57376 Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Proposed Rules 

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. 

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, 

Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Proposed Rules 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 § 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 § 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 

§ 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 § 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 § 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 § 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 

57378 Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Proposed Rules 

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. 

Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Proposed Rules 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 § 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 § 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 § 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 § 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 § 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 § 505.13, 

§ 505.15, and § 505.17, the loan would 

be forgiven. Therefore, we would send 

57380 Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Proposed Rules 

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 § 505.13, 

§ 505.15, and § 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. 

Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Proposed Rules 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: 

§ 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 

§ 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 § 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 § 505.15 of this 

subpart. 

§ 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. 

§ 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 § 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 § 505.7(b) of this part. 

§ 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 § 505.13, § 505.15, and 

§ 505.17 of this part, CMS will send a 

written notification of approval for loan 

57382 Federal Register / Vol. 70, No. 189 / Friday, September 30, 2005 / Proposed Rules 

forgiveness to the qualifying hospital 90 

days before the end of the loan 

deferment period defined in § 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 § 505.13, § 505.15, or 

§ 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