[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

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TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

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Part D--Primary Health Care

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Subpart V--Healthy Communities Access Program

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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.

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