[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.

           *       *       *       *       *       *       *


                                  
