[Federal Register Volume 65, Number 3 (Wednesday, January 5, 2000)]
[Notices]
[Pages 495-498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-125]


-----------------------------------------------------------------------

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 A[email protected].

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

[[Page 496]]

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 cost-
effectiveness 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 rubidium-82 
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

[[Page 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 multi-disciplinary 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

[[Page 498]]

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