[Federal Register Volume 69, Number 79 (Friday, April 23, 2004)]
[Notices]
[Pages 22065-22079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9127]



[[Page 22065]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-5004-N]


Medicare Program; Voluntary Chronic Care Improvement Under 
Traditional Fee-for-Service Medicare

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice informs interested parties of an opportunity to 
apply to implement and operate a chronic care improvement program as 
part of Phase I (CCI-I) of the Voluntary Chronic Care Improvement Under 
Traditional Fee-for-Service (FFS) Medicare initiative as authorized by 
section 721 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Pub. L. 108-173).
    Eligible Organizations: Organizations eligible to apply to 
implement and operate chronic care improvement programs under CCI-I 
include: (1) Disease management organizations; (2) health insurers; (3) 
integrated delivery systems; (4) physician group practices; (5) a 
consortium of entities; or (6) any other legal entity that meets the 
requirements of this notice.

FOR FURTHER INFORMATION CONTACT: For information concerning this 
initiative, contact Raymond Wedgeworth, CMS Project Officer, at (410) 
786-6676, or [email protected].

DATES: Applications must be received on or before 5 p.m. e.s.t. on 
August 6, 2004, to be considered.

ADDRESSES: Mail applications to: Centers for Medicare & Medicaid 
Services, Attention: Raymond Wedgeworth, Mail Stop: C4-15-17, 7500 
Security Boulevard, Baltimore, Maryland 21244.
    Because of staff and resource limitations, we cannot accept 
applications by facsimile (FAX) transmission or by e-mail.
    Format: Applicants must submit a completed Medicare Waiver 
Application. Although this is not a demonstration, CCI-I will contain 
study elements, such as a control group and an evaluation. For this 
reason, we have decided to use the Medicare Waiver Application as the 
most appropriate available tool at this time. Application forms may be 
found online at: http://www.cms.hhs.gov/medicarereform/ccip/default.asp. Please refer to the file code CMS-5004-N in the upper 
right hand corner on your application cover page. Detailed instructions 
for completing and submitting applications appear with the application 
form and are supplemented by information in the ``Requirements for 
Submission'' section of this notice.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 721 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003, Pub. L. 108-173, adds a new section 1807 
``Voluntary Chronic Care Improvement Under Traditional Fee-for-Service 
(FFS) Medicare'' to the Social Security Act (the Act). Section 
1807(a)(1) of the Act specifies that the Secretary shall provide for 
the phased-in development, testing, evaluation, and implementation of 
chronic care improvement programs. Each program shall be designed to 
improve clinical quality and beneficiary and provider satisfaction and 
achieve spending targets with respect to expenditures for targeted 
beneficiaries with one or more threshold conditions. Section 1807(c)(1) 
of the Act requires the Secretary to enter into agreements to expand 
the implementation of CCI programs or components to additional 
geographic areas, which may include the implementation of CCI on a 
national basis, if CCI-I programs meet certain statutory requirements. 
This initiative represents one of multiple strategies that the 
Department of Health and Human Services (DHHS) is developing and 
testing to improve chronic care, accelerate the adoption of health 
information technology, reduce avoidable costs, and diminish health 
disparities among Medicare beneficiaries nationally.
    In CCI-I, the Centers for Medicare and Medicaid Services (CMS) 
plans to test programs in approximately ten areas in which in the 
aggregate at least 10 percent of the Medicare FFS population resides. 
In these initial programs, we will focus primarily on implementing and 
evaluating programs for beneficiaries with congestive heart failure 
(CHF) and/or diabetes with significant co-morbidities (hereafter 
referred to as complex diabetes). In one or two areas, we may focus on 
beneficiaries with chronic obstructive pulmonary disease (COPD). The 
Secretary will define the selection criteria and prospectively identify 
at least 30,000 beneficiaries in each area, split between intervention 
and control groups.
    One awardee will be selected per area to offer intervention group 
beneficiaries services in CCI-I. Organizations will provide support in 
improving beneficiaries' self-care and provide them and their providers 
enhanced information and information tools to increase adherence to 
evidence-based care. As specified in sections 1807(a)(3) and section 
1807(d)(3) of the Act, participation in the programs will be voluntary 
and will not change the amount, duration or scope of participants' FFS 
Medicare benefits. FFS Medicare benefits will continue to be covered, 
administered and paid under the traditional FFS Medicare program. 
Programs will be of no charge to the beneficiary. Awardees will not be 
able to restrict beneficiary access to care (for example, there can be 
no utilization review or gatekeeper function) or restrict beneficiaries 
to a limited number of doctors in a network.
    We are particularly interested in applications for programs in 
geographic areas (for example, States, metropolitan statistical areas) 
that have a high prevalence of CHF and/or diabetes, or COPD among 
Medicare FFS beneficiaries and poor Medicare quality rankings compared 
to national averages. Applicants may propose to serve one or more 
areas, but we may request that applicants adjust their proposed service 
areas to ensure that the population is of an appropriate size and does 
not interfere with current FFS chronic care demonstrations.
    As specified in section 1807(f)(2)(A) of the Act, awardees will be 
paid a monthly fee per participant; however, payment will be contingent 
on improvements in clinical quality of care, beneficiary and provider 
satisfaction, and savings to Medicare in the intervention groups 
compared to control groups. The planned duration of CCI-I is three 
years.
    CCI-I programs will be evaluated by an independent evaluator per 
section 1807(b)(5) of the Act.
    The principal objectives of CCI-I are to develop and test new 
strategies to improve quality of care and beneficiary and provider 
satisfaction cost-effectively for chronically ill FFS Medicare 
beneficiaries that are scalable, replicable and adaptable nationally.

A. Program Authorization

    Section 1807(b) of the Act requires the Secretary to provide for 
the phased-in development, testing, evaluation, and implementation of 
chronic care improvement programs. The purpose of Phase I, the 
developmental phase of the Voluntary Chronic Care Improvement Under 
Traditional FFS Medicare initiative (CCI), is to develop and test, 
through randomized controlled trials, the cost-effectiveness of 
programs for target populations that may benefit from program 
participation. The Secretary will evaluate whether quality of care

[[Page 22066]]

and satisfaction improve for targeted beneficiaries with threshold 
conditions and will ensure that Medicare expenditures, including CCI 
fees, for these programs do not exceed what estimated Medicare 
expenditures would have been for the targeted populations in the 
absence of the CCI programs.

B. Concerns

    Widespread failings in chronic care management are a major national 
concern. Many of these failings stem from systemic problems rather than 
lack of effort or intent by providers to deliver high quality care. 
Medicare beneficiaries are disproportionately affected because they 
typically have multiple chronic health problems. (Anderson, G. 
Testimony before the Subcommittee on Health of the House Committee on 
Ways and Means, Hearing on Promoting Disease Management in Medicare. 16 
April 2002. http://www.partnershipforsolutions.org/DMS/files/4_16_02_testimony.doc). Beneficiaries who have multiple progressive chronic 
diseases are a large and costly subgroup of the Medicare population: 
Medicare beneficiaries with five or more chronic conditions represent 
20 percent of the Medicare population but 66 percent of program 
spending.
    Congestive Heart Failure (CHF) and diabetes are among the five most 
common chronic diseases in the Medicare population. Beneficiaries with 
these diseases tend to have complex self-care regimens and medical care 
needs. In addition, many of these beneficiaries have other chronic 
conditions that add to their self-care burdens and risks of developing 
co-morbid conditions, complications, and acute care crises. The health 
risks of these beneficiaries depend heavily on how effectively they are 
able to control their conditions in their daily lives and whether or 
not they receive appropriate medical care and effective coordination of 
their care. Controlling their conditions successfully may require 
ongoing guidance and support beyond individual provider settings.
    According to findings from the 1999 Medicare Current Beneficiary 
Survey, individuals with CHF represent 14 percent of non-
institutionalized FFS Medicare beneficiaries and account for 43 percent 
of Medicare expenditures, including treatment for all their health 
problems. Individuals with diabetes represent 18 percent of 
beneficiaries and 32 percent of FFS Medicare expenditures. (Foote, S. 
Population-based Disease Management in Fee-For-Service Medicare. Health 
Affairs, Web Exclusive, 30 July 2003, W3-350.). Each year, 10 percent 
of the Medicare population accounts for two-thirds of all Medicare FFS 
program payments. (Centers for Medicare and Medicaid Services. CMS 
Chart Book June 2002 edition, Section III. A, p. 29.) Many of these 
high-cost beneficiaries suffer from progressive chronic diseases, such 
as CHF and/or diabetes, and most of the Medicare expenditures for their 
care are for multiple and often preventable hospitalizations.
    Prevalence rates of diabetes and CHF are even higher among 
minorities than among all Medicare beneficiaries. For example, the 
Centers for Disease Control and Prevention reports that 23.0 percent of 
black males and 23.5 percent of Hispanic males ages 65-74 have diabetes 
compared to 16.4 percent of white males and 15.4 percent of all 
individuals in that age group. Black and Hispanic females in that age 
group have diabetes prevalence rates of 25.4 percent and 23.8 percent, 
respectively, compared to 12.8 percent for white females and 15.4 
percent for all individuals in that age group. (Centers for Disease 
Control and Prevention, National Center for Chronic Disease Prevention 
and Health Promotion, Diabetes Surveillance System. See www.cdc.gov/diabetes/statistics/prev/national/f5dt2000.htm. Given these prevalence 
figures, improving quality and adherence to evidence-based care should 
also improve outcomes and thus reduce racial and ethnic disparities, 
which is consistent with HHS' Healthy People 2010 goals.
    The Institute of Medicine's landmark report Crossing the Quality 
Chasm: A New Health System for the 21st Century (National Academy 
Press, 2001) highlighted the challenges of assuring that patients with 
major chronic conditions such as CHF and diabetes receive adequate 
care. The current health care delivery system is structured and 
financed to manage acute care episodes, not to manage and support 
individuals with progressive chronic diseases. Providers of care are 
organized and paid for services provided in discrete settings (for 
example, hospitals, physician offices, home health care, long-term 
care, preventive services, etc.). Some literature supports an argument 
that provider incentives favor focusing on each patient only while he 
or she is within the provider's care setting. (Todd, W. and Nash, T., 
eds. Disease Management, A Systems Approach to Improving Patient 
Outcomes). Patient care can be fragmented and poorly coordinated and 
patient information difficult to integrate among settings as patients 
move from one care setting to another. Providers may lack timely and 
complete patient clinical information to fully assess their patients' 
needs and to help prevent complications. Ongoing support to 
beneficiaries for managing their conditions outside their physicians' 
offices is rare.
    Fragmentation of care is a particularly serious problem for 
Medicare beneficiaries. The average Medicare beneficiary sees seven 
different physicians and fills upwards of 20 prescriptions per year. 
(Anderson, G. Chronic Conditions: Making the Case for Ongoing Care. 
Partnership for Solutions and the Robert Wood Johnson Foundation, p. 
4). In a recent survey, 18 percent of people with chronic conditions 
reported having duplicate tests or procedures and 17 percent received 
conflicting information from providers. (Anderson, p. 32) Providers 
reported feeling ill-prepared to manage chronically ill patients and 
reported that poor coordination of care led to poor outcomes. 
(Anderson, p. 36).
    The gap between what we know is appropriate care for patients with 
chronic diseases and the care they actually receive is significant. 
According to findings of a recent national study, only 56 percent of 
patients with chronic diseases received recommended care based on well-
established guidelines referenced by the researchers. Among patients in 
the study sample who had CHF, only 64 percent received recommended 
care, and among those with diabetes, only 45 percent received 
recommended care. Specifically, only 24 percent of diabetes patients in 
the study received three or more glycosylated hemoglobin tests over a 
two-year period. (McGlynn, E., Asch, S., Adams, J., Keesey, J., Hicks, 
J., DeCristofaro, A., Kerr, E. The Quality of Health Care Delivered to 
Adults in the United States. New England Journal of Medicine. 2003; 
348:26:2635-2645). Similarly, in a recent study of practice patterns 
under Medicare, researchers found that, across all States, an average 
of 66 percent of Medicare beneficiaries with heart failure received ACE 
inhibitors and 16 percent with diabetes received a lipid test. (Jencks, 
S., Huff, E., Cuerdon, T. Change in the Quality of Care Delivered to 
Medicare Beneficiaries, 1998-1999 to 2000-2001. Journal of the American 
Medical Association. 2003; 289; 305-312).
    Quality of care is not a function of regional spending levels under 
FFS Medicare. In a carefully controlled national study, Fisher et al., 
found that, ``quality of care in higher-spending regions was no better 
on most measures and was worse for several preventive measures.'' 
(Fisher, E.S., Wennberg,

[[Page 22067]]

D.E., Stukel, T.A., Gottlieb, D.J., Lucas, F.L., Pinder, E.L. The 
implications of regional variations in Medicare spending. Part 1: The 
content, quality, and accessibility of care. Ann Intern Med. 2003; 
138:273-87). Thus, managing care in a cost-effective manner may in fact 
raise the quality of care delivered if incentives are properly 
designed.
    Moreover, health information technology is expected to improve 
quality and fundamentality change the way health care is provided 
(Institute of Medicine, IOM 2004) by providing actionable evidence at 
the point of care, reducing errors, duplicate tests, unnecessary 
admissions, adverse events, and rejected claims.

C. Current Chronic Care Improvement Initiatives

    Many payers in the private sector have begun sponsoring chronic 
care improvement initiatives, such as disease management and intensive 
case management programs, in an attempt to address pervasive problems 
in ensuring that chronically ill individuals receive appropriate care. 
The intensive case management programs are typically designed to assist 
patients who develop costly and complex medical care needs and who need 
help arranging for appropriate care. Private sector disease management 
programs often include: Patient self-care support, provider information 
support, and use of integrative clinical information systems to collect 
and synthesize patient information from the fragmented segments of the 
health care delivery system. These disease management programs are 
often designed to--

 Supply providers with timely, actionable clinical 
information regarding their patients;
 Provide clinical decision support for patients and 
providers based on evidence-based guidelines;
 Promote care coordination; and
 Guide and encourage patients in adhering to 
prescribed care management plans and self-care regimens.

The programs are also typically designed to ensure that preventive 
measures are taken when appropriate (for example, screening tests) and 
to prevent or mitigate complications that may result in costly 
hospitalizations or emergency room visits. In most programs, individual 
participants are assessed and stratified by their risk levels and self-
care concerns, permitting interventions to be targeted based on 
individual needs. Some programs also provide social services, 
transportation, and tracking of prescription medications.
    While many private sector disease management programs initially had 
a single-disease focus, many organizations today are attempting to 
support patients in managing their self-care holistically, including 
all their co-morbid conditions, regardless of the threshold condition 
that triggered eligibility for the program.
    Many of the current private sector disease management programs are 
population-based, meaning that organizations are held accountable to 
improve quality and cost outcomes for prospectively identified target 
populations. Organizations often agree to put some of their fees at 
risk if they fail to achieve savings. Organizations often stratify 
individuals according to risk and tailor interventions to reflect the 
intensity of changing individual needs; however, the programs are 
responsible for achieving performance standards across the identified 
population, regardless of which interventions are provided.
    The National Committee for Quality Assurance (NCQA), the American 
Accreditation Healthcare Commission/URAC and the Joint Commission on 
Accreditation of Healthcare Organizations (JCAHO) have developed 
quality standards and certification programs for disease management 
programs.
    The chronic care improvement programs to be tested under CCI-I will 
have some program characteristics in common with the aforementioned 
private sector disease management programs, but will need to be adapted 
to suit the unique needs of beneficiaries in the FFS Medicare 
environment.

II. Provisions of This Notice

A. Purpose/Design

    Section 1807 of the Act authorizes the Secretary to begin building 
chronic care improvement programs under the Medicare FFS program, 
incorporating relevant features from private sector programs, but 
allowing sufficient flexibility for us and the awardees to adapt the 
design of CCI-I programs to meet the unique needs of the Medicare 
population. For example, applicants will need to consider how to serve 
individuals with complex problems that might typically be referred for 
case management under private sector plans since FFS Medicare does not 
operate an intensive case management program. Organizations will have 
the latitude to stratify targeted beneficiaries according to risk and 
need and to tailor interventions to the unique needs of FFS Medicare 
beneficiaries, including self-care and caregiver support, care 
coordination, education, and use of in-home monitoring devices as 
appropriate.
    As specified in section 1807(f)(3)(B)(ii) of the Act, the 
organizations will also be required to agree to assume financial risk 
in the event of failure to meet agreed upon performance guarantees for 
clinical quality, beneficiary and provider satisfaction and savings 
targets. We have established that financial risk is fee risk. Thus, we 
believe that the chronic care improvement organizations in CCI-I will 
have strong incentives to reach the targeted beneficiaries and their 
providers on a continuing basis to help them improve chronic care 
management. The CCI-I organizations will be expected to track and 
improve the health outcomes of all identified members of their 
intervention group, not just those who seek treatment during a given 
time period.
1. Eligible Organizations
    Section 1807(a)(2)(B) of the Act defines the organizations eligible 
to apply to implement and operate chronic care improvement programs 
under CCI-I. These include:

    (1) Disease management organizations;
    (2) Health insurers;
    (3) Integrated delivery systems;
    (4) Physician group practices;
    (5) A consortium of entities; or
    (6) Any other legal entity that the Secretary determines to be 
appropriate.

The Secretary has determined an appropriate legal entity is one that 
meets the requirements of this notice.
2. Identification of Intervention Groups
    Section 1807(d) of the Act requires the Secretary to identify 
targeted beneficiaries who may benefit from CCI-I. Section 
1807(a)(2)(E) of the Act defines a targeted beneficiary for a CCI 
program as a FFS beneficiary with a threshold condition covered under 
the program.
    Threshold condition is defined in section 1807(a)(2)(D) as a 
chronic condition, such as CHF, diabetes, or COPD, or other diseases or 
conditions selected by the Secretary as appropriate for the 
establishment of a CCI program. For CCI-I, we have chosen to focus 
initially on beneficiaries who have CHF and/or complex diabetes, or 
Chronic Obstructive Pulmonary Disease (COPD) because they are major 
population subgroups within Medicare with significant health risks and 
disproportionately high health care

[[Page 22068]]

costs that are not being consistently well managed. Evidence from 
research and private sector experience suggests that chronic care 
improvement programs may produce measurable improvements in quality and 
health status and yield net reductions in health care spending for 
these subgroups by lowering their hospital admission rates and 
emergency service use, but the population-based programs have not been 
rigorously tested in large populations of people aged 65 and older or 
with severely disabling conditions in a FFS context. CCI-I will permit 
us to implement and rigorously test these programs under Medicare FFS.
    Section 1807(d) of the Act requires the Secretary to establish a 
method for identifying eligible beneficiaries for CCI-I. Thus, we have 
established that eligible beneficiaries will be those beneficiaries who 
meet the inclusion and exclusion criteria established by us and who are 
identified by us for randomization. Through analysis of Medicare 
historical claims data, we initially plan to prospectively identify 
eligible beneficiaries in each CCI-I geographic area (henceforth 
referred to as a ``target population''). To be eligible for inclusion 
in a target population under CCI-I, Medicare beneficiaries must be 
enrolled in Parts A and B, have CHF and/or complex diabetes, or COPD, 
and have Medicare as primary payer.
    Beneficiaries with CHF and/or complex diabetes will be identified 
using a combination of two or more professional visits on separate 
dates for CHF or complex diabetes (or a hospitalization for CHF) based 
on 1 year of historical claims data. Based on literature reviews and 
extensive input from the private sector, we have decided to focus on 
eligible beneficiaries with these threshold conditions who have 
moderate to high Hierarchical Coexisting Condition (HCC) risk 
adjustment scores in order to achieve our clinical and financial 
objectives within the 3-year program window (see our Web site, http://www.cms.hhs.gov/medicarereform/ccip/default.asp, for further 
information on HCC risk adjustment scoring).
    Because of the high prevalence of COPD in the Medicare population, 
we will consider testing programs targeting beneficiaries with COPD in 
one or two geographic areas if an applicant(s) presents a strong 
proposal(s). For these program(s), beneficiaries with COPD will be 
identified using two or more professional visits on separate dates for 
COPD or a hospitalization in the year based on 1 year of historical 
claims data. Eligible beneficiaries with COPD will have moderate to 
high HCC risk adjustment scores as well.
    As part of the process for identifying beneficiaries who might 
benefit from CCI-I, we have established that the following groups of 
beneficiaries will be excluded from CCI-I. We will not consider 
beneficiaries if they are currently or become enrolled in any of the 
following:
     Medicare End-Stage Renal Disease (ESRD) program;
     Hospice;
     Medicare Advantage (Medicare+Choice) plan; or
     A CMS FFS chronic care demonstration.
    Detailed documentation on the inclusion and exclusion criteria 
above, and a more detailed explanation of the identification 
methodology, including the HCC risk score cut-off for each threshold 
condition, will be included with the dataset we will provide for 
bidding purposes. (See Section II.B. of this notice for further details 
on the bidding process.)
    As specified in section 1807(b)(1) of the Act, CCI-I requires 
randomized controlled trials for Phase I. Our expectation is to 
randomize beneficiaries in the target population in each area into 
intervention and control groups at the beneficiary level. Randomization 
is intended to ensure comparability on factors that could affect 
performance improvement and overall health care costs.
    In addition, we may request the applicant to adjust the size of the 
proposed geographic area to ensure that the population is of the 
appropriate minimum size to meet the requirements specified in section 
1807(b)(3)(A) of the Act, that CCI-I in the aggregate cover areas in 
which at least 10 percent of the Medicare population resides or address 
other issues like conflicts with Medicare FFS demonstrations. If the 
applicant and CMS cannot come to an agreement on the size of the 
geographic area, that could be a basis to reject the proposal. Effects 
on clinical quality, beneficiary and provider satisfaction and total 
Medicare costs for individuals with CHF, for those with diabetes and 
CHF, and for those with complex diabetes will be evaluated. Programs 
targeting beneficiaries with COPD will be evaluated separately.
3. Identification of Potential Geographic Areas
    We are interested in applications that target areas with higher 
than average prevalence of CHF or complex diabetes, or COPD, and low 
Medicare quality rankings.
    We are particularly interested in applications for geographic areas 
that do not conflict with a currently operating FFS chronic care 
demonstration designed to reduce Medicare expenditures through care 
coordination, disease management or other care management efforts (see 
chart containing a list of the FFS chronic care demonstration areas). 
Running a CCI-I program in the same geographic area as the 
demonstration, even if enrollees in CCI-I cannot participate in the 
demonstration, could confound the results of the CCI-I study by cross-
contamination of control groups. Chronic care improvement programs 
would be measured against the results of organizations running other 
demonstrations. To the extent that these demonstrations are successful 
in reducing the costs of their enrollees, chronic care improvement 
organizations would have a more difficult time demonstrating measurable 
quality improvement, beneficiary and provider satisfaction and savings. 
Moreover, we believe it would be inappropriate to cut into the enrollee 
pools of existing demonstrations for potential enrollees in order to 
assign populations of beneficiaries to CCI-I programs. However, 
applicants who are interested in proposing an area where a 
demonstration exists in part of a State are encouraged to contact us 
for further details concerning how they might structure their CCI-I 
proposals in a manner that will not cause cross-contamination with an 
ongoing FFS chronic care demonstration.

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                                                Medicare fee for                                                      Medicare
                    State                            service           Percent       Percent CHF    Percent COPD    quality rank        Geographic areas with conflicting demonstraions \f\
                                                beneficiaries \a\   diabetes \b\         \c\             \d\             \e\
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United States................................          34,717,973              17              12              12
Alabama......................................             661,747              20              14              15              42
Alaska.......................................              45,728               9               6               6              33
Arizona......................................             474,227              12               9              10              29  AZ
Arkansas.....................................             436,271              15              13              12              48  NW AR

[[Page 22069]]

 
California...................................           2,557,305               7               5               5              44  CA
Colorado.....................................             339,159              12              11              12               7  CO
Connecticut..................................             454,662              18              12              12               9  S Central CT
Delaware.....................................             114,806              22              14              12              14
DC...........................................              73,382              11               7               4              37  DC
Florida......................................           2,240,227              18              12              15              41  N FL
Georgia......................................             927,667              20              13              13              47
Hawaii.......................................             116,160               2               2               1              16
Idaho........................................             158,301              13              10               9              22
Illinois.....................................           1,535,043              17              13              11              46  Rural/E IL
Indiana......................................             854,548              19              14              14              27  Central/Western IN
Iowa.........................................             474,090              16              11              11               6  NE IA, NW IA
Kansas.......................................             371,539              15              12              11              30
Kentucky.....................................             622,181              19              13              16              40
Louisiana....................................             543,327              20              15              12              51  Corridor I-49
Maine........................................             225,477              16              11              14               3  ME
Maryland.....................................             651,698              18              12              11              25  Mont. Cnty, DC Suburbs, Baltimore
Massachusetts................................             768,883              17              12              12              15
Michigan.....................................           1,376,774              22              14              14              26  MI
Minnesota....................................             596,098              14              10               8              10  E Rural MN, S Central MN
Mississippi..................................             430,625              19              13              11              50
Missouri.....................................             764,550              17              14              13              28  SW MO, St. Louis
Montana......................................             142,428              11              10              11              13  SE MT
Nebraska.....................................             251,062              15              12              10              12
Nevada.......................................             176,387              12               9              11              35
New Hampshire................................             176,330              16              11              12               1  SW NH
New Jersey...................................           1,089,135              21              16              13              43
New Mexico...................................             211,363              14               9              11              36  NM
New York.....................................           2,327,080              21              16              12              24  NYC
North Carolina...............................           1,141,084              20              12              12              23  NW NC
North Dakota.................................             104,775              14              10               9               4
Ohio.........................................           1,497,640              20              15              14              38
Oklahoma.....................................             473,529              16              14              13              45
Oregon.......................................             336,477              10               7               7              11
Pennsylvania.................................           1,623,162              20              14              13              31  Eastern PA, Central NE PA
Rhode Island.................................             117,890              19              13              13              17
South Carolina...............................             597,582              22              13              12              32
South Dakota.................................             122,324              13              11              10              20  SD
Tennessee....................................             829,852              19              13              14              39  NE TN
Texas........................................           2,112,410              19              14              12              49  Houston, Urban/S TX
Utah.........................................             210,115              15              11               6               5
Vermont......................................              92,798              15              10              11               2  E VT
Virginia.....................................             914,745              19              12              11              18  SW VA, Richmond
Washington...................................             616,018              13              10               9              19  W Central WA
West Virginia................................             324,294              22              14              17              34
Wisconsin....................................             769,142              16              11               9               8  N Central WI
Wyoming......................................              67,139              13              11              13              21  N WY
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Sources:
\a\ Health Insurance Reform Project, George Washington University: Analysis of 5 percent Standard Analytic File (SAF), Denominator Files, Number of FFS Enrollees by State.
\b\ Health Insurance Reform Project, George Washington University: Analysis of 5 percent SAF, All Physician-Supplier Claims, Percent of FFS Enrollees in State with Diabetes Diagnosis Reported.
 
\c\ Health Insurance Reform Project, George Washington University: Analysis of 5 percent SAF, All Physician-Supplier Claims, Percent of FFS Enrollees in State with CHF Diagnosis Reported.
\d\ Health Insurance Reform Project, George Washington University: Analysis of 5 percent SAF, All Physician-Supplier Claims, Percent of FFS Enrollees in State with COPD Diagnosis Reported.
\e\ Jencks, S., Huff, E., Cuerdon, T. Change in the Quality of Care Delivered to Medicare Beneficiaries, 1998-1999 to 2000-2001. Journal of the American Medical Association. 289; 305-312;
  2003.
\f\ CMS, Office of Research, Development and Information, Listing of Demonstrations.

4. Outreach to Intervention Group
    Beneficiary participation in CCI-I will be strictly voluntary. 
Eligible beneficiaries who are randomized to be contacted by us for 
potential participation in a CCI-I program (henceforth referred to as 
``intervention group'') will be notified of the opportunity to 
participate through a letter from the Medicare program including the 
information specified by section 1807(d)(2) of the Act. The letter will 
provide a description of the program and give the beneficiary an 
opportunity to decline to be contacted by the CCI-I organization. The 
letter will detail how the beneficiary can obtain further information 
about the program. We will then expect each awardee to contact the 
intervention group beneficiaries in its area who did

[[Page 22070]]

not decline to be contacted to describe the program, confirm 
participation, and initiate support services. Beneficiaries who 
confirmed participation will be presumed to be ``participants'' until 
they either become ineligible (for example, join a Medicare Advantage 
plan) or notify the awardee or us that they no longer want to be 
contacted by the awardee. Participation is still voluntary and the 
beneficiary may terminate participation at any time.
    We will provide awardees with historical Medicare claims data and 
other information on the intervention group beneficiaries who did not 
decline to be contacted in their geographic areas. Awardees will use 
the data for outreach and preliminary assessment of beneficiary risk 
levels and support needs. Our data will not include beneficiary phone 
numbers.
    We will expect applicants' proposals to specify detailed 
descriptions about their outreach protocols, including for example, 
frequency and number of outreach attempts, and how the applicant will 
assure that outreach efforts are respectful of the beneficiary. The 
``outreach period'' will consist of 6 months. We reserve the right to 
negotiate limits on the number and/or frequency of outreach attempts 
during the outreach period, and may specify that awardees will be 
required to cease further outreach efforts after the outreach period.
    Under our authority in section 1807(e)(4)(B) of the Act, awardees 
will be required to maintain records of beneficiary contact and 
confirmation of their participation in the program. We will also 
require awardees to share beneficiary eligibility and participation 
status (that is, whether a beneficiary declined to participate or 
terminated participation) with us on a regular basis.
    We will expect applicants to provide projections as to the percent 
of intervention group beneficiaries confirming participation, the 
percent of beneficiaries declining to be contacted (to the awardee or 
to us), the percent of beneficiaries they expect they will be unable to 
reach, and the percent of participants terminating participation.
    Private sector experience has shown that this approach to program 
start-up facilitates ramping up participation levels rapidly and 
reaches individuals who are likely to benefit significantly from 
participating but who are not otherwise likely to take the initiative 
to seek this assistance. Programs will be evaluated based on health and 
cost outcomes of their entire intervention group, including those 
beneficiaries who chose not to be contacted, beneficiaries who dropped 
out of the program at any time, and those beneficiaries the awardee was 
unable to reach, over time and as compared to control groups. 
Beneficiaries in the control groups will not be contacted to inform 
them of the program, and therefore will not have the opportunity to 
decline to participate.
5. Program Characteristics
    As specified in section 1807(a)(3) of the Act, participation in 
CCI-I will not--

     Expand the amount, duration or scope of a 
beneficiary's FFS Medicare benefits;
     Provide an entitlement for participation in a 
CCI program;
     Provide for any hearing or appeal rights with 
respect to a CCI program; or
     Provide benefits under a CCI program for which a 
claim may be submitted to the Secretary by any provider or supplier of 
services.

    Additionally, Medicare beneficiaries will continue to have access 
to care and the same freedom of choice of providers as they do 
currently. Participants can drop out of the program at any time. 
Awardees must track and inform us of all participants who drop out of 
programs. Awardees must be able to demonstrate that they conduct their 
CCI-I programs in accordance with section 1807(e) of the Act.
    As specified in section 1807(e)(1) and (e)(2) of the Act, CCI-I 
programs must develop a care management plan with each participant. In 
carrying out the care management plan and other CCI-I activities, 
chronic care improvement organizations shall:
    1. Guide the participant in managing the participant's health 
(including all co-morbidities, relevant health care services, and 
pharmaceutical needs) and in performing activities as specified under 
the elements of the care management plan of the participant;
    2. Use decision-support tools such as evidence-based practice 
guidelines or other criteria as determined by the Secretary (see the 
paragraph below for details on other criteria); and
    3. Develop a clinical information database to track and monitor 
each participant across settings and to evaluate outcomes.
    We plan to provide monthly or quarterly claims data to awardees for 
their assigned populations to support these activities.
    Section 1807(e)(4)(B) of the Act specifies that the Secretary also 
has the discretion to establish additional program requirements beyond 
those specified in section 1807(e) of the Act. We are particularly 
interested in programs that have a track record of success in engaging 
beneficiaries' physicians and other providers in information sharing 
and in working with community organizations, local and state agencies, 
and other organizations that serve the proposed target populations. 
Many chronic care improvement programs have developed integrative 
information infrastructures, new applications of information and 
communication technologies, expert clinical systems that incorporate 
evidence-based guidelines for multiple conditions, and predictive 
modeling capabilities to support their operations. Others have been 
working to develop interoperative electronic health records and other 
health information technology used at the point of care to improve 
quality and safety. We are interested in receiving applications from 
organizations that have proven to be successful in applying tools to 
meet the individual needs of participants and their providers, reduce 
fragmentation in patient information, and facilitate better 
communications between chronically ill beneficiaries and their 
providers at the point of care.
    We recognize that some of these tools and capabilities may be 
proprietary. We are not seeking ownership of the tools, protocols, 
materials, and capabilities and we will work with awardees to ensure 
that the confidentiality of proprietary tools and capabilities is 
protected. Nonetheless, it is essential that we be able to conduct a 
thorough evaluation of CCI-I to understand how the programs operate and 
assess their effectiveness. Transparency is essential. Therefore, 
awardees must agree to the following statement: ``At any phase in CCI-
I, including at its conclusion, the awardee, if so requested by the 
project officer, must deliver to us all chronic care management 
software, algorithms and associated documentation, as well as 
beneficiary health information, program operational methods, and other 
data used by the awardee in the course of performing the services 
pursuant to CCI-I, to be used by us solely to further the purpose of 
CCI-I.'' The data will not be subject to use for any other purpose 
without written permission of the awardee. All proprietary information 
and technology of the awardee (including, without limitation, the 
specific proprietary algorithms used by the awardee for CCI-I) is and 
remains the sole property of the awardee. We do not acquire (by license 
or otherwise, whether express or implied) any intellectual property 
rights or other rights to the proprietary information or technology.

[[Page 22071]]

    CCI-I programs must comply with all applicable laws, including but 
not limited to privacy laws and the Health Insurance Portability and 
Accountability Act (HIPAA).
6. Billing and Payment
    Section 1807(f)(2)(A) of the Act specifies that each awardee will 
be paid a fee for each participant per month in CCI-I. The fee amounts 
to be paid to awardees may vary because we envision testing a range of 
program models that may have different cost structures. We will 
establish fee amounts by agreement with each awardee.
    Claims for medical services provided to participants will continue 
to be covered, administered, and paid under the Medicare FFS program. 
The monthly rate paid to awardees for providing chronic care 
improvement support to participants will be considered a programmatic 
administrative fee, and no beneficiary coinsurance amount or deductible 
liability will be applied. During the outreach period, we will pay a 
per beneficiary monthly payment for all intervention group 
beneficiaries, except those who declined to be contacted either to us 
or to the awardee. After the outreach period, we will pay a per 
participant monthly fee for all beneficiaries who confirm 
participation, until they become ineligible or terminate their 
participation in the program. We will not pay any per participant 
monthly fees for beneficiaries who have not been reached by the time 
the outreach period comes to a close unless agreed to by us and the 
awardee and specified in the CCI-I agreements. No program start-up 
funds will be allowable for costs incurred prior to program 
implementation. No added payments will be made to awardees for their 
program evaluation costs, travel, capital investments, data collection, 
or any activity related to CCI-I. All program costs must be factored 
into the per-participant fee. The bid should not include CMS 
programmatic costs as the standardized satisfaction survey or 
collection of information on control group beneficiaries, etc.
7. Performance Standards: Clinical Quality, Beneficiary Satisfaction 
and Savings Guarantees
    Section 1807(f)(3)(A) of the Act specifies that each agreement with 
an awardee will specify performance standards for improving clinical 
quality, improving beneficiary and provider satisfaction and achieving 
savings. As part of the application process, we will expect applicants 
to set forth their projections for improvement on clinical quality and 
savings on a year-to-year basis in the intervention group and as 
compared to the control group. The projections set forth by awardees in 
their applications and agreed upon by us may be included in their CCI-I 
agreements as standards that will be used in monitoring performance.
    Section 1807(f)(3)(B)(i) of the Act also specifies that each 
agreement will provide for adjustment in payment rates in the event the 
Secretary determines that the awardee failed to meet its agreed-upon 
performance standards.
    Applicants will be expected to propose performance guarantees for 
the first two performance standards, quality improvement and 
beneficiary satisfaction, and propose payment adjustment amount(s) and 
methods of liability calculation to be applied in the event of failure 
to meet the proposed quality improvement and satisfaction guarantees. 
The proposed guarantees for quality improvement can relate to 
achievement of agreed-upon standards collectively rather than on 
individual measures. The proposed guarantees will be evaluated as part 
of the review of proposals. Performance guarantees, liability 
calculation methods, and payment amounts agreed upon by us will be 
included in agreements with awardees. We may terminate a program after 
18 months of operation if the Secretary determines the program is not 
demonstrating significant progress in improving clinical quality and 
beneficiary satisfaction. Provisions relating to termination for non-
performance, including the methodology used to determine any fees to be 
returned to us, will be specified in the CCI-I agreements. It is 
important to reiterate that awardees' performance will be measured on 
the entire intervention group (which includes those beneficiaries who 
chose not to be contacted, beneficiaries who dropped out of the program 
at any time, and those beneficiaries the awardee was unable to reach, 
for all months in which they were eligible to participate).
    For the third performance standard, savings, section 1807(f)(4) of 
the Act requires the Secretary to ensure budget neutrality. To ensure 
that neutrality, we are specifying that each awardee will also be 
required to guarantee that the total of Medicare claims payments for 
beneficiaries in the intervention group and chronic care improvement 
fees under CCI-I paid for participants will be no more than 95 percent 
of the amount that total Medicare claims payments would have been 
absent CCI-I, as measured by claims for the corresponding control group 
over a 3-year period (applicants will be given the opportunity to 
propose multiple payment and savings guarantees structures, as 
described further in section II.B.6 of this notice). Beginning in 2006, 
beneficiaries will have the opportunity to purchase Medicare 
prescription drug coverage under Pub. L. 108-173. We intend to include 
Medicare drug expenditures in the calculation of total Medicare 
expenditures.
    Section 1807(f)(1)(B)(ii) of the Act specifies that organizations 
must assume financial risk for performance under CCI-I agreements. We 
are establishing that, in the event that 5 percent net savings is not 
achieved over the 3-year program window, the awardee will be required 
to refund to the government the amount of excess expenditures made 
under CCI-I, up to the full amount of the total chronic care 
improvement fees paid to the awardee. We may require awardees to make 
refunds to the government based on interim performance monitoring 
results or we may specify in agreements with awardees some other 
mechanisms to limit our exposure, but the final financial settlement 
will be based on 3-year program performance.
    Throughout CCI-I, CMS and our contractor, in conjunction with the 
awardee, will monitor Medicare benefit expenditures using Medicare 
administrative claims records. Net savings will be calculated by 
comparing the average Medicare expenditures per person per month, 
including program fees, for the identified intervention group 
(including those who declined to be contacted, those who could not be 
reached or those who terminated participation) to the average Medicare 
expenditures per person per month for beneficiaries in the control 
group in the geographic area. All months for which a beneficiary was 
eligible to participate in the intervention or control group will be 
included, regardless of the number of months a beneficiary actually 
participated in the program. Net savings calculations will include 
appropriate claims run-out for both the intervention and control 
groups.
8. Reconciliation Process
    We will hire an independent contractor to monitor clinical quality, 
beneficiary and provider satisfaction, utilization, and costs for 
purposes of interim payment adjustments and to perform final financial 
reconciliation at the end of the 3-year program period to determine any 
refunds due to the government from awardees in the event awardees fail 
to achieve agreed-upon

[[Page 22072]]

performance guarantees over the 3-year program window.
    As noted previously, awardees are to assume financial risk related 
to fees, not insurance risk. Awardees will be required to establish a 
system to compensate Medicare (up to 100 percent of the applicant's 
chronic care improvement fees) in the event that they fail to achieve 
their performance guarantees. Applicants will need to demonstrate 
financial solvency to assure us of their capacity to refund us up to 
100 percent of their fees if this situation occurs, through available 
reserves, reinsurance, withholds, or other appropriate means. Awardees 
will be required to agree in writing to performance standards, 
guarantees, and liability calculation methodology as a condition of 
acceptance of CCI-I awards, and will have an opportunity to review the 
annual and final calculations when completed.
9. Program Monitoring
    We will conduct ongoing formative program monitoring throughout the 
period of program operations. The formative evaluation will be 
conducted in collaboration with CMS and awardees to help identify and 
address operational problems, foster continuing improvement in program 
operations, and inform us as to how we might expand the program as 
specified by section 1807(c) of the Act if Phase I is successful.
    Section 1807(f)(1)(B)(i) of the Act specifies that the Secretary 
may establish other requirements as appropriate. Thus, awardees will be 
required to cooperate with our implementation contractor, including 
submitting performance monitoring data and operational metrics, as well 
as hosting site visits as requested. Program monitoring includes both 
performance monitoring (on clinical quality, beneficiary and provider 
satisfaction and savings targets) and operational metrics (including 
but not limited to, outreach and engagement rates, and management 
information). Awardees will be expected to provide us with ongoing 
program monitoring information by tracking various measures of program 
performance and operational metrics. Awardees will be expected to track 
clinical quality, satisfaction, utilization, and cost measures on 
participants on a continuing basis and to analyze trends quarterly. The 
requirements for data exchange and reporting will be established in 
CCI-I agreements to satisfy our need for program monitoring and the 
independent evaluator's needs for program analysis.
10. Independent Formal Evaluation
    Pursuant to section 1807(b)(5) of the Act, we will hire an 
independent contractor for the formal evaluation of program results. 
The independent evaluator will study the experience of the intervention 
group in each area compared to the relevant control group to ascertain 
the ability of each program and individual elements of each program to 
improve clinical quality, achieve high levels of beneficiary and 
provider satisfaction, promote efficient use of health care services, 
and produce savings for Medicare in the intervention group (as 
specified by section 1807(b)(5) of the Act). Awardees will be expected 
to cooperate with the independent evaluator, to participate in case 
studies of their programs, and to track and provide agreed-upon 
performance data for participants as needed for the independent 
contactor's performance evaluation. Detailed definitions of the 
indicators, measures, and calculation methods to be used in determining 
performance will be agreed upon by us and specified in the CCI-I 
agreements. A commonly acceptable standardized beneficiary and provider 
satisfaction survey instrument will be developed to compare 
satisfaction levels between the control groups and the intervention 
groups.

B. Requirements for Submission

1. Awardee Selection Process
    We will select awardees for CCI-I in a staged process. In the first 
stage, we will provide prospective applicants with a de-identified data 
set of Medicare claims information for a national sample of 
beneficiaries who meet the inclusion and exclusion criteria for CCI-I. 
This data set will be available on CD-ROM. Prior to receiving the data 
on CD-ROM, applicants will be required to download, sign and mail to us 
a Data Use Agreement that will be posted on our Web site in advance of 
the publication of this notice. The applicant will analyze the data and 
submit an application and bid, including proposed target population 
(CHF, complex diabetes, or COPD), geographic area, per participant per 
month fees and performance guarantees. Applicants should base their 
proposals on 20,000 beneficiaries in the intervention group. Applicants 
may propose to serve a larger size population as well, but, for 
comparability, applicants must submit at least one proposal based on 
20,000 beneficiaries in the intervention group. We reserve the right to 
negotiate and limit the size of the population. Applicants may propose 
adjustment factors to account for any differences between the 
nationally representative sample population and the actual population 
in their proposed geographic area that may warrant changes in 
performance projections, payment structure, or guarantees. We reserve 
the right to reject proposed adjustment factors. Applicants will have 
90 days from the date the data are made available to submit 
applications.
    In the second stage, our review panel will evaluate all submitted 
applications based upon the application evaluation criteria listed in 
section II.C. of this notice and will recommend applicants to be 
considered for the second stage of the awardee selection process. We 
may conduct site visits to selected applicants based upon review panel 
recommendations.
    For applicants who are selected as finalists, we will provide the 
actual historical data for the applicable target population in the 
applicant's proposed geographic area. Finalists will analyze the data 
to determine if originally proposed and agreed upon adjustment 
factor(s) apply. (Adjustment factors must be specified in the initial 
application in order to be applied at this point.) If the applicant 
finds that an adjustment in the proposed payment or savings guarantees 
applies due to the differences in the data, we will verify the analysis 
and findings prior to entering into an agreement with the awardee.
    The Administrator will make the final selections. Only one awardee 
will be selected for any given geographic area, and will be provided 
with HIPAA compliant identified data once selected. We may add to the 
intervention group individuals who meet the eligibility criteria for 
the original cohort.
2. Application
    Applicants must submit completed applications following the 
standard format outlined in our Medicare Waiver Application in order to 
be considered for review by the technical review panel. Although this 
is not a demonstration, CCI-I will contain study elements, such as a 
control group and an evaluation. For this reason, we have decided to 
use the Medicare Waiver Application. The application is available 
online at: http://www.cms.hhs.gov/medicarereform/ccip/default.asp. 
Applicants should also include in their applications the information 
requested below related to each section of the Application. Only 
applications that follow the standard Medicare Waiver Application 
format and include the information requested in the Application 
instructions and in this CCI-I notice will be reviewed.

[[Page 22073]]

Additional information about CCI-I, for example, fact sheets, press 
releases, question and answer documents, and information about the 
bidders' conference will be posted on the Web site. All questions must 
be submitted to us in writing; all responses will be posted on our Web 
site.
    As noted in the Application instructions, applications must be 
typed using 12-point font with 1-inch page margins. The applications 
must not exceed 40 double-spaced pages, exclusive of the cover letter, 
executive summary, forms, and appendices. An unbound original, 2 
copies, and 3 electronic copies on CD-ROM of the Application must be 
submitted. Applicants may, but are not required to, submit a total of 
10 copies to assure that each reviewer receives an application in the 
manner intended by the applicant (for example, collated, tabulated, 
color copies, etc.). Hard copies and electronic copies must be 
identical. Applicants must designate one copy as the official proposal.
    Applications will be reviewed by the technical review panel only if 
they are received on or before 5 p.m. EST on August 6, 2004. At a 
minimum, applicants should ensure that their applications and 
supplemental materials include the information requested below by 
section of the application.
    1. Cover Letter.
    2. Application Form.
    3. Executive Summary.
    4. Rationale for Proposed Geographic Area and Target Population 
(Problem Statement).
    Applicants should describe the geographic area(s) they propose to 
serve (for example, State, metropolitan statistical area) and explain 
the rationale for targeting each proposed geographic area. Applicants 
should specify which target population they intend to serve (CHF and/or 
complex diabetes, or COPD). Applicants should specify the size of the 
population they intend to serve if it differs from the required 
proposal based on 20,000 beneficiaries in the intervention group. 
Applicants should describe the demographics of the Medicare FFS 
population in the area, utilization rates, prevalence rates of CHF and 
complex diabetes or COPD in the Medicare population, and Medicare 
quality rankings (as defined by Jencks, S., Huff, E., Cuerdon, T. 
Change in the Quality of Care Delivered to Medicare Beneficiaries, 
1998-1999 to 2000-2001. Journal of the American Medical Association. 
2003; 289; 305-312) for the area with comparisons to national averages. 
The current health care delivery system and access to care in the 
proposed geographic area should be briefly described. Obstacles to 
providing chronic care improvement services in the area should also be 
explained.
    Applicants need not provide a description of Medicare coverage and 
payment or discuss implications of changes as called for in the 
standard application instructions as neither coverage nor payment for 
Medicare benefits and services will change under CCI-I.
5. Chronic Care Improvement Program Design
    Applicants should describe the proposed program and explain how the 
proposed interventions will improve clinical quality, beneficiary and 
provider satisfaction, and achieve savings for the intervention group.
    In this section, applicants should explain how the proposed program 
will address each of the following activities (see section II.C. of 
this notice for further details on the application evaluation process):

     A plan for outreach.
     Describe how the program will actively engage 
participants and the rate at which the applicant expects to ramp up the 
program. Provide a detailed description about outreach protocols, 
including for example, frequency and number of outreach attempts.
     Describe how program will assure that outreach 
efforts are respectful of beneficiaries. Describe how program will 
overcome language or cultural barriers, or cognitive impairment in 
outreach.
     Describe how the program plans to reach out to 
physicians to inform them of the program.
     A plan to assess and stratify participants.
     Describe how the program will stratify 
participants by risk (including types and frequencies of interventions 
for beneficiaries at various strata and an explanation of when and how 
patients are transitioned between levels of intensity, if at all).
     Describe the stratification tool and whether it 
was validated.
     Describe how the program will screen each 
participant for conditions other than threshold conditions, such as 
impaired cognitive ability and co-morbidities.
     Frequency and type of interventions.
     Describe how the program will work with 
beneficiaries to develop and carry out their care management plans as 
specified in section 1807(e) of the Act.
     Describe how a beneficiary communicates with the 
program and how the program communicates with the beneficiary.
     Describe how the program will determine the 
appropriateness of chronic care improvement interventions as specified 
in section 1807(e)(2) of the Act, such as self-care education for 
beneficiaries or caregivers, education for physicians, the use of 
monitoring technologies, provision of information about hospice care, 
pain and palliative care, and end-of-life care, etc.
     Describe how the program will increase use of 
preventive services.
     Describe how the program will guide the 
participant in managing his/her health, including all co-morbidities, 
relevant health care services and pharmaceutical needs. Describe how 
the program will improve efficiency and effectiveness of utilization of 
Medicare services.
     Appropriate services and educational materials 
for participants.
     Describe how the program will ensure that all 
chronic care improvement services provided are tailored to meet the 
needs of all participants, including those with limited reading skills, 
with diverse cultural and ethnic backgrounds, with sensory/physical/
mental disabilities or cognitive impairment, or primary languages other 
than English.
     Describe how the program will use decision-
support tools to ensure adherence to evidence-based medicine and 
monitoring of quality standards.
     Describe how the program will ensure use of 
clinical protocols or evidence-based medicine to guide care delivery 
and management.
     Adequate mechanisms for ensuring physician 
integration with the program.
     Describe the program's strategy to encourage 
physicians and other providers to actively participate in the program.
     Describe how the program will integrate 
beneficiaries' physicians and other providers into the program and 
ensure that the program enhances patient-provider relationships.
     Describe how the program will ensure exchange of 
patient information with applicable providers in an effective, timely, 
and confidential manner across care settings.
     Describe how the program will facilitate access 
to timely and accurate patient information at the point of care. If the 
program includes incentives for the physician to adopt or use decision-
support tools or other health information technology, describe the 
basis and impact of these incentives.
     Adequate mechanisms for ensuring coordination 
with State and local agencies.

[[Page 22074]]

     Describe how the program will coordinate, if 
applicable, with State and local agencies, as well as other 
organizations that serve the target population.
     Adequate mechanisms for supporting participants 
with more intensive needs.
     Describe strategies for supporting participants 
with more intensive needs (for example, describe whether there will be 
a care coordination or intensive case management program as part of the 
overall CCI-I program or some other mechanism for supporting this 
population).
     Data to be collected, data sources, and data 
analyses.
     Describe data to be collected and data sources.
     Describe how the program will collect 
information on intervention group beneficiaries that are not available 
from claims data (for example, laboratory results, prescription drug 
data, clinical information from physicians).
     Describe data analyses.
     Describe how the program will ensure privacy of 
participant information.
     Describe how the program will develop a clinical 
information database to track and monitor patients' major chronic 
conditions and integrate management for participants who have multiple 
co-morbid conditions, such as diabetes and depression, across settings 
and to evaluate outcomes.
     Describe the data exchange between the program, 
physicians and beneficiaries. Describe whether physicians can access 
participant information on their patients. Describe process for sharing 
sensitive information between physicians (for example, HIV status or 
mental health diagnoses).
     Describe how the program will anticipate 
incorporating prescription drug data, including claims after 2006, to 
the extent possible.

    In addition, applicants should provide sample communications and 
educational materials to be used with participants and providers and 
explain any plans to customize them for Medicare.
    Applicants do not need to describe how beneficiaries will be 
assigned to intervention and control groups, as we will be responsible 
for that function under CCI-I.
6. Organizational Structure and Capabilities
    Applicants should demonstrate that they have the management 
capacity and organizational infrastructure to carry out CCI-I.
    At a minimum, in addition to the information requested in the 
Application instructions, applicants should explain how the 
organization has demonstrated capacity in each of the areas listed 
below (see section II.C. of this notice for further details on the 
application evaluation process) and how their programs could be 
expanded or replicated over time.

     Staff.
     Describe type of staff, level of staff, level of 
effort required to provide the service.
     Describe staff to participant ratios and 
required qualifications of staff that will be providing services to the 
participants.
     Describe similar detailed information on any 
services to be performed on a sub-contracted or affiliated basis (List 
full name and address of any subcontractors involved in the services to 
be performed. Describe all handoffs and coordination arrangements).
     Describe qualifications of the non-clinical 
staff that will be responsible for the information systems, data 
analysis, and other major program functions.
     Describe organizational and reporting structure 
of personnel.
     Provide a listing of key personnel.
     Provide a breakout of staff responsibilities.
     Facilities.
     Describe locations that will be used to operate 
CCI-I.
     Describe typical hours of operation (EST) in 
terms of hours per day and days per week, including types of staff 
available during these hours of operation. (If the organization is not 
open 24 hours per day, 7 days a week, describe the process 
beneficiaries follow to contact professional staff.)
     Equipment.
     Describe equipment, including participant 
monitoring equipment or electronic input devices.
     Strong working relationships with local 
providers.
     Describe how the organization reaches out to 
local providers.
     Provide contact information for at least two 
physicians who provide care to program participants or representatives 
from physician associations who have worked with the organization and 
who will serve as references.
     Strong working relationships with community 
organizations in the area.
     Describe how the organization interacts with 
local community organizations (such as Quality Improvement 
Organizations, among others).
     Provide contact information for at least two 
community organizations who have worked with the organization and who 
will serve as references.
     Provide contact information for a hospital or 
health plan medical director who has worked with the organization and 
who will serve as a reference.
     Appropriate information and financial systems.
     Describe the organization's information and 
financial systems, including the organization's computer systems 
capabilities and how the applicant collects, integrates, analyzes, and 
reports data necessary to support program components. (Describe the 
data repository, and how the applicant's computer systems can transmit 
data to us.)
     Provide samples of clinical, financial and 
management information reports used in program operations.
     Describe the modification of its existing data 
systems, if necessary.
     Describe how the organization ensures compliance 
with all applicable laws, including but not limited to privacy laws and 
HIPAA.
     With respect to data flows between organizations 
and us and within organizations, identify participating organizations, 
their covered entity status and the relationships among the partners. 
Indicate these data flows, detailing who is receiving what information 
and for what purpose.
     Clinical protocols to guide care delivery and 
management.
     Describe the clinical protocols used to guide 
interventions, as well as processes and responsibilities for updating 
them (clinical protocols must be derived from evidence-based medicine 
or nationally accepted practice guidelines). Describe how clinical 
protocols will support all of a participant's co-morbidities, not just 
his/her threshold condition.
     Ongoing performance monitoring.
     Specify additional clinical and services 
indicators other than the performance standards specified in section 
II.B.7 of this notice and the timetable that the program proposes to 
use to monitor health status and quality of care by condition and 
severity level for all conditions, including co-morbidities.
     Organizational background and references.
     Describe the organization's history (including 
how long the organization has been in business, including any relevant 
predecessor companies), ownership, and current products and services.

[[Page 22075]]

     For consortia, provide a history of the 
consortium and any supporting relevant experiences of the partners 
collectively and/or individually.
     Provide references (including name, title, and 
telephone number) for two organizations for which the applicant has 
developed and currently administers programs of similar scope and 
complexity as the proposed program.
     Indicate the numbers of beneficiaries now under 
active management by the applicant for CHF, for complex diabetes, and 
for each other type of major chronic condition the applicant manages 
(including as a co-morbid condition).
     Describe the organization's risk management 
history or demonstrated capability to operate with fee risk.
     Indicate agreement to language regarding 
proprietary data, materials, systems, etc. in the Program 
Characteristics part of section II.A. of this notice.
     Accreditation.
     Describe accreditation for disease management or 
chronic care improvement programs, if any. Section 1807(e)(5) of the 
Act specifies that the Secretary may consider deeming accredited 
organizations as meeting the CCI-I requirements. In the interest of 
encouraging proposals from a broad array of organizational models, we 
are not deeming accredited organizations at this time; however, we will 
consider accreditation as a factor.

    Applicants who are selected as finalists in the second stage of the 
awardee selection process will also be expected to provide detailed 
financial statements.
    For consortia, applicants should describe how the new entity will 
achieve the organizational capacity functions listed below. Consortia 
may draw from the organizational qualifications of each of the 
partners, but applicants should emphasize the capabilities of the 
collective partnership. Consortia should describe the 
interrelationships between the partners, a plan for dedicated resources 
to develop infrastructure and seamless program cohesion (including 
integrated interventions, communications, information systems, etc.), 
and a plan for governance and management structure with dedicated 
staffing and resources.
7. Performance Results

Past Performance: Clinical Quality, Beneficiary and Provider 
Satisfaction and Savings.

    In addition to supplying the information requested in the 
Application instructions, applicants should describe how their proposed 
interventions are likely to have a positive effect on clinical quality, 
beneficiary and provider satisfaction, and savings for the intervention 
group within the proposed geographic area. Applicants should show 
evidence of positive outcomes from prior and current efforts. 
Applicants must quantify their results for other large target 
populations of individuals with CHF, complex diabetes, COPD, or other 
major chronic conditions. Claims of prior success should include 
definitions of performance measures used, evaluation methods, as well 
as explanations of the length of time over which performance was 
measured. For savings, to the extent possible, applicants should 
include evidence of success in improving outcomes based on paid claims 
data. If a consortium has no prior experience to draw from, the 
applicant should, to the best of its ability, provide the relevant 
experiences of one or more of the components of the consortium.

Performance Projections

    As discussed in section II.A of this notice, we will expect 
applicants to lay out their projections for improvement in clinical 
quality, beneficiary and provider satisfaction, and savings year to 
year in the intervention group and as compared to the control group. 
The projections set forth by awardees in their applications may be 
included in their CCI-I agreements as standards for monitoring 
performance. As mentioned in section II.B. of this notice, we have 
created a database of one year of historical data on a nationally 
representative target population. As appropriate, the organization 
should use this database as a point of reference to project performance 
improvements. The organization should also describe to what baseline 
values its projections apply and what adjustment factors would apply if 
the true baseline values were outside of the anticipated range.
     We have identified a core set of clinical 
quality indicators. The applicant should provide projected rates of 
improvement the awardee expects to achieve in each year of CCI-I on 
each proposed quality performance measure in the intervention group as 
compared to the prior year and as compared to the control group. The 
applicant should also include additional measures it could track. For 
each measure, the applicant should indicate its ability to track the 
measure, data sources that would be used, and projected improvement 
rates. Further information will be posted on our Web site. The measures 
presented here are subject to change.
     The applicant should provide projected savings 
for each year of the program in addition to the aggregate savings 
projections specified in section II.B.8 of this notice.
     The applicant should provide projections on 
operational metrics for each year of the program, including but not 
limited to, outreach and engagement rates. The applicants should 
provide detailed projections as to the percent of intervention group 
beneficiaries confirming participation, the percent of beneficiaries 
declining to be contacted (to us or to the awardee), the percent of 
beneficiaries they expect they will be unable to reach, and the percent 
terminating participation.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Projected % improvement in intervention group    Projected % change compared to control group
                                                                         over prior year                 -----------------------------------------------
                Measure                   Data source*  -------------------------------------------------
                                                               1YR             2YRS            3YRS             1YR            2YRS            3YRS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Heart Failure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assessment of left ventricular
 ejection fraction
Blood Pressure controlled (< 130/85)
Use of angiotensin converting enzyme
 inhibitors (ACE-I)/angiotensin
 receptor blockers (ARB) or
 hydralazine/isosorbide for patients
 with LVEF < .4
Dose of ACE-I
Use of beta-blockers for patients with
 LVEF < .4
Monitoring daily weights

[[Page 22076]]

 
Sodium intake counseling
Compliance with medication regimen
Spironolactone for patients with AHA/
 ACC III or IV classification
Daily aspirin, other antiplatelet or
 anticoagulant
---------------------------------------
                                                                        Diabetes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Hemoglobin A1c test
Lipid profile performed once every
 year
Eye exam performed once every year
Monitoring for nephropathy (test for
 microalbumin) or receiving treatment
 for nephropathy
Annual foot exam performed
HbA1c controlled (<=7.0)
Lipids controlled (LDL <130 mg/dl)
 within past 2 years
Poor HbA1c control (9.0
 percent)
Blood pressure controlled (<130/80)
Patients with microalbuminuria on ACE
 or ARB
Compliance with medication regimen
Daily aspirin
---------------------------------------
                                                                          COPD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Systemic corticosteroids for acute
 exacerbation
Oxygen therapy
Smoking quit rate
Annual spirometry testing
Oxygen status
--------------------------------------------------------------------------------------------------------------------------------------------------------


--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Projected % improvement in intervention group  Projected % change compared to control group
                                                                            over prior year                ---------------------------------------------
      Condition              Measure         Data source*  ------------------------------------------------
                                                                  1YR            2YRS            3YRS             1YR            2YRS           3YRS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Other Co-Morbid Conditions (Specify by Condition)
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
 
 
 
 
 
 
 
--------------------------------------------------------------------------------------------------------------------------------------------------------


--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Projected % improvement in intervention group    Projected % change compared to control group
                                                                         over prior year                 -----------------------------------------------
                Measure                   Data source*  -------------------------------------------------
                                                               1YR             2YRS            3YRS             1YR            2YRS            3YRS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Preventive Measures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Receipt of pneumococcal vaccine ever
Annual flu shot
Cigarette smoking cessation counseling
Nutrition screening/counseling
Depression screening
---------------------------------------
                                                           Utilization of Health Care Services
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hospital admission rates
Hospital re-admission rates
Emergency service utilization rates
Rate of hospitalizations for lower
 extremity complications (for diabetes
 patients)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Data Source: C=Claims, SR=Self-Report, VSR=Validated Self-Report, P=Provider, S=Survey, PBM=Pharmacy Benefit Manager, L=Labs, CR=Chart Review


[[Page 22077]]

8. Payment Methodology & Budget Neutrality
    Using the historical claims database of a representative target 
population that we provide (available on CD-ROM), applicants must 
provide a fee proposal in the format of Model 1 below for comparability 
across applications. We will also entertain applications that propose 
up to two additional payment proposals. All applicants must propose a 
payment structure that guarantees 5 percent net savings and places 
chronic care improvement fees at 100 percent risk for savings 
shortfalls relative to that target. For comparability, in this model, 
applicants should base this payment structure on 20,000 beneficiaries 
in the intervention group. All applicants must submit this bid in the 
format specified in Model 1. In addition, applicants may also include 
up to two alternative payment structures for programs in which 
organizations guarantee more than 5 percent net savings and/or propose 
to serve larger populations. In these scenarios, the applicant could 
propose to limit its fee risk associated with any shortfall relative to 
the proposed savings guarantee. Under these alternatives, however, an 
awardee would still be responsible for refunding us the full amount of 
its fees if net savings fall below 5 percent.

------------------------------------------------------------------------
                                                       Alternate fee
                                 Model 1  5% net    structure   5% net savings
 
------------------------------------------------------------------------
Per participant fee/month.....  $--------/month..  $--------/month.
Percent net Medicare savings    5%...............  ----%.
 guaranteed.
Percent fees at risk for        100%.............  100% on 5% net
 guaranteed savings.                                savings; Define fee
                                                    risk for net savings
                                                     5% and <
                                                    guarantee.
------------------------------------------------------------------------

    An applicant should describe the components of its monthly fee. The 
proposed fee should include the projected cost for each chronic care 
improvement service, including any ancillary services, such as 
transportation or provision of equipment, and administrative costs in 
aggregate and per participant. All administrative costs relating to 
CCI-I should be included in this budget, including costs for 
recruitment, travel, capital investments, data collection, profit, and 
any other relevant items or services. An applicant should describe the 
assumptions that underlie its price structure, including but not 
limited to, expected outreach and engagement rates, assessment rates, 
levels of intervention intensity, drop-out rates, etc.
    In addition, in conjunction with each bid, the applicant should:
     Describe what differences, if any, in the 
demographic composition or claims experience of the population in the 
selected geographic area relative to the national sample would require 
adjustment in the proposed fees or savings guarantees (for example, 
hospital admission rates); and
     Specify the proposed adjustment factor to be 
used to calculate final fees and performance guarantees if the 
identified values in the actual target population falls outside the 
corridor for which the proposed fees apply.
    An applicant should also propose fee adjustments in the event its 
program fails to achieve agreed-upon performance guarantees for 
clinical quality improvement and beneficiary and satisfaction. An 
applicant should provide a detailed explanation of its proposed fee 
adjustments and methods for calculating liability in the event of 
failure to meet agreed-upon performance guarantees.

Medicare Expenditure Projections

    The applicant should estimate the expected total yearly Medicare 
expenditures for the population in the sample dataset and give 
projections for the intervention group with and without CCI-I, and the 
resulting net savings to Medicare by major service category, for 
example, inpatient hospitalizations, outpatient services, emergency 
department utilization and physician office visits. While we do not 
have historical claims data available for drug costs, we will include 
Medicare prescription drug expenditures in cost comparisons between the 
intervention and control groups beginning in 2006. The applicant should 
explain any differences it projects in drug costs between the 
intervention and control group and how these differences (if any) are 
accounted for in its 3-year net savings projection. Estimates of 
expenditures with CCI-I should include chronic care improvement fees as 
well as the payments for traditional Medicare benefits provided to the 
intervention group as described in section II.A Purpose/Design (Billing 
and Payment section) of this notice.
    An applicant should show the basis for the assumptions used in its 
proposed payment methodology and budget. The strength of the evidence 
supporting these estimates will be considered in evaluating the 
proposals. Further, applicants selected for award will be required to 
submit data supporting their utilization and financial assumptions 
prior to award. CMS or its financial contractor will use the 
information provided by the applicant, as well as Medicare claims and 
other data, to determine an estimate of what we would pay to provide 
care for a population similar to the projected intervention group both 
with and without CCI-I.
9. Implementation Plan
    An applicant should provide the implementation information 
requested in the waiver application as well as those listed below.
     Provide schedule with timelines for all 
essential tasks.
     Describe modifications to protocols, services, 
outreach, education initiatives, timelines, etc., if any.
     Describe what process improvements the 
organization has made in the last 12 months as part of continuous 
quality improvement related to providers, patients, health plans, 
communication, health education and/or training. Describe the 
organization's plan for implementing process improvements.
     Among the staff named and biographies provided, 
identify the individual who will be the liaison to us for CCI-I.
10. Supplemental Materials (Appendices)

C. Application Evaluation Process and Criteria

    As noted in the Waiver Application instructions, a panel of experts 
will conduct a review of responsive proposals. The panelists' 
evaluations will contain numerical ratings based on the application 
evaluation criteria, rankings for all responsive proposals, and a 
written assessment of each application.

[[Page 22078]]

1. Application Evaluation Criteria and Weights

a. Rationale for Proposed Geographic Area and Target Population (5 
Points)

    The proposal provides a thorough and convincing rationale for 
choosing the targeted population in the selected geographic area as 
specified in section II.B. of this notice, including:
     Demographics and socio-economic characteristics.
     Access to and utilization of health care 
services, and Medicare quality ranking.
     Characteristics of the health care delivery 
system.
     Prevalence of CHF and complex diabetes, or COPD.
     Obstacles to providing chronic care improvement 
services.

b. Chronic Care Improvement Program (25 Points)

    The proposal describes or demonstrates clear and convincing 
evidence that program design will improve quality of care for 
participating beneficiaries and reduce aggregate costs to Medicare 
(with any applicable supporting materials) as specified in section 
II.B. of this notice, including:
     A plan for outreach to the intervention group.
     A plan to assess, stratify, and screen 
participants.
     Frequency and type of interventions, including 
plan for development and implementation of care management plans.
     Appropriate services and educational materials 
for participants.
     Adequate mechanisms for ensuring physician 
integration with the program.
     Adequate mechanisms for ensuring coordination 
with State and local agencies.
     Adequate mechanisms for handling participants 
with more intensive needs.
     Data to be collected, data sources, and data 
analyses.

c. Organizational Capabilities and Structure (25 Points)

    The proposal describes or demonstrates clear and convincing 
evidence that the organization has the structure and capacity to 
conduct the chronic care improvement program effectively as specified 
in section II.B. of this notice, including:
     Staff.
     Facilities.
     Equipment.
     Clinical protocols to guide care delivery and 
management.
     Strong working relationships with local 
providers.
     Strong working relationships with community 
organizations in the area.
     Appropriate information and financial systems.
     Ongoing performance monitoring.
     Organizational background and references.
     Accreditation, if any.

d. Performance Results: Past Performance and Performance Projections 
(25 Points)

    The proposal describes or demonstrates clear and convincing 
evidence that the organization can produce a positive effect on 
clinical quality, beneficiary and provider satisfaction, and savings 
with respect to the intervention group in the selected geographic area 
as specified in section II.B. of this notice, including:
     Positive outcomes from prior and current 
efforts, including quantified results for clinical quality, beneficiary 
and provider satisfaction and savings.
     Past success in performance standards data 
capture and management necessary to monitoring this type of program.
     Reasonableness of projections for quality 
improvement and beneficiary and provider satisfaction.
     Willingness to work with us to determine data to 
be collected and procedures for submission of those data.
     Willingness to cooperate in independent formal 
and formative evaluations of CCI-I.

e. Payment Methodology & Budget Neutrality (20 Points)

    The proposal describes or demonstrates clear and convincing 
evidence that the proposed fees and performance guarantees are 
appropriate to improve quality of care for participating beneficiaries 
and reduce aggregate costs to Medicare as specified in section II.B.6 
of this notice, including:
     Justification and explanation for the proposed 
chronic care improvement fees.
     Reasonableness of the proposed chronic care 
improvement fees and savings guarantees.
     Reasonableness of applicant's estimates of the 
expected net Medicare savings and the expected total yearly Medicare 
expenditures for the intervention and control groups.
     Financial solvency and an ability to compensate 
Medicare in the event the organization fails to meet its performance 
targets, including reinsurance, withholds, unreserved assets or some 
other means.
2. Final Selection
    The CMS Administrator will make the final selection of 
organizations for CCI-I from among the most highly qualified 
applicants, taking into consideration a number of factors, including 
operational feasibility, geographic location, and Medicare program 
priorities (for example, testing a variety of approaches for delivering 
services, targeting beneficiaries, payment, and using integrative 
information and communications tools). We will also conduct a financial 
analysis of these proposals and evaluate the proposed programs to 
ensure that aggregate Medicare program expenditures will be reduced. 
Applicants must be aware that proposals may be accepted in whole or in 
part. Awards may be subject to special terms and conditions that are 
identified during the review process. We reserve the right to conduct 
one or more site visits before making awards. The Administrator 
reserves the right to negotiate and limit the size of the population 
and the number of areas. We expect to make the awards in the fall of 
2004. Once awarded, CCI-I will be phased in over a period of time.

III. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its 
usefulness in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information 
collection burden.
     The quality, utility, and clarity of the 
information to be collected.
     Recommendations to minimize the information 
collection burden on the affected public, including automated 
collection techniques.
    Therefore, we are soliciting public comment on each of these issues 
that contain information collection requirements:
    This notice informs interested parties of an opportunity to apply 
for a pilot program agreement for the Voluntary Chronic Care 
Improvement Under Fee-for-Service Medicare initiative. If interested, 
applicants must submit a completed Medicare Demonstration Waiver 
Application that can be found online at: http://www.cms.hhs.gov/medicarereform/ccip/default.asp.

[[Page 22079]]

Requirements for this submission are described in Section B of this 
notice.
    The burden associated with this information collection is estimated 
to be 1,200 hours annually (80 hours per response x 15 respondents).
    This information collection requirement is subject to the PRA; 
however, the burden associated with this requirement is currently 
approved under OMB control number 0938-0880 entitled ``Medicare 
Demonstration Waiver Application'' with a current expiration date of 7/
31/2006.
    If you comment on these information collection and recordkeeping 
requirements, please mail copies directly to the following:
    Centers for Medicare & Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Regulations Development Group, Attn: 
Dawn Willinghan, CMS-5004-N, Room C5-14-03, 7500 Security Boulevard, 
Baltimore, MD 21244-1850; and
    Office of Information and Regulatory Affairs, Office of Management 
and Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Brenda Aguilar, CMS Desk Officer.
    Comments submitted to OMB may also be emailed to the following 
address: e-mail: [email protected]; or faxed to OMB at (202) 395-
6974.

    Authority: Section 721 of Pub. L. 108-173, the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003.


(Catalog of Federal Domestic Assistance Program No. 93.779, Health 
Care Financing Research, Demonstrations and Evaluations).

    Dated: March 3, 2004.
Dennis G. Smith,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-9127 Filed 4-20-04; 8:45 am]
BILLING CODE 4120-01-P