[Federal Register Volume 68, Number 107 (Wednesday, June 4, 2003)]
[Notices]
[Pages 33495-33506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-5003-N]
RIN 0938-ZA39


Medicare Program; Demonstration: End-Stage Renal Disease--Disease 
Management

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 for a waiver allowing them to participate in the End-Stage Renal 
Disease (ESRD) Disease Management Demonstration. We are planning a 
demonstration that will increase the opportunity for Medicare 
beneficiaries with ESRD to receive integrated disease management 
services and to test the effectiveness of paying for services received 
by these beneficiaries in a new way. The demonstration aims to test the 
effectiveness of disease management models to increase quality of care 
for ESRD patients while ensuring that this care is provided more 
effectively and efficiently. The demonstration features two distinct 
payment options: (1) Capitation, and (2) a fee-for-service bundled 
payment option. Organizations participating under the capitation 
payment option will be responsible for providing all Medicare covered 
services for beneficiaries who choose to participate in the 
demonstration. We plan to use risk-adjusted ESRD capitation rates being 
developed for use in the demonstration. A similar system of payment 
rates for ESRD is planned for the M+C program in 2005.
    Organizations participating under the fee-for-service bundled 
payment model will provide disease management services and dialysis 
services. They will receive payment for an expanded set of dialysis 
services, which includes items additional to those included under the 
current composite rate for outpatient dialysis services. Organizations 
under this option will be required through disease management to 
coordinate non-ESRD services, but will not have to provide or contract 
for these services directly.
    Organizations under both capitation and fee-for-service bundled 
payment models will be subject to a reconciliation around the risk-
adjusted ESRD payment rate. Organizations under the capitation model 
will be able to propose risk-sharing arrangements, which would allow 
them to share any losses or gains with us. Applicants under the fee-
for-service bundled payment model will share 50 percent/50 percent on 
gains and losses (or a similar arrangement to assure budget 
neutrality). The maximum amount of the incurred gain or loss for the 
applicant under the fee-for-service bundled payment model will be the 
amount of the additional payment for the expanded set of dialysis 
services.
    A competitive application process will be used to select 
organizations to participate in this demonstration. The demonstration 
is planned for 4 years.

DATES: Applications will be considered timely if we receive them on or 
before September 2, 2003.

ADDRESSES: Mail applications to: Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Office of Research, 
Development, and Information, Division of Demonstration Programs, Attn: 
Sid Mazumdar, Mail Stop: C4-17-27, 7500 Security Boulevard, Baltimore, 
Maryland 21244. Applications must be typed for clarity and should not 
exceed 40 double-spaced pages, exclusive of the executive summary, 
resumes, forms, and documentation supporting the cost proposal. Because 
of staffing and resource limitations, we cannot accept applications by 
facsimile (FAX) transmission. Applications postmarked after the closing 
date, or postmarked on or before the closing date but not received in 
time for panel review, will be considered late applications.

FOR FURTHER INFORMATION CONTACT: Sid Mazumdar, CMS Project Officer, at 
(410) 786-6673, or [email protected].

Eligible Organizations

    Potentially qualified applicants are companies experienced with 
providing services to ESRD patients. The demonstration will be 
especially appropriate for dialysis providers and disease management 
organizations. It will also be open to Medicare+Choice organizations 
and integrated health care systems.

SUPPLEMENTARY INFORMATION:

I. Background

A. Problem

    Many Medicare+Choice organizations and private insurers have 
realized the importance of the effective coordination of care for 
persons with chronic conditions. The quality and cost of the care 
generally can be improved through better integration of the delivery 
system. The Medicare program is evaluating payment methods to create 
incentives to improve the quality of care, encourage

[[Page 33496]]

the coordination of services, and control costs.
    Beneficiaries with (ESRD) are the only group eligible for benefits 
under Medicare Parts A and B who are prohibited from enrolling in M+C 
organizations, although a beneficiary who develops ESRD after enrolling 
in an M+C plan may remain enrolled.
    Medicare coverage of individuals with ESRD was initiated in 1972 
with the goal of providing life-saving treatment to patients with 
chronic renal failure. Over 30 years, the number of individuals with 
ESRD covered by the Medicare program has grown far beyond its expected 
size and budget, from 7,000 patients in the first year to more than 
350,000 in 2001. The ESRD population is currently growing at 7 percent 
per year and has doubled in the past decade.
    In recent years, the ESRD population has accounted for an 
increasing proportion of Medicare outlays. Between 1992 and 2001, 
Medicare spending for outpatient dialysis services furnished by 
freestanding facilities increased by about 10 percent per year. 
Intravenous medications have also increased Medicare spending for ESRD. 
Spending for injectible drugs increased from $1.3 billion in 1998 to 
$2.3 billion in 2001. In 2001, Medicare expenditures for ESRD amounted 
to $15 billion. The total Medicare cost for the ESRD program is 
projected to more than double in the next 10 years.

B. Approaches and Demonstration Project

    This demonstration follows an earlier ESRD managed care 
demonstration. In 1993, the Congress required the Secretary to conduct 
an ESRD Managed Care Demonstration Project. As a result of this 
mandate, section 13567(b) of the Omnibus Budget Reconciliation Act 
(OBRA) 1993, Pub. L. 103-66, we implemented a demonstration that 
allowed ESRD patients to enroll in managed care settings. Participating 
managed care organizations were to be responsible for the total medical 
care of ESRD enrollees as well as provide specific case management 
functions and additional benefits of utility to the ESRD population.
    Responding to our solicitation, three organizations joined the 
demonstration; Kaiser Permanente in southern California, Health Options 
Incorporated in Florida, and Xantus Corporation in Tennessee. Kaiser 
Permanente and Health Options Incorporated remained in the 
demonstration. Xantus discontinued demonstration operations in March 
2000. The organizations that remained were a health maintenance 
organization (HMO) and an HMO subsidiary, both with separate M+C 
contracts.
    The CMS-sponsored evaluation for the project shows the 
demonstration approach to be operationally feasible and the quality of 
care was maintained or improved. Overall, the patients who were 
enrolled in the demonstration reported high satisfaction, improved 
quality of life, and positive clinical outcomes. The executive summary 
of this report is available at http://cms.hhs.gov/researchers/reports/2002/execsum.pdf.
    We plan the new demonstration to foster more types of integrated 
care for Medicare beneficiaries with ESRD. We seek to test innovative 
approaches to integrating the chronic care management services for 
patients with ESRD with other acute care services. Responding to 
published research on the effectiveness of disease management methods 
in treating ESRD patients, the demonstration aims to test the 
effectiveness of disease management models to increase quality of care 
for ESRD patients while ensuring that this care is provided more 
effectively and efficiently. Disease management techniques are intended 
to improve patient care and save money by coordinating interventions 
and educating patients about managing ESRD and its comorbid conditions.
    National organizations have defined approaches to disease 
management, in order to improve patient outcomes while containing 
health care costs. Disease management programs tend to target persons 
whose primary health problem is a specific disease, along with comorbid 
conditions. Interventions tend to be highly structured and emphasize 
the use of standard protocols and adherence to clinical guidelines.
    Common features to disease management include:
    [sbull] Identification of patients and matching the intervention 
with the need.
    [sbull] Use of evidence-based practice guidelines.
    [sbull] Services designed to enhance patient self-management and 
treatment plan adherence, including education and behavior modification 
programs.
    Additional features essential for disease management of ESRD 
include:
    [sbull] A central role for the nephrologist.
    [sbull] Management of the many comorbid conditions of ESRD.
    [sbull] Care managers with specialized knowledge of diet, 
medications, total health status, and personal needs of ESRD patients.
    [sbull] Integrated administrative and financial arrangements among 
providers of services to ESRD beneficiaries.
    The new demonstration includes three delivery models and two 
payment models, or options. The delivery models are: (1) Managed care, 
(2) models similar to the approach taken under the Program for All-
Inclusive Care for the Elderly (PACE-type) under sections 1894 and 1934 
of the Social Security Act, and (3) fee-for-service. The two payment 
options are (1) capitation and (2) fee-for-service bundled payment. The 
capitation payment option applies to both managed care and PACE-type 
delivery models. The fee-for-service bundled payment delivery option 
would apply only to the fee-for-service model. The delivery and payment 
models have different implementation methods that are discussed in this 
solicitation. For each model, the organization will take responsibility 
for operations such as enrollment (capitation payment model), disease 
management, care coordination, and financial management.
    An additional component to the demonstration payment method, for 
both managed care and fee-for-service is an incentive payment for 
quality. Under the demonstration, we will reserve five percent of the 
payment, either capitation or bundled payment, to be available for 
quality incentive payments. Capitation payments would be set at 95 
percent of the risk-adjusted ESRD payment rate. Ninety-five percent of 
the additional payment for an expanded bundle will be paid for the fee-
for-service option.
    For both models, goals for a demonstration organization would be to 
implement clinical protocols for common clinical events, as well as for 
objectives as anemia management and diabetes management, and for 
quality of care in areas such as dialysis treatment modality, 
consideration for transplantation, post-transplantation follow-up, 
management of vascular access, prevention of peritoneal catheter exit 
site infections, and monitoring of dialysis adequacy. A site would 
coordinate inpatient, outpatient, and home-based services, ensuring 
continuity of care for multiple chronic care problems and 
comorbidities, in particular, cardiovascular disease, hypertension, and 
diabetes.

II. Capitation Payment Model (Managed Care and PACE-Type Delivery 
Models)

    Under the capitation payment model, organizations serving ESRD 
patients would receive a risk-adjusted ESRD capitation payment in order 
to test the effectiveness of disease management models in increasing 
quality of care for

[[Page 33497]]

ESRD patients while containing costs. Organizations participating under 
capitation arrangements would be responsible for managing the care of 
ESRD patients and providing all Medicare covered services for enrolled 
beneficiaries. Participating organizations may propose to cover 
additional services that are not currently covered by Medicare. The 
following are examples of these additional services:
    [sbull] Transportation.
    [sbull] Nutritional services.
    [sbull] Dental services.
    [sbull] Prescription drugs (full or limited).
    [sbull] Preventive care aimed at comorbidities.
    [sbull] Home care services.
    [sbull] Exercise programs.
    [sbull] Education on disease.
    [sbull] Counseling (including spiritual).
    [sbull] Diabetes management.
    [sbull] Cardiovascular management.

Beneficiaries would agree, as a condition of participation in the 
demonstration, to receive services through the participating 
organization. Organizations responding must demonstrate capability to 
identify beneficiaries for the demonstration, and they must be licensed 
to bear risk. Organizations would be required to meet M+C conditions 
regarding access and availability of care.

A. Managed Care Model

    The managed care delivery model may be attractive to organizations 
such as large dialysis providers and entities that currently offer M+C 
plans. The optimal approach for these organizations would consider 
arrangements with hospitals and other providers to service the entire 
range of health care needs for ESRD patients, including 
transplantation. These companies would coordinate referrals for the 
comorbidities of ESRD patients and therefore should be able to manage 
treatments to improve quality and reduce costs compared to fee-for-
service. Care coordination has the potential to enhance the continuity 
of patient care, improve clinical outcomes, and improve patient 
satisfaction. Managed care organizations would contract with disease 
management entities or directly provide disease management to all 
participating beneficiaries.
    Studies have reported the growth over the past decade of for-profit 
dialysis facilities and chains of dialysis facilities under common 
ownership. According to a recent report, the five largest dialysis 
corporations provide services to more than 70 percent of all dialysis 
patients in the U.S. (Source: United States Renal Data System). The 
capitation payment model will provide an incentive for these companies 
to combine their services with those of other healthcare providers to 
create efficient systems for the care of ESRD patients. The 
demonstration also will capitalize on the clinical, financial, and 
organizational expertise of independent dialysis companies. Other 
companies, including single-or multi-site disease management companies, 
have shown potential for cost savings through clinical and 
organizational innovations. Networks that coordinate the entire range 
of patients' care will enhance the continuity of care for illnesses and 
conditions that impact ESRD patients. Since ESRD patients will choose 
whether to participate or remain in fee-for-service, companies already 
serving patients on a fee-for-service basis that participate in the 
managed care model of this demonstration will be required to continue 
these fee-for-service arrangements for patients who do not choose to 
participate in the demonstration. However, it is expected that many, if 
not all, will enroll.

B. PACE-Type Model

    The PACE program provides for managed care services for very frail 
community dwelling elderly, most of who are dually eligible for 
Medicare and Medicaid. The PACE-type model is a variation of the 
managed care model described above, although with greater emphasis on 
patient care coordination. For the purposes of this project, the PACE-
type model would be a delivery option, receiving no additional payment 
beyond the risk-adjusted ESRD rates. In the PACE-type model, the 
provider would ensure that all services, including those provided by 
contracted providers, would be controlled by an interdisciplinary team 
composed of professional and para-professional staff (for example, 
physicians, nurse practitioners, registered nurses, licensed practical 
nurses, occupational therapists, physical therapists, dietitians, day 
health center supervisors, recreation therapists, social workers, 
health workers, and drivers). The team would have responsibility for 
assessing participant needs, formulating care plans, directly 
delivering services, managing the care provided by contracted 
providers, and providing ongoing monitoring of treatment outcomes. 
Constant monitoring effectively would disclose potential needs for care 
plan adjustments. The team also would have the responsibility for 
maintaining high quality of care while simultaneously controlling 
program costs.
    Organizations providing dialysis as well as other health care 
services exclusively to ESRD patients may base their delivery system on 
a variation of the PACE-type model emphasizing disease management 
protocols and multidisciplinary team management at one central site. 
Flexibility would be allowed in designing service delivery provisions, 
to be negotiated during the period before implementation. Organizations 
proposing the PACE-type model will not be required to only include dual 
eligible ESRD beneficiaries.

C. Eligibility Requirements

    For the capitation model, an applicant organization must have at 
least preliminary arrangements with other organizations to assure the 
integrated provision of all Medicare-covered services. We expect 
organizations to select geographic areas where they will make 
arrangements with hospitals and other providers to service the entire 
range of Medicare covered health care needs of ESRD patients. All 
services should be geographically accessible to all ESRD patients in a 
service area (for example, within one hour or 50 miles of a patient's 
residence). However, special transportation arrangements may be needed 
to make transplant services available. Applications should include 
discussion of proximity of service providers, including hours of 
availability and other aspects of access. Maps would be useful. We 
encourage programs to allow a wide choice of modalities, while 
recognizing that for certain qualified applicants this choice is 
necessarily limited to in-center dialysis only.
    All persons eligible for the Medicare ESRD benefit and in the 
service area would have the opportunity to participate on a voluntary 
basis except for patients who become eligible for the Medicare hospice 
benefit prior to enrolling in the demonstration. Demonstration sites 
could exclude patients according to particular criteria, including 
those under 18 years old, if justified. The demonstration organization 
would make clear that patient participation is entirely voluntary and 
that the ESRD beneficiary who chooses not to do so remains entitled to 
all Medicare-covered services.
    Information provided by the provider to beneficiaries would include 
the network of providers who have contracted with the demonstration 
organization, including dialysis facilities, hospitals, and transplant 
surgeons, and that receiving services

[[Page 33498]]

through this network is a condition of participation in the 
demonstration.

D. Payment

    For the managed care and PACE-type models, we plan to use risk-
adjusted ESRD capitation payment rates being developed for the 
demonstration. These rates are part of the development of the 
``selected significant conditions'' model for M+C risk adjustment. A 
similar set of payment rates for ESRD is planned for the M+C program in 
2005. This risk adjuster will factor a greater number of comorbidities 
into the payment. The capitation payment method would depend on an 
organization's ability to submit data for relevant diagnoses recorded 
during hospital inpatient stays, hospital outpatient visits and 
physician visits. For the proposed new payment methodology for M+C 
ESRD, see http://www.cms.hhs.gov/healthplans/rates/2004/45day-section-b.asp. The actual ESRD risk-adjusted payment rates for 2004 will be 
available on our Web site in the near future.
    The methodology will pay separate payment rates for dialysis, 
transplant, and post-transplant modalities. The organization would 
submit monthly data indicating the modality status for enrollees. The 
developmental phase for the demonstration would offer a period when CMS 
and organizations would be able to work together to establish the 
operational requirements of specific payment options. There will be no 
phase-in of the risk adjusted ESRD rates for the demonstration--payment 
will begin with one hundred percent, or full, risk adjustment. The 
actual payment amount will be reduced by five percent, which will be 
available later depending on performance on quality measures.

III. Fee-for-Service Bundled Payment Model

    This delivery and payment model is appropriate for organizations 
such as disease management companies, dialysis facilities, and 
integrated health systems that will conduct disease management for ESRD 
patients and provide dialysis services under a new bundled payment 
methodology. Organizations will be expected to coordinate all services 
utilized by patients receiving dialysis through the organization. They 
will not be responsible for providing services other than disease 
management and dialysis services, and Medicare will process and pay all 
claims on a fee-for-service basis.
    However, the organizations will be partially at risk for expenses 
incurred by Medicare for patients who receive dialysis services through 
the organization. Annually, we will conduct a reconciliation, wherein 
patients' total Medicare costs will be compared to what their risk-
adjusted payment amounts would be. (See Financial Risk, below.) For the 
purposes of the reconciliation, organizations will be accountable for a 
patient's Medicare expenses until a patient either begins to receive 
dialysis services in another dialysis facility or in a nursing home, 
that is, the patient's care is no longer managed by the organization. 
(As an example, if a patient receiving services in a demonstration 
dialysis facility is admitted to a hospital and then returns to the 
facility for dialysis, the Medicare cost for the hospital stay will be 
counted as part of the demonstration organization's expenses.) Under 
this payment option, the maximum amount of incurred gain or loss for 
the organization will be equivalent to the total amount of the add-on 
payment for the expanded bundle.
    The organization would identify distinct facilities that will 
participate in the demonstration. To minimize favorable selection, all, 
or nearly all, patients treated within the set of facilities that are 
included in the demonstration would be paid for under the bundled rate. 
The beneficiaries would be informed that the organization is 
participating in a new payment and disease management project. The 
organization would make special arrangements for those patients who 
choose to opt out of the demonstration. An acceptable arrangement would 
involve placing a patient who chooses to opt out in another facility, 
while ensuring that location and transportation arrangements are 
convenient for the patient. If this condition is not met, we would make 
arrangements for these people to continue in the facility under a 
separate payment from the demonstration. In addition, we would not 
include dialysis patients in the demonstration who are members of M+C 
plans.
    The demonstration payment for the bundle is constructed as an add-
on to the otherwise applicable specific composite rate payment for each 
geographic area, as listed in the CMS Program Memorandum for February 
1, 2001 (Transmittal A-01-19). The expanded bundle add-on includes 
payment for several classes of drugs: Erythropoietin, Levocarnitine, 
phosphate binders, iron supplements, and Vitamin D analogs; necessary 
laboratory tests; and radiology. (See appendix I for a full list of 
items under the bundled payment.) Applicants for this option will have 
the choice of also including vascular access services in the expanded 
bundle add-on. Nearly all routine dialysis services are included in the 
bundle. Other items and services will be separately billable outside 
the bundle. Organizations will not be able to bill separately for items 
in the bundle.
    The Medicare add-on payment for the expanded bundle not including 
vascular access services is $71.63 per session. The add-on payment for 
the bundle including vascular access services is $86.63. (These numbers 
include a one percent deduction for Medicare savings.) These payments 
do not include any potential co-payments and were calculated on 
Medicare claims data from July 2000 through December 2001, and will be 
used exclusively for this demonstration. We will update the payment for 
the expanded bundle to reflect changes in Medicare payment levels.
    The add-on bundle rates include payment for disease management 
services. Organizations must provide a detailed description of the 
disease management services they will provide, including information on 
their proposed interventions, the type and number of patients to whom 
each intervention is targeted, and the frequency with which such 
interventions are expected. Applicants should also describe how these 
services will increase quality and reduce costs.
    In accordance with the withhold for quality, five percent will be 
subtracted from the bundled payment rate. As described below, the five 
percent will be available later depending on performance on quality 
measures.
    In rare circumstances when patients use other dialysis facilities, 
the organization will be responsible for reimbursing the facility at 
Medicare fee-for-service payment levels. It will have received the 
bundled payment on behalf of the beneficiary who is temporarily absent 
from the geographic area. Applicants should consider in their proposals 
what constitutes a temporary absence. The organization will continue to 
provide disease management services and coordinate other Medicare 
services while the patient is away.
    Applicants proposing the fee-for-service option with the bundled 
dialysis payment should be aware that the implementation period will be 
at least six months, because of significant bill-paying systems 
changes. We will update the payment for the expanded bundle on an 
annual basis to reflect changes in Medicare payment levels. Facilities 
will be able to participate under this option for patients receiving 
home dialysis services under Method I. Demonstration payments will not 
be made for Method II home dialysis patients.

[[Page 33499]]

IV. Supplemental Coverage

    The demonstration will be open to ESRD beneficiaries for whom 
Medicare is either primary or secondary payer. In the case of 
demonstration participants for whom another payer is primary, the 
demonstration organization must submit valid bills with the primary 
payer to collect the appropriate payment amount as specified by the 
demonstration's payment rules.
    To make the demonstration financially viable, participating 
organizations may collect cost-sharing in the form of premiums, 
deductibles, and co-payments to beneficiaries in lieu of the cost-
sharing amounts for which beneficiaries are responsible under the 
ordinary fee-for-service payment rules. To be financially attractive to 
beneficiaries, these should have actuarial values that are lower than 
current Medicare fee-for-service cost-sharing.
    A beneficiary participating in the demonstration may choose to 
retain his or her Medigap policy. Participating organizations should 
clearly explain to beneficiaries the advantages of retaining and risks 
of discontinuing their Medigap coverage. Under the fee-for-service 
bundled payment option, participating organizations will be able to 
bill any supplemental insurance plan that the enrolled beneficiary 
holds for cost-sharing purposes. If a secondary payer is Medicaid or a 
group health plan, that payer may pay some or all of a beneficiary's 
monthly premium for enrollment.
    Under the demonstration, an organization receiving a fully 
capitated payment may pursue the possibility of billing existing 
Medigap policies held by a beneficiary participating in the 
demonstration, or bill Medicaid, for the amount of cost-sharing that 
otherwise would be paid under Medicare fee-for-service. The 
demonstration organizations may attempt to make such arrangements with 
Medigap plans, State Medicaid agencies, and State insurance regulators.
    Beneficiaries participating in the capitation demonstration will 
have the option of terminating supplementary coverage. In these cases, 
the selected demonstration organizations must work with the 
beneficiaries to ensure that either their policy is maintained at the 
end of the demonstration, or that beneficiaries understand that if they 
drop supplemental coverage, enrollment in their supplemental plans is 
not guaranteed at the end of the demonstration. It will be incumbent on 
the demonstration organizations to provide proper notice to potentially 
participating beneficiaries about their Medigap rights if the 
individual's participation in the demonstration ceases. Specifically, 
the demonstration organization should be explicit in its marketing 
information to beneficiaries about the scope of rights that accrue to 
patients under age 65 in the particular State.\1\
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    \1\ Generally, an individual who voluntarily disenrolls from a 
managed care demonstration will not have guaranteed issue rights. If 
an individual is enrolled in a managed care demonstration and 
enrollment ceases under circumstances set forth in section 
1851(e)(4) of the Act (for example, the demonstration is 
terminated), the individual will have the right to buy certain 
Medigap plans on a guaranteed issue basis (generally Plans A, B, C 
or F). This right generally will not accrue to an individual who 
wishes to voluntarily disenroll from the managed care demonstration. 
It also generally will not apply if an individual is enrolled in the 
fee-for-service model of the demonstration, since the statutory 
provision in section 1882(s)(3)(B)(iii) of the Act provides 
guaranteed issue rights to individuals in a managed care 
organization.
    If an individual drops a Medigap policy to enroll in the ESRD 
managed care demonstration and it is the first time the individual 
has enrolled in Medicare managed care, that individual has a 12-
month trial period. The individual may disenroll from the 
demonstration within the first 12 months and purchase his or her 
former Medigap policy, if it is still available from the same 
issuer. If the former policy is not available, the individual can 
buy Medigap Plans A, B, C, or F. Individuals who join the 
demonstration upon first becoming eligible for Medicare Part A at 
age 65 would not have ``trial period'' rights.
    It is important to note that Federal law does not require a 
Medigap open enrollment period for beneficiaries under age 65, so 
Medigap insurers do not have to sell policies to this population. 
State law governs what Medigap choices are available to Medicare 
beneficiaries under age 65. Currently, twenty-two States have laws 
that provide Medigap rights to beneficiaries under 65. The Medigap 
plans available to the under-65 population vary by State.
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    If the beneficiary intends to cancel a Medigap policy and if the 
arrangements with the supplemental insurer do not guarantee that the 
beneficiary has the same coverage at the end of the demonstration, it 
must be clear that the beneficiary chooses to participate in the 
demonstration with full knowledge of this possibility. Providers and 
beneficiaries are advised that the demonstration is time-limited, and 
that dropping a Medigap policy presents a significant risk. We will 
ensure that demonstration organizations communicate the advisability of 
maintaining Medigap coverage to potential participants.
    When demonstration awards are made, the Terms and Conditions will 
require that the awardee submit for our approval a Phasedown Plan 
explaining how demonstration participants are to be assisted in 
converting back to previous insurance coverage and fee-for-service care 
at the conclusion of the demonstration, as well as during the project. 
This requirement will apply to organizations under both capitation and 
fee-for-service bundled payment models.

V. Financial Risk

A. Risk-Bearing Requirements

    We will work with organizations that have requested capitation 
payment in the pre-implementation period to assure they meet the risk-
bearing requirements under their State. We will consider the individual 
circumstances of the provider in relation to State law and the 
demonstration project, but we cannot exempt organizations from State 
law. Organizations will be required to meet all of the State's 
insurance requirements to the extent applicable. There is no risk-
bearing licensure requirement for the fee-for-service model.

B. Risk Sharing

    Organizations may propose risk-sharing arrangements under either 
the capitation or fee-for-service bundled payment options. If risk 
sharing is included for the capitation option, a year-end 
reconciliation will be conducted to compare an actual Medical-Loss-
Ratio (MLR) to a target Medical-Loss-Ratio. Any differences, either 
gains or losses, would be shared on a symmetrical basis by the 
organization and us. As part of the proposal, organizations should 
submit a projected revenue and expense statement showing calendar year 
2004 estimated per member per month Medicare revenue and member 
premium; benefit expenses (hospital inpatient, hospital outpatient, 
dialysis, professional, other Medicare services, and non-Medicare 
services); and administrative expenses. The statement should show any 
co-payment credits for the various services and reflect payment from 
Medicaid or supplemental insurers. A target MLR will result from the 
ratio of benefit expenses to revenues. One year after the end of each 
operational year, the organization should send a certified actual 
revenue and expense report to determine the actual MLR.
    If risk sharing is proposed, there should be three calculations of 
projected savings/losses--optimistic or best case assumptions, expected 
or normal assumptions, and pessimistic or worst-case assumptions. 
Budget neutrality should be assessed for each situation. The risk-
sharing proposal must include a 2 percent full-risk corridor above and 
below the targeted Medical-Loss-Ratio. In addition, prior to awards, we 
will work with applicants to determine whether the proposed Medical-
Loss-Ratio is set at a level where the risk-

[[Page 33500]]

sharing arrangement is projected to be budget neutral under expected or 
normal assumptions. If risk sharing is proposed for the capitation 
model, we will share risk only on medical benefit expenses. 
Administrative expenses must be reasonable and consistent with prior 
practices. Applicants can propose the percentages of risk sharing and 
risk corridors, but these must be symmetrical, for example, 50 percent 
organization/50 percent CMS beyond the 2 percent full risk corridor; 40 
percent organization/60 percent CMS beyond the 2 percent full risk 
corridor on gains and losses. Seventy-five percent is the most we will 
share on gains or losses.
    For the fee-for-service option, a CMS reconciliation will be 
conducted to compare total Medicare payments made on behalf of patients 
receiving dialysis and disease management services to total risk-
adjusted ESRD payments that would have been received under the 
capitation payment model (minus the dollar amount of the one percent 
subtracted from the payment for the expanded bundle). It is expected 
that through efficiencies generated by disease management and a bundled 
dialysis payment, organizations will break even or achieve overall 
savings. Similar to the capitation model, there will be a 2 percent 
full-risk corridor above and below the targeted payment amount. 
Organizations will share with CMS 50 percent/50 percent on gains and 
losses resulting from the reconciliation beyond the full-risk corridor 
on gains and losses (or a similar arrangement to assure budget 
neutrality). The maximum amount of incurred gain or loss will be 
equivalent to the amount of the add-on payment for the expanded bundle. 
For the purposes of the reconciliation, organizations will be 
responsible for a patient's Medicare expenses until a patient either 
begins to receive dialysis services in another dialysis facility or in 
a nursing home. A 12-month period will be allowed for claim lag.
    Similar to the capitation model, fee-for-service applicants should 
outline calculations of budget neutrality under optimistic or best-case 
assumptions, expected or normal assumptions, and pessimistic or worst-
case assumptions.

VI. Legislative Authority

    Depending on the model chosen by the applicant and approved by us, 
the demonstration project and the waivers granted to permit it would be 
authorized by one of two statutory provisions, or by both such 
provisions. The original ESRD managed care demonstration described 
above was, as noted, conducted in accordance with specific 
Congressional authority for such a demonstration in the context of 
``Social HMO'' or ``SHMO'' demonstration projects. The managed care 
model demonstrations, as well as those we are referring to as ``PACE-
type'', would be authorized under this broad authority. These types of 
demonstration models would also be authorized by the authority in 
section 402 of the Social Security Amendments of 1967, 42 U.S.C. 
section 1395b-1, which permits demonstrations, testing ``changes in 
methods of payment'' and the waiver of rules relating to payment, as 
well as the coverage of services not otherwise covered by Medicare. In 
the case of a fee-for-service demonstration model, this latter 
authority would authorize the demonstration.

A. SHMO Authority

    Section 2355 of the Deficit Reduction Act of 1984 (Pub. L. 98-369) 
required the Secretary to approve applications to carry out SHMO 
demonstrations to provide for the integration of health and social 
services under the direct financial management of a provider of 
services. Up to four additional projects were mandated by section 
4207(b)(4) of the Omnibus Budget Reconciliation Act (OBRA) of 1990, 
Pub. L. 101-508. (This authority, as amended, is referred to as SHMO 
II.) In accordance with the previous demonstration, we are interpreting 
the term ``project'' to refer to the overall demonstration project, and 
that a significant number of organizations can participate in the 
proposed demonstration.
    Section 13567(b)(2)(B) of the Omnibus Budget Reconciliation Act of 
1993 (Pub. L. 103-66) mandated that these demonstration waivers be 
extended through the end of 1997 and required at least one of the four 
new projects: ``to demonstrate * * * the effectiveness and feasibility 
of innovative approaches to refining, targeting and financing 
methodologies and benefit design, including the effectiveness and 
feasibility of integrating acute and chronic care management for 
patients with end-stage renal disease through expanded community care 
case management services.''
    The Congress subsequently mandated that these demonstrations be 
extended. Section 631 of the Medicare, Medicaid and SCHIP Benefits 
Improvement Act of 2000 (BIPA) mandated an extension through August of 
2003. While under current statute, a mandate that the demonstrations 
continue would expire on that date; we believe that to the extent a 
demonstration is otherwise permitted under the SHMO authority, it can 
be conducted under this authority subsequent to this date.
    The Congress in Section 4207(b) of the Omnibus Budget 
Reconciliation Act of 1990 provided authority to waive ``any 
requirements of titles XVIII or XIX of the Social Security Act that, if 
imposed, would prohibit such project from being conducted.''

B. Section 402 Authority

    Section 402(a)(1)(A) of the Social Security Amendments of 1967, 42 
U.S.C. section 1395b-1(a)(1)(A), authorizes the Secretary to develop 
and engage in demonstrations ``* * * to determine whether, and if so 
which, changes in the method of payment or reimbursement * * * for 
health care and services under health programs established by the 
Social Security Act * * * would have the effect of increasing 
efficiency and economy of health services under such programs through 
the creation of additional incentives to these ends without adversely 
affecting the quality of such services * * *.'' Section 402(a)(1)(B), 
42 U.S.C Sec.  1395b-1(a)(1)(B) authorizes a demonstration to determine 
whether covering services not otherwise covered by Medicare (in this 
case, disease management services) would result in more economical 
provisions of Medicare covered services.
    Under section 402(b) of the Social Security Amendments of 1967 (42 
U.S.C. 1395b-1(b)), the Secretary may waive requirements in title XVIII 
that relate to reimbursement or payment. This authority will allow 
payment on a capitation basis rather than under the Medicare fee-for-
service rules, and would allow fee-for-service/bundled payment and risk 
sharing around a traditional fee-for-service payment system. Section 
402(a)(2), 42 U.S.C. Sec.  1395b-1(a)(2), authorizes Medicare trust 
funds to cover the costs of the additional services under section 
402(a)(1)(B).

VII. Quality Assurance and Improvement

A. Quality Indicators

    Under the demonstration, we would link financial incentives to 
improvements in quality outcome indicators. Five percent of the 
capitation or expanded bundle payment rates will be reserved for 
incentive payments related to quality improvement activities.
    For determining the incentive payment, we will use indicators 
profiled in the ESRD Clinical Performance Measures (CPM) Project. 
Indicators for the incentive payment will include adequacy of dialysis, 
anemia

[[Page 33501]]

management, serum albumin, bone disease, and vascular access.
    Organizations will be able to earn all or part of the five percent 
withheld for quality. For each of the five measures, an organization 
will earn one half of one percent for achieving either of the 
improvement or the threshold targets outlined below. Appropriate 
targets will be used for patients receiving peritoneal dialysis. For 
each measure, the amount of incentive would be weighted according to 
the proportion of hemodialysis to peritoneal dialysis patients.
    The demonstration will require further indicators for the 
evaluation of disease management efforts. Although not representing 
factors in the calculation of the financial incentive, organizations 
will be monitored for quality indicators measuring potential outcomes 
of disease management. Indicators of particular interest include blood 
pressure control, comprehensive diabetes care, adult immunizations, 
measures of successful transplantation or referrals for transplant 
evaluation, quality of life (QoL or CAHPS surveys), patient safety, 
psychiatric evaluation, referral and follow-up, and the percentage of 
referrals with consult and discharge summaries. The evaluation of the 
demonstration will assess all available measures of quality of care in 
the context of the demonstration. In addition, the demonstration will 
require at its initiation an updated Form CMS-2728 (that is, ESRD 
Medical Evidence Report Medicare Entitlement and/or Patient 
Registration) to be submitted for each patient. The 2728 will be used 
as a baseline for patient demographics, clinical lab values, and co-
morbid conditions. This baseline data will be used along with the CPM 
Data to monitor patient enrollment so that selection bias is minimized. 
They will also be used for patient care monitoring to ensure that 
patients receive at least the same level of medically necessary 
services and medications as determined by the patient's phyisican as 
they received, prior to enrollment.

B. Incentive Payment for Quality

    There will be two kinds of quality outcome targets--targets for an 
organization's improvement over time and those that measure an 
organization against a predetermined threshold level that takes into 
account nationwide performance for a quality indicator.
    Improvement targets would be set using a methodology that bases the 
target on improvements in the ``quality deficit''. The quality deficit 
would be defined as 100 percent minus the organization's actual rate 
for assigned beneficiaries in the previous year. Improvement targets 
would be set at 10 percent over the deficit from 100 percent. Threshold 
targets would be set at 20 percent above the nationwide percent deficit 
from 100 percent.

Improvement Target = [Percent of patients in previous year meeting 
quality indicator + (10 percent * (100 percent-Percent of patients in 
previous year meeting quality indicator))]
Threshold Target = [Nationwide percent of patients meeting quality 
indicator + (20 percent * (100 percent-Nationwide percent of patients 
meeting quality indicator))]

    The targets would be re-evaluated annually. Each measure would be 
worth an equal proportion of the total five percent reserved for 
quality improvement. Allowing organizations to earn incentive payments 
by meeting/exceeding either predefined thresholds or improvement 
targets would require bigger improvements for low performers than high 
performers and would take into account that it may be more difficult to 
improve on already high performance.
Example
(Quality Indicator: Adequacy of Hemodialysis, Percent of patients 
receiving hemodialysis with KT/V = 1.2. Nationwide Percent: 
86 percent, Source: 2001 Annual Report on ESRD Clinical Performance 
Measures Project)
    For Organization A, 80 percent of hemodialysis patients in the 
previous year had a Kt/V = 1.2.
    [sbull] The organization's improvement target would be 82 percent 
[80 percent + (10 percent * (100-80))].
    If 82 percent of the organization's hemodialysis patients have a 
Kt/V = 1.2 in the operational year, the organization would 
earn half of the incentive payment for this quality indicator for 
meeting the improvement target.
    [sbull] The nationwide percent of patients with Kt/V = 
1.2 is 86 percent; therefore, the threshold target is 88.8 percent [86 
percent + (20 percent * (100-86))].
    If 89 percent of the organization's hemodialysis patients have a 
Kt/V = 1.2 in the operational year, then the organization 
would earn half of the incentive payment for this quality indicator for 
meeting the threshold target.

C. Clinical Quality Data Collection

    For quality data assurance, we would use the Clinical Performance 
Measures Project data system, which is administered by the Quality 
Measurement and Health Assessment Group, Center for Beneficiary 
Choices, CMS. The CPM Project would provide data within 9 to 12 months 
for all five measures discussed above. By way of contrast, data using 
claims are less complete and take longer to obtain. Currently, CPM data 
are collected annually over a three-month time frame. For the 
demonstration, we intend to collect these data quarterly to examine 
trends more closely. Although the current CPM project only reports 
these indicators for a small percentage of dialysis patients, this 
demonstration would require a 100 percent reported sample. A CMS pilot 
project under development for electronic submission of clinical ESRD 
data may be ready within the next year. If feasible, we would require 
demonstration sites to utilize this system. The developmental period 
will be used to verify the details of reporting for individual sites, 
for example, how values will be established for patients with multiple 
observations in a quarter.

D. Quality Improvement

    An optimal organization would include an approach to improving and 
ensuring quality of care for Medicare ESRD patients. Quality of care 
strategies would be beneficial if they are patient-centered and focus 
on outcomes of care and could be measured and monitored. The quality 
improvement program would include the following features:
    [sbull] Written quality improvement policies and procedures
    [sbull] Written patient education program
    [sbull] A standing quality improvement committee
    [sbull] Patient grievance and appeal systems
    [sbull] Provider credentialing system

VIII. Budget Neutrality

    This demonstration must be budget neutral. This means that the 
expected costs that are incurred to Medicare for each site under the 
demonstration can be no more than the expected costs were the 
demonstration not to occur. Before awards are made, our actuaries will 
review and approve documentation to support budget neutrality 
calculations.

IX. Evaluation and Reporting Requirements

    We plan to award a separate contract to evaluate the ESRD 
demonstration. Awardees for the demonstration would agree to cooperate 
with our evaluation contractor, including participation in periodic 
site visits and providing information necessary to conduct the 
evaluation. The specific requirements for sites related to the 
evaluation of the demonstration would be finalized once

[[Page 33502]]

an evaluation contract has been awarded.
    In addition, awardees under the fee-for-service bundled payment 
option will be required to provide line item billing for all non-
composite expanded bundle services. For both capitation and fee-for-
service bundled payment options, ability to submit data under the CPM 
project will be beneficial.

X. Submission of Applications

A. Purpose

    This notice solicits applications for demonstration projects that 
increase the opportunity for Medicare beneficiaries with ESRD to 
receive integrated care management. The demonstration aims to test the 
effectiveness of disease management models to increase quality of care 
for ESRD patients while ensuring that this care is provided more 
effectively and efficiently.
    Participating organizations will be able to solicit participation 
in the demonstration by patients whom they currently treat in the fee-
for-service system as well as new patients. Organizations under both 
capitation and fee-for-service bundled payment models will be subject 
to a reconciliation around the risk-adjusted ESRD rates. (For the fee-
for-service bundled payment option, one percent of the amount of the 
add-on to the bundled payment will be subtracted from this target.) 
Organizations under the capitation model will be able to propose 
symmetrical risk sharing arrangements around a two percent corridor, 
which would allow them to share any losses or gains with us. Applicants 
under the fee-for-service bundled payment model will share around a two 
percent corridor with CMS 50 percent/50 percent on gains and losses. 
The maximum amount of incurred gain or loss will be equivalent to the 
amount of the add-on payment for the expanded bundle. An incentive 
payment for quality is also included in the demonstration. The 
demonstration is planned for four years.

B. Submission of Applications

    Each applicant organization is to submit one application regardless 
of the number of proposed demonstration sites. The application is to be 
coordinated and submitted by a component of the organization that 
currently treats or organizes the treatment of ESRD patients. If 
applicable, variations related to proposed sites should be outlined in 
the application text or supplemental materials.
    We are seeking innovative proposals from qualified organizations 
that can test whether care of Medicare beneficiaries with ESRD can be 
more efficiently and effectively provided using models involving 
disease management, and whether clinical outcomes can be improved with 
a cost that is budget neutral to the Medicare program.
    Interested organizations are able to use the capitation and fee-
for-service bundled payment models outlined in this solicitation. 
Organizations in the demonstration will adopt one of the managed care, 
PACE-type or fee-for-service bundled payment delivery models. For the 
capitation models, the entire range of medical needs of ESRD patients 
must be addressed through a network of contracted or affiliated 
providers.
    In order to be considered for review by the technical review panel, 
applicants must submit their applications in the standard format 
outlined in our Medicare Waiver Demonstration Application. Applications 
not received in this format will not be considered. The Medicare Waiver 
Demonstration Application may be accessed at the following Internet 
address: http://www.cms.hhs.gov/healthplans/research. The application 
outlines all application requirements including the format and content 
requirements.
    Queries for the narrative portion of the application should be 
submitted in writing by mail, fax, or e-mail to: Sid Mazumdar, 7500 
Security Boulevard, C4-17-27, Baltimore, MD 21244-1850: FAX: 410 786-
1048, E-mail: [email protected], or [email protected].
    Applications should be sent to: Sid Mazumdar, Project Officer, 
Division of Demonstration Programs, Centers for Medicare & Medicaid 
Services, C4-17-27, 7500 Security Boulevard, Baltimore, MD 21244-1850.

C. Evaluation Process and Criteria

    If the application meets the basic eligibility requirements (that 
is, responds to all components of the solicitation), it will be 
referred to a technical review panel for evaluation and scoring. Panels 
of experts from the government or private sector will conduct an 
independent review. The panelists' comments and evaluations will be 
transcribed into a summary statement that will serve as the basis for 
award decisions. The panelists' evaluations will contain numerical 
ratings based on the rating criteria specified in this section, the 
ranking of all applications, and a written assessment of each 
application. In addition, we will conduct a financial analysis of the 
recommended proposals and evaluate the proposed projects to assure that 
they are budget neutral.
    The evaluation criteria and weights are described below. These 
criteria are intended to identify specific information that will be 
useful for evaluating the application for the ESRD Disease Management 
Demonstration and how the applicant will be evaluated on that 
information in accordance with the Medicare Demonstration Waiver 
Application referenced above.
1. Purpose of Project/Statement of Problem (10 points)
    The applicant will be evaluated on how it defines the purpose of 
the ESRD demonstration project, that is, the specific goals and 
objectives to be achieved, and how taking part in the demonstration 
will lead to these goals. A successful applicant should include an 
explanation of its ability to manage care, access, additional benefits, 
and costs for ESRD patients. A successful application would also 
include specific indicators that could be used to measure these goals 
and, if possible, appropriate comparison groups.
2. Technical Approach (40 points)
    (a) Organizational Structure and Service Delivery Capacity. 
Organizations may consist of single or multiple sites, and the central 
component may be an organization other than a dialysis company (for 
example, an organization specializing in disease management). If the 
central component of the demonstration organization is a disease 
management or other kind of organization, it would have established 
relationships with facilities that provide dialysis services.
    (b) Description of Sites Specific to the Demonstration. Applicants 
will be evaluated on their operational structure. In addition, an 
applicant will be evaluated on its explanation of how its 
organizational components will coordinate to provide medical treatment 
and disease management to ESRD patients. It will also be evaluated on 
the experience and background of its component parts in serving ESRD 
patients.
    An applicant organization may propose to operate the demonstration 
at more than one site. The applicant will identify which of the three 
delivery options--managed care, PACE-type, or fee-for-service bundled 
payment options it chooses for the demonstration, as well as explain 
the nature of any affiliations with providers, persons, and 
organizations. An applicant for the capitation option will also be 
evaluated

[[Page 33503]]

on how it will provide non-ESRD medical services to its population.
    Applicants will be evaluated on their infrastructure to carry out 
the selected delivery model. This may include:
    [sbull] Facilities.
    [sbull] Equipment.
    [sbull] Appropriate information and financial services.
    [sbull] Ability to handle claims to pay providers (for the managed 
care and PACE-type models).
    [sbull] Composition of the multidisciplinary team and how the team 
will function (for the PACE-type model).
    [sbull] Any special arrangements that may be needed to make 
transplant services available.
    Applicants under all three delivery options--managed care, PACE-
type and the fee-for-service bundled payment--should identify the 
dialysis facilities where services will be provided, and how patients 
receiving services in those facilities will receive information about 
the demonstration project, including information on the advantages of 
retaining and risks of discontinuing Medigap coverage. It is expected 
that the bundled payment will be for all patients at the facility. In 
the event that a patient does not want to receive services at the 
facility, the applicant organization should identify other dialysis 
facilities conveniently located and with openings so as to allow a 
patient to receive services. If such a facility is not located within a 
reasonable distance, the applicant organization should state how it 
will accommodate patients who do not wish to participate. Applicants 
should also address what arrangements it will make for traveling 
patients who receive care in other facilities.
    Whether an applicant proposes to serve a disadvantaged population 
or area will be an important consideration as to whether it is selected 
for the demonstration. Applications will be evaluated on how they 
propose to reach out to minorities or other disadvantaged individuals. 
A demographic profile of the service area, including estimated numbers 
of ESRD patients by age, sex, race and ethnicity, treatment status/
modality and poverty status, along with any relevant socioeconomic or 
transportation issues, will be considered in determining the 
demonstration site's potential for assisting a disadvantaged population 
or area.
    (c) Disease Management Features. Applicants will be evaluated on 
their disease management program, including their understanding of the 
role of the nephrologist in the care of the ESRD patient and the role 
of the care manager in providing or coordinating services beyond the 
dialysis facility. In addition, applicants will be evaluated on:
    [sbull] The proposed disease management services and how they will 
increase quality and reduce costs.
    [sbull] The proposed roles of the physician, case managers, and 
other appropriate staff such as advanced practice nurses, in planning 
for and coordinating the care of ESRD patients.
    [sbull] The schedule of visits with the nephrologist and frequency 
of dialysis.
    [sbull] The methods of training to ensure a team of care managers 
with specialized knowledge of diet and medications, as well as other 
personal needs of ESRD patients.
    [sbull] How multidisciplinary teams will be used to serve ESRD 
patients, including the composition of these teams and proposed 
activities.
    [sbull] The development and use of protocols to guide case 
managers' activities.
    [sbull] If applicable, accreditation specific to disease management 
by a national organization.
    (d) Service Package
    Under the capitation option, all Medicare-covered services are to 
be provided. If a demonstration organization participates in a State 
Medicaid program, then it must work with that State program to meet its 
requirements. Applicants will be evaluated on their experience with the 
special clinical, service, and social support needs of the ESRD 
population and any measures they plan to take to enhance these measures 
in the demonstration. Applicants will be evaluated on their ability to 
offer patients a wide choice of treatment modalities, although it is 
recognized that certain providers may be limited in offering this 
choice.
3. Financial and Organizational Capability (35 points)
    (a) Ability to Bear Risk. Applicants must be in compliance with 
State laws and regulations. Any activities undertaken by an 
organization under the capitation payment model cannot place the 
organization in conflict with State requirements on financial risk-
bearing. If applicable, applicants will be evaluated on their ability 
to meet risk-bearing requirements.
    (b) Ability to Meet Enrollment Projections. Applications will also 
be evaluated on how many beneficiaries are expected to be treated each 
year at each site. Under the capitation options, the applicant will be 
evaluated on its marketing strategy, including its plans to enroll both 
current and new patients to the demonstration. In addition, the 
applicant will be evaluated on how it explains how beneficiaries will 
be informed about supplemental insurance (Medigap) policies and 
protections. The applicant may restrict eligibility of enrollees by age 
or other criteria, as long as it gives an acceptable justification.
    (c) Staffing. Applicants will be evaluated on demonstrated 
expertise among key personnel, including the following:
    [sbull] Clinical knowledge and experience, including nephrology.
    [sbull] Managed care and disease management expertise.
    [sbull] Financial management expertise.
    (d) Financial and Organizational Provisions. Applicants will be 
evaluated on the attractiveness to beneficiaries of Medicare cost-
sharing arrangements under the demonstration.
    Applicants choosing either the capitation payment or fee-for-
service bundled payment options will be evaluated on their projection 
for attaining budget neutrality for the Medicare program. Applicants 
for the fee-for-service bundled payment option should include the 
expanded bundle payment as a medical expense, and project budget 
neutrality by comparing the payment to costs savings from the disease 
management intervention on an annual basis. Applicants should justify 
their proposed cost savings by projections of reduced utilization, 
references to disease management literature, and the organization's 
experience. An applicant for the fee-for-service bundled payment option 
should estimate the amount of ESRD and non-ESRD Medicare claims for its 
patient population.
    If proposing risk sharing for the capitation option, an applicant 
will be evaluated on the quality of their projected revenue and expense 
statements, as well as on their analysis of budget neutrality. An 
applicant for the capitation option will be evaluated on the 
appropriateness of its Medical Loss Ratio.
    (e) Ability to Implement. The applicant's organization will be 
evaluated on the basis of its ability to effectively develop and 
implement this demonstration project (including evidence of approval by 
governing boards), commitment of funds to planning and development, and 
formation of multi-disciplinary and cross-component task forces. The 
demonstration allows organizations to shift from treating patients in 
fee-for-service to treating them in managed care. Applicants choosing 
the managed care or PACE-type delivery option must explain how this 
change in service delivery will be completed, including

[[Page 33504]]

articles of incorporation and protocols for patients. The applicant 
should state how these elements will impact care, as well as service 
integration, utilization, access and availability.
    Also, the applicant will be judged on its experience in conducting 
projects of similar clinical scope and organizational complexity as 
that proposed for the demonstration.
    (f) Information Systems and Management Plan. Applicant 
organizations will be evaluated on whether they have sufficient 
management and clinical information systems and reporting mechanisms to 
implement the demonstration, including the ability and commitment to 
provide individual health status (for example, the Health Outcomes 
Survey) and utilization data. In addition, the applicant should 
delineate the information that will be collected to support this 
demonstration, for example, the CMS 2728 (both for new patients and 
existing patients pending demonstration entry), line item costs for 
prescribed medications, labs, radiology and other services, all 
comorbid conditions, patient demographics and facility characteristics.
4. Capability for Quality Assessment and Improvement (15 points)
    Under the demonstration, we will link financial incentives to 
improvements in quality outcome indicators.
    Knowledge and participation in our ESRD Clinical Performance 
Measures Project will be beneficial.
    Applicants will also be evaluated on their quality improvement 
system, including the following:
    [sbull] Written quality improvement policies and procedures.
    [sbull] A standing quality improvement committee.
    [sbull] Patient grievance and appeal systems.
    [sbull] Provider credentialing system.
    [sbull] Organizational modification methodology for applicants 
planning to shift from fee-for-service to the managed care model.
    An organization's application will be evaluated on how it will 
measure improvements in health outcomes attributable to its disease 
management interventions.

XI. Final Awards

    From among the most highly qualified applicants, the final 
selection of projects for the demonstration will be made by the 
Administrator and will take into consideration a number of factors, 
including operational feasibility, budget neutrality, geographic 
location, and program priorities (such as testing a variety of 
approaches for delivering services, targeting beneficiaries, and 
payment). We reserve the right to determine the scope of the project, 
which includes limiting the number of awards and beneficiaries covered 
under the demonstration. In evaluating applications, we rely on our 
past experience with successful and unsuccessful demonstrations. We 
expect to make the awards in 2003.

XII. Collection of Information Requirements

    The application and instructions associated with this solicitation 
are approved under OMB control number 0938-0880, with a current 
expiration date of 05/31/03. We have requested a three year extension 
of the application. Pending OMB approval, this current application is 
valid through the interim period. The form and instructions can be 
obtained from the CMS web site referenced elsewhere in this notice.

Appendix I: Services Included in the Expanded Dialysis Bundle

A. Drugs

EPO (Erythropoietin, Epoetin Alpha) HCPCS Codes Q9920-Q9940 Aranesp 
(J0880)
Iron (J1750, J1755, J1760, J1770, J1780, J2915, J2916)
Vitamin D (J0630, J0635, J0636, J2500, J1270)
Levocarnitine (J1955)
Phosphate Binders (J0610)

B. Labs/Radiology

Laboratory HCPCS Codes (208 codes)

73120 X-Ray Exam Hand
75710 Artery X-Rays Arm/Leg
75716 Artery X-Rays Arms/Legs
75774 Artery X-Ray, Each Vessel
75893 Venous Sampling by Catheter
75964 Repair Artery Blockage; Each
76070 CT Scan, Bone Density Study
76075 Dual Energy X-Ray Study
76092 Mammogram, Screening
76778 Echo Exam Kidney Transplant
78070 Parathyroid Nuclear Imaging
78351 Bone Mineral Dual Photon
80048 Basic Metabolic Panel
80051 Electrolyte Panel
80053 Comp Metabolic Panel
80061 Lipid Panel
80069 Renal Function Panel
80074 Acute Hepatitis Panel
80076 Hepatic Function Panel
80156 Assay Carbamazepine
80162 Assay for Digoxin
80185 Assay for Phenytoin
80186 Assay for Phenytoin, Free
80197 Assay for Tacrolimus
80198 Assay for Theophylline
80202 Assay for Vancomycin
80410 Calcitonin Stimulation Panel
81000 Urinalysis, Nonauto, W/Scope
81001 Urinalysis, Auto, W/Scope
81002 Urinalysis, Nonauto W/O Scop
81003 Urinalysis, Auto, W/O Scope
81005 Urinalysis
81007 Urine Screen for Bacteria
81015 Microscopic Exam Urine
82009 Test for Acetone/Ketones
82010 Acetone Assay
82017 Acylcarnitines, Quant
82040 Assay Serum Albumin
82042 Assay Urine Albumin
82108 Assay, Aluminum
82232 Beta-2 Protein
82247 Bilirubin Total
82248 Bilirubin Direct
82270 Test Feces Blood
82306 Assay Vitamin D
82307 Assay Vitamin D
82308 Assay Calcitonin
82310 Assay Calcium
82330 Assay Calcium
82374 Assay Blood Carbon Dioxide
82379 Assay Carnitine
82435 Assay Blood Chloride
82465 Assay Serum Cholesterol
82550 Assay CK (CPK)
82565 Assay Creatinine
82570 Assay Urine Creatinine
82575 Creatinine Clearance Test
82607 Vitamin B-12
82728 Assay Ferritin
82746 Blood Folic Acid Serum
82747 Folic Acid, RBC
82800 Blood PH
82803 Blood Gases: PH, PO2, PCO2
82805 Blood Gases W/O2 Saturation
82810 Blood Gases, O2 Sat Only
82945 Glucose Other Fluid
82947 Assay Quantitative, Glucose
82948 Reagent Strip/Blood Glucose
82950 Glucose Test
82977 Assay GGT
83036 Glycated Hemoglobin Test
83540 Assay Iron
83550 Iron Binding Test
83718 Blood Lipoprotein Assay
83735 Assay Magnesium
83937 Assay Osteocalcin
83970 Assay Parathormone
83986 Assay Body Fluid Acidity
84075 Assay Alkaline Phosphatase
84100 Assay Phosphorus
84105 Assay Urine Phosphorus
84132 Assay Serum Potassium
84133 Assay Urine Potassium
84134 Assay Prealbumin
84155 Assay Protein
84160 Assay Serum Protein
84295 Assay Serum Sodium
84315 Body Fluid Specific Gravity
84443 Assay Thyroid Stim Hormone
84450 Transferase (AST) (SGOT)
84460 Alanine Amino (ALT) (SGPT)
84466 Transferrin
84478 Assay Triglycerides
84520 Assay Urea Nitrogen
84540 Assay Urine Urea-N
84545 Urea-N Clearance Test
84630 Assay Zinc
85002 Bleeding Time Test
85004 Automated Diff WBC Count
85007 Differential WBC Count
85008 Nondifferential WBC Count
85009 Differential WBC Count
85013 Hematocrit
85014 Hematocrit
85018 Hemoglobin
85021 Automated Hemogram
85022 Automated Hemogram
85025 Automated Hemogram
85027 Automated Hemogram
85032 Manual Cell Count, Each

[[Page 33505]]

85041 Red Blood Cell (RBC) Count
85044 Reticulocyte Count
85045 Reticulocyte Count
85046 Reticyte, HGB Concentrate
85048 White Blood Cell (WBC) Count
85049 Automated Platelet Count
85345 Coagulation Time
85347 Coagulation Time
85348 Coagulation Time
85520 Heparin Assay
85595 Platelet Count, Automated
85610 Prothrombin Time
85611 Prothrombin Test
85651 RBC SED Rate, Nonauto
85652 RBC SED Rate, Auto
85730 Thromboplastin Time, Partial
85732 Thromboplastin Time, Partial
86140 C-Reactive Protein
86317 Immunoassay, Infectious Agen
86590 Streptokinase, Antibody
86644 CMV Antibody
86645 CMV Antibody, IGM
86687 HTLV-I
86688 HTLV-II
86689 HTLV/HIV Confirmatory Test
86692 Hepatitis, Delta Agent
86701 HIV-1
86702 HIV-2
86703 HIV-1/HIV-2, Single Assay
86704 HEP B Core AB Test
86705 HEP B Core AB Test
86706 HEP B Surface AB Test
86707 HEP BE AB Test
86708 HEP A AB Test
86709 HEP A AB Test
86803 HEP C AB Test
86804 HEP C AB Test Confirm
86812 HLA Typing, A, B, /C
86813 HLA Typing, A, B, /C
86816 HLA Typing, DR/DQ
86817 HLA Typing, DR/DQ
86900 Blood Typing, ABO
86901 Blood Typing, RH (D)
86903 Blood Typing, Antigen Screen
86904 Blood Typing, Patient Serum
86905 Blood Typing, RBC Antigens
86906 Blood Typing, Rh Phenotype
87040 Blood Culture Bacteria
87070 Culture Specimen, Bacteria
87071 Culture Bact
87072 Culture Specimen By Kit
87073 Culture Bact
87075 Culture Specimen, Bacteria
87076 Bacteria Identification
87077 Culture Bact
87081 Bacteria Culture Screen
87084 Culture Specimen By Kit
87086 Urine Culture, Colony Count
87088 Urine Bacteria Culture
87147 Culture Typing, Serologic
87163 Culture, Any Source, Add'l ID Reqd
87181 Antibiotic Sensitivity, Each
87184 Antibiotic Sensitivity, Each
87185 Enzyme Detection
87186 Antibiotic Sensitivity, MIC
87187 Antibiotic Sensitivity, MBC
87188 Antibiotic Sensitivity, Each
87190 TB Antibiotic Sensitivity
87197 Bactericidal Level, Serum
87205 Smear/Stain, Interpret
87271 CMV, DFA
87340 HEP B Surface AG, EIA
87341 HEP B HBSAG Neutral AG, EIA
87350 HEP B AG, EIA
87380 HEP Delta AG, EIA
87390 HIV-1 AG, EIA
87391 HIV-2 AG, EIA
87515 HEP B, DNA, Direct
87516 HEP B, DNA, AMP
87517 HEP B, DNA, Quant
87520 HEP C, RNA, Direct
87521 HEP C, RNA, AMP
87522 HEP C, RNA, Quant
87525 HEP G, DNA, DIRECT
87526 HEP G, DNA, AMP
87527 HEP G, DNA, Quant
89050 Body Fluid Cell Count
89051 Body Fluid Cell Count
93000 Electrocardiogram Complete
93005 Electrocardiogram Tracing
93010 Electrocardiogram Report
93040 Rhythm ECG w/Report
93041 Rhythm ECG Tracing
93042 Rhythm ECG Report
93307 Echo Exam Heart
93308 Echo Exam Heart
G0001 Drawing Blood for Specimen
G0202 Screening Mammography, Digital

C.Vascular Access

Vascular Access HCPCS Codes (122 Codes)

00350 Anes-Major Vessels Neck; Nos
00532 Anes-Access Cent Venous Circ
01784 Anesthesia-AV Fistula
01844 ANES-VASC Shunt, Shunt Revis
35180 Repair Blood Vessel Lesion
35190 Repair Blood Vessel Lesion
35206 Repair Blood Vessel Lesion
35226 Repair Blood Vessel Lesion
35236 Repair Blood Vessel Lesion
35256 Repair Blood Vessel Lesion
35450 Repair Arterial Blockage
35451 Repair Arterial Blockage
35452 Repair Arterial Blockage
35453 Repair Arterial Blockage
35454 Repair Arterial Blockage
35455 Repair Arterial Blockage
35456 Repair Arterial Blockage
35457 Repair Arterial Blockage
35458 Repair Arterial Blockage
35459 Repair Arterial Blockage
35460 Repair Venous Blockage
35470 Repair Arterial Blockage
35471 Repair Arterial Blockage
35472 Repair Arterial Blockage
35473 Repair Arterial Blockage
35474 Repair Arterial Blockage
35475 Repair Arterial Blockage
35476 Repair Venous Blockage
35860 Explore Limb Vessels
35875 Remove Clot In Graft
35876 Remove Clot In Graft
35900 Excision Of Infected Graft--Extremity
35903 Excise Graft Extremity
35910 Excision Of Infected Graft--Extremity
36000 Place Needle In Vein
36005 Injection, Venography
36011 Place Catheter In Vein
36140 Establish Access To Artery
36145 Artery To Vein Shunt
36215 Place Catheter In Artery
36216 Place Catheter In Artery
36217 Place Catheter In Artery
36245 Place Catheter In Artery
36246 Place Catheter In Artery
36247 Place Catheter In Artery
36400 Drawing Blood
36406 Drawing Blood
36410 Drawing Blood
36420 Establish Access To Vein
36425 Establish Access To Vein
36488 Insert Catheter Vein
36489 Insert Catheter Vein
36490 Insert Catheter Vein
36491 Insert Catheter Vein
36493 Reposition CVC
36533 Insert Access Port
36534 Revise Access Port
36535 Remove Access Port
36550 Declot Vascular Device
36800 Insert Cannula
36810 Insert Cannula
36815 Insert Cannula
36819 AV Fusion By Basilic Vein
36820 AV Anastomosis-Perm Access
36821 Artery-Vein Fusion
36825 Artery-Vein Graft
36830 Artery-Vein Graft
36831 AV Fistula Excision
36832 AV Fistula Revision
36833 AV Fistula
36834 Repair A-V Aneurysm
36835 Artery To Vein Shunt
36860 Ext Cannula Declotting
36861 Cannula Declotting
36870 Thrombectomy
37190 Repair A-V Aneurysm
37201 Transcatheter Therapy Infuse
37205 Transcatheter Stent
37206 Transcatheter Stent Add-On
37207 Transcatheter Stent
37208 Transcatheter Stent Add-On
37209 Exchange Arterial Catheter
37607 Ligate Fistula
49420 Insert Abdominal Drain
49421 Insert Abdominal Drain
49422 Remove Perm Cannula/Catheter
71010 Chest X-Ray
71015 Chest X-Ray
71020 Chest X-Ray
71021 Chest X-Ray
71022 Chest X-Ray
71030 Chest X-Ray
71035 Chest X-Ray
75790 Visualize A-V Shunt
75820 Vein X-Ray Arm/Leg
75822 Vein X-Ray Arms/Legs
75860 Vein X-Ray Neck
75894 X-Rays Transcatheter Therapy
75896 X-Rays Transcatheter Therapy
75898 Follow-Up Angiogram
75900 Arterial Catheter Exchange
75901 Mechanical Removal Of Pericath Obstructive Material
75902 Mechanical Removal Of Intraluminal Obstructive Material
75960 Transcatheter Intro Stent
75961 Retrieve Broken Catheter
75962 Repair Arterial Blockage
75978 Repair Venous Blockage
76080 X-Ray Exam Fistula
76942 Echo Guide For Biopsy
76960 Echo Guidance Radiotherapy
93900 Duplex Scan Of Hemodialysis Access
93922 Extremity Study
93923 Extremity Study
93925 Lower Extremity Study
93926 Lower Extremity Study
93930 Upper Extremity Study
93931 Upper Extremity Study
93965 Extremity Study
93970 Extremity Study
93971 Extremity Study
A4300 Cath Impl Vasc Access Portal
M0900 Excision Without Graft


[[Page 33506]]


    Authority: Section 402 of the Social Security Act Amendments of 
1967 (42 U.S.C. 1395b1).

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

    Dated: May 10, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.

[FR Doc. 03-13829 Filed 5-29-03; 12:09 pm]
BILLING CODE 4120-01-P