[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Proposed Rules]
[Page 57376-57382]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se05-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 Part CFR 505
[CMS-1320-P]
RIN 0938-AN93
Medicare Program; Health Care Infrastructure Improvement Program;
Forgiveness of Indebtedness
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would implement section 1016 of the
Medicare Prescription Drug, Improvement and Modernization Act of 2003
(MMA) (Pub. L. 108-173) by establishing the loan forgiveness criteria
for qualifying hospitals who receive loans under the Health Care
Infrastructure Improvement Program.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on November 29,
2005.
ADDRESSES: In commenting, please refer to file code CMS-1320-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments.
(Attachments should be in Microsoft Word, WordPerfect, or
Excel; however, we prefer Microsoft Word.)
2. By mail. You may mail written comments (one original and two
copies) to the following address ONLY: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-1320-
P, P.O. Box 8020, Baltimore, MD 21244-8020.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-9994 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201; or
7500 Security Boulevard, Baltimore, MD 21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Tzvi Hefter, (410) 786-4487 (For information on the loan terms).
Melinda Jones (410) 786-7069 (For information on loan forgiveness
criteria).
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this proposed rule to assist CMS in fully
considering issues and developing policies. You can assist CMS by
referencing the file code CMS-1320-P and the specific ``issue
identifier'' that precedes the section on which you choose to comment.
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. CMS posts all electronic
comments received before the close of the comment period on its public
Web site as soon as possible after they have been received. Hard copy
comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, at the headquarters of the Centers for
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore,
Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4
p.m. To schedule an appointment to view public comments, phone 1-800-
743-3951.
I. Background
Section 1016 of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended Title XVIII
of the Social Security Act (the Act) to establish section 1897 of the
Act, the Health Care Infrastructure Improvement Program (Loan Program).
Section 1897 of the Act authorizes the Secretary of the U.S. Department
of Health and Human Services (Secretary) to establish a loan program
that provides loans to qualifying hospitals for payment of the capital
costs of eligible projects.
Section 1897(c) as amended by Section 6045 of the Emergency
Supplemental Appropriations Act for Defense, the Global War on Terror,
and Tsunami Relief, 2005 (Tsunami Relief Act of 2005) (Pub. L. 109-13)
defines a qualifying hospital as a hospital or entity that is engaged
in research in the causes, prevention, and treatment of cancer; and is
designated as a cancer center by the National Cancer Institute (NCI) or
is designated by the State legislature as the official cancer institute
of the State and such designation by the State legislature occurred
prior to December 8, 2003. Section 1897(c)(3) of the Act also specifies
that an entity has the same meaning as specified in section 501(c)(3)
of the Internal Revenue Code of 1986 and is exempt from tax under
section 501(a) of the Code; has at least one existing memorandum of
understanding or affiliation agreement with a hospital located in the
State in which the entity is located; and retains clinical outpatient
treatment for cancer on site as well as lab research and education and
outreach for cancer in the same facility.
Section 1897(d) of the Act specifies that an eligible project is a
project of a qualifying hospital that is designed to improve the health
care infrastructure of the hospital, including construction,
renovation, or other capital improvements.
Section 1897(f) of the Act states that the Secretary may forgive a
loan provided to a qualifying hospital, under terms and conditions that
are analogous to the loan forgiveness provision for student loans under
part D of title IV of the Higher Education Act of 1965, (20 U.S.C.1087a
et seq.). However, the Secretary shall condition such forgiveness on
the establishment by the hospital of--(1) An outreach program for
cancer prevention, early diagnosis and treatment that provides services
to a substantial majority of the residents of the State or region,
including residents of rural areas; (2) an outreach program for cancer
prevention, early diagnosis,
[[Page 57377]]
and treatment that provides services to multiple Indian Tribes; and (3)
unique research resources (such as population databases); or an
affiliation with an entity that has unique research resources.
Also, section 1897(h) of the Act states that the Secretary shall
submit to Congress a report on the projects for which loans are
provided under this section and a recommendation as to whether Congress
should authorize the Secretary to continue loans under this section
beyond fiscal year 2008.
Furthermore, prior to the Tsunami Relief Act of 2005, section
1897(g)(1) of the Act appropriated $200,000,000 to carry out the loan
program. The funds allocated for the loan program are to remain
available during the period beginning on July 1, 2004, and ending on
September 30, 2008. However, the Congress rescinded $58,000,000 leaving
$142,000,000 available for the loan program. The statute also states
that not more than $2,000,000 can be used for the administration of the
loan program for each of the fiscal years (that is, 2004 through 2008).
No administrative funding was used in fiscal year 2004.
In addition, section 1897(i) of the Act as amended by section
6045(b) of the Tsunami Relief Act of 2005 states that there shall be no
administrative or judicial review of any determination made by the
Secretary under this section.
II. Provisions of the Proposed Regulation
Section 1897 of the Act authorizes the Secretary to establish a
loan program that provides loans to qualifying hospitals for payment of
the capital costs of qualifying projects. Section 1897 of the Act also
requires that criteria be established for--(1) selecting among
qualifying hospitals that apply to participate in the loan program; and
(2) the forgiving of indebtedness (hereinafter referred to as loan
forgiveness). This proposed rule would establish the loan forgiveness
criteria for qualifying hospitals that participate in the loan program.
We are publishing a separate rulemaking document for selecting
qualifying hospitals to participate in the Health Care Infrastructure
Improvement program (loan program).
A. Conditions for Loan Forgiveness (Proposed Sec. 505.13)
[If you choose to comment on issues in this section, please include the
caption ``Conditions for Loan Forgiveness'' at the beginning of your
comments.]
Section 1897(f) of the Act authorizes the Secretary to forgive a
loan provided to a qualifying hospital under terms and conditions that
are analogous to the loan forgiveness provision for student loans under
part D of title IV of the Higher Education Act of 1965 [20 U.S.C. 1087a
et seq.). The student loan program specifies that in order to be
eligible for loan forgiveness, borrowers are required to satisfy
certain conditions, such as, completing a service obligation which
satisfies certain terms and conditions as determined by the Secretary.
Therefore, we propose to apply the loan forgiveness model of the
student loan program and require that a hospital complete a service
obligation which satisfies certain terms and conditions in order to
qualify for loan forgiveness. That is, we are proposing that to fulfill
the service obligation borrowers must meet the loan forgiveness
conditions discussed herein that are based on section 1897(f) of the
Act which states that the Secretary shall condition such forgiveness on
the establishment by the hospital of--(1) an outreach program for
cancer prevention, early diagnosis, and treatment that provides
services to a substantial majority of the residents of a State or
region, including residents of rural areas; (2) an outreach program for
cancer prevention, early diagnosis, and treatment that provides
services to multiple Indian tribes; and (3) unique research resources
(such as population databases); or an affiliation with an entity that
has unique research resources.
In addition, we are proposing that the qualifying hospital must
submit a written request for loan forgiveness to CMS by the effective
date of the final rule.
Furthermore, we are proposing specific criteria that a qualifying
hospital must follow to meet the conditions for loan forgiveness.
B. Plan Criteria for Meeting the Conditions for Loan Forgiveness
(Proposed Sec. 505.15)
[If you choose to comment on issues in this section, please include the
caption ``Criteria for meeting the conditions for loan forgiveness'' at
the beginning of your comments.]
In order to qualify for loan forgiveness, the qualifying hospital
must meet the specific criteria proposed at Sec. 505.13. We would
organize the loan forgiveness criteria into 3 domains. These domains
are consistent with the section 1897(f)(A),(B), and (C) of the Act. The
three proposed domains are--(1) Outreach program for cancer prevention,
early diagnosis, and treatment that provides services to a substantial
majority of the residents of a State or region, including residents of
rural areas; (2) outreach program for cancer prevention, early
diagnosis, and treatment that provides services to multiple Indian
tribes; and (3) unique research resources (such as population
databases); or an affiliation with an entity that has unique research
resources.
In proposed Sec. 505.3, we would define ``outreach programs'' as
formal cancer programs for teaching, diagnostic screening, therapy or
treatment, prevention, or interventions to enhance the health and
knowledge of their designated population(s). Likewise, we are proposing
to define ``unique research resources'' as resources that are used for
the purpose of discovering or testing options related to the causes,
prevention, and treatment of cancer. We are soliciting comments on
these definitions.
We are proposing at Sec. 505.13(c) that the qualifying hospital
must submit to CMS by the timeframe specified by the Secretary the
following: (1) A written request for loan forgiveness; (2) a plan
describing how the qualifying hospital would establish, implement or
maintain existing outreach programs for its targeted populations; and
(3) how it would establish or maintain existing unique research
resources over the loan deferment period. We propose to make that
timeframe 60 days after the publication of the final rule.
We are also proposing in Sec. 505.15 that the qualifying hospital
designate in its plan, the population(s) for which it would target its
outreach programs and be held accountable in the assessment for loan
forgiveness. The qualifying hospital's target populations for the
outreach programs must include a substantial majority of the residents
of a State or region, including residents of rural areas and multiple
Indian tribes that the qualifying hospital services. We are proposing
that the qualifying hospital must describe how it would designate the
targeted populations to include residents of rural areas. CMS also
proposes that for a list of Indian tribes eligible for inclusion in the
target population, qualifying hospitals would refer to the notice on
``Indian Entities Recognized and Eligible to Receive Services from the
United States Bureau of Indian Affairs.'' The most recent notice was
published in the Federal Register on December 5, 2003 (68 FR 68180).
Qualifying hospitals should use this list when designating the target
population for outreach programs servicing multiple Indian tribes in
its plan to CMS.
We invite public comments on the type of information that must be
included in the plan and the timeframe
[[Page 57378]]
for a qualifying hospital to submit its plan to CMS. We are also
soliciting comments on whether we should provide more specific criteria
for the qualifying hospital to use in defining its targeted
populations.
We believe that 60 days after the final rule publication date is
reasonable time for qualifying hospitals intending to apply for loan
forgiveness to prepare and submit their initial plan, since the loan
deferment period is 60 months after notification of acceptance in the
program and the qualifying hospital would be assessed on its
performance during the loan deferment period.
Furthermore, we believe that requiring the qualifying hospitals to
submit a plan in which they would determine the targeted population,
the types of cancers (that is, the cancer types to be considered),
goals for improving prevention, diagnosis, and treatment, and the
measures to track their progress in reaching the goals provides
flexibility to the qualifying hospitals as they develop, implement, or
maintain their outreach programs.
We also believe that it is appropriate to request this level of
detail from the qualifying hospitals because section 1897(h) of the Act
requires the Secretary to submit a report to the Congress before fiscal
year 2008. The report must indicate the projects for which loans are
provided under this section and recommend whether the Congress should
authorize the Secretary to continue loans under beyond fiscal year
2008. Receiving this information from the qualifying hospitals is
necessary for the Secretary to make a fully informed recommendation to
the Congress.
1. Domain 1: Outreach Program That Services a Substantial Majority of
the Residents of a State or Region, Including Residents of Rural Areas
We are proposing that the qualifying hospitals plan include a
description of how it would establish, develop, implement, or maintain
an existing outreach program that services a substantial majority of
the residents of a State or region, including residents of rural areas
for cancer prevention, early diagnosis, and treatment over the loan
deferment period including proposed intervention approaches. The plan
must--(1) identify the target population in accordance with section
1897(f)(A) of the Act; (2) identify the cancer type(s) that would be
included in the outreach program and how they were determined; (3)
describe the intervention approaches it would consider using in its
outreach program; (4) propose goals for improvement in each of the
three areas (that is, prevention, early diagnosis, and treatment)
during the loan deferment period for each cancer type identified; and
(5) identify measures that would be used to track annual progress in
meeting the proposed goals in the three areas for each cancer type
identified.
2. Domain 2: Outreach Program That Services Multiple Indian Tribes
We are proposing that the qualifying hospitals plan include a
description of how it would establish or develop, implement, or
maintain an existing outreach program that services multiple Indian
Tribes for cancer prevention, early diagnosis, and treatment over the
loan deferment period including proposed intervention approaches. The
plan must--(1) designate the target population using the notice on
``Indian Entities Recognized and Eligible to Receive Services from the
United States Bureau of Indian Affairs'' published in the Federal
Register on December 5, 2003 (68 FR 68180), in order to meet the
requirements at section 1897(f)(B) of the Act; (2) identify the cancer
type(s) that would be included in the outreach program and how they
were determined; (3) describe the intervention approaches it would
consider using in its outreach program; (4) propose goals for
improvement in each of the three areas (that is, prevention, early
diagnosis, and treatment) during the loan deferment period for each
cancer type identified; and (5) identify measures that would be used to
track annual progress in meeting the proposed goals in the three areas
for each cancer type identified.
3. Domain 3: Unique Research Resources or an Affiliation With an Entity
That Has Unique Research Resources
We are proposing that the qualifying hospital would describe in its
plan how it would establish or maintain existing unique research
resources or an affiliation with an entity that has unique research
resources and what those unique resources are.
C. Proposed Plan Criteria
1. Targeted Population
For targeting multiple Indian tribes, we are proposing that
qualifying hospitals refer to the notice on ``Indian Entities
Recognized and Eligible to Receive Services from the United States
Bureau of Indian Affairs.'' The most recent notice was published in the
Federal Register on December 5, 2003 (68 FR 68180). Qualifying
hospitals would use this list when designating the target population
for outreach programs servicing multiple Indian tribes since these are
the Indian tribes that have unique legal status under Federal law.
For other target populations, we are not proposing how the
qualifying hospital should determine or designate the population as
long as it encompasses a substantial majority of the residents of a
State or region, including residents of rural areas that it services.
We believe that the qualifying hospital is in the best position to
designate the targeted populations for their outreach programs to the
substantial majority of residents and to rural areas. We believe that
allowing the qualifying hospital to designate its populations provides
flexibility over the life of the loan deferment period as its
populations change due to results from its outreach programs, treatment
services, or other reasons. However, we are proposing that the
qualifying hospital provide sufficient detail in its initial plan to
clearly describe how it designated its targeted populations and that
the populations designated should be in accordance with the provisions
of the statute. The qualifying hospital should include in the plan such
details as demographic information for the targeted population
generally and some initial estimates of relevant rates of diagnosis of
and death from cancers prevalent in its population(s).
2. Identification of the Cancer Types
In this proposed rule, we are not proposing specific cancers (or
the number of cancer types) that the qualifying hospital must focus on
in its outreach programs. Again, we believe that the qualifying
hospital is in the best position to determine the types of cancer to
target in its outreach programs and that allowing the qualifying
hospital to determine the cancer types provides flexibility over the
life of the loan deferment period as the population changes or cancer
prevention and treatment services improve. However, we are proposing
that the qualifying hospital provides sufficient detail in its initial
plan to clearly describe how it would identify the cancer types that it
is targeting. The reasons for selecting specific cancers may include
such things as high prevalence or incidence, high mortality or
morbidity, easily treatable, available screening techniques, and easily
diagnosed. The four most common cancers--prostate, breast, lung, and
colon/rectum--accounted for more than half of all new cases of cancer
in 1998 and qualifying hospitals may wish to target these cancers in
their outreach programs. [National Cancer Policy Board (IOM). Ensuring
Quality Cancer Care.
[[Page 57379]]
Washington DC: National Academy Press, 1999]
3. Intervention Approaches
In this propose rule, we are not mandating specific intervention
approaches that the qualifying hospital must conduct in its outreach
programs. We believe that the qualifying hospital is in the best
position to determine the types of interventions to implement based on
its target population and the types of cancers included in its outreach
programs. We believe that allowing the qualifying hospital to determine
its specific interventions provides flexibility to the qualifying
hospital to try different approaches over the life of the loan
deferment period. However, we are proposing that the qualifying
hospital provide sufficient detail in its initial plan and subsequent
progress reports to clearly describe the approaches it will be
conducting or implementing, including the reasons why the intervention
approaches were selected and why they may make a difference in
improving cancer care for the targeted population.
4. Goals for Improvement
We are proposing in Sec. 505.15 that the qualifying hospital
include in its plan, improvement goals for the prevention, early
diagnosis, and treatment, for each cancer type identified in its
outreach programs. The qualifying hospital must work towards these
goals during the loan deferment period. We believe that it is important
to establish goals for improving performance over the loan deferment
period as one way to document the potential impact of its outreach
programs on improvement in the care provided to the targeted
populations. This would help the qualifying hospital determine if its
outreach programs are getting the desired results.
As previously indicated, we are not proposing specific goals for
the qualifying hospital to achieve. However, we are proposing that the
qualifying hospital must determine its own improvement goals for each
cancer type (that is for the prevention, early diagnosis, and
treatment). We believe that it is important for the qualifying hospital
to determine its own goals because it is in the best position to know
or understand the various factors or barriers in its population
(community) that may influence the achievement of the goals and work
towards overcoming them. For example, if the qualifying hospital
selects breast cancer as one of the cancer types it would focus on for
the designated population, the qualifying hospital may select a goal of
decreasing the number of new initial breast cancer diagnosis or cases
by 10 percent from the previous year (a prevention goal), or select a
goal of increasing the number of mammograms performed by 10 percent
from the previous year (an early diagnosis goal), or select a goal of
increasing the number of patients who receive their first treatment
after initial diagnosis within the time period specified by the
appropriate clinical practice guidelines (a treatment goal). We
understand that there are many factors to take into account when
selecting goals, but we believe that it is important for the qualifying
hospital to work towards established goals so that it can determine if
its outreach programs are having the desired effect and changes to its
outreach approaches can be made as needed.
5. Measures
We are proposing in Sec. 505.17 that the qualifying hospital
include in its initial plan at least one measure (for example, either
an outcome measure or a process measure) used to track its progress in
achieving the goals it has established for each area of prevention,
early diagnosis, and treatment, for each cancer type identified in its
plan. We are not proposing the specific measures that the qualifying
hospital should track because we believe that the qualifying hospital
is in the best position to determine the appropriate measures.
Furthermore, we believe that it provides flexibility and allows the
goals to be revised because of various factors or barriers (for
example, community) that may influence the achievement of the goal to
have changed. For example, if the qualifying hospital identifies lung
cancer as one of the cancer types it would focus on for the designated
population, the qualifying hospital may select the percent of patients
enrolled in smoking cessation sessions and who quit smoking for 1 year
or more as a measure to track its prevention goal. The qualifying
hospital may select the percent of patients at high risk for developing
lung cancer who receive a screening test as a measure to track its
early diagnosis goal, and it may select the percent of patients who
were initially diagnosed with lung cancer and received the appropriate
treatment timely to track its treatment goal. The goal that is selected
should drive what measure is selected for tracking the goal, such as
goals for early diagnosis and treatment.
6. Unique Research Resources
We are proposing in Sec. 505.15(b) that the qualifying hospital
include in its plan a description of how it would establish or maintain
existing unique research resources or how it would establish or
maintain an existing affiliation with another entity that has unique
research resources. Examples of unique research resources are a
population database, a cancer biomedical informatics system, a
surveillance system for observing or measuring cancer incidence,
morbidity, survival, and/or mortality, an epidemiology study, an end
results database, or a tumor registry. We are soliciting comments on
other unique research resources that may be available.
D. Reporting Requirements for Meeting the Conditions for Loan
Forgiveness (Proposed Sec. 505.17)
[If you choose to comment on issues in this section, please include the
caption ``Reporting Requirements'' at the beginning of your comments.]
We are proposing that the qualifying hospital must submit annual
progress reports to CMS describing its progress in achieving its plan
or any changes to the initial plan. We would review the annual progress
reports and provide feedback to the qualifying hospital, so that it is
aware of its loan forgiveness status during the loan deferment period.
Annual progress reports from the qualifying hospital would allow us
to monitor the qualifying hospitals performance in meeting the
conditions for loan forgiveness during the loan deferment period. We
intend to monitor the qualifying hospitals' performance during the
entire loan deferment period to ensure that these qualifying hospitals
meet the conditions for loan forgiveness. We would require qualifying
hospitals to submit the final progress report to us 6 months before the
end of the loan deferment period. At that time, we would determine
whether the qualifying hospital has met the loan forgiveness
conditions. We are proposing this timeframe since determinations of
loan forgiveness must be made at the end of 5 years.
E. Approval or Denial of Loan Forgiveness (Proposed Sec. 505.19)
[If you choose to comment on issues in this section, please include the
caption ``Approval or Denial of loan forgiveness'' at the beginning of
your comments.]
We are proposing that if a qualifying hospital meets the
conditions, plan criteria, and reporting requirements for loan
forgiveness specified in Sec. 505.13, Sec. 505.15, and Sec. 505.17,
the loan would be forgiven. Therefore, we would send
[[Page 57380]]
written notification for the loan forgiveness approval to the loan
recipient 90 days before the end of the loan deferment period. We are
proposing that if the loan recipient does not meet the conditions, plan
criteria, or reporting requirements for the loan forgiveness specified
in Sec. 505.13, Sec. 505.15, and Sec. 505.17, we would send written
notification for the denial of the loan forgiveness.
III. Collection of Information Requirements
The collection of information requirements at 5 CFR part 1320 are
applicable to requirements affecting 10 or more entities. While this
proposed rule contains information collection requirements, because we
believe that these requirements would affect less than 10 entities, we
believe that these collection requirements are exempt from OMB for
review and approval, as specified at 5 CFR 1320.3(c)(4). Consequently,
this proposed rule need not be reviewed by the Office of Management and
Budget under the authority of the Paperwork Reduction Act of 1995.
IV. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents, we are not able to acknowledge
or respond to them individually. We will consider all comments we
receive by the date and time specified in the DATES section of this
preamble. Thus, when we proceed with a subsequent document, we will
respond to the comments in the preamble to that document.
V. Regulatory Impact
A. Overall Impact
We have examined the impacts of this proposed 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 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) 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 proposed rule is not a major rule because it does not have an
effect of more than $100 million in any 1 year.
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 small governmental
jurisdictions. 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. For purposes of the RFA, all
hospitals are considered small businesses according to the Small
Business Administration's latest size standards with total revenues of
$26 million or less in any 1 year (for further information, see the
Small Business Administration's regulation at 65 FR 69432, November 17,
2000). Individuals and States are not included in the definition of a
small entity. This proposed rule affects qualifying hospitals as
defined by section 1897 of the Act that have been selected to receive
funds under the loan program. We believe a total of 61 facilities meet
the definition of qualifying hospitals under section 1897 of the Act
(that is, 60 NCI cancer centers and 1 State legislature designated
cancer institute, but only a few hospitals would actually be selected
to receive funds under the loan program and be eligible for loan
forgiveness).
In addition, section 1102(b) of the Act requires CMS 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, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. None of the eligible
facilities are 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 who mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. This proposed rule does
not mandate any requirements for State, local, or tribal governments,
nor would it result in expenditures by the private sector of $120
million in any 1 year.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Section 1897 of the Act directly specifies that no
provisions under the Program implemented by this proposed rule would
relieve an obligation of State and local permits or limit or otherwise
supersede any State or local law.
B. Anticipated Effects
1. Effects on Hospitals
The provisions of this proposed rule are limited to qualifying
hospitals that have received funds under the loan program and are
eligible for loan forgiveness. Only 61 facilities would meet the
definition of qualified hospitals as required by section 1897 of the
Act. Since the capital costs of projects which the loan program is
designed to pay for are likely to be substantial and expensive, we
expect only a small percentage of the 61 eligible facilities would
actually be granted loans under this provision before the funds are
exhausted and therefore be eligible for loan forgiveness. For the few
qualifying hospitals that would receive funds under the loan program,
we expect they would use the money on projects that are ``designed to
improve the healthcare infrastructure of the hospital including
construction, renovation, or other capital improvements'' and which
would result in better facilities in which to provide cancer care to
our beneficiaries. To qualify for loan forgiveness, the qualifying
hospitals must meet the conditions specified in section 1897(f) of the
Act, which we believe would positively impact the cancer care our
beneficiaries receive. As well, the qualifying hospitals would realize
a benefit when their loans are forgiven. However, we believe that the
effect would be limited to those few qualifying hospitals that have
received loan funds and are eligible for loan forgiveness. Thus, the
provisions in this proposed rule would not have a significant economic
impact on a substantial number of hospitals.
2. Effects on the Medicare and Medicaid Programs
The $142 million in available loan funds is appropriated for the
loan program and not more than $2,000,000 may be used for the
administration costs of the loan program.
[[Page 57381]]
C. Alternatives Considered
We considered no alternatives to the policies in this proposed rule
since the statute authorizes the conditions under which the Secretary
may forgive a loan provided under the Health Care Infrastructure
Improvement Program.
D. Conclusion
For these reasons, we are not preparing further analyses for either
the RFA or section 1102(b) of the Act because we have determined that
this rule would not have a significant economic impact on a substantial
number of small entities or a significant impact on the operations of a
substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 505
Administrative practice and procedure, Health facilities, Loan
programs, Infrastructure improvement program, Reporting and
recordkeeping, and Rural areas.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services is proposing to amend 42 CFR chapter IV as follows:
SUBCHAPTER H--HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM
PART 505--THE ESTABLISHMENT OF THE HEALTH CARE INFRASTRUCTURE
IMPROVEMENT PROGRAM
1. The authority citation for part 505 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C 1302 and 1395hh).
2. In 505.3 is amended by republishing the introductory text and
adding the following definitions in alphabetical order to read as
follows:
Sec. 505.3 Definitions
For purposes of this subpart, the following definitions apply:
* * * * *
Outreach programs mean formal cancer programs for teaching,
diagnostic screening, therapy or treatment, prevention, or
interventions to enhance the health and knowledge of their designated
population(s).
* * * * *
Unique research resources means resources that are used for the
purpose of discovering or testing options related to the causes,
prevention, and treatment of cancer.
3. A new Subpart B is added to read as follows:
Subpart B--Forgiveness of Indebtedness
Secs.
505.13 Conditions for loan forgiveness.
505.15 Plan criteria for meeting the conditions for loan
forgiveness.
505.17 Reporting requirements for meeting the conditions for loan
forgiveness.
505.19 Approval or denial of loan forgiveness.
Subpart B--Forgiveness of Indebtedness
Sec. 505.13 Conditions for loan forgiveness.
The Secretary may forgive a loan provided under this part if the
qualifying hospital meets the following conditions:
(a) Must be selected to participate in the loan program specified
in Sec. 505.5(c) of this part.
(b) Has established the following:
(1) An outreach program for cancer prevention, early diagnosis, and
treatment that provides services to a substantial majority of the
residents of a State or region, including residents of rural areas;
(2) An outreach program for cancer prevention, early diagnosis, and
treatment that provides services to multiple Indian tribes; and
(3) Unique research resources (such as population databases) or an
affiliation with an entity that has unique research resources.
(c) Submits to CMS within the timeframe specified by the Secretary
a--
(1) Written request for loan forgiveness; and
(2) Loan forgiveness plan that meets the criteria specified in
Sec. 505.15 of this subpart.
Sec. 505.15 Plan criteria for meeting the conditions for loan
forgiveness.
The qualifying hospital requesting loan forgiveness must submit to
CMS a plan specifying how it will develop, implement, or maintain an
existing outreach program for cancer prevention, early diagnosis, and
treatment for a substantial majority of the residents of a State or
region, including residents of rural areas and for multiple Indian
Tribes and specifying how the qualifying hospital will establish or
maintain existing unique research resources or an affiliation with an
entity that has unique research resources.
(a) Outreach programs. The initial plan must specify how the
hospital will establish or develop, implement, or maintain existing
outreach programs. The plan must--
(1) Address cancer prevention for cancers that are prevalent in the
designated populations or cancers that are targeted by the qualifying
hospital, interventions, and goals for decreasing the targeted cancer
rates during the loan deferment program; and
(2) Address early diagnosis of cancers that are prevalent in the
designated populations or cancers that are targeted by the qualifying
hospital, interventions, and goals for improving early diagnosis rates
for the targeted cancer(s) during the loan deferment period;
(3) Address cancer treatment for cancers that are prevalent in the
designated populations or cancers that are targeted by the qualifying
hospital, interventions, and goals for improving cancer treatment rates
for the targeted cancer(s) during the loan deferment; and
(4) Identify the measures that will be used to determine the
qualifying hospital's annual progress in meeting the initial goals
specified in paragraphs (a)(1) through (a)(3) of this section.
(b) Unique research resources. The plan must specify how the
qualifying hospital will establish or maintain existing unique research
resources or an affiliation with an entity that has unique research
resources.
Sec. 505.17 Reporting requirements for meeting the conditions for
loan forgiveness.
(a) Annual reporting requirements. On an annual basis, the
qualifying hospital must submit a report to CMS that updates the plan
specified in Sec. 505.15 of this subpart by--
(1) Describing the qualifying hospital's progress in meeting its
initial plan goals;
(2) Describing any changes to the qualifying hospital's initial
plan goals; and
(3) Including at least one measure used to track the qualifying
hospital's progress in meeting its plan goals.
(b) Review of annual reports. CMS will review each qualifying
hospital's annual report to provide the hospital with feedback
regarding its loan forgiveness status.
(c) Final reporting requirements. A qualifying hospital must submit
its final written report to CMS 6 months before the end of the loan
deferment period specified in Sec. 505.7(b) of this part.
Sec. 505.19 Approval or denial of loan forgiveness.
(a) Approval of loan forgiveness. If a qualifying hospital has met
the conditions, plan criteria, and reporting requirements for loan
forgiveness specified in Sec. 505.13, Sec. 505.15, and Sec. 505.17
of this part, CMS will send a written notification of approval for loan
[[Page 57382]]
forgiveness to the qualifying hospital 90 days before the end of the
loan deferment period defined in Sec. 505.7(b) of this part.
(b) Denial of loan forgiveness. If a qualifying hospital has not
met the conditions, plan criteria, or reporting requirements for loan
forgiveness specified in Sec. 505.13, Sec. 505.15, or Sec. 505.17 of
this part, CMS will send a written notification of denial for loan
forgiveness to the qualifying hospital.
Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: June 28, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: August 3, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-19307 Filed 9-23-05; 4:00 pm]
BILLING CODE 4120-03-P