Catastrophic Health
Emergency Fund
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§ 136.501
Definitions.
As used in this subpart:
Alternate Resource means any
Federal, State, Tribal, local, or private
source of reimbursement for which the
patient is eligible. 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 and
Medicaid), other Federal health care
programs, State, Tribal or local health
care programs, Veterans Health
Administration, and private insurance.
Catastrophic Health Emergency Fund
(CHEF) means the fund created by
Congress to cover extraordinary medical
expenses incurred for catastrophic
illnesses and disasters covered by a
purchased/referred care (PRC) program
of the Indian Health Service (IHS),
whether such program is carried out by
IHS or an Indian Tribe or Tribal
organization under the Indian SelfDetermination and Education
Assistance Act.
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. CHEF is
intended to shield IHS and Tribal PRC
operations from financial disruption
caused by the intensity of high cost
illnesses and/or events.
Disaster means a situation which
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.
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—
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Jkt 238001
(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.
Threshold Cost means the designated
amount above which incurred medical
costs will be considered for CHEF
reimbursement after a review of the
authorized expenses and diagnosis.
§ 136.502
Purpose of the regulations.
(a) 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]. 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.
(b) These regulations:
(1) Establish definitions of terms
governing CHEF, including definitions
of disasters and catastrophic illnesses
for which the cost of treatment provided
under contract would qualify for
payment from CHEF;
(2) Establish a threshold level for
reimbursement for the cost of treatment;
(3) 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
(4) Establish procedures for
reimbursements pending the outcome or
payment by alternate resources.
§ 136.503
Threshold cost.
A Service Unit shall not be eligible for
reimbursement from 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
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Fmt 4702
Sfmt 4702
4243
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
medical services from private or public
vendors under PRC are eligible to
participate. CHEF payments shall be
based only on valid PRC expenditures,
including expenditures for exigent
medical circumstances without prior
PRC authorization. Reimbursement from
CHEF will not be made if applicable
PRC requirements are not followed.
(a) Claim Submission. Requests for
reimbursement from 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.
(b) Content of Claims. All claims
submitted for reimbursement must
include:
(1) A fully completed Catastrophic
Health Emergency Fund Reimbursement
Request Form.
(2) A statement of the provider’s
charges in paper form. The paper form
must comply 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) 1450,
American Dental Association (ADA)
dental claim form, CMS 1500, 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 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
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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 IHS
processes the claim. To the extent funds
are available, 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 CHEF.
§ 136.505
Reimbursable services.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
The costs of catastrophic illnesses and
disasters for distinct episodes of care are
eligible for reimbursement from 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.
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Jkt 238001
§ 136.506
Alternate resources.
(a) Expenses paid by alternate
resources are not eligible for payment by
PRC or reimbursement by CHEF. No
payment shall be made from 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, Tribal, local, or
private source of reimbursement for
which the patient is eligible. A patient
shall be considered eligible for such
resources and no payment shall be made
from 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,
Tribal 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 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.
(a) All CHEF records and documents
will be subject to review by the
respective Area and by Headquarters.
(b) Internal audits and administrative
reviews may be conducted as necessary
to ensure compliance with PRC
regulations and CHEF policies.
§ 136.508
funds.
Recovery of reimbursement
In the event a Service Unit has been
reimbursed from CHEF for an episode of
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Fmt 4702
Sfmt 9990
care and that same episode of care
becomes eligible for and is paid by any
Federal, State, Tribal, local, or private
source (including third party insurance)
the Service Unit shall return all CHEF
funds received for that episode of care
to the CHEF at IHS Headquarters. These
recovered CHEF funds will be used to
reimburse other valid CHEF requests.
§ 136.509
Reconsideration and appeals.
(a) Any Service Unit to whom
payment from CHEF is denied will be
notified of the denial in writing together
with a statement of the reason for the
denial. In order to seek review of the
denial decision, the Service Unit must
follow the procedures set forth in
paragraphs (b) and (c) of this section.
(b) Within 30 days from the receipt of
the denial provided in paragraph (a) 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.
(c) 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
30 days of receipt of the denial. The
appeal shall be in writing and shall set
forth the grounds supporting the appeal.
The decision of the Director, Indian
Health Service, shall constitute the final
administrative action.
[FR Doc. 2016–01138 Filed 1–25–16; 8:45 am]
BILLING CODE 4165–16–P
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Agencies
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Proposed Rules]
[Pages 4239-4244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01138]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
42 CFR Part 136
RIN 0905AC97
Catastrophic Health Emergency Fund
AGENCY: Indian Health Service, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Indian Health Service (IHS) administers the Catastrophic
Health Emergency Fund, The purpose of CHEF is to meet the extraordinary
medical costs associated with the treatment of victims of disasters or
[[Page 4240]]
catastrophic illnesses who are within the responsibility of the
Service. This proposed rule: Proposes definitions governing the CHEF;
establishes that a Service Unit shall not be eligible for reimbursement
for the cost of treatment until the episode of care's cost has reached
a certain threshold; establishes a procedure for reimbursement for
certain services exceeding a threshold cost; establishes a procedure
for payment for certain cases; and, establishes a procedure to ensure
payment will not be made from CHEF if other sources of payment
(Federal, state, local, private) are available.
DATES: To be assured consideration, written comments must be received
at the address below, no later than 5 p.m. on March 11, 2016. The IHS
Area and program offices will send copies of this notice to each Tribe
within their jurisdiction.
ADDRESSES: In commenting, please refer to file code 0905AC97. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission. You may submit comments in one of four
ways (please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
Comment'' instructions.
2. By regular mail. You may mail written comments to the following
address only: Betty Gould, Regulations Officer, Indian Health Service,
Office of Management Services, Division of Regulatory Affairs, 5600
Fishers Lane, Mailstop: 09E70, Rockville, Maryland 20857.
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 above address.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to the address above.
If you intend to deliver your comments to the Rockville address,
please call telephone number (301) 443-1116 in advance to schedule your
arrival with one of our staff members.
Comments will be made available for public inspection at the
Rockville address from 8:30 a.m. to 5:00 p.m., Monday-Friday, two weeks
after publication of this notice.
FOR FURTHER INFORMATION CONTACT: Carl Harper, Director, Office of
Resource Access and Partnerships, Indian Health Service, 5600 Fishers
Lane, Mailstop: 10E85C, Rockville, Maryland 20857, Telephone (301) 443-
1553.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments as soon
as possible after they have been received to the following Web site:
https://www.regulations.gov. Follow the search instructions on the Web
site to view public comments.
I. Background
The purpose of 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. IHS
administers CHEF to reimburse certain IHS and Tribal purchased/referred
care (PRC) costs that exceed the cost threshold. Although 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. IHS developed operating guidelines in August of 1987, which
were approved by the Office of Management and Budget (OMB) for the
management of CHEF. Those guidelines were developed with input from
Tribal organizations and 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 Indian
Health Care Improvement Act (IHCIA), Public Law 94-437. Section 202 of
IHCIA [25 U.S.C. 1621a] establishes 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 this regulation.
II. Provisions of This Proposed Regulation
This regulation proposes to (1) establish definitions governing
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 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 of the portion of the costs for authorized services that
exceed such threshold costs; (4) establish a procedure for payment from
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
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 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. 450 et seq.] and may not be allocated, apportioned, or
delegated to a Service Unit, Area Office, or any other organizational
unit. Accordingly, the IHS Division of Contract Care within the Office
of Resource Access and Partnerships at Headquarters shall remain
responsible for administration of CHEF.
A. Definitions
IHS proposes establishing the following definitions for governing
CHEF, including definitions of disasters and catastrophic illnesses:
1. Alternate Resources--any Federal, State, Tribal, local, or
private source of coverage for which the patient is eligible. 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 and Medicaid), other Federal health care programs,
State, Tribal or local health care programs, Veterans Health
Administration, and private insurance, including Tribal self-insurance.
2. Catastrophic Health Emergency Fund (CHEF)--the fund established
by Congress to reimburse extraordinary medical expenses incurred for
catastrophic illnesses and disasters covered by a PRC program of the
IHS, whether such program is carried out by IHS or an Indian Tribe or
Tribal organization under the Indian Self-Determination and Education
Assistance Act.
3. Catastrophic Illness--a medical condition that is costly by
virtue of the intensity and/or duration of its
[[Page 4241]]
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. CHEF is intended to shield IHS and Tribal PRC
operations from financial disruption caused by the intensity of high
cost illnesses and/or events.
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.
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
which 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 designated amount above which incurred
medical costs will be considered for CHEF reimbursement after a review
of the authorized expenses and diagnosis.
B. Threshold Cost
IHCIA section 202 provides that a Service Unit shall not be
eligible for reimbursement from 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.
IHS intends to set the initial threshold governed by this rule at
$19,000 for FY 2016. In reaching this determination, IHS adopted the
recommendation of the IHS Director's Workgroup on Improving PRC. 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 CHEF earlier in the FY 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
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, IHS intends
to set the initial threshold at $19,000 for FY 2016, with increases in
subsequent years based on the annual Consumer Price Index.
C. Compliance With PRC Regulations
IHS proposes to follow PRC regulations 42 CFR part 136 for payment
from CHEF. For example, payment or reimbursement from 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 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 CHEF requests for CHEF reimbursement to ensure consistency
with PRC regulations.
D. Alternate Resources
In accordance with section 202(d)(5) of IHCIA [25 U.S.C. 1621a
(d)(5)], alternate resources must be exhausted before reimbursement is
made from CHEF. No reimbursement shall be made from CHEF to any Service
Unit to the extent the patient is eligible to receive payment for
treatment from any other Federal, State, Tribal, local, or private
source of reimbursement. 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 IHS,
whether or not such resources actually make payment. 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 CHEF to the extent IHS would not consider the
other resources to be ``alternate resources'' under the applicable
regulations and IHS policy. Expenses paid by alternate resources are
not eligible for payment by PRC or reimbursement by CHEF. However, if
the patient becomes eligible for alternate resources, the Service Unit
shall return all funds reimbursed from 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 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 CHEF. Reimbursable
costs are those costs that exceed the threshold requirement after
payment has been made by all alternate resources such as Federal,
State, Tribal, 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 CHEF shall be
subject to availability of funds.
F. Recovery of CHEF Reimbursement Funds
In the event a PRC program has been reimbursed from CHEF for an
episode of care and that same episode of care becomes eligible for and
is paid by any Federal, State, Tribal, local, or private source
(including third party insurance), the PRC program shall return all
CHEF funds received for that episode of care to the CHEF at IHS
Headquarters. These recovered CHEF funds will be used to reimburse
other valid CHEF requests.
III. Collection of Information Requirements
Prior to implementing the rule, 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 we normally receive
on Federal Register documents, we are not
[[Page 4242]]
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 this preamble, 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); the Congressional Review Act [5
U.S.C. 804(2)]; and E.O. 13175 Consultation and Coordination with
Indian Tribal Governments.
A. E.O. 12866
E.O. 12866 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). In accordance with E.O. 12866,
Agencies must submit a regulatory impact analysis for those regulatory
actions that are ``significant'' within the meaning of ``economically
significant.'' A regulatory action is economically significant if it is
anticipated to ``(1) have an annual effect on the economy of $100
million or more'' or (2) to ``adversely affect in a material way the
economy, a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or Tribal
governments or communities.'' This rule is not being treated as a
``significant regulatory action'' under section 3(f) of E.O. 12866.
Accordingly, the rule has not been reviewed by the Office of Management
and Budget.
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.
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 in any one year. 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 $100 million
in any one year. The IHS FY 2015 annual appropriation for CHEF was
$51.5 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 $100 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. Congressional Review Act
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2)--it
does not or is not likely to result in:
(1) An annual effect on the economy of $100,000,000 or more;
(2) a major increase in costs or prices for consumers, individual
industries, Federal, State, or local government agencies, or geographic
regions; or
(3) significant adverse effects on competition, employment,
investment, productivity, innovation, or on the ability of United
States-based enterprises to compete with foreign-based enterprises in
domestic and export markets. The term does not include any rule
promulgated under the Telecommunications Act of 1996 and the amendments
made by that Act.
F. 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.
These guidelines were developed with input from Tribes and IHS
personnel who work with the daily processing and management of PRC
resources. The IHS Director's Workgroup on Improving PRC met and
discussed these guidelines on October 12-13, 2010, and June 1-2, 2011,
in Denver, Colorado, and on January 11-12, 2012, in Albuquerque, New
Mexico. 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 Tribal consultation with affected
Tribes by giving interested Tribes the opportunity to comment on the
regulation before it is finalized. In addition, IHS issued ``Dear
Tribal Leader'' letters related to the development of these regulations
on February 9, 2011, and May 6, 2013. 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, Contract Health Services, Health, Health
facilities, Health service delivery areas, Indians.
Dated: November 10, 2015.
Robert G. McSwain,
Principal Deputy Director, Indian Health Service.
Dated: January 11, 2016.
Sylvia M. Burwell,
Secretary, Health and Human Services.
For the reasons set out in the preamble, the Indian Health Service
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. 136.501-136.509 to read
as follows:
Subpart L--Indian Catastrophic Health Emergency Fund
Sec.
136.501 Definitions.
136.502 Purpose of the regulations.
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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.
Subpart L--Indian Catastrophic Health Emergency Fund
Sec. 136.501 Definitions.
As used in this subpart:
Alternate Resource means any Federal, State, Tribal, local, or
private source of reimbursement for which the patient is eligible. 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 and Medicaid), other Federal health care programs,
State, Tribal or local health care programs, Veterans Health
Administration, and private insurance.
Catastrophic Health Emergency Fund (CHEF) means the fund created by
Congress to cover extraordinary medical expenses incurred for
catastrophic illnesses and disasters covered by a purchased/referred
care (PRC) program of the Indian Health Service (IHS), whether such
program is carried out by IHS or an Indian Tribe or Tribal organization
under the Indian Self-Determination and Education Assistance Act.
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.
CHEF is intended to shield IHS and Tribal PRC operations from financial
disruption caused by the intensity of high cost illnesses and/or
events.
Disaster means a situation which 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.
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.
Threshold Cost means the designated amount above which incurred
medical costs will be considered for CHEF reimbursement after a review
of the authorized expenses and diagnosis.
Sec. 136.502 Purpose of the regulations.
(a) 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]. 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.
(b) These regulations:
(1) Establish definitions of terms governing CHEF, including
definitions of disasters and catastrophic illnesses for which the cost
of treatment provided under contract would qualify for payment from
CHEF;
(2) Establish a threshold level for reimbursement for the cost of
treatment;
(3) 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
(4) 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 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. CHEF payments shall be based only on valid PRC
expenditures, including expenditures for exigent medical circumstances
without prior PRC authorization. Reimbursement from CHEF will not be
made if applicable PRC requirements are not followed.
(a) Claim Submission. Requests for reimbursement from 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.
(b) Content of Claims. All claims submitted for reimbursement must
include:
(1) A fully completed Catastrophic Health Emergency Fund
Reimbursement Request Form.
(2) A statement of the provider's charges in paper form. The paper
form must comply 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) 1450, American Dental Association (ADA) dental claim
form, CMS 1500, 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 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
[[Page 4244]]
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 IHS
processes the claim. To the extent funds are available, 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 CHEF.
Sec. 136.505 Reimbursable services.
The costs of catastrophic illnesses and disasters for distinct
episodes of care are eligible for reimbursement from 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 CHEF. No payment shall be made from
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, Tribal, local, or private source of reimbursement for which the
patient is eligible. A patient shall be considered eligible for such
resources and no payment shall be made from 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, Tribal 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 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.
(a) All CHEF records and documents will be subject to review by the
respective Area and by Headquarters.
(b) Internal audits and administrative reviews may be conducted as
necessary to ensure compliance with PRC regulations and CHEF policies.
Sec. 136.508 Recovery of reimbursement funds.
In the event a Service Unit has been reimbursed from CHEF for an
episode of care and that same episode of care becomes eligible for and
is paid by any Federal, State, Tribal, local, or private source
(including third party insurance) the Service Unit shall return all
CHEF funds received for that episode of care to the CHEF at 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 CHEF is denied will be
notified of the denial in writing together with a statement of the
reason for the denial. In order to seek review of the denial decision,
the Service Unit must follow the procedures set forth in paragraphs (b)
and (c) of this section.
(b) Within 30 days from the receipt of the denial provided in
paragraph (a) 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.
(c) 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 30 days of
receipt of the denial. The appeal shall be in writing and shall set
forth the grounds supporting the appeal. The decision of the Director,
Indian Health Service, shall constitute the final administrative
action.
[FR Doc. 2016-01138 Filed 1-25-16; 8:45 am]
BILLING CODE 4165-16-P