39–006 

109TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 109–104 

PATIENT NAVIGATOR OUTREACH AND CHRONIC DISEASE 

PREVENTION ACT OF 2005 

JUNE 7, 2005.—Committed to the Committee of the Whole House on the State of 

the Union and ordered to be printed 

Mr. BARTON of Texas, from the Committee on Energy and 

Commerce, submitted the following 

R E P O R T 

[To accompany H.R. 1812] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 1812) to amend the Public Health Service Act to authorize a demonstration grant program to provide patient navigator 

services to reduce barriers and improve health care outcomes, and 

for other purposes, having considered the same, report favorably 

thereon without amendment and recommend that the bill do pass. 

CONTENTS 

Page 

Purpose and Summary ............................................................................................ 2 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 2 

Committee Consideration ........................................................................................ 2 

Committee Votes ...................................................................................................... 2 

Committee Oversight Findings ............................................................................... 3 

Statement of General Performance Goals and Objectives .................................... 3 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 3 

Committee Cost Estimate ....................................................................................... 3 

Congressional Budget Office Estimate ................................................................... 3 

Federal Mandates Statement ................................................................................. 4 

Advisory Committee Statement .............................................................................. 4 

Constitutional Authority Statement ...................................................................... 4 

Applicability to Legislative Branch ........................................................................ 4 

Section-by-Section Analysis of the Legislation ...................................................... 4 

Changes in Existing Law Made by the Bill, as Reported ..................................... 8 

2 

PURPOSE AND SUMMARY

H.R. 1812 amends the Public Health Service Act to authorize the 

Secretary of the Department of Health and Human Services to conduct a demonstration program to promote model ‘‘patient navigator’’ programs to improve health care outcomes for individuals 

with cancer or other chronic diseases, with a specific emphasis on 

health disparity populations. 

BACKGROUND AND NEED FOR LEGISLATION

Improving health care outcomes for all Americans requires substantial improvement in health disparity populations, populations—not defined solely by race and ethnicity—that have a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates as compared to the 

health status of the general population. Patient navigator programs 

provide outreach to communities to seek preventative care and coordinate health care services for individuals who are at risk for or 

who have a chronic disease. For example, the Ralph Lauren Center 

for Cancer Care and Prevention, a partnership between Memorial 

Sloan-Kettering and North General Hospital in Harlem, New York, 

operates a patient navigator program to help patients and family 

members deal with the complexities of the health care system. By 

coordinating health care services through a patient navigator, the 

patient navigator programs strive to shorten the period of time 

when a patient is screened for cancer or other chronic disease and 

further diagnosis and treatment, if needed. 

H.R. 1812 authorizes the Secretary of Health and Human Services to conduct a demonstration program to evaluate the impact of 

patient navigator programs on improving health care outcomes. 

HEARINGS

The Committee on Energy and Commerce has not held hearings 

on the legislation. 

COMMITTEE CONSIDERATION

On Wednesday, April 27, 2005, the Subcommittee on Health met 

in open markup session and approved H.R. 1812 for Full Committee consideration, without amendment, by a voice vote, a 

quorum being present. On Wednesday, May 4, 2005, the Full Committee met in open markup session and ordered H.R. 1812 favorably reported to the House, without amendment, by a voice vote, 

a quorum being present. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. There were no 

record votes taken in connection with ordering H.R. 1812 reported. 

A motion by Mr. Barton to order H.R. 1812 reported to the House, 

without amendment, was agreed to by a voice vote. 

3 

COMMITTEE OVERSIGHT FINDINGS

Pursuant to clause 3(c)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee has not held oversight or legislative hearings on this legislation. 

STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The goal of H.R. 1812 is to establish a demonstration program 

to evaluate the impact of ‘‘patient navigator’’ programs on improving health care outcomes for individuals with cancer or other 

chronic disease. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 1812, the 

Patient Navigator Outreach and Chronic Disease Prevention Act of 

2005, would result in no new or increased budget authority, entitlement authority, or tax expenditures or revenues. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974: 

U.S. CONGRESS, CONGRESSIONAL BUDGET OFFICE, Washington, DC, May 5, 2005. 

Hon. JOE BARTON, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 1812, Patient Navigator 

Outreach and Chronic Disease Prevention Act of 2005. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Shinobu Suzuki. 

Sincerely, 

ELIZABETH M. ROBINSON

(For Douglas Holtz-Eakin, Director). 

Enclosure. 

H.R. 1812—Patient Navigator Outreach and Chronic Disease Prevention Act of 2005 

H.R. 1812 would amend the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants for 

the development and operation of programs that provide ‘‘patient 

navigator’’ services. Patient navigators assist patients in overVerDate Aug 04 2004 09:20 Jun 08, 2005 Jkt 039006 PO 00000 Frm 00003 Fmt 6659 Sfmt 6602 E:\HR\OC\HR104.XXX HR104
4 

coming obstacles to the prompt diagnosis and treatment of health 

problems, in part by identifying sources of care and insurance, coordinating referrals, and facilitating enrollment in clinical trials. 

The bill also would require the Secretary to conduct a study and 

report to the Congress within six months of completion of the grant 

program. The bill would authorize the appropriation of $2 million in 2006, $5 million in 2007, $8 million in 2008, $6.5 million in 2009 and 

$3.5 million in 2010. Based on spending patterns for similar programs, and assuming appropriation of the authorized amounts, 

CBO estimates that implementing H.R. 1812 would cost $23 million from 2006 through 2010. The legislation would not affect direct 

spending or receipts. 

H.R. 1812 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act. If state, 

local, or tribal governments choose to participate in the grant program as authorized by the bill, any costs resulting from grant conditions would be incurred voluntarily. 

The CBO staff contact for the estimate is Shinobu Suzuki. This 

estimate was approved by Peter H. Fontaine, Deputy Assistant Director for Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

CONSTITUTIONAL AUTHORITY STATEMENT

Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House 

of Representatives, the Committee finds that the Constitutional authority for this legislation is provided in Article I, section 8, clause 

3, which grants Congress the power to regulate commerce with foreign nations, among the several States, and with the Indian tribes. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section one provides the short title of the bill, the ‘‘Patient Navigator Outreach and Chronic Disease Prevention Act of 2005.’’

Section 2. Patient navigator grants 

Section 2 authorizes the Secretary of the Department of Health 

and Human Services, acting through the Administrator of the 

Health Resources and Services Administration (HRSA), to make 

5 

grants to eligible entities for the development and operation of 

demonstration programs to provide patient navigator services to 

improve health care outcomes. 

Eligible entities include a public or nonprofit private health center, a community health center, a health facility operated by or 

pursuant to a contract with the Indian Health Service, a hospital, 

a cancer center, a rural health clinic, an academic health center, 

or a nonprofit entity that enters into a partnership or coordinates 

referrals with such health care facilities to provide patient navigator services. With respect to a nonprofit entity, the Committee 

does not intend the term ‘‘coordinates referrals with’’ to imply that 

a nonprofit entity must jointly file a grant application with a 

health care facility. Instead, the Committee fully expects the Administrator of HRSA to evaluate nonprofit entity applications by 

the strength of the nonprofit entity’s ability to provide all of the requirements of patient navigator services, including referrals to specific facilities, as well as the ability of the nonprofit organization 

to conduct outreach activities for prevention services and treatment 

programs. 

The Committee recognizes the challenges of some communities in 

overcoming significant barriers to high quality health care services, 

including geographic isolation, cultural and linguistic barriers, limited transportation services, lack of health insurance and information about health options, and socioeconomic status. Therefore, section 2 requires the Administrator of HRSA to give preference to 

grant applicants who target populations in greatest need and utilize patient navigators to help overcome these and other barriers 

in order to reduce health care disparities and improve health care 

outcomes. 

Eligible entities shall use the grant to recruit, assign, train, and 

employ patient navigators who have a direct knowledge of the communities they serve. The term ‘‘patient navigator’’ is defined to 

mean an individual who has completed a training program approved by the Secretary to perform the duties outlined in the legislation. It is the Committee’s intent that the Secretary develop specific requirements related to the patient navigator training programs to ensure the quality of services provided to patients by patient navigators. Such requirements may include minimum qualification requirements, such as education requirements, prior work 

experience, appropriate background checks, specified levels of expertise in health care of the community, and oversight or supervision requirements by licensed professionals. The Committee recognizes that there will be grant applicants with varying levels of 

experience in patient navigation. Some may have existing trained 

patient navigators who want to expand their services; others may 

have no trained navigators, but are well positioned to begin providing patient navigator services with appropriate training. An allowable use of part of the funds under this grant would be to provide navigator training, a plan for which should be included in the 

grant application. 

Patient navigators must coordinate health care services and provider referrals, facilitate the involvement of community organizations to provide assistance to patients, facilitate enrollment in clinical trials, anticipate barriers within the health care system and 

help ensure prompt diagnostic care and treatment, coordinate with 

6 

appropriate health insurance ombudsman programs, and conduct 

ongoing outreach to health disparity populations and other individuals to seek preventative care. 

Section 2 includes a rule of construction to clarify that the bill 

does not authorize funding for the delivery of health care services 

other than the patient navigator duties outlined in the legislation. 

It is the Committee’s view that this provision would prohibit use 

of demonstration program funds by a patient navigator to provide 

direct health care or treatment to a patient, even if the patient 

navigator is a licensed medical provider. 

The Committee fully expects that patient navigators will assist 

uninsured individuals with enrolling in appropriate health coverage programs, including private insurance, publicly funded programs like Medicaid, as well as health care savings accounts. Section 2 further clarifies that grant recipients cannot accept any referral fee, kickback, or other item of value in return for referring 

an individual to a particular health care provider, nor may the 

grant recipient will use any of the funds provided under this program to pay any fees or costs resulting from any litigation, arbitration, mediation, or other proceeding to resolve a legal dispute. 

Maintaining confidentiality of patient medical information is a 

concern, given that patient navigators will likely receive sensitive 

health information during the performance of their activities. It is 

the Committee’s view that most, if not all eligible entities would be 

covered health care providers under, and thus subject to, the 

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Beside health care providers, other nonprofit entities are 

also eligible entities under this program, but only if they enter into 

a ‘‘partnership or coordinates referrals’’ with one of these health 

care providers. It is the Committee’s view that these nonprofit entities would be considered to be ‘‘business associates’’ of the covered 

entities under HIPAA and thus also subject to the requirements of 

HIPAA. 

To the extent the patient navigator services are provided through 

an eligible entity that is a covered entity for HIPAA purposes, the 

patient navigator is likely to be a workforce member of the covered 

entity or of a business associate of a covered entity. Thus, the Committee expects the majority, if not all patient navigators will need 

to abide by the Privacy Rule in using or disclosing protected health 

information about the patients to whom they provide services. The 

Privacy Rule allows protected health information to be used and 

disclosed by a covered entity for the core functions of treatment, 

payment, and health care operations, and that do not need patient 

authorization of these uses or disclosures. In reviewing the types 

of functions that a patient navigator is likely to perform and that 

the purposes for these services is to facilitate the patient’s access 

to quality care, it appears that most of the services would fit within 

one or more of the HIPAA core functions. 

The Secretary, acting through the Administrator of HRSA, must 

coordinate and ensure the participation of the Indian Health Service, the National Cancer Institute, the Office of Rural Health Policy, and other such office and agencies deemed appropriate by the 

Secretary, regarding the design and evaluation of the demonstration program. The Committee strongly encourages the Administrator of HRSA to also coordinate with the Office of Minority 

7 

Health and Health Disparities at HRSA and Bureau of Primary 

Health Care at HRSA, as well as other similar offices throughout 

the Department of Health and Human Services. To facilitate the 

operation of the program, the Committee has assigned primary responsibility to the Administrator of HRSA. However, the Committee recognizes the distinct role of each of these offices and agencies within the Department of Health and Human Services, and 

therefore requires close coordination to maximize the impact of the 

patient navigator demonstration program. 

Section 2 also requires the Secretary to ensure coordination of 

the demonstration program with existing authorized programs in 

order to facilitate access to high-quality health care services (e.g., 

the Community Access Program administered by HRSA and the 

breast and cervical cancer screening programs administered by the 

Centers for Disease Control and Prevention.) Additionally, if grant 

recipients are already receiving federal funds for activities similar 

to those described under this program, at the time of the grant application, the applicant may not receive a grant under this section 

unless the entity can demonstrate that amounts received under 

this grant will be utilized to provide new services, or to serve new 

classes of individuals who would not otherwise be served. By including this provision, the Committee wants to ensure that the patient navigator grants provided for under this section provide 

added value or new community services without duplicating programs or efforts that would qualify for funding under current law. 

An eligible entity may receive a grant for a period of not more 

than three years. The Secretary may, based on extenuating circumstances, approve an extension of the grant period for up to one 

year. The demonstration program expires on September 30, 2010. 

Eligible entities must establish baseline measures and benchmarks to evaluate program outcomes. The Secretary may require 

grant recipients to submit interim reports on grant program outcomes. The Secretary may provide Congress with interim reports 

on the progress of the demonstration program. The Secretary is required to conduct an evaluation of the results of the program no 

later than six months after the completion of the demonstration 

grant program. To effectively measure program outcomes, the Committee recommends that the Secretary collect and include the following data in the final report to Congress: the patient’s insurance 

status, income, education level, gender, age, race and ethnicity, the 

number of patients navigated, demographic coverage area, screening location and date, type and stage of diagnosis, point at which 

the navigator was brought into the process, type of navigator (lay 

or professional), barriers the patient encountered and how they 

were resolved, compliance rate for appointments and follow-up 

exams, number of patients referred (e.g., to treatment, pharmaceutical assistance programs, ombudsman programs/other health 

insurance programs, community organizations) and follow-up outcomes (e.g., number of uninsured who get health coverage, etc.), 

time interval between diagnosis or referral and resolution date, and 

the final outcome or result. For applicants who are providing training for patient navigators, the report should also include the plan 

for such training and the outcomes. 

Finally, section 2 authorizes to be appropriated $2 million in fiscal year 2006, $5 million in fiscal year 2007, $8 million in fiscal 

8 

year 2008, $6.5 million in fiscal year 2009, and $3.5 million in fiscal year 2010 to carry out the patient navigator demonstration program. Amounts appropriated will be available through the end of 

fiscal year 2010. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

In compliance with clause 3(e) of rule XIII of the Rules of the 

House of Representatives, changes in existing law made by the bill, 

as reported, are shown as follows (new matter is printed in italic 

and existing law in which no change is proposed is shown in 

roman): 

PUBLIC HEALTH SERVICE ACT 

* * * * * * * 

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC 

HEALTH SERVICE 

* * * * * * * 

PART D—PRIMARY HEALTH CARE

* * * * * * * 

Subpart V—Healthy Communities Access Program 

* * * * * * * 

SEC. 340A. PATIENT NAVIGATOR GRANTS. 

(a) GRANTS.—The Secretary, acting through the Administrator of 

the Health Resources and Services Administration, may make 

grants to eligible entities for the development and operation of demonstration programs to provide patient navigator services to improve 

health care outcomes. The Secretary shall coordinate with, and ensure the participation of, the Indian Health Service, the National 

Cancer Institute, the Office of Rural Health Policy, and such other 

offices and agencies as deemed appropriate by the Secretary, regarding the design and evaluation of the demonstration programs. 

(b) USE OF FUNDS.—The Secretary shall require each recipient of 

a grant under this section to use the grant to recruit, assign, train, 

and employ patient navigators who have direct knowledge of the 

communities they serve to facilitate the care of individuals, including by performing each of the following duties: 

(1) Acting as contacts, including by assisting in the coordination of health care services and provider referrals, for individuals who are seeking prevention or early detection services for, 

or who following a screening or early detection service are 

found to have a symptom, abnormal finding, or diagnosis of, 

cancer or other chronic disease. 

(2) Facilitating the involvement of community organizations 

in assisting individuals who are at risk for or who have cancer 

or other chronic diseases to receive better access to high-quality 

health care services (such as by creating partnerships with patient advocacy groups, charities, health care centers, community 

hospice centers, other health care providers, or other organizations in the targeted community). 

9 

(3) Notifying individuals of clinical trials and, on request, facilitating enrollment of eligible individuals in these trials. 

(4) Anticipating, identifying, and helping patients to overcome barriers within the health care system to ensure prompt 

diagnostic and treatment resolution of an abnormal finding of 

cancer or other chronic disease. 

(5) Coordinating with the relevant health insurance ombudsman programs to provide information to individuals who are at 

risk for or who have cancer or other chronic diseases about 

health coverage, including private insurance, health care savings accounts, and other publicly funded programs (such as 

Medicare, Medicaid, health programs operated by the Department of Veterans Affairs or the Department of Defense, the 

State children’s health insurance program, and any private or 

governmental prescription assistance programs). 

(6) Conducting ongoing outreach to health disparity populations, including the uninsured, rural populations, and other 

medically underserved populations, in addition to assisting 

other individuals who are at risk for or who have cancer or 

other chronic diseases to seek preventative care. 

(c) PROHIBITIONS.— (1) REFERRAL FEES.—The Secretary shall require each recipient of a grant under this section to prohibit any patient navigator providing services under the grant from accepting any referral fee, kickback, or other thing of value in return for referring an individual to a particular health care provider. 

(2) LEGAL FEES AND COSTS.—The Secretary shall prohibit the 

use of any grant funds received under this section to pay any 

fees or costs resulting from any litigation, arbitration, mediation, or other proceeding to resolve a legal dispute. 

(d) GRANT PERIOD.— (1) IN GENERAL.—Subject to paragraphs (2) and (3), the Secretary may award grants under this section for periods of not 

more than 3 years. 

(2) EXTENSIONS.—Subject to paragraph (3), the Secretary 

may extend the period of a grant under this section. Each such 

extension shall be for a period of not more than 1 year. 

(3) LIMITATIONS ON GRANT PERIOD.—In carrying out this section, the Secretary— (A) shall ensure that the total period of a grant does not 

exceed 4 years; and 

(B) may not authorize any grant period ending after September 30, 2010. 

(e) APPLICATION.—

(1) IN GENERAL.—To seek a grant under this section, an eligible entity shall submit an application to the Secretary in such 

form, in such manner, and containing such information as the 

Secretary may require. 

(2) CONTENTS.—At a minimum, the Secretary shall require 

each such application to outline how the eligible entity will establish baseline measures and benchmarks that meet the Secretary’s requirements to evaluate program outcomes. 

(f) UNIFORM BASELINE MEASURES.—The Secretary shall establish 

uniform baseline measures in order to properly evaluate the impact 

of the demonstration projects under this section. 

10 

(g) PREFERENCE.—In making grants under this section, the Secretary shall give preference to eligible entities that demonstrate in 

their applications plans to utilize patient navigator services to overcome significant barriers in order to improve health care outcomes 

in their respective communities. 

(h) DUPLICATION OF SERVICES.—An eligible entity that is receiving Federal funds (including funds through a grant under section 

340, which is commonly referred to as the ‘‘Healthy Communities 

Access Program’’) for activities described in subsection (b) on the 

date on which the entity submits an application under subsection 

(e), may not receive a grant under this section unless the entity can 

demonstrate that amounts received under the grant will be utilized 

to expand services or provide new services to individuals who would 

not otherwise be served. 

(i) COORDINATION WITH OTHER PROGRAMS.—The Secretary shall 

ensure coordination of the demonstration grant program under this 

section with existing authorized programs in order to facilitate access to high-quality health care services. 

(j) STUDY; REPORTS.—

(1) FINAL REPORT BY SECRETARY.—Not later than 6 months 

after the completion of the demonstration grant program under 

this section, the Secretary shall conduct a study of the results 

of the program and submit to the Congress a report on such results that includes the following: 

(A) An evaluation of the program outcomes, including—

(i) quantitative analysis of baseline and benchmark 

measures; and 

(ii) aggregate information about the patients served 

and program activities. 

(B) Recommendations on whether patient navigator programs could be used to improve patient outcomes in other 

public health areas. 

(2) INTERIM REPORTS BY SECRETARY.—The Secretary may provide interim reports to the Congress on the demonstration grant 

program under this section at such intervals as the Secretary 

determines to be appropriate. 

(3) REPORTS BY GRANTEES.—The Secretary may require grant 

recipients under this section to submit interim and final reports 

on grant program outcomes. 

(k) RULE OF CONSTRUCTION.—This section shall not be construed 

to authorize funding for the delivery of health care services (other 

than the patient navigator duties listed in subsection (b)). 

(l) DEFINITIONS.—In this section: 

(1) The term ‘‘eligible entity’’ means a public or nonprofit private health center (including a Federally qualified health center 

(as that term is defined in section 1861(aa)(4) of the Social Security Act)), a health facility operated by or pursuant to a contract with the Indian Health Service, a hospital, a cancer center, a rural health clinic, an academic health center, or a nonprofit entity that enters into a partnership or coordinates referrals with such a center, clinic, facility, or hospital to provide 

patient navigator services. 

(2) The term ‘‘health disparity population’’ means a population that, as determined by the Secretary, has a significant 

disparity in the overall rate of disease incidence, prevalence, 

11 

morbidity, mortality, or survival rates as compared to the 

health status of the general population. 

(3) The term ‘‘patient navigator’’ means an individual who 

has completed a training program approved by the Secretary to 

perform the duties listed in subsection (b). 

(m) AUTHORIZATION OF APPROPRIATIONS.— (1) IN GENERAL.—To carry out this section, there are author- ized to be appropriated $2,000,000 for fiscal year 2006, 

$5,000,000 for fiscal year 2007, $8,000,000 for fiscal year 2008, 

$6,500,000 for fiscal year 2009, and $3,500,000 for fiscal year 

2010. 

(2) AVAILABILITY.—The amounts appropriated pursuant to 

paragraph (1) shall remain available for obligation through the 

end of fiscal year 2010. 

* * * * * * * 

Æ