Section 506 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003-Limitation on Charges for Services Furnished by Medicare Participating Inpatient Hospitals to Individuals Eligible for Care Purchased by Indian Health Programs, 30706-30711 [07-2740]
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Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Rules and Regulations
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Dated: May 22, 2007.
Russell L. Wright, Jr.,
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[FR Doc. E7–10696 Filed 6–1–07; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
42 CFR Part 136
42 CFR Part 489
[CMS–2206–F]
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RIN 0917–AA02
Section 506 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003—Limitation
on Charges for Services Furnished by
Medicare Participating Inpatient
Hospitals to Individuals Eligible for
Care Purchased by Indian Health
Programs
Indian Health Service (IHS),
Center elsewhere for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
AGENCY:
15:23 Jun 01, 2007
Final rule.
SUMMARY: The Secretary of the
Department of Health and Human
Services (HHS) hereby issues this final
rule establishing regulations required by
section 506 of the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 (MMA), (Pub. L. 108–173).
Section 506 of the MMA amended
section 1866 (a)(1) of the Social Security
Act to add subparagraph (U) which
requires hospitals that furnish inpatient
hospital services payable under
Medicare to participate in the contract
health services program (CHS) of the
Indian Health Service (IHS) operated by
the IHS, Tribes, and Tribal
organizations, and to participate in
programs operated by urban Indian
organizations that are funded by IHS
(collectively referred to as I/T/Us) for
any medical care purchased by those
programs. Section 506 also requires
such participation to be in accordance
with the admission practices, payment
methodology, and payment rates set
forth in regulations established by the
Secretary, including acceptance of no
more than such payment rates as
payment in full.
DATES: These final regulations are
effective July 5, 2007.
FOR FURTHER INFORMATION CONTACT: Carl
Harper, Director, Office of Resource
Access and Partnerships, IHS, 801
Thompson Avenue, Twinbrook Metro
Plaza Suite 360, Rockville, Maryland
20852, telephone (301) 443–2694.
Dorothy Dupree, Director, Tribal Affairs
Group, OEA, CMS, 7500 Security
Boulevard, Mail Stop: C1–13–11,
Baltimore, Maryland 21244, telephone
(410) 786–1942. (These are not toll free
numbers.)
SUPPLEMENTARY INFORMATION:
I. Background
Center for Medicare & Medicaid
Services
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ACTION:
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On April 28, 2006, IHS and CMS
published proposed rules in the Federal
Register (71 FR 25124) as mandated by
section 506(c) of the MMA, which
requires the Secretary to publish rules
implementing the requirements of
section 506 of the MMA. Under that
statutory provision, hospitals that
furnish inpatient hospital services
payable under Medicare are required to
participate both in the contract health
service (CHS) program of IHS operated
by IHS, Tribes, and Tribal organizations,
and in programs operated by urban
Indian organizations (I/T/Us) that are
funded by the IHS, for medical care
purchased by those programs. Section
506 also requires such participation to
be in accordance with the admission
practices, payment methodology, and
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payment rates set forth in regulations
established by the Secretary, including
acceptance of no more than such rate as
payment in full. The proposed rule
provided interested persons until June
27, 2006 to submit written comments.
II. Provisions of the Proposed
Regulations
a. The Proposed Rule
We proposed to amend the IHS
regulations at 42 CFR part 136, by
adding a new subpart D to describe the
payment methodology and other
requirements for Medicare-participating
hospitals and critical access hospitals
(CAHs) that furnish inpatient services,
either directly or under arrangement, to
individuals who are authorized to
receive services from such hospitals
under a CHS program of the IHS, Tribes,
and Tribal organizations, and IHSfunded programs operated by urban
Indian organizations (collectively, I/T/U
programs). As provided in the statute,
we also proposed to amend CMS
regulations at 42 CFR part 489 to require
Medicare-participating hospitals and
critical access hospitals (CAHs) that
furnish inpatient hospital services to
individuals who are eligible for and
authorized to receive items and services
covered by such I/T/U programs to
accept no more than the payment
methodology under 42 CFR part 136,
subpart D as payment in full for such
items and services. The proposed rule
did not include additional regulation of
admission practices.
b. Summary of Changes in the Final
Rule
In reviewing several comments, IHS
and CMS determined that the payment
methodology in the proposed rule was
not adequately explained. Therefore, we
are clarifying the payment
methodologies established by this
regulation to include more detail. For
hospital services that would be paid
under prospective payment systems
(PPS) by the Medicare program, the
basic payment methodology under this
rule is based on the applicable PPS. For
example, inpatient hospital services of
acute care hospitals, psychiatric
hospitals, rehabilitation hospitals, and
long-term care hospitals will be paid
based on the same four Medicare PPS
systems as would be used to pay for
similar hospital services to the
hospitals’ Medicare patients, as
described under 42 CFR part 412, while
outpatient hospital services and skilled
nursing facility services (SNF) will be
paid based on their Medicare PPS
systems, as described under 42 CFR part
419 (outpatient) and 42 CFR part 413
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(SNF) respectively. The basic payment
methodology under this rule for
Medicare-participating hospitals that
furnish inpatient services but are
exempt from PPS and currently receive
reasonable cost reimbursement under
the Medicare program (for example,
critical access hospitals (CAHs),
children’s hospitals, cancer hospitals,
and certain other hospitals reimbursed
by Medicare under special
arrangements), is based on 42 CFR part
413, which addresses reasonable cost
reimbursement.
In addition, based on the comments
received, IHS and CMS determined that
the requirement that providers
participate in IHS and Tribal CHS
programs and IHS-funded urban Indian
organization programs was not clear in
the proposed rule and additional
guidance was needed. Therefore, we
clarified that hospitals participating in
Medicare that furnish inpatient hospital
services will be required to accept the
payment methodology and no more than
the rates established under 42 CFR part
136, subpart D as payment in full for
such services. This change also clarifies
that such hospitals may not refuse
service to an individual on the basis that
the individual may be eligible for
payment under such CHS and IHSfunded urban Indian programs. We did
not include additional prohibitions on
discrimination in admission practices
because such requirements are already
covered and enforced by the HHS Office
for Civil Rights under existing
regulations at 45 CFR part 80.
III. Analysis of and Responses to Public
Comments
The IHS received 35 comments from
Tribes, Tribal organizations, hospital
associations, CAHs, and individuals.
The IHS, in partnership with CMS,
carefully reviewed the submissions by
individuals, groups, Indian, and nonIndian organizations. We did not
consider 4 of these comments, because
they were received after the closing
date. Of the 31 timely comments, 26
comments supported the proposed
regulation. Several comments requested
clarification of certain sections of the
rule.
Comment: We received 10 comments
that expressed serious concern
regarding the long delay in publication
of the proposed rule and requested
expedited publication of a final rule.
Response: The development of this
final rule has been a long and careful
process, involving consultation with the
Tribes through the CMS Tribal
Technical Advisory Group, and close
collaboration between IHS and CMS. An
incidental benefit of this process has
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been greater understanding by all
parties of the service delivery and
payment processes that are at issue in
this rule.
Comment: A number of the comments
from Tribes and Tribal organizations
expressed concerns that affected Indian
health programs would need training to
fully implement and monitor the
participation and payment
requirements.
Response: IHS is authorized to
provide technical assistance regarding
implementation of this final rule. Tribal
program representatives can contact Mr.
Carl Harper at the phone number listed
in the contact information.
Comment: One commenter expressed
concern that American Indian/Alaska
Native (AI/AN) populations have many
complications and co-morbidities that
do not exist to the same extent in the
patient population as a whole, including
diabetes, cardiovascular disease, injury,
trauma, and alcoholism. The commenter
suggested that costs to treat this
population are higher and suggested IHS
would be paying less for its patient
population than Medicare actually pays
for services furnished to a comparable
population.
Response: Patients who are more
seriously ill tend to require a higher
level of hospital resources than patients
who are less seriously ill even though
they may be admitted to the hospital for
the same reason. Recognizing this,
Medicare payments can be higher for
patients in certain diagnostic-related
groups (DRGs) based on a secondary
diagnosis that could indicate specific
complications or co-morbidities. Also,
the DRG groupings take into
consideration co-morbidity factors, and
payment adjustments that would be
available to reflect the higher costs of
disproportionate share hospital
adjustments and outlier payments are
provided for exceptionally high cost
cases, all of which would address high
costs of this patient population. As a
result, IHS payment under this rule will
reflect the serious health issues faced by
its patient population.
Comment: One commenter expressed
concern that the CHS program payments
are not always timely and should be
paid in accordance with Medicare
timeline requirements.
Response: This regulation addresses
practices, payment methodologies, and
rates of payment that are not already
addressed under current laws or
regulations. The time frame for paying
claims authorized by IHS under the CHS
program is already governed by section
220 of the Indian Health Care
Improvement Act (IHCIA).
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Comment: One commenter expressed
concern that payment for services
should be absolute for services
rendered, not at the service unit’s
discretion. In addition, this commenter
suggested IHS set the timeline for
notification of emergency services at a
minimum of 30 days following services
rendered.
Response: Payment for services is
based on a medical priority system
which is based on the availability of
funds as established under 42 CFR part
136, subpart C. Under subpart C of title
42, notification of emergency services
must be provided within 72 hours after
the beginning of treatment or admission
to a health care facility. The timeline for
notification of emergency services for
the elderly and disabled is currently set
at 30 days in accordance with section
406 of the IHCIA.
Comment: One commenter expressed
concern that the proposed rule places an
additional burden on hospitals by
capping rates paid to public and private
non-IHS funded hospitals, with no
additional responsibility or
accountability placed on I/T/U
programs regarding payments to such
hospitals.
Response: This rule would provide for
rates that hospitals accept under the
Medicare program. We do not believe
these rates place an additional burden
on hospitals.
Comment: One commenter asked
whether the payment rates required
under this rule would apply to claims
for services furnished by long-term care
hospitals, independent inpatient
rehabilitation facilities, and inpatient
psychiatric facilities to individuals who
were authorized for the service by an
I/T/U program.
Response: Long-term care hospitals,
independent inpatient rehabilitation
facilities, and inpatient psychiatric
facilities are covered by these rules
because they meet the criteria of section
506 of the MMA: They are covered by
the definition of ‘‘hospital’’ in section
1861(e) or (f), as applicable, of the
Social Security Act and they furnish
inpatient hospital services. They will be
paid based upon their respective
Medicare PPS systems.
Comment: A commenter asked
whether agents will be precluded from
charging the I/T/U for the records
needed for payment determination or
quality assurance in cases in which a
facility is using an outside agent to
manage its medical records and patient
information.
Response: Under section 136.30(j),
additional payment would not be
available for the cost of copying of
medical records to an outside agent who
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manages medical records and patient
information.
Comment: One commenter expressed
concern that the proposed rule does not
clearly define what it means to
‘‘participate’’ in programs operated by
IHS, Tribes, Tribal organizations, or
urban Indian (I/T/U) programs.
Response: Participation in I/T/U
programs means that all hospitals
covered by this rule must accept the
admission practices, payment
methodology, and no more than the
rates of payment established under this
rule as payment in full for items and
services purchased by I/T/U programs
for individuals eligible for and referred
by such programs. To clarify that
acceptance of these requirements is
mandatory for participation in
Medicare, IHS has revised the proposed
rule in two ways. First, subsections (a)
and (b) of 42 CFR 136.30 have been
amended to clarify which entities are
affected by the rule and the services that
will be covered. Second, 42 CFR 489.29
has also been amended to be consistent
with 42 CFR part 136, subpart D.
Paragraph (b) has been added to 42 CFR
489.29 to clarify that hospitals cannot
deny services to an individual on the
basis that payment for such services is
authorized by an I/T/U program.
However, the rule does not provide
additional regulation of discrimination
in admission practices because such
requirements are already covered and
enforced by the HHS Office for Civil
Rights under existing regulations at 45
CFR part 80.
Comment: One commenter asked
whether hospitals which are not
reimbursed on a reasonable cost basis
will be reimbursed based on the
Medicare DRGs or other prospective
payment rate.
Response: We have clarified the
payment methodology in the final rule
in response to this comment. We are
clarifying that, for hospital services that
would be paid under prospective
payment systems (PPS) by the Medicare
program, the basic payment
methodology under this rule is based on
the applicable PPS. For example,
inpatient services furnished by acute
care hospitals, psychiatric hospitals,
rehabilitation hospitals, and long-term
care hospitals will be paid based on
their respective PPS used in the
Medicare program to pay for similar
hospital services to the hospitals’
Medicare patients, as described under
42 CFR part 412, while outpatient
hospital services and skilled nursing
facility (SNF) services will be paid
based on their Medicare PPS, as
described under 42 CFR part 419
(outpatient) and 42 CFR part 413 (SNF)
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respectively. Under the basic payment
methodology of this rule for Medicareparticipating hospitals that furnish
inpatient services but are exempt from
PPS and currently receive reasonable
cost reimbursement under the Medicare
program (for example, CAHs, children’s
hospitals, cancer hospitals, and certain
other hospitals reimbursed by Medicare
under special arrangements), I/T/Us will
reimburse such hospitals for claims in
accordance with 42 CFR part 413, which
addresses reasonable cost
reimbursement. In other words,
hospitals reimbursed by Medicare on a
reasonable cost basis will not be paid by
use of DRGs or other case classification
systems used under the various
Medicare PPS payment methods. To
clarify what hospitals can expect to
receive as reimbursements, IHS has
created two basic payment
determinations under section 136.30(c)
in the final rule; one for PPS based
payments and one for payments based
on reasonable costs.
Comment: Two commenters
recommended that payment
adjustments for organ acquisition costs,
blood clotting factors, new technology
services, and disproportionate share be
included in the interim payment
calculations in order to provide for an
appropriate level of reimbursement.
Response: IHS agrees that payment
adjustments for the types of services
listed above should be included in the
payment calculations in order to
provide for an appropriate level of
reimbursement. Payment adjustments
for disproportionate share and new
medical technology already are
included in the PPS methodology under
subparts F and G of part 412. Moreover,
to ensure that hospitals receiving PPS
payment include these payment
adjustments, IHS will use the Medicare
PRICER system (or a similar system) in
calculating final payment. The system
includes adjustments such as those
above. For items not adjusted within the
system, the IHS fiscal intermediary will
be instructed to use standard payments
calculated by CMS (for example,
payments based on the Average Sales
Price (ASP) for hemophilia clotting
factors). To clarify that such payments
will be added to the basic rate
calculation, IHS has added a new
section 136.30(d) to the rule.
Comment: Several commenters
expressed concern that the interim
payment rates will have a financial
impact on CAHs. Another commenter
expressed concern about the per diem
mechanism used to make interim
payments to CAHs because there is no
requirement to follow Medicare
regulations by the I/T/U.
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Response: The economic financial
impact study conducted by an IHS fiscal
intermediary demonstrates that the
interim payment rates will have limited
financial impact on rural and small
rural hospitals as explained in section
VI of this final rule, Regulatory Impact
Statement. Moreover, in revising the
proposed adoption of the Medicare
payment methodologies in section
136.30(c) of the final rule, IHS has
identified two basic determinations for
payment. Payments to CAHs are covered
under section 136.30(c)(2). IHS will
follow payment guidance based on the
reasonable cost methodology under 42
CFR 413.70, ‘‘Payment for services of a
CAH’’. As with other payments based on
reasonable cost, payments to CAHs will
be based on the interim payment rate
established under 42 CFR part 413,
subpart E.
Comment: One commenter asked
whether the final rule will be applied to
claims which are received after the
effective date, regardless of the date of
service, or only to claims with a date of
service after the effective date.
Response: The requirements of the
final rule will apply to claims with a
date of service on or after the effective
date of the final regulation.
Comment: A commenter asked
whether contracts will become
invalidated by this regulation or remain
in effect until they expire in situations
in which a hospital contract is currently
in place with IHS, which has rates that
are not based on Medicare or are not
less than Medicare rates.
Response: Medicare-participating
hospitals that furnish inpatient services
must accept the rate methodology
established under this regulation as a
condition of participation in the
Medicare program. Current hospital
contract rates that are lower than the
rates established by this regulation will
continue to apply in accordance with
section 136.30(c).
Comment: One commenter asked if
the Medicare timely filing guidelines
will be waived and/or modified for
claims when the I/T/U (1) is not the
primary payor and the patient has
alternate resources or, (2) delayed in
sending out a timely purchase order.
Response: Under 42 CFR 136.61, as
applied in this rule, the I/T/U program
is the payor of last resort for individuals
eligible for any alternate resources. The
timely filing period under 42 CFR
424.44 and provisions of the Medicare
Claims Processing Manual will apply to
all claims submitted to an I/T/U
program for payment.
Comment: One commenter asked the
IHS to remove the Health Insurance
Portability and Accountability Act
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(HIPAA) requirement for electronic
claim submission.
Response: If the I/T/U program
accepts paper claims, this is still an
acceptable format for claims
submission. However, if non-I/T/U
providers generally submit their claims
electronically to other payers, they
should also do so for I/T/U payers that
accept electronic claims. HIPAA
requires electronic claims to be filed
using the standard 837 format.
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IV. Collection of Information
Requirements
This document does not impose any
new information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35). Note: The burden
requirements in section 136.30(h)(1) for
submitting a claim form are currently
approved under OMB approval number
0938–0279.
V. Regulatory Impact Statement
The IHS has examined the impact of
this final rule as required by Executive
Order 12866 (September 1993,
Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
section 1102(b) of the Social Security
Act, the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104–4), and
Executive Order 13132.
Executive Order 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). A regulatory impact
analysis (RIA) must be prepared for
major rules with economically
significant effects ($100 million or more
in any 1 year). This action is not a
significant regulatory action under
Executive Order 12866. Further
regulatory evaluation is not necessary
because the economic impact will be
minimal.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and
government agencies. Most hospitals
and most other providers and suppliers
are small entities, either by nonprofit
status or by having revenues of $6
million to $29 million in any 1 year.
Individuals and States are not included
in the definition of a small entity.
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The I/T/Us have entered into
contracts with many public and private
non-I/T Medicare-participating
hospitals at rates less than or equal to
the rate proposed in this rule. IHS
intends to continue existing contracts
with these hospitals; however, to the
extent that I/T/Us are not able to
negotiate a contract with a hospital,
payment rates established by this rule
will apply. This action will alleviate the
need for and administrative burden of
negotiating rates through individual
contracts by IHS as well as the
Medicare-participating hospitals.
The IHS conducted a study to
determine the financial impact the
interim payment rates, as proposed by
this regulation, would have on public
and private non-I/T/U hospitals. As part
of this study, IHS compared the interim
rates to the rates that IHS has negotiated
per contracts with public and private
non-I/T/U hospitals. For FY 2003, of the
387 hospitals that IHS does business
with, IHS has negotiated contracts with
48 percent of these hospitals. Based on
IHS data, the findings revealed the
overall negative impact on these public
and private non-I/T/U hospitals would
be less than 1 percent. Of the 387
hospitals in the study, 105 are rural
hospitals. Out of the 105 rural hospitals,
84 are small rural hospitals (less than
100 beds). By comparing the interim
rate to full billed charges, (that is, what
IHS pays if a contract is not negotiated)
revealed a negative financial impact of
8 percent on these rural hospitals.
Further analysis of the inpatient bed
utilization by hospital revealed IHS
represents less than 2 percent of the
rural and small rural hospitals total
business meaning that 98 percent of the
hospitals’ income comes from other
sources. For these reasons, IHS has
determined that the rates proposed by
these regulations will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq.
In addition, section 1102(b) of the Act
requires IHS to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 603 of the
RFA. For purposes of section 1102(b) of
the Act, IHS defines a small rural
hospital as a hospital that is located
outside of a Metropolitan Statistical
Area and has fewer than 100 beds. For
the reasons provided above, IHS has
determined that this rule will not have
a significant impact on the operations of
a substantial number of small rural
hospitals. Section 202 of the Unfunded
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30709
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose requirements mandate
expenditure in any 1 year by State,
local, or Tribal governments, in the
aggregate, or by the private sector, of
$120 million. This proposal would not
impose substantial Federal mandates on
State, local or Tribal governments or
private sector.
Executive Order 13132 establishes
certain requirements that an Agency
must meet when it promulgates a final
rule that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
It has been determined that this action
would not have a substantial direct
effect on the States, on the relationship
between the national Government and
the States, or on the distribution of
power and responsibilities among the
various levels of government, and
therefore would not have Federalism
implications.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance)
List of Subjects
42 CFR Part 136
American Indian, Alaska Natives,
Health, Medicare.
42 CFR Part 489
Health facilities, Medicare, Reporting
and recordkeeping requirements.
Dated: November 2, 2006.
Charles W. Grim,
Assistant Surgeon General, Director, Indian
Health Service.
Dated: November 16, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Dated: April 18, 2007.
Michael O. Leavitt,
Secretary.
The Indian Health Service is
amending 42 CFR Chapter I as set forth
below:
I
PART 136—INDIAN HEALTH
1. The authority citation for part 136
continues to read as follows:
I
Authority: 25 U.S.C. 13; 42 U.S.C.
1395cc(a)(1)(U), 42 U.S.C. 2001 and 2003,
unless otherwise noted.
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2. Add new subpart D consisting of
§§ 136.30 through 136.32, to read as
follows:
I
Subpart D—Limitation on Charges for
Services Furnished by MedicareParticipating Hospitals to Indians
Sec.
136.30 Payment to Medicare-participating
hospitals for authorized Contract Health
Services.
136.31 Authorization by urban Indian
organization.
136.32 Disallowance.
Subpart D—Limitation on Charges for
Services Furnished by MedicareParticipating Hospitals to Indians
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§ 136.30 Payment to Medicareparticipating hospitals for authorized
Contract Health Services.
(a) Scope. All Medicare-participating
hospitals, which are defined for
purposes of this subpart to include all
departments and provider-based
facilities of hospitals (as defined in
sections 1861(e) and (f) of the Social
Security Act) and critical access
hospitals (as defined in section
1861(mm)(1) of the Social Security Act),
that furnish inpatient services must
accept no more than the rates of
payment under the methodology
described in this section as payment in
full for all items and services authorized
by IHS, Tribal, and urban Indian
organization entities, as described in
paragraph (b) of this section.
(b) Applicability. The payment
methodology under this section applies
to all levels of care furnished by a
Medicare-participating hospital,
whether provided as inpatient,
outpatient, skilled nursing facility care,
as other services of a department,
subunit, distinct part, or other
component of a hospital (including
services furnished directly by the
hospital or under arrangements) that is
authorized under part 136, subpart C by
a contract health service (CHS) program
of the Indian Health Service (IHS); or
authorized by a Tribe or Tribal
organization carrying out a CHS
program of the IHS under the Indian
Self-Determination and Education
Assistance Act, as amended, Pub. L. 93–
638, 25 U.S.C. 450 et seq.; or authorized
for purchase under § 136.31 by an urban
Indian organization (as that term is
defined in 25 U.S.C. 1603(h)) (hereafter
‘‘I/T/U’’).
(c) Basic determination. (1) Payment
for hospital services that the Medicare
program would pay under a prospective
payment system (PPS) will be based on
that PPS. For example, payment for
inpatient hospital services shall be
made per discharge based on the
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15:23 Jun 01, 2007
Jkt 211001
applicable PPS used by the Medicare
program to pay for similar hospital
services under 42 CFR part 412.
Payment for outpatient hospital services
shall be made based on a PPS used in
the Medicare program to pay for similar
hospital services under 42 CFR part 419.
Payment for skilled nursing facility
(SNF) services shall be based on a PPS
used in the Medicare program to pay for
similar SNF services under 42 CFR part
413.
(2) For Medicare participating
hospitals that furnish inpatient services
but are exempt from PPS and receive
reimbursement based on reasonable
costs (for example, critical access
hospitals (CAHs), children’s hospitals,
cancer hospitals, and certain other
hospitals reimbursed by Medicare under
special arrangements), including
provider subunits exempt from PPS,
payment shall be made per discharge
based on the reasonable cost methods
established under 42 CFR part 413,
except that the interim payment rate
under 42 CFR part 413, subpart E shall
constitute payment in full for
authorized charges.
(d) Other payments. In addition to the
amount payable under paragraph (c)(1)
of this section for authorized inpatient
services, payments shall include an
amount to cover: The organ acquisition
costs incurred by hospitals with
approved transplantation centers; direct
medical education costs; units of blood
clotting factor furnished to an eligible
patient who is a hemophiliac; and the
costs of qualified non-physician
anesthetists, to the extent such costs
would be payable if the services had
been covered by Medicare. Payment
under this subsection shall be made on
a per discharge basis and will be based
on standard payments established by
the Centers for Medicare & Medicaid
Services (CMS) or its fiscal
intermediaries.
(e) Basic payment calculation. The
calculation of the payment by I/T/Us
will be based on determinations made
under paragraphs (c) and (d) of this
section consistent with CMS
instructions to its fiscal intermediaries
at the time the claim is processed.
Adjustments will be made to correct
billing or claims processing errors,
including when fraud is detected.
I/T/Us shall pay the providing hospital
the full PPS based rate, or the interim
reasonable cost rate, without reduction
for any co-payments, coinsurance, and
deductibles required by the Medicare
program from the patient.
(f) Exceptions to payment calculation.
Notwithstanding paragraph (e) of this
section, if an amount has been
negotiated with the hospital or its agent
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
by the I/T/U, the I/T/U will pay the
lesser of: The amount determined under
paragraph (e) of this section or the
amount negotiated with the hospital or
its agent, including but not limited to
capitated contracts or contracts per
Federal law requirements;
(g) Coordination of benefits and
limitation on recovery. If an I/T/U has
authorized payment for items and
services provided to an individual who
is eligible for benefits under Medicare,
Medicaid, or another third party
payor—
(1) The I/T/U shall be the payor of last
resort under § 136.61;
(2) If there are any third party payers,
the I/T/U will pay the amount for which
the patient is being held responsible
after the provider of services has
coordinated benefits and all other
alternative resources have been
considered and paid, including
applicable co-payments, deductibles,
and coinsurance that are owed by the
patient; and
(3) The maximum payment by the
I/T/U will be only that portion of the
payment amount determined under this
section not covered by any other payor;
and
(4) The I/T/U payment will not
exceed the rate calculated in accordance
with paragraph (e) of this section or the
contracted amount (plus applicable cost
sharing), whichever is less; and
(5) When payment is made by
Medicaid it is considered payment in
full and there will be no additional
payment made by the I/T/U to the
amount paid by Medicaid (except for
applicable cost sharing).
(h) Claims processing. For a hospital
to be eligible for payment under this
section, the hospital or its agent must
submit the claim for authorized
services—
(1) On a UB92 paper claim form (until
abolished, or on an officially adopted
successor form) or the HIPAA 837
electronic claims format ANSI X12N,
version 4010A1 (until abolished, or on
an officially adopted successor form)
and include the hospital’s Medicare
provider number/National Provider
Identifier; and
(2) To the I/T/U, agent, or fiscal
intermediary identified by the I/T/U in
the agreement between the I/T/U and
the hospital or in the authorization for
services provided by the I/T/U; and
(3) Within a time period equivalent to
the timely filing period for Medicare
claims under 42 CFR 424.44 and
provisions of the Medicare Claims
Processing Manual applicable to the
type of item or service provided.
(i) Authorized services. Payment shall
be made only for those items and
E:\FR\FM\04JNR1.SGM
04JNR1
Federal Register / Vol. 72, No. 106 / Monday, June 4, 2007 / Rules and Regulations
services authorized by an I/T/U
consistent with part 136 of this title or
section 503(a) of the Indian Health Care
Improvement Act (IHCIA), Public Law
94–437, as amended, 25 U.S.C. 1653(a).
(j) No additional charges. A payment
made in accordance with this section
shall constitute payment in full and the
hospital or its agent may not impose any
additional charge—
(1) On the individual for I/T/U
authorized items and services; or
(2) For information requested by the
I/T/U or its agent or fiscal intermediary
for the purposes of payment
determinations or quality assurance.
§ 136.31 Authorization by urban Indian
organization.
An urban Indian organization may
authorize for purchase items and
services for an eligible urban Indian (as
those terms are defined in 25 U.S.C.
1603(f) and (h)) according to section 503
of the IHCIA and applicable regulations.
Services and items furnished by
Medicare-participating inpatient
hospitals shall be subject to the payment
methodology set forth in § 136.30.
§ 136.32
Disallowance.
(a) If it is determined that a hospital
has submitted inaccurate information
for payment, such as admission,
discharge or billing data, an I/T/U may
as appropriate—
(1) Deny payment (in whole or in
part) with respect to any such services,
and;
(2) Disallow costs previously paid,
including any payments made under
any methodology authorized under this
subpart. The recovery of payments made
in error may be taken by any method
authorized by law.
(b) For cost based payments
previously issued under this subpart, if
it is determined that actual costs fall
significantly below the computed rate
actually paid, the computed rate may be
retrospectively adjusted. The recovery
of overpayments made as a result of the
adjusted rate may be taken by any
method authorized by law.
The Centers for Medicare & Medicaid
Services is amending 42 CFR Chapter
IV, as set forth below:
I
Subpart B—Essentials of Provider
Agreements
4. A new § 489.29 is added to subpart
B to read as follows:
I
§ 489.29 Special requirements concerning
beneficiaries served by the Indian Health
Service, Tribal health programs, and urban
Indian organization health programs.
(a) Hospitals (as defined in sections
1861(e) and (f) of the Social Security
Act) and critical access hospitals (as
defined in section 1861(mm)(1) of the
Social Security Act) that participate in
the Medicare program and furnish
inpatient hospital services must accept
the payment methodology and no more
than the rates of payment established
under 42 CFR part 136, subpart D as
payment in full for the following
programs:
(1) A contract health service (CHS)
program under 42 CFR part 136, subpart
C, of the Indian Health Service (IHS);
(2) A CHS program under 42 CFR part
136, subpart C, carried out by an Indian
Tribe or Tribal organization pursuant to
the Indian Self-Determination and
Education Assistance Act, as amended,
Public Law 93–638, 25 U.S.C. 450 et
seq.; and
(3) A program funded through a grant
or contract by the IHS and operated by
an urban Indian organization under
which items and services are purchased
for an eligible urban Indian (as those
terms are defined in 25 U.S.C. 1603 (f)
and (h)).
(b) Hospitals and critical access
hospitals may not refuse service to an
individual on the basis that the payment
for such service is authorized under
programs described in paragraph (a) of
this section.
[FR Doc. 07–2740 Filed 6–1–07; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 300
[Docket No. 070215036–7107–02; I.D.
012307A]
RIN 0648–AU79
rmajette on PROD1PC64 with RULES
PART 489—PROVIDER AGREEMENTS
AND SUPPLIER APPROVAL
International Fisheries; Pacific Tuna
Fisheries; Restrictions for 2007 Purse
Seine and Longline Fisheries in the
Eastern Tropical Pacific Ocean
3. The authority citation for part 489
continues to read as follows:
AGENCY:
I
Authority: Sec. 1102 and 1871 of the Social
Security Act (42 U.S.C. 1302 and 1395hh).
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15:23 Jun 01, 2007
Jkt 211001
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Department of Commerce.
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
ACTION:
30711
Final rule.
SUMMARY: NMFS publishes this final
rule to implement the 2007 management
measures to reduce overfishing of the
eastern tropical Pacific Ocean (ETP)
tuna stocks in 2007, consistent with
recommendations by the Inter-American
Tropical Tuna Commission (IATTC) that
have been approved by the Department
of State (DOS) under the Tuna
Conventions Act. The U.S. purse seine
fishery for yellowfin, bigeye, and
skipjack tunas in the ETP will be closed
for a 6–week period beginning August 1,
2007, through September 11, 2007. The
longline fishery for bigeye tuna will
close when a 500 metric ton (mt) limit
has been reached. These actions are
taken to limit fishing mortality caused
by purse seine fishing and longline
fishing in the ETP and contribute to
long-term conservation of the tuna
stocks at levels that support healthy
fisheries.
DATES: The 2007 purse seine fishery
closure for yellowfin, bigeye, and
skipjack tunas is effective on 12:00 a.m.
Pacific Time, August 1, 2007, through
11:59 p.m. Pacific Time, September 11,
2007. For 2007, NMFS will close the
bigeye longline fishery through
appropriate procedures to ensure that
the bigeye longline tuna catch does not
exceed 500 mt.
ADDRESSES: Copies of the regulatory
impact review/final regulatory
flexibility analysis (FRFA) may be
obtained from the Southwest Regional
Administrator, Southwest Region,
NMFS, 501 West Ocean Boulevard,
Suite 4200, Long Beach, CA 90802–
4213.
FOR FURTHER INFORMATION CONTACT: J.
Allison Routt, Sustainable Fisheries
Division, Southwest Region, NMFS,
(562) 980–4030.
This Federal Register document is
also accessible via the Internet at the
Office of the Federal Register’s website
at https://www.gpoaccess.gov/
SUPPLEMENTARY INFORMATION: The
United States is a member of the IATTC,
which was established by international
agreement through the Convention for
the Establishment of an Inter-American
Tropical Tuna Commission
(Convention), which was signed in
1949. The IATTC was established to
ensure the effective international
conservation and management of highly
migratory species of fish in the ETP. For
the purposes of these closures, the ETP
is defined to include the waters
bounded by the coast of the Americas,
the 40° N. and 40° S. parallels, and the
150° W. meridian. The IATTC has
maintained a scientific research and
E:\FR\FM\04JNR1.SGM
04JNR1
Agencies
[Federal Register Volume 72, Number 106 (Monday, June 4, 2007)]
[Rules and Regulations]
[Pages 30706-30711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-2740]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
42 CFR Part 136
Center for Medicare & Medicaid Services
42 CFR Part 489
[CMS-2206-F]
RIN 0917-AA02
Section 506 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003--Limitation on Charges for Services Furnished
by Medicare Participating Inpatient Hospitals to Individuals Eligible
for Care Purchased by Indian Health Programs
AGENCY: Indian Health Service (IHS), Center elsewhere for Medicare &
Medicaid Services (CMS), Health and Human Services (HHS).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Secretary of the Department of Health and Human Services
(HHS) hereby issues this final rule establishing regulations required
by section 506 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA), (Pub. L. 108-173). Section 506 of the
MMA amended section 1866 (a)(1) of the Social Security Act to add
subparagraph (U) which requires hospitals that furnish inpatient
hospital services payable under Medicare to participate in the contract
health services program (CHS) of the Indian Health Service (IHS)
operated by the IHS, Tribes, and Tribal organizations, and to
participate in programs operated by urban Indian organizations that are
funded by IHS (collectively referred to as I/T/Us) for any medical care
purchased by those programs. Section 506 also requires such
participation to be in accordance with the admission practices, payment
methodology, and payment rates set forth in regulations established by
the Secretary, including acceptance of no more than such payment rates
as payment in full.
DATES: These final regulations are effective July 5, 2007.
FOR FURTHER INFORMATION CONTACT: Carl Harper, Director, Office of
Resource Access and Partnerships, IHS, 801 Thompson Avenue, Twinbrook
Metro Plaza Suite 360, Rockville, Maryland 20852, telephone (301) 443-
2694. Dorothy Dupree, Director, Tribal Affairs Group, OEA, CMS, 7500
Security Boulevard, Mail Stop: C1-13-11, Baltimore, Maryland 21244,
telephone (410) 786-1942. (These are not toll free numbers.)
SUPPLEMENTARY INFORMATION:
I. Background
On April 28, 2006, IHS and CMS published proposed rules in the
Federal Register (71 FR 25124) as mandated by section 506(c) of the
MMA, which requires the Secretary to publish rules implementing the
requirements of section 506 of the MMA. Under that statutory provision,
hospitals that furnish inpatient hospital services payable under
Medicare are required to participate both in the contract health
service (CHS) program of IHS operated by IHS, Tribes, and Tribal
organizations, and in programs operated by urban Indian organizations
(I/T/Us) that are funded by the IHS, for medical care purchased by
those programs. Section 506 also requires such participation to be in
accordance with the admission practices, payment methodology, and
payment rates set forth in regulations established by the Secretary,
including acceptance of no more than such rate as payment in full. The
proposed rule provided interested persons until June 27, 2006 to submit
written comments.
II. Provisions of the Proposed Regulations
a. The Proposed Rule
We proposed to amend the IHS regulations at 42 CFR part 136, by
adding a new subpart D to describe the payment methodology and other
requirements for Medicare-participating hospitals and critical access
hospitals (CAHs) that furnish inpatient services, either directly or
under arrangement, to individuals who are authorized to receive
services from such hospitals under a CHS program of the IHS, Tribes,
and Tribal organizations, and IHS-funded programs operated by urban
Indian organizations (collectively, I/T/U programs). As provided in the
statute, we also proposed to amend CMS regulations at 42 CFR part 489
to require Medicare-participating hospitals and critical access
hospitals (CAHs) that furnish inpatient hospital services to
individuals who are eligible for and authorized to receive items and
services covered by such I/T/U programs to accept no more than the
payment methodology under 42 CFR part 136, subpart D as payment in full
for such items and services. The proposed rule did not include
additional regulation of admission practices.
b. Summary of Changes in the Final Rule
In reviewing several comments, IHS and CMS determined that the
payment methodology in the proposed rule was not adequately explained.
Therefore, we are clarifying the payment methodologies established by
this regulation to include more detail. For hospital services that
would be paid under prospective payment systems (PPS) by the Medicare
program, the basic payment methodology under this rule is based on the
applicable PPS. For example, inpatient hospital services of acute care
hospitals, psychiatric hospitals, rehabilitation hospitals, and long-
term care hospitals will be paid based on the same four Medicare PPS
systems as would be used to pay for similar hospital services to the
hospitals' Medicare patients, as described under 42 CFR part 412, while
outpatient hospital services and skilled nursing facility services
(SNF) will be paid based on their Medicare PPS systems, as described
under 42 CFR part 419 (outpatient) and 42 CFR part 413
[[Page 30707]]
(SNF) respectively. The basic payment methodology under this rule for
Medicare-participating hospitals that furnish inpatient services but
are exempt from PPS and currently receive reasonable cost reimbursement
under the Medicare program (for example, critical access hospitals
(CAHs), children's hospitals, cancer hospitals, and certain other
hospitals reimbursed by Medicare under special arrangements), is based
on 42 CFR part 413, which addresses reasonable cost reimbursement.
In addition, based on the comments received, IHS and CMS determined
that the requirement that providers participate in IHS and Tribal CHS
programs and IHS-funded urban Indian organization programs was not
clear in the proposed rule and additional guidance was needed.
Therefore, we clarified that hospitals participating in Medicare that
furnish inpatient hospital services will be required to accept the
payment methodology and no more than the rates established under 42 CFR
part 136, subpart D as payment in full for such services. This change
also clarifies that such hospitals may not refuse service to an
individual on the basis that the individual may be eligible for payment
under such CHS and IHS-funded urban Indian programs. We did not include
additional prohibitions on discrimination in admission practices
because such requirements are already covered and enforced by the HHS
Office for Civil Rights under existing regulations at 45 CFR part 80.
III. Analysis of and Responses to Public Comments
The IHS received 35 comments from Tribes, Tribal organizations,
hospital associations, CAHs, and individuals. The IHS, in partnership
with CMS, carefully reviewed the submissions by individuals, groups,
Indian, and non-Indian organizations. We did not consider 4 of these
comments, because they were received after the closing date. Of the 31
timely comments, 26 comments supported the proposed regulation. Several
comments requested clarification of certain sections of the rule.
Comment: We received 10 comments that expressed serious concern
regarding the long delay in publication of the proposed rule and
requested expedited publication of a final rule.
Response: The development of this final rule has been a long and
careful process, involving consultation with the Tribes through the CMS
Tribal Technical Advisory Group, and close collaboration between IHS
and CMS. An incidental benefit of this process has been greater
understanding by all parties of the service delivery and payment
processes that are at issue in this rule.
Comment: A number of the comments from Tribes and Tribal
organizations expressed concerns that affected Indian health programs
would need training to fully implement and monitor the participation
and payment requirements.
Response: IHS is authorized to provide technical assistance
regarding implementation of this final rule. Tribal program
representatives can contact Mr. Carl Harper at the phone number listed
in the contact information.
Comment: One commenter expressed concern that American Indian/
Alaska Native (AI/AN) populations have many complications and co-
morbidities that do not exist to the same extent in the patient
population as a whole, including diabetes, cardiovascular disease,
injury, trauma, and alcoholism. The commenter suggested that costs to
treat this population are higher and suggested IHS would be paying less
for its patient population than Medicare actually pays for services
furnished to a comparable population.
Response: Patients who are more seriously ill tend to require a
higher level of hospital resources than patients who are less seriously
ill even though they may be admitted to the hospital for the same
reason. Recognizing this, Medicare payments can be higher for patients
in certain diagnostic-related groups (DRGs) based on a secondary
diagnosis that could indicate specific complications or co-morbidities.
Also, the DRG groupings take into consideration co-morbidity factors,
and payment adjustments that would be available to reflect the higher
costs of disproportionate share hospital adjustments and outlier
payments are provided for exceptionally high cost cases, all of which
would address high costs of this patient population. As a result, IHS
payment under this rule will reflect the serious health issues faced by
its patient population.
Comment: One commenter expressed concern that the CHS program
payments are not always timely and should be paid in accordance with
Medicare timeline requirements.
Response: This regulation addresses practices, payment
methodologies, and rates of payment that are not already addressed
under current laws or regulations. The time frame for paying claims
authorized by IHS under the CHS program is already governed by section
220 of the Indian Health Care Improvement Act (IHCIA).
Comment: One commenter expressed concern that payment for services
should be absolute for services rendered, not at the service unit's
discretion. In addition, this commenter suggested IHS set the timeline
for notification of emergency services at a minimum of 30 days
following services rendered.
Response: Payment for services is based on a medical priority
system which is based on the availability of funds as established under
42 CFR part 136, subpart C. Under subpart C of title 42, notification
of emergency services must be provided within 72 hours after the
beginning of treatment or admission to a health care facility. The
timeline for notification of emergency services for the elderly and
disabled is currently set at 30 days in accordance with section 406 of
the IHCIA.
Comment: One commenter expressed concern that the proposed rule
places an additional burden on hospitals by capping rates paid to
public and private non-IHS funded hospitals, with no additional
responsibility or accountability placed on I/T/U programs regarding
payments to such hospitals.
Response: This rule would provide for rates that hospitals accept
under the Medicare program. We do not believe these rates place an
additional burden on hospitals.
Comment: One commenter asked whether the payment rates required
under this rule would apply to claims for services furnished by long-
term care hospitals, independent inpatient rehabilitation facilities,
and inpatient psychiatric facilities to individuals who were authorized
for the service by an I/T/U program.
Response: Long-term care hospitals, independent inpatient
rehabilitation facilities, and inpatient psychiatric facilities are
covered by these rules because they meet the criteria of section 506 of
the MMA: They are covered by the definition of ``hospital'' in section
1861(e) or (f), as applicable, of the Social Security Act and they
furnish inpatient hospital services. They will be paid based upon their
respective Medicare PPS systems.
Comment: A commenter asked whether agents will be precluded from
charging the I/T/U for the records needed for payment determination or
quality assurance in cases in which a facility is using an outside
agent to manage its medical records and patient information.
Response: Under section 136.30(j), additional payment would not be
available for the cost of copying of medical records to an outside
agent who
[[Page 30708]]
manages medical records and patient information.
Comment: One commenter expressed concern that the proposed rule
does not clearly define what it means to ``participate'' in programs
operated by IHS, Tribes, Tribal organizations, or urban Indian (I/T/U)
programs.
Response: Participation in I/T/U programs means that all hospitals
covered by this rule must accept the admission practices, payment
methodology, and no more than the rates of payment established under
this rule as payment in full for items and services purchased by I/T/U
programs for individuals eligible for and referred by such programs. To
clarify that acceptance of these requirements is mandatory for
participation in Medicare, IHS has revised the proposed rule in two
ways. First, subsections (a) and (b) of 42 CFR 136.30 have been amended
to clarify which entities are affected by the rule and the services
that will be covered. Second, 42 CFR 489.29 has also been amended to be
consistent with 42 CFR part 136, subpart D. Paragraph (b) has been
added to 42 CFR 489.29 to clarify that hospitals cannot deny services
to an individual on the basis that payment for such services is
authorized by an I/T/U program. However, the rule does not provide
additional regulation of discrimination in admission practices because
such requirements are already covered and enforced by the HHS Office
for Civil Rights under existing regulations at 45 CFR part 80.
Comment: One commenter asked whether hospitals which are not
reimbursed on a reasonable cost basis will be reimbursed based on the
Medicare DRGs or other prospective payment rate.
Response: We have clarified the payment methodology in the final
rule in response to this comment. We are clarifying that, for hospital
services that would be paid under prospective payment systems (PPS) by
the Medicare program, the basic payment methodology under this rule is
based on the applicable PPS. For example, inpatient services furnished
by acute care hospitals, psychiatric hospitals, rehabilitation
hospitals, and long-term care hospitals will be paid based on their
respective PPS used in the Medicare program to pay for similar hospital
services to the hospitals' Medicare patients, as described under 42 CFR
part 412, while outpatient hospital services and skilled nursing
facility (SNF) services will be paid based on their Medicare PPS, as
described under 42 CFR part 419 (outpatient) and 42 CFR part 413 (SNF)
respectively. Under the basic payment methodology of this rule for
Medicare-participating hospitals that furnish inpatient services but
are exempt from PPS and currently receive reasonable cost reimbursement
under the Medicare program (for example, CAHs, children's hospitals,
cancer hospitals, and certain other hospitals reimbursed by Medicare
under special arrangements), I/T/Us will reimburse such hospitals for
claims in accordance with 42 CFR part 413, which addresses reasonable
cost reimbursement. In other words, hospitals reimbursed by Medicare on
a reasonable cost basis will not be paid by use of DRGs or other case
classification systems used under the various Medicare PPS payment
methods. To clarify what hospitals can expect to receive as
reimbursements, IHS has created two basic payment determinations under
section 136.30(c) in the final rule; one for PPS based payments and one
for payments based on reasonable costs.
Comment: Two commenters recommended that payment adjustments for
organ acquisition costs, blood clotting factors, new technology
services, and disproportionate share be included in the interim payment
calculations in order to provide for an appropriate level of
reimbursement.
Response: IHS agrees that payment adjustments for the types of
services listed above should be included in the payment calculations in
order to provide for an appropriate level of reimbursement. Payment
adjustments for disproportionate share and new medical technology
already are included in the PPS methodology under subparts F and G of
part 412. Moreover, to ensure that hospitals receiving PPS payment
include these payment adjustments, IHS will use the Medicare PRICER
system (or a similar system) in calculating final payment. The system
includes adjustments such as those above. For items not adjusted within
the system, the IHS fiscal intermediary will be instructed to use
standard payments calculated by CMS (for example, payments based on the
Average Sales Price (ASP) for hemophilia clotting factors). To clarify
that such payments will be added to the basic rate calculation, IHS has
added a new section 136.30(d) to the rule.
Comment: Several commenters expressed concern that the interim
payment rates will have a financial impact on CAHs. Another commenter
expressed concern about the per diem mechanism used to make interim
payments to CAHs because there is no requirement to follow Medicare
regulations by the I/T/U.
Response: The economic financial impact study conducted by an IHS
fiscal intermediary demonstrates that the interim payment rates will
have limited financial impact on rural and small rural hospitals as
explained in section VI of this final rule, Regulatory Impact
Statement. Moreover, in revising the proposed adoption of the Medicare
payment methodologies in section 136.30(c) of the final rule, IHS has
identified two basic determinations for payment. Payments to CAHs are
covered under section 136.30(c)(2). IHS will follow payment guidance
based on the reasonable cost methodology under 42 CFR 413.70, ``Payment
for services of a CAH''. As with other payments based on reasonable
cost, payments to CAHs will be based on the interim payment rate
established under 42 CFR part 413, subpart E.
Comment: One commenter asked whether the final rule will be applied
to claims which are received after the effective date, regardless of
the date of service, or only to claims with a date of service after the
effective date.
Response: The requirements of the final rule will apply to claims
with a date of service on or after the effective date of the final
regulation.
Comment: A commenter asked whether contracts will become
invalidated by this regulation or remain in effect until they expire in
situations in which a hospital contract is currently in place with IHS,
which has rates that are not based on Medicare or are not less than
Medicare rates.
Response: Medicare-participating hospitals that furnish inpatient
services must accept the rate methodology established under this
regulation as a condition of participation in the Medicare program.
Current hospital contract rates that are lower than the rates
established by this regulation will continue to apply in accordance
with section 136.30(c).
Comment: One commenter asked if the Medicare timely filing
guidelines will be waived and/or modified for claims when the I/T/U (1)
is not the primary payor and the patient has alternate resources or,
(2) delayed in sending out a timely purchase order.
Response: Under 42 CFR 136.61, as applied in this rule, the I/T/U
program is the payor of last resort for individuals eligible for any
alternate resources. The timely filing period under 42 CFR 424.44 and
provisions of the Medicare Claims Processing Manual will apply to all
claims submitted to an I/T/U program for payment.
Comment: One commenter asked the IHS to remove the Health Insurance
Portability and Accountability Act
[[Page 30709]]
(HIPAA) requirement for electronic claim submission.
Response: If the I/T/U program accepts paper claims, this is still
an acceptable format for claims submission. However, if non-I/T/U
providers generally submit their claims electronically to other payers,
they should also do so for I/T/U payers that accept electronic claims.
HIPAA requires electronic claims to be filed using the standard 837
format.
IV. Collection of Information Requirements
This document does not impose any new information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35). Note: The burden
requirements in section 136.30(h)(1) for submitting a claim form are
currently approved under OMB approval number 0938-0279.
V. Regulatory Impact Statement
The IHS has examined the impact of this final rule as required by
Executive Order 12866 (September 1993, Regulatory Planning and Review),
the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-
354), section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 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). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). This action
is not a significant regulatory action under Executive Order 12866.
Further regulatory evaluation is not necessary because the economic
impact will be minimal.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and government agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $6
million to $29 million in any 1 year. Individuals and States are not
included in the definition of a small entity.
The I/T/Us have entered into contracts with many public and private
non-I/T Medicare-participating hospitals at rates less than or equal to
the rate proposed in this rule. IHS intends to continue existing
contracts with these hospitals; however, to the extent that I/T/Us are
not able to negotiate a contract with a hospital, payment rates
established by this rule will apply. This action will alleviate the
need for and administrative burden of negotiating rates through
individual contracts by IHS as well as the Medicare-participating
hospitals.
The IHS conducted a study to determine the financial impact the
interim payment rates, as proposed by this regulation, would have on
public and private non-I/T/U hospitals. As part of this study, IHS
compared the interim rates to the rates that IHS has negotiated per
contracts with public and private non-I/T/U hospitals. For FY 2003, of
the 387 hospitals that IHS does business with, IHS has negotiated
contracts with 48 percent of these hospitals. Based on IHS data, the
findings revealed the overall negative impact on these public and
private non-I/T/U hospitals would be less than 1 percent. Of the 387
hospitals in the study, 105 are rural hospitals. Out of the 105 rural
hospitals, 84 are small rural hospitals (less than 100 beds). By
comparing the interim rate to full billed charges, (that is, what IHS
pays if a contract is not negotiated) revealed a negative financial
impact of 8 percent on these rural hospitals. Further analysis of the
inpatient bed utilization by hospital revealed IHS represents less than
2 percent of the rural and small rural hospitals total business meaning
that 98 percent of the hospitals' income comes from other sources. For
these reasons, IHS has determined that the rates proposed by these
regulations will not have a significant economic impact on a
substantial number of small entities within the meaning of the
Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
In addition, section 1102(b) of the Act requires IHS to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, IHS defines a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. For the reasons provided
above, IHS has determined that this rule will not have a significant
impact on the operations of a substantial number of small rural
hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose requirements mandate expenditure in any 1 year
by State, local, or Tribal governments, in the aggregate, or by the
private sector, of $120 million. This proposal would not impose
substantial Federal mandates on State, local or Tribal governments or
private sector.
Executive Order 13132 establishes certain requirements that an
Agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on State and local governments,
preempts State law, or otherwise has Federalism implications. It has
been determined that this action would not have a substantial direct
effect on the States, on the relationship between the national
Government and the States, or on the distribution of power and
responsibilities among the various levels of government, and therefore
would not have Federalism implications.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance)
List of Subjects
42 CFR Part 136
American Indian, Alaska Natives, Health, Medicare.
42 CFR Part 489
Health facilities, Medicare, Reporting and recordkeeping
requirements.
Dated: November 2, 2006.
Charles W. Grim,
Assistant Surgeon General, Director, Indian Health Service.
Dated: November 16, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: April 18, 2007.
Michael O. Leavitt,
Secretary.
0
The Indian Health Service is amending 42 CFR Chapter I as set forth
below:
PART 136--INDIAN HEALTH
0
1. The authority citation for part 136 continues to read as follows:
Authority: 25 U.S.C. 13; 42 U.S.C. 1395cc(a)(1)(U), 42 U.S.C.
2001 and 2003, unless otherwise noted.
[[Page 30710]]
0
2. Add new subpart D consisting of Sec. Sec. 136.30 through 136.32, to
read as follows:
Subpart D--Limitation on Charges for Services Furnished by Medicare-
Participating Hospitals to Indians
Sec.
136.30 Payment to Medicare-participating hospitals for authorized
Contract Health Services.
136.31 Authorization by urban Indian organization.
136.32 Disallowance.
Subpart D--Limitation on Charges for Services Furnished by
Medicare-Participating Hospitals to Indians
Sec. 136.30 Payment to Medicare-participating hospitals for
authorized Contract Health Services.
(a) Scope. All Medicare-participating hospitals, which are defined
for purposes of this subpart to include all departments and provider-
based facilities of hospitals (as defined in sections 1861(e) and (f)
of the Social Security Act) and critical access hospitals (as defined
in section 1861(mm)(1) of the Social Security Act), that furnish
inpatient services must accept no more than the rates of payment under
the methodology described in this section as payment in full for all
items and services authorized by IHS, Tribal, and urban Indian
organization entities, as described in paragraph (b) of this section.
(b) Applicability. The payment methodology under this section
applies to all levels of care furnished by a Medicare-participating
hospital, whether provided as inpatient, outpatient, skilled nursing
facility care, as other services of a department, subunit, distinct
part, or other component of a hospital (including services furnished
directly by the hospital or under arrangements) that is authorized
under part 136, subpart C by a contract health service (CHS) program of
the Indian Health Service (IHS); or authorized by a Tribe or Tribal
organization carrying out a CHS program of the IHS under the Indian
Self-Determination and Education Assistance Act, as amended, Pub. L.
93-638, 25 U.S.C. 450 et seq.; or authorized for purchase under Sec.
136.31 by an urban Indian organization (as that term is defined in 25
U.S.C. 1603(h)) (hereafter ``I/T/U'').
(c) Basic determination. (1) Payment for hospital services that the
Medicare program would pay under a prospective payment system (PPS)
will be based on that PPS. For example, payment for inpatient hospital
services shall be made per discharge based on the applicable PPS used
by the Medicare program to pay for similar hospital services under 42
CFR part 412. Payment for outpatient hospital services shall be made
based on a PPS used in the Medicare program to pay for similar hospital
services under 42 CFR part 419. Payment for skilled nursing facility
(SNF) services shall be based on a PPS used in the Medicare program to
pay for similar SNF services under 42 CFR part 413.
(2) For Medicare participating hospitals that furnish inpatient
services but are exempt from PPS and receive reimbursement based on
reasonable costs (for example, critical access hospitals (CAHs),
children's hospitals, cancer hospitals, and certain other hospitals
reimbursed by Medicare under special arrangements), including provider
subunits exempt from PPS, payment shall be made per discharge based on
the reasonable cost methods established under 42 CFR part 413, except
that the interim payment rate under 42 CFR part 413, subpart E shall
constitute payment in full for authorized charges.
(d) Other payments. In addition to the amount payable under
paragraph (c)(1) of this section for authorized inpatient services,
payments shall include an amount to cover: The organ acquisition costs
incurred by hospitals with approved transplantation centers; direct
medical education costs; units of blood clotting factor furnished to an
eligible patient who is a hemophiliac; and the costs of qualified non-
physician anesthetists, to the extent such costs would be payable if
the services had been covered by Medicare. Payment under this
subsection shall be made on a per discharge basis and will be based on
standard payments established by the Centers for Medicare & Medicaid
Services (CMS) or its fiscal intermediaries.
(e) Basic payment calculation. The calculation of the payment by I/
T/Us will be based on determinations made under paragraphs (c) and (d)
of this section consistent with CMS instructions to its fiscal
intermediaries at the time the claim is processed. Adjustments will be
made to correct billing or claims processing errors, including when
fraud is detected. I/T/Us shall pay the providing hospital the full PPS
based rate, or the interim reasonable cost rate, without reduction for
any co-payments, coinsurance, and deductibles required by the Medicare
program from the patient.
(f) Exceptions to payment calculation. Notwithstanding paragraph
(e) of this section, if an amount has been negotiated with the hospital
or its agent by the I/T/U, the I/T/U will pay the lesser of: The amount
determined under paragraph (e) of this section or the amount negotiated
with the hospital or its agent, including but not limited to capitated
contracts or contracts per Federal law requirements;
(g) Coordination of benefits and limitation on recovery. If an I/T/
U has authorized payment for items and services provided to an
individual who is eligible for benefits under Medicare, Medicaid, or
another third party payor--
(1) The I/T/U shall be the payor of last resort under Sec. 136.61;
(2) If there are any third party payers, the I/T/U will pay the
amount for which the patient is being held responsible after the
provider of services has coordinated benefits and all other alternative
resources have been considered and paid, including applicable co-
payments, deductibles, and coinsurance that are owed by the patient;
and
(3) The maximum payment by the I/T/U will be only that portion of
the payment amount determined under this section not covered by any
other payor; and
(4) The I/T/U payment will not exceed the rate calculated in
accordance with paragraph (e) of this section or the contracted amount
(plus applicable cost sharing), whichever is less; and
(5) When payment is made by Medicaid it is considered payment in
full and there will be no additional payment made by the I/T/U to the
amount paid by Medicaid (except for applicable cost sharing).
(h) Claims processing. For a hospital to be eligible for payment
under this section, the hospital or its agent must submit the claim for
authorized services--
(1) On a UB92 paper claim form (until abolished, or on an
officially adopted successor form) or the HIPAA 837 electronic claims
format ANSI X12N, version 4010A1 (until abolished, or on an officially
adopted successor form) and include the hospital's Medicare provider
number/National Provider Identifier; and
(2) To the I/T/U, agent, or fiscal intermediary identified by the
I/T/U in the agreement between the I/T/U and the hospital or in the
authorization for services provided by the I/T/U; and
(3) Within a time period equivalent to the timely filing period for
Medicare claims under 42 CFR 424.44 and provisions of the Medicare
Claims Processing Manual applicable to the type of item or service
provided.
(i) Authorized services. Payment shall be made only for those items
and
[[Page 30711]]
services authorized by an I/T/U consistent with part 136 of this title
or section 503(a) of the Indian Health Care Improvement Act (IHCIA),
Public Law 94-437, as amended, 25 U.S.C. 1653(a).
(j) No additional charges. A payment made in accordance with this
section shall constitute payment in full and the hospital or its agent
may not impose any additional charge--
(1) On the individual for I/T/U authorized items and services; or
(2) For information requested by the I/T/U or its agent or fiscal
intermediary for the purposes of payment determinations or quality
assurance.
Sec. 136.31 Authorization by urban Indian organization.
An urban Indian organization may authorize for purchase items and
services for an eligible urban Indian (as those terms are defined in 25
U.S.C. 1603(f) and (h)) according to section 503 of the IHCIA and
applicable regulations. Services and items furnished by Medicare-
participating inpatient hospitals shall be subject to the payment
methodology set forth in Sec. 136.30.
Sec. 136.32 Disallowance.
(a) If it is determined that a hospital has submitted inaccurate
information for payment, such as admission, discharge or billing data,
an I/T/U may as appropriate--
(1) Deny payment (in whole or in part) with respect to any such
services, and;
(2) Disallow costs previously paid, including any payments made
under any methodology authorized under this subpart. The recovery of
payments made in error may be taken by any method authorized by law.
(b) For cost based payments previously issued under this subpart,
if it is determined that actual costs fall significantly below the
computed rate actually paid, the computed rate may be retrospectively
adjusted. The recovery of overpayments made as a result of the adjusted
rate may be taken by any method authorized by law.
0
The Centers for Medicare & Medicaid Services is amending 42 CFR Chapter
IV, as set forth below:
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
0
3. The authority citation for part 489 continues to read as follows:
Authority: Sec. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart B--Essentials of Provider Agreements
0
4. A new Sec. 489.29 is added to subpart B to read as follows:
Sec. 489.29 Special requirements concerning beneficiaries served by
the Indian Health Service, Tribal health programs, and urban Indian
organization health programs.
(a) Hospitals (as defined in sections 1861(e) and (f) of the Social
Security Act) and critical access hospitals (as defined in section
1861(mm)(1) of the Social Security Act) that participate in the
Medicare program and furnish inpatient hospital services must accept
the payment methodology and no more than the rates of payment
established under 42 CFR part 136, subpart D as payment in full for the
following programs:
(1) A contract health service (CHS) program under 42 CFR part 136,
subpart C, of the Indian Health Service (IHS);
(2) A CHS program under 42 CFR part 136, subpart C, carried out by
an Indian Tribe or Tribal organization pursuant to the Indian Self-
Determination and Education Assistance Act, as amended, Public Law 93-
638, 25 U.S.C. 450 et seq.; and
(3) A program funded through a grant or contract by the IHS and
operated by an urban Indian organization under which items and services
are purchased for an eligible urban Indian (as those terms are defined
in 25 U.S.C. 1603 (f) and (h)).
(b) Hospitals and critical access hospitals may not refuse service
to an individual on the basis that the payment for such service is
authorized under programs described in paragraph (a) of this section.
[FR Doc. 07-2740 Filed 6-1-07; 8:45 am]
BILLING CODE 4165-16-P