[Senate Report 109-73]
[From the U.S. Government Publishing Office]
Calendar No. 115
109th Congress Report
SENATE
1st Session 109-73
======================================================================
PATIENT NAVIGATOR OUTREACH AND CHRONIC DISEASE PREVENTION ACT OF 2005
_______
May 25, 2005.--Ordered to be printed
_______
Mr. Enzi, from the Committee on Health, Education, Labor, and Pensions,
submitted the following
R E P O R T
[To accompany S. 898]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 898) 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, reports favorably thereon with an
amendment in the nature of a substitute and recommends that the
bill (as amended) do pass.
CONTENTS
Page
I. Purpose and Summary..............................................1
II. Background and need for legislation..............................2
III. Legislative history and committee action.........................2
IV. Explanation of bill and committee views..........................2
V. Cost estimate....................................................5
VI. Application of law to the legislative branch.....................5
VII. Regulatory impact statement......................................6
VIII.Section-by-section analysis......................................6
IX. Changes in existing law..........................................7
I. Purpose and Summary
The purpose of S. 898, the ``Patient Navigator Outreach and
Chronic Disease Prevention Act of 2005'' is 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.
II. 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 preventive 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 diseases and
further diagnosis and treatment, if needed.
S. 898 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.
III. Legislative History and Committee Action
On April 25, 2005, Sen. Hutchison, Bingaman, Brownback,
Kennedy, and Cochran introduced S. 898, the ``Patient
Navigator, Outreach and Chronic Disease Prevention Act of
2005.'' On April 27, 2005, the committee held an executive
session to consider S. 898. After accepting a manager's
amendment by unanimous voice vote, the committee approved S.
898 by unanimous voice vote.
IV. Explanation of Bill and Committee Views
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 the
Indian Health Services providers or tribal organizations, a
hospital, a cancer center, a rural health clinic, an academic
health center, or a nonprofit entity that enters into a
partnership or coordinatesreferrals with such health care
facilities. 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 required 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, a lack of quality
health care providers, 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.
It is the committee's intent that the Secretary would
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 or 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.
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 a patient navigator from directly
providing health care or treatment to a patient funded by the
demonstration program, even if the patient navigator is a
licensed medical provider.
The committee fully expects that patient navigators will
assist the uninsured individuals in enrolling in appropriate
health coverage programs.
Maintaining the 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.
Besides 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 that 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 they do not need patient
authorization for 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 Administrator of HRSA must coordinate and ensure the
participation of the Indian Health Service, the National Cancer
Institute, the Office of Rural Health Policy, the Office of
Minority Health 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 and the
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 Healthy Communities
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 must describe how 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. In 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.
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, 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.
V. Cost Estimate
U.S. Congress,
Congressional Budget Office,
Washington, DC, May 5, 2005.
Hon. Michael B. Enzi,
Chairman, Committee on Health, Education, Labor, and Pensions,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 898, 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.
S. 898--Patient Navigator Outreach and Chronic Disease Prevention Act
of 2005
S. 898 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 6 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 S. 898 would cost $23
million from 2006 through 2010. The legislation would not
affect direct spending or receipts.
S. 898 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 this estimate is Shinobu Suzuki.
This estimate was approved by Peter H. Fontaine, Deputy
Assistant Director for Budget Analysis.
VI. Application of Law to the 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.
VII. Regulatory Impact Statement
The committee has determined that there will be de minimus
changes to the regulatory burden due to this bill.
VIII. Section-by-Section Analysis of the Legislation
Section 1. Short title
This section 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 the
Indian Health Services providers or tribal organizations, 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.
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. Health disparity
populations are defined as 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.
Eligible entities may 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.
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 culturally competent
and linguistically appropriate outreach to health disparity
populations and other individuals to seek preventive 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.
Section 2 further clarifies that the grant recipients
cannot accept any referral fee, kickback, or other thing of
value in return for referring an individual to a particular
health care provider or that 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.
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.
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 Healthy Communities
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 must describe how 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.
An eligible entity may receive a grant for a period of not
more than 3 years. The Secretary may, based on extenuating
circumstances, approve an extension of the grant period for up
to 1 year. The demonstration program expires on September 30,
2010.
Grant recipients must establish baseline measures and
benchmarks to evaluate program outcomes. The Secretary may
require grant recipients to submit interim reports on grant
program outcomes, as well as 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 180 days after the completion of
the demonstration grant program.
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.
X. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, 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 A--RESEARCH AND INVESTIGATION
in general
SEC. 301.
(a) * * *
* * * * * * *
PART D--PRIMARY HEALTH CARE
Subpart I--Health Centers
SEC. 330. [254B] HEALTH CENTERS.
(a) Definition of Health Center.--
(1) In general.--* * *
* * * * * * *
Subpart V--Healthy Communities Access Program
SEC. 340. GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFICIENCY, AND
COORDINATION OF SERVICES FOR THE UNINSURED AND
UNDERINSURED.
(a) In General--* * *
* * * * * * *
(k) * * *
(l) * * *
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
toreceive 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 triads 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 entitiesthat
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 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 180
days 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) 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) Interim 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.
* * * * * * *