Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Notices 495

application process. An application

package can be obtained from HCFA,

which describes the demonstration and

the criteria to be used in reviewing

applications. Applications are due to

HCFA 90 days after the publication of

this notice.

DATES: Closing date for submission of

applications will be April 4, 2000, 5

p.m. E.S.T.

APPLICATIONS: To receive an application

package, and for further information,

contact Sid Mazumdar, (410) 786–6673.

ADDRESSES: Mail correspondence to the

following: Health Care Financing

Administration, Room C4–14–15, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850, Attention: Sid

Mazumdar.

I. Background

Section 4628 of the Balanced Budget

Act of 1997 requires a demonstration

which will permit direct Graduate

Medical Education payments ordinarily

paid to a teaching hospital to be paid to

a consortium. According to the

legislation, a qualifying consortium is to

consist of a teaching hospital (with one

or more residency programs) and at least

one of the following: a school of

allopathic or osteopathic medicine,

another teaching hospital (which can be

a children’s hospital), a Federally

Qualified Health Center, a medical

group practice, a managed care entity, or

an entity furnishing outpatient services.

The legislation gives authority to the

Secretary of Health and Human Services

to expand the definition of an

organization qualified to participate in a

consortium.

Organizations that are already

established will be able to begin the

demonstration in July 2000. Other

consortia will begin with the

demonstration payment in July 2001. No

consortium projects will begin after the

summer of 2001. Applying consortia

must provide letters of commitment

demonstrating that all participating

organizations agree to the proposed

system of governance and methodology

for distributing funds. HCFA will

evaluate applications on how the

proposed project will help achieve

stated goals; the system of

administration and decision making;

plans for quality improvement and

evaluation; and staff and capability for

education and training. Applicants will

be evaluated according to a numerical

scoring system corresponding to the

specific criteria that are described in the

application.

II. Payment Methodology

HCFA will pay to the consortium the

fraction (or entirety) of the direct

Graduate Medical Education (GME)

payment of the teaching hospital(s) that

the consortium agrees upon, subject to

HCFA’s approval. This amount will be

subtracted from HCFA’s payment to the

teaching hospitals. The demonstration

will be budget neutral, that is, it will

allow no more money to be paid to the

consortium than what the direct GME

payment would otherwise have been to

its participating entities. The

application package contains a more

detailed explanation of the payment

methodology.

Authority: Section 4628 of the Balanced

Budget Act of 1997, Public Law 105–33.

(Catalog of Federal Domestic Assistance

Program No. 93.779, Health Financing,

Demonstrations, and Experiments)

Dated: December 15, 1999.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–121 Filed 1–4–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3028–N]

Medicare Program; Notice of the

Solicitation for Proposals To Expand

the Medicare Lifestyle Modification

Program Demonstration

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces our

solicitation for proposals to expand the

Medicare Lifestyle Modification

Program Demonstration to one

additional, national multi-site

cardiovascular lifestyle modification

program. The purpose of this

demonstration is to test the feasibility

and cost-effectiveness of providing

payment for cardiovascular lifestyle

modification program services to

Medicare beneficiaries. This

demonstration will test proven and

intensive programs designed to reduce

or reverse the progression of

cardiovascular disease of patients at risk

for invasive treatment procedures. The

expansion will allow for a comparison

between two different lifestyle

modification models across several

factors, including price. The

demonstration began October 1, 1999

and will be conducted over a 4-year

period. Currently, the demonstration is

being implemented at several sites

subscribing to one multi-site lifestyle

modification program model.

Enrollment for each multi-site program

is limited to 1,800 Part B eligible

Medicare beneficiaries who satisfy

specific clinical admission criteria.

DATES: Letters of Intent: Letters of Intent

must be received by the HCFA project

officer by February 4, 2000.

Proposals: Proposals (an original and

5 copies), each with a copy of the timely

letter of intent, must be received by the

HCFA project officer by April 4, 2000.

ADDRESSES: Letters of Intent and

Proposals: Department of Health and

Human Services, Health Care Financing

Administration, Attention: Armen

Thoumaian, Ph.D., Project Officer,

Medicare Lifestyle Modification

Program Demonstration, Office of

Clinical Standards and Quality, Mail

Stop: S3–02–01, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Demonstration Website:

www.hcfa.gov/quality/qlty-3.htm.

FOR FURTHER INFORMATION CONTACT:

Armen Thoumaian, Ph.D., (410) 786–

6672, or e-mail Athoumaian@hcfa.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Problem

Research has provided evidence that

specific lifestyle changes can lead to a

decrease in the levels of cardiovascular

risk factors, resulting in lower morbidity

and mortality associated with coronary

artery disease (CAD). Lifestyle

modification programs are increasingly

becoming an approach to the secondary

prevention of coronary disease

morbidity. The programs may reduce

the incidence of hospitalizations and

invasive procedures among patients

with substantial coronary occlusion.

Studies have shown that controlling

single risk factors such as a low-fat diet,

smoking cessation, exercise, or stress

management are beneficial in the

treatment of cardiovascular disease.

Other psycho-social risk factors,

including depression and social

isolation, have already been shown to be

important. Multi-factorial risk reduction

programs that include reduction of some

or all of these risk factors in a

comprehensive cardiovascular lifestyle

management program, however, have

yet to be evaluated for their

effectiveness or long-term cost savings

in the Medicare population.

We currently pay for 12 weeks of

cardiac rehabilitation services for

Medicare patients who have a prior

496 Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Notices

diagnosis of myocardial infarction or

who have had a recent cardiac

revascularization procedure or both.

Coverage under the Medicare cardiac

rehabilitation benefit is more limited

than that contained in a comprehensive

lifestyle modification program. We are

investigating the benefits of covering a

complete package of services offered

under an established, national multi-site

lifestyle modification program. Lessons

learned from this demonstration will

provide us with information needed to

explore the possibility of providing this

type of program as an alternative to

more customary medical management

(for example, medications, angioplasty,

and heart bypass surgery) when

medication is not effective.

B. Demonstration Description

Through our Office of Clinical

Standards and Quality (OCSQ), we

published a notice in the Federal

Register that announced our

implementation of a demonstration to

evaluate the feasibility and costeffectiveness of cardiovascular lifestyle

modification (64 FR 53394, October 1,

1999). The demonstration period began

on October 1, 1999 and will provide a

3-year enrollment period ending on

October 1, 2002, with payment through

September 30, 2003 (for a total of 4

years). Enrollment in the demonstration

is limited to Part B eligible Medicare

beneficiaries who meet specific clinical

criteria that document significant

cardiovascular disease.

There are many cardiovascular

lifestyle modification programs across

the country. Each varies in program

length, treatment services offered, and

program cost. Few of these programs

have published results about their

success in reducing coronary artery

disease. This demonstration began at

sites licensed to conduct the 12-month

long Dr. Ornish Program for Reversing

Heart Disease. These facilities offer a

cardiovascular lifestyle modification

program where the treatment length and

the type and amount of services offered

are standardized. In addition, although

limited, there are published studies

about this program that provide some

degree of evidence of its success in

reducing or reversing the progression of

cardiovascular disease in patients who

complete the program. Beginning a

demonstration with these facilities was

a logical choice to provide a standard of

care and quality oversight for Medicare

beneficiaries. The standardized program

also means that a single price can be

negotiated for program enrollment

across the sites. Total enrollment for

this multi-site program is limited to

1,800 Part B eligible Medicare

beneficiaries who satisfy clinical

admission criteria.

C. Clinical Criteria for Beneficiary

Enrollment Under the Demonstration

Under this Medicare demonstration,

we pay for a package of specific services

that we do not cover under the regular

Medicare program. Under these

circumstances, the appropriateness of

care provided is of obvious concern.

The criteria for enrollment in the

demonstration reflect clinical standards

to ensure the services offered can

provide the most appropriate and

beneficial treatment to those enrolled.

We are interested in a treatment from

which the Medicare patient can

experience a measurable and immediate

benefit with a potential for a lifetime

benefit. In this case, we are interested in

treatment that brings about the reversal

of coronary artery occlusion,

amelioration of symptoms from

coronary artery disease, or some other

positive, observable change in the

patient’s condition. We require that the

Medicare beneficiaries who meet the

clinical criteria for enrollment under the

demonstration will be only people with

substantial CAD.

The program sites selected for this

demonstration must add specific

requirements to their admission

screening criteria. First, patients

participating in the demonstration must

have Part B Medicare eligibility at the

time of enrollment. Second, we require

the following four clinical criteria under

the demonstration for enrollment of

Medicare beneficiaries:

1. The presence of angina as a medical

condition for each Medicare beneficiary.

2. One of the following diagnostic

studies, which demonstrate clinically

significant ventricular myocardium at

risk for infarction (EKG/stress testing/

angina surveys without additional

imaging studies will not be accepted):

a. Coronary angiogram (with

estimated ejection fraction)

demonstrating lesions in certain

vessels—

Greater than 70 percent left anterior

descending coronary artery (LAD).

Greater than 70 percent right coronary

artery (RCA).

Greater than 70 percent left

circumflex coronary artery.

Greater than 50 percent left main

coronary artery.

b. Reversible perfusion defect on

nuclear imaging study.

c. Inducible wall motion abnormality

on stress echo.

d. Cardiac positron emission

tomography (PET) scan with rubidium82 showing perfusion defect.

3. The beneficiary’s physician must

have recommended that, as an option,

the beneficiary undergo

revascularization (coronary artery

bypass graft (CABG) or angioplasty) in

the near future. The beneficiary’s

physician must be comfortable that the

beneficiary is clinically stable to

undergo comprehensive lifestyle

changes as an alternative intervention.

4. The beneficiary must be willing to

make these comprehensive lifestyle

changes.

Finally, a beneficiary with any of the

following clinical criteria is excluded

from participating in the demonstration:

1. Acute myocardial infarction within

the 2-week period before enrollment.

2. Left main disease greater than 50

percent occlusion.

3. Three-vessel disease with

decreased ejection fraction.

4. Unstable angina.

5. CABG surgery within 4 weeks of

enrollment (unless otherwise approved

for participation by his or her

physician).

6. Previous angioplasty within 6

months of enrollment.

7. Hypotensive response to exercise

(greater than 20 mm Hg drop in systolic

pressure).

8. History of exercise-induced

ventricular tachycardia or third degree

heart block without evidence of current

stability.

9. Non-ischemic cardiomyopathy (EF

less than 40 percent), without evidence

of significant CAD.

10. Class IV congestive heart failure

(CHF).

11. History of malignant ventricular

arrhythmia or use of automatic

implantable defibrillator.

12. Residence beyond 90 minutes

commuting time to the program site.

13. Significantly impaired cognitive

function (for example, dementia).

14. Potentially fatal co-morbidity (for

example, metastatic cancer) and

unlikely to survive 1 year after entrance

into the project.

The selected demonstration sites of

the multi-site program must assure that

the criteria for inclusion have been met

and that none of the exclusion criteria

are present for any Medicare beneficiary

seeking enrollment in the program. In

addition, each beneficiary’s personal

physician must certify that the

beneficiary meets the clinical eligibility

requirements to participate in the

cardiovascular lifestyle modification

program before the beneficiary enrolls

in the program.

D. Quality Monitoring and Evaluation

The continuous monitoring of the

quality of care delivered to Medicare

Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Notices 497

beneficiaries undergoing lifestyle

modification and a continuous

assessment of possible health risks to

individual beneficiaries are essential

during this demonstration. We have

contracted a Medicare Peer Review

Organization to provide continuous

quality monitoring of the demonstration

sites to help assure the safety of

Medicare patients. In addition, we will

conduct an evaluation of the

demonstration through a separate

contract with an independent research

firm to determine the feasibility and

cost-effectiveness of providing payment

for cardiovascular lifestyle modification

program services to Medicare

beneficiaries. The evaluation will

compare the outcomes of Medicare

beneficiaries participating in the

demonstration with other Medicare

beneficiaries, matched according to

disease severity and other

characteristics, who are receiving more

customary treatments for coronary

artery disease. Specifically, we are

interested in comparing the outcomes of

beneficiaries who go through the

demonstration with Medicare

beneficiaries who are recommended for

re-vascularization but initially opted for

medical management. Demonstration

sites selected must cooperate with the

quality monitoring and review

contractor and the evaluation

contractor.

II. Provisions of This Notice

A. Purpose

We are interested in expanding the

Medicare Lifestyle Modification

Program Demonstration. The expansion

will allow us to compare different

lifestyle modification models across

several factors, including price. We are

limiting the expanded demonstration to

one additional, national multi-site

cardiovascular lifestyle modification

program offering a 12-month multidisciplinary clinical outpatient program

of lifestyle modification services to

Medicare beneficiaries through a

program currently provided to the

general public. We will pay for a

program of lifestyle modification

treatment services for up to 1,800

Medicare beneficiaries diagnosed with

severe CAD who enroll before October

1, 2002.

This notice announces our solicitation

for proposals from established, national

multi-site lifestyle modification

programs having the characteristics

listed in section II.B. of this notice. All

interested offerors must provide a full

description of their program

characteristics, so that we can make an

award determination based on the

organization, the quality and safety of

the program, and the capability to

recruit a sufficient number of Medicare

beneficiaries. A Letter of Intent and

Proposal from the parent entity

licensing, franchising, or otherwise

representing the multi-site lifestyle

modification program are required as

described in sections II.B. and II.C. of

this notice.

We will negotiate a fixed payment

rate with an entity representing all of

the licensed sites participating in the

parent program. We will present sites

licensed by the parent program with the

negotiated rate agreement and

demonstration protocol and ask them to

consider participating in the

demonstration. We will ask those sites

that agree to participate to enter into

individual agreements with us to abide

by the terms and conditions for

participation in the demonstration.

Demonstration sites will receive the

negotiated fixed rate (absent inflationary

adjustments) for the completed program.

We will monitor quality and evaluate

the demonstration as described earlier

to determine if this service would

benefit the Medicare population.

Under the demonstration, we will pay

all approved sites of the multi-site

program 80 percent of the negotiated

fixed payment amount for the complete

treatment episode when a beneficiary

completes the 12-month program. If

there is a beneficiary disenrollment

from the program before completing the

12-month program, we will pay the

demonstration site a pro-rated portion of

the total payment for that beneficiary.

This payment amount will apply to

treatment at all participating

demonstration sites in the multi-site

program and remain fixed during the

demonstration period. The

demonstration site may collect the

remaining 20 percent of the fixed

payment amount from the beneficiary as

a program or enrollment fee. Under the

demonstration, an individual site may

elect to waive this fee, but if it chooses

to do so, it must waive it for all

Medicare beneficiaries who enroll in the

demonstration. As part of the proposal,

applicants must propose an all-inclusive

payment amount for the complete 12-

month lifestyle modification program to

be offered to Medicare beneficiaries.

The selectee must cooperate with

quality monitoring efforts and the

formal evaluation of the demonstration.

We will provide no additional funding.

B. Letter of Intent

An organization that believes it meets

the requirements of section II.C. of this

notice must submit a Letter of Intent to

submit a Proposal. The signed Letter of

Intent must be received by the HCFA

project officer by the date in the DATES

section of this notice. The Letter of

Intent must indicate the applicant’s

intention to submit a completed

Proposal for the demonstration.

Submitting a Letter of Intent does not

obligate the applicant to submit a

Proposal. The letter must be signed by

a duly authorized official and include

the following information about the

applicant:

—Name.

—Address.

—Contact person.

—Business telephone number.

—All existing HCFA provider

number(s).

—An Employer Identification Number

(EIN) for basic identification

purposes.

The HCFA project officer, or designee,

will contact the specified representative

(contact person) for each timely

submitted Letter of Intent to discuss the

application process. Organizations that

submit a timely Letter of Intent must

submit a completed original Proposal

and 5 copies (along with a copy of the

previously submitted Letter of Intent) to

the HCFA project officer by the date in

the DATES section of this notice.

C. Proposals of Eligible Organizations

The offeror must provide information

describing the nature of its program,

how it is perceived as innovative, and

any scientifically based evidence

supporting the success of its program in

reducing the need for inpatient invasive

procedures. We are interested in

Proposals from a national, multi-site

lifestyle modification program that can

satisfy the requirements of this section.

We will consider only proposals that are

responsive to the requirements for

submission under this solicitation.

Proposals must be no more than 45

pages in length, including appendices

and attachments. Our technical review

panel will review and consider only

those Proposals that we receive by the

date in the DATES section of this notice

and for which we receive a timely Letter

of Intent.

A program that wishes to be

considered for this payment

demonstration must submit a Proposal

that includes evidence of the following:

1. The existence of a parent

organization that has developed,

designed, and continuously monitored

its program. The parent organization

must have legal responsibility for the

licensing of its affiliates and must

provide to its licensees all proprietary,

clinical, marketing, and administrative

materials. A standardized package of

498 Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Notices

instructions must be available in the

form of manuals, audiotapes, and

videotapes and must be provided to all

sites as part of the licensing

arrangement.

2. A list of multiple sites or affiliates

that are located in various geographic

locations throughout the United States

and that use the parent organization’s

name and are recognized as entities of

the parent organization. The parent

organization must provide initial on-site

training to all affiliated staff and

schedule regular on-site visits to ensure

adherence to the prescribed regimen.

3. A standardized protocol that

describes the program in detail and

includes a prescription of a low-fat diet,

lifestyle counseling, nutrition

education, supervised exercise, stress

management training, group support,

and smoking cessation. In addition, the

protocol must provide for medical lipid

management. The protocol must have a

defined treatment plan that provides the

length of the regimen and the sessions

(by frequency and time). Patient and

staff goals must be specified. The

manual must contain a description of

staffing needs, educational

requirements, and the roles and

responsibilities of all personnel.

4. A formal management plan that

describes the coordination of reporting

and communicating to the affiliated

sites (for example, regular phone

conferences, annual or bi-annual

retreats, and electronic messaging). A

recognized program or site coordinator

must act as a liaison at the parent site

to provide guidance and address issues

that arise during day-to-day operations.

5. A minimum of 3 years of

continuous operation using the

standardized protocol. Affiliates must

have a minimum of 1 year of experience

in providing the same standardized

services and should be recognized as a

part of, or operate under, a larger

corporate entity that is a Medicare

provider.

6. A record of successful marketing of

its program to, or its use by, the age 65

and over population, including the

under-served and minority populations.

7. A record of successful patient

adherence to the program.

8. Coverage by a minimum of one

major private insurer.

9. The capability or potential of

receiving and transmitting information

electronically between its sites and

HCFA.

This notice is not covered by the

Paperwork Reduction Act of 1995 and

accordingly was not reviewed by the

Office of Management and Budget. In

accordance with Executive Order 12866,

this notice was not reviewed by the

Office of Management and Budget.

We have examined this notice in

accordance with Executive Order 13132,

Federalism, and have determined that it

will not have any negative impact on

the rights, roles, or responsibilities of

State, local, or Tribal governments.

Authority: Sections 402(a)(1)(G) and (a)(2)

of the Social Security Amendments of 1967

(Public Law 90–248), as amended (42 U.S.C.

1395b–1(a)(1)(G) and (a)(2)).

(Catalog of Federal Domestic Assistance

Program No. 93.779; Health Financing,

Demonstrations, and Experiments)

Dated: December 15, 1999.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–125 Filed 1–4–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3029–WN]

Medicare Program; Cancellation of the

Meeting of the Medical and Surgical

Procedures Panel of the Medicare

Coverage Advisory Committee—

January 19 and 20, 2000

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting cancellation.

SUMMARY: This notice announces the

cancellation of the January 19 and 20,

2000 meeting of the Medical and

Surgical Procedures Panel of the

Medicare Coverage Advisory Committee

(MCAC).

FOR FURTHER INFORMATION CONTACT:

Constance A. Conrad, Executive

Secretary, 410–786–4631.

SUPPLEMENTARY INFORMATION: This

notice announces the cancellation of the

January 19 and 20, 2000 meeting of the

Medical and Surgical Procedures Panel

of the MCAC. Notice of the meeting was

given on December 13, 1999 (64 FR

69538). The meeting will be

rescheduled and announced in a

subsequent Federal Register notice.

Authority: 5 U.S.C. App. 2, section 10(a)(1)

and (a)(2).

(Catalog of Federal Domestic Assistance

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: December 14, 1999.

Jeffrey L. Kang,

Director, Office of Clinical Standards and

Quality, Health Care Financing

Administration.

[FR Doc. 00–123 Filed 1–4–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Statement of Organization, Functions,

and Delegations of Authority

Part F of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services, Health Care Financing

Administration (HCFA), (Federal

Register, Vol. 62, No. 85, pp. 24122,

24123, and 24124, dated Friday, May 2,

1997) is amended to update the Office

of Communications and Operations

Support (OCOS) and the Center for

Beneficiary Services (CBS) functional

statements to reflect the transfer of the

Agency’s beneficiary-centered

communications functions from OCOS

to CBS. CBS made additional changes to

the organization’s functional statement

to more accurately reflect the Center’s

responsibilities.

The specific amendments to Part F are

described below.

Section F.20.A.5. (Functions),

paragraph 6, Office of Communications

and Operations Support (FAL) and

paragraph 10, Center for Beneficiary

Services (FAQ), are amended by

deleting both organizations’ functional

statements in their entirety and

replacing them with the following:

6. Office of Communications and

Operations Support (FAL)

• Serves a neutral broker

coordination role, including scheduling

meetings and briefings for the

Administrator and coordinating

communications between and among

central and regional offices, in order to

ensure that emerging issues are

identified early, all concerned

components are directly and fully

involved in policy development/

decision-making and that all points of

view are presented.

• Coordinates and monitors assigned

agency initiatives which are generally

tactical, short-term and crosscomponent in nature (e.g., legislative

implementation).

• Provides operational and analytical

support to the Executive Council.

• Manages speaking and meeting

requests for or on behalf of the