[House Report 109-104]
[From the U.S. Government Publishing Office]
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
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.
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 overcoming 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 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 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 likeMedicaid, 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 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 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).
(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.
(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, 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
authorized 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.
* * * * * * *