[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1278 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 1278
To amend the Public Health Service Act to provide for a public response
to the public health crisis of pain, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 18, 2003
Mr. Wyden, (for himself, Mr. Smith, Mr. Rockefeller, and Mr. Breaux)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, and Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for a public response
to the public health crisis of pain, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Conquering Pain
Act of 2003''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title.
Sec. 2. Findings.
Sec. 3. Definitions.
TITLE I--EMERGENCY RESPONSE TO THE PUBLIC HEALTH CRISIS OF PAIN
Sec. 101. Guidelines for the treatment of pain.
Sec. 102. Patient expectations to have pain and symptom management.
Sec. 103. Quality improvement projects.
Sec. 104. Pain coverage quality evaluation and information.
Sec. 105. Surgeon General's report.
TITLE II--DEVELOPING COMMUNITY RESOURCES
Sec. 201. Family support networks in pain and symptom management.
TITLE III--REIMBURSEMENT BARRIERS
Sec. 301. Reimbursement barriers report.
Sec. 302. Insurance coverage of pain and symptom management.
TITLE IV--IMPROVING FEDERAL COORDINATION OF POLICY, RESEARCH, AND
INFORMATION
Sec. 401. Advisory Committee on Pain and Symptom Management.
Sec. 402. Institutes of Medicine report on controlled substance
regulation and the use of pain medications.
Sec. 403. Conference on pain research and care.
TITLE V--DEMONSTRATION PROJECTS
Sec. 501. Provider performance standards for improvement in pain and
symptom management.
Sec. 502. End of life care demonstration projects.
SEC. 2. FINDINGS.
Congress finds that--
(1) pain is often left untreated or under-treated
especially among older patients, African Americans, Hispanics
and other minorities, and children;
(2) chronic pain is a public health problem affecting at
least 50,000,000 Americans through some form of persisting or
recurring symptom;
(3) 40 to 50 percent of patients experience moderate to
severe pain at least half the time in their last days of life;
(4) 70 to 80 percent of cancer patients experience
significant pain during their illness;
(5) one in 7 nursing home residents experience persistent
pain that may diminish their quality of life;
(6) despite the best intentions of physicians, nurses,
pharmacists, and other health care professionals, pain is often
under-treated because of the inadequate training of clinicians
in pain management;
(7) despite the best intentions of physicians, nurses,
pharmacists, mental health professionals, and other health care
professionals, pain and symptom management is often suboptimal
because the health care system has focused on cure of disease
rather than the management of a patient's pain and other
symptoms;
(8) the technology and scientific basis to adequately
manage most pain is known;
(9) pain should be considered the fifth vital sign; and
(10) coordination of Federal efforts is needed to improve
access to high quality effective pain and symptom management in
order to assure the needs of chronic pain patients and those
who are terminally ill are met.
SEC. 3. DEFINITIONS.
In this Act:
(1) Chronic pain.--The term ``chronic pain'' means a pain
state that is persistent and in which the cause of the pain
cannot be removed or otherwise alleviated. Such term includes
pain that may be associated with long-term incurable or
intractable medical conditions or disease.
(2) End of life care.--The term ``end of life care'' means
a range of services, including hospice care, provided to a
patient, in the final stages of his or her life, who is
suffering from 1 or more conditions for which treatment toward
a cure or reasonable improvement is not possible, and whose
focus of care is palliative rather than curative.
(3) Family support network.--The term ``family support
network'' means an association of 2 or more individuals or
entities in a collaborative effort to develop multi-
disciplinary integrated patient care approaches that involve
medical staff and ancillary services to provide support to
chronic pain patients and patients at the end of life and their
caregivers across a broad range of settings in which pain
management might be delivered.
(4) Hospice.--The term ``hospice care'' has the meaning
given such term in section 1861(dd)(1) of the Social Security
Act (42 U.S.C. 1395x(dd)(1)).
(5) Medication therapy management services.--The term
``medication therapy management services'' means consultations
with a physician or other health care professional (including a
pharmacist) who is practicing within the scope of the
professional's license, concerning a patient which results in--
(A) a change in the drug regimen of the patient to
avoid an adverse drug interaction with another drug or
disease state;
(B) a change in inappropriate drug dosage or dosage
form with respect to the patient;
(C) discontinuing an unnecessary or harmful
medication with respect to the patient;
(D) an initiation of medication therapy for a
medical condition of the patient;
(E) consultation with the patient or a caregiver in
a manner that results in a significant improvement in
drug regimen compliance; or
(F) patient and caregiver understanding of the
appropriate use and adherence to medication therapy.
(6) Pain and symptom management.--The term ``pain and
symptom management'' means services provided to relieve
physical or psychological pain or suffering, including any 1 or
more of the following physical complaints--
(A) weakness and fatigue;
(B) shortness of breath;
(C) nausea and vomiting;
(D) diminished appetite;
(E) wasting of muscle mass;
(F) difficulty in swallowing;
(G) bowel problems;
(H) dry mouth;
(I) failure of lymph drainage resulting in tissue
swelling;
(J) confusion;
(K) dementia;
(L) delirium;
(M) anxiety;
(N) depression; and
(O) other related symptoms.
(7) Palliative care.--The term ``palliative care'' means
the total care of patients whose disease is not responsive to
curative treatment, the goal of which is to provide the best
quality of life for such patients and their families. Such
care--
(A) may include the control of pain and of other
symptoms, including psychological, social and spiritual
problems;
(B) affirms life and regards dying as a normal
process;
(C) provides relief from pain and other distressing
symptoms;
(D) integrates the psychological and spiritual
aspects of patient care;
(E) offers a support system to help patients live
as actively as possible until death; and
(F) offers a support system to help the family cope
during the patient's illness and in their own
bereavement.
(8) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
TITLE I--EMERGENCY RESPONSE TO THE PUBLIC HEALTH CRISIS OF PAIN
SEC. 101. GUIDELINES FOR THE TREATMENT OF PAIN.
(a) Development of Website.--Not later than 2 months after the date
of enactment of this Act, the Secretary, acting through the Agency for
Healthcare Research and Quality, shall develop and maintain an Internet
website to provide information to individuals, health care
practitioners, and health facilities concerning evidence-based practice
guidelines developed for the treatment of physical and psychological
pain. Websites in existence on such date may be used if such websites
meet the requirements of this section.
(b) Requirements.--The website established under subsection (a)
shall--
(1) be designed to be quickly referenced by health care
practitioners; and
(2) provide for the updating of guidelines as scientific
data warrants.
(c) Provider Access to Guidelines.--
(1) In general.--In establishing the website under
subsection (a), the Secretary shall ensure that health care
facilities have made the website known to health care
practitioners and that the website is easily available to all
health care personnel providing care or services at a health
care facility.
(2) Use of certain equipment.--In making the information
described in paragraph (1) available to health care personnel,
the facility involved shall--
(A) ensure that such personnel have access to the
website through the computer equipment of the facility;
(B) carry out efforts to inform personnel at the
facility of the location of such equipment; and
(C) ensure that patients, caregivers, and support
groups are provided with access to the website.
(3) Rural areas.--
(A) In general.--A health care facility,
particularly a facility located in a rural or
underserved area, without access to the Internet shall
provide an alternative means of providing practice
guideline information to all health care personnel.
(B) Alternative means.--The Secretary shall
determine appropriate alternative means by which a
health care facility may make available practice
guideline information on a 24-hour basis, 7 days a week
if the facility does not have Internet access. The
criteria for adopting such alternative means should be
clear in permitting facilities to develop alternative
means without placing a significant financial burden on
the facility and in permitting flexibility for
facilities to develop alternative means of making
guidelines available. Such criteria shall be published
in the Federal Register.
SEC. 102. PATIENT EXPECTATIONS TO HAVE PAIN AND SYMPTOM MANAGEMENT.
(a) In General.--The administrator of each of the programs
described in subsection (b) shall ensure that, as part of any
informational materials provided to individuals under such programs,
such materials shall include information, where relevant, to inform
such individuals that they should expect to have their pain assessed
and should expect to be provided with effective pain and symptom
relief, when receiving benefits under such program.
(b) Programs.--The programs described in this subsection shall
include--
(1) the medicare and medicaid programs under titles XIX and
XXI of the Social Security Act (42 U.S.C. 1935 et seq., 1936 et
seq.);
(2) programs carried out through the Public Health Service;
(3) programs carried out through the Indian Health Service;
(4) programs carried out through health centers under
section 330 of the Public Health Service Act (42 U.S.C. 254b);
(5) the Federal Employee Health Benefits Program under
title 5, United States Code;
(6) the Civilian Health and Medical Program of the
Uniformed Services (CHAMPUS) as defined in section 1073(4) of
title 10, United States Code; and
(7) other programs administered by the Secretary.
SEC. 103. QUALITY IMPROVEMENT EDUCATION PROJECTS.
The Secretary shall provide funds for the implementation of special
education projects, in as many States as is practicable, to be carried
out by peer review organizations of the type described in section 1152
of the Social Security Act (42 U.S.C. 1320c-1) to improve the quality
of pain and symptom management. Such projects shall place an emphasis
on improving pain and symptom management at the end of life, and may
also include efforts to increase the quality of services delivered to
chronic pain patients and the chronically ill for whom pain may be a
significant symptom.
SEC. 104. PAIN COVERAGE QUALITY EVALUATION AND INFORMATION.
(a) In General.--Section 1851(d)(4) of the Social Security Act (42
U.S.C. 42 U.S.C. 1395w-21(d)(4)) is amended--
(1) in subparagraph (A), by adding at the end the
following:
``(ix) The organization's coverage of pain
and symptom management.''; and
(2) in subparagraph (D)--
(A) in clause (iii), by striking ``and'' at the
end;
(B) in clause (iv), by striking the period and
inserting ``, and''; and
(C) by adding at the end the following:
``(v) not later than 2 years after the date
of enactment of this clause, an evaluation
(which may be made part of any other relevant
report of quality evaluation that the plan is
required to prepare) for the plan (updated
annually) that indicates the performance of the
plan with respect to access to, and quality of,
pain and symptom management, including such
management as part of end of life care. Data
shall be posted in a comparable manner for
consumer use on www.medicare.gov.''.
(b) Effective Date.--The amendments made by paragraph (1) apply to
information provided with respect to annual, coordinated election
periods (as defined in section 1851(e)(3)(B) of the Social Security Act
(42 U.S.C. 1395-21(e)(3)(B)) beginning after the date of enactment of
this Act.
SEC. 105. SURGEON GENERAL'S REPORT.
Not later than October 1, 2004, the Surgeon General shall prepare
and submit to the appropriate committees of Congress and the public, a
report concerning the state of pain and symptom management in the
United States. The report shall include--
(1) a description of the legal and regulatory barriers that
may exist at the Federal and State levels to providing adequate
pain and symptom management;
(2) an evaluation of provider competency in providing pain
and symptom management;
(3) an identification of vulnerable populations, including
children, advanced elderly, non-English speakers, and
minorities, who may be likely to be underserved or may face
barriers to access to pain management and recommendations to
improve access to pain management for these populations;
(4) an identification of barriers that may exist in
providing pain and symptom management in health care settings,
including assisted living facilities;
(5) an identification of patient and family attitudes that
may exist which pose barriers in accessing pain and symptom
management or in the proper use of pain medications;
(6) an evaluation of medical, nursing, and pharmacy school
training and residency training for pain and symptom
management;
(7) a review of continuing medical education programs in
pain and symptom management; and
(8) a description of the use of and access to mental health
services for patients in pain and patients at the end of life.
TITLE II--DEVELOPING COMMUNITY RESOURCES
SEC. 201. FAMILY SUPPORT NETWORKS IN PAIN AND SYMPTOM MANAGEMENT.
(a) Establishment.--The Secretary, acting through the Public Health
Service, shall award grants for the establishment of 6 National Family
Support Networks in Pain and Symptom Management (in this section
referred to as the ``Networks'') to serve as national models for
improving the access and quality of pain and symptom management to
chronic pain patients (including chronically ill patients for whom pain
is a significant symptom) and those individuals in need of pain and
symptom management at the end of life and to provide assistance to
family members and caregivers.
(b) Eligibility and Distribution.--
(1) Eligibility.--To be eligible to receive a grant under
subsection (a), an entity shall--
(A) be an academic facility or other entity that
has demonstrated an effective approach to training
health care providers including mental health
professionals concerning pain and symptom management
and palliative care services; and
(B) prepare and submit to the Secretary an
application (to be peer reviewed by a committee
established by the Secretary), at such time, in such
manner, and containing such information as the
Secretary may require.
(2) Distribution.--In providing for the establishment of
Networks under subsection (a), the Secretary shall ensure
that--
(A) the geographic distribution of such Networks
reflects a balance between rural and urban needs; and
(B) at least 3 Networks are established at academic
facilities.
(c) Activities of Networks.--A Network that is established under
this section--
(1) shall provide for an integrated interdisciplinary
approach, that includes psychological and counseling services,
to the delivery of pain and symptom management;
(2) shall provide community leadership in establishing and
expanding public access to appropriate pain care, including
pain care at the end of life;
(3) shall provide assistance, through caregiver supportive
services, that include counseling and education services;
(4) shall develop a research agenda to promote effective
pain and symptom management for the broad spectrum of patients
in need of access to such care that can be implemented by the
Network;
(5) shall provide for coordination and linkages between
clinical services in academic centers and surrounding
communities to assist in the widespread dissemination of
provider and patient information concerning how to access
options for pain management;
(6) shall establish telemedicine links to provide education
and for the delivery of services in pain and symptom
management;
(7) shall develop effective means of providing assistance
to providers and families for the management of a patient's
pain 24 hours a day, 7 days a week; and
(8) may include complimentary medicine provided in
conjunction with traditional medical services.
(d) Provider Pain and Symptom Management Communications Projects.--
(1) In general.--Each Network shall establish a process to
provide health care personnel with information 24 hours a day,
7 days a week, concerning pain and symptom management. Such
process shall be designed to test the effectiveness of specific
forms of communications with health care personnel so that such
personnel may obtain information to ensure that all appropriate
patients are provided with pain and symptom management.
(2) Termination.--The requirement of paragraph (1) shall
terminate with respect to a Network on the day that is 2 years
after the date on which the Network has established the
communications method.
(3) Evaluation.--Not later than 60 days after the
expiration of the 2-year period referred to in paragraph (2), a
Network shall conduct an evaluation and prepare and submit to
the Secretary a report concerning the costs of operation and
whether the form of communication can be shown to have had a
positive impact on the care of patients in chronic pain or on
patients with pain at the end of life.
(4) Rule of construction.--Nothing in this subsection shall
be construed as limiting a Network from developing other ways
in which to provide support to families and providers, 24 hours
a day, 7 days a week.
(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $18,000,000 for fiscal years
2004 through 2006.
TITLE III--REIMBURSEMENT BARRIERS
SEC. 301. REIMBURSEMENT BARRIERS REPORT.
The Medicare Payment Advisory Commission (MedPac) established under
section 1805 of the Social Security Act (42 U.S.C. 1396b-6) shall
conduct a study, and prepare and submit to the appropriate committees
of Congress a report, concerning--
(1) the manner in which medicare policies may pose barriers
in providing pain and symptom management and palliative care
services in different settings, including a focus on payment
for nursing home and home health services;
(2) the identification of any financial barriers that may
exist within the medicare and medicaid programs under titles
XVIII and XIX of the Social Security Act (42 U.S.C. 1395 et
seq., 1396 et seq.) that interfere with continuity of care and
interdisciplinary care or supportive care for the broad range
of chronic pain patients (including patients who are
chronically ill for whom pain is a significant symptom), and
for those who are terminally ill, and include the
recommendations of the Commission on ways to eliminate those
barriers that the Commission may identify;
(3) the reimbursement barriers that exist, if any, in
providing pain and symptom management through hospice care,
particularly in rural areas, and if barriers exist,
recommendations concerning adjustments that would assist in
assuring patient access to pain and symptom management through
hospice care in rural areas;
(4) whether the medicare reimbursement system provides
incentives to providers to delay informing terminally ill
patients of the availability of hospice and palliative care;
and
(5) the impact of providing payments for medication therapy
management services in pain and symptom management and
palliative care services.
SEC. 302. INSURANCE COVERAGE OF PAIN AND SYMPTOM MANAGEMENT.
(a) In General.--The General Accounting Office shall conduct a
survey of public and private health insurance providers, including
managed care entities, to determine whether the reimbursement policies
of such insurers inhibit the access of chronic pain patients to pain
and symptom management and pain and symptom management for those in
need of end-of-life care (including patients who are chronically ill
for whom pain is a significant symptom). The survey shall include a
review of formularies for pain medication and the effect of such
formularies on pain and symptom management.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the General Accounting Office shall prepare and submit to the
appropriate committees of Congress a report concerning the survey
conducted under subsection (a).
TITLE IV--IMPROVING FEDERAL COORDINATION OF POLICY, RESEARCH, AND
INFORMATION
SEC. 401. ADVISORY COMMITTEE ON PAIN AND SYMPTOM MANAGEMENT.
(a) Establishment.--The Secretary shall establish an advisory
committee, to be known as the Advisory Committee on Pain and Symptom
Management, to make recommendations to the Secretary concerning a
coordinated Federal agenda on pain and symptom management.
(b) Membership.--The Advisory Committee established under
subsection (a) shall be comprised of 11 individuals to be appointed by
the Secretary, of which at least 1 member shall be a representative
of--
(1) physicians (medical doctors or doctors of osteopathy)
who treat chronic pain patients or the terminally ill;
(2) nurses who treat chronic pain patients or the
terminally ill;
(3) pharmacists;
(4) hospice;
(5) pain researchers;
(6) patient advocates;
(7) caregivers; and
(8) mental health providers.
The members of the Committee shall designate 1 member to serve as the
chairperson of the Committee.
(c) Meetings.--The Advisory Committee shall meet at the call of the
chairperson of the Committee.
(d) Agenda.--The agenda of the Advisory Committee established under
subsection (a) shall include--
(1) the development of recommendations to create a
coordinated Federal agenda on pain and symptom management;
(2) the development of proposals to ensure that pain is
considered as the fifth vital sign for all patients;
(3) the identification of research needs in pain and
symptom management, including gaps in pain and symptom
management guidelines;
(4) the identification and dissemination of pain and
symptom management practice guidelines, research information,
and best practices;
(5) proposals for patient education concerning how to
access pain and symptom management across health care settings;
(6) the manner in which to measure improvement in access to
pain and symptom management and improvement in the delivery of
care;
(7) the development of ongoing strategies to assure the
aggressive use of pain medications, including opiods,
regardless of health care setting; and
(8) the development of an ongoing mechanism to identify
barriers or potential barriers to pain and symptom management
created by Federal policies.
(e) Recommendation.--Not later than 2 years after the date of
enactment of this Act, the Advisory Committee established under
subsection (a) shall prepare and submit to the Secretary
recommendations concerning a prioritization of the need for a Federal
agenda on pain and symptom management, and ways in which to better
coordinate the activities of entities within the Department of Health
and Human Services, and other Federal entities charged with the
responsibility for the delivery of health care services or research on
pain and symptom management with respect to pain management.
(f) Consultation.--In carrying out this section, the Advisory
Committee shall consult with all Federal agencies that are responsible
for providing health care services or access to health services to
determine the best means to ensure that all Federal activities are
coordinated with respect to research and access to pain and symptom
management.
(g) Administrative Support; Terms of Service; Other Provisions.--
The following shall apply with respect to the Advisory Committee:
(1) The Committee shall receive necessary and appropriate
administrative support, including appropriate funding, from the
Department of Health and Human Services.
(2) The Committee shall hold open meetings and meet not
less than 4 times per year.
(3) Members of the Committee shall not receive additional
compensation for their service. Such members may receive
reimbursement for appropriate and additional expenses that are
incurred through service on the Committee which would not have
incurred had they not been a member of the Committee.
(4) The requirements of Appendix 2 of title 5, United
States Code.
SEC. 402. INSTITUTES OF MEDICINE REPORT ON CONTROLLED SUBSTANCE
REGULATION AND THE USE OF PAIN MEDICATIONS.
(a) In General.--The Secretary, acting through a contract entered
into with the Institute of Medicine, shall review findings that have
been developed through research conducted concerning--
(1) the effects of controlled substance regulation on
patient access to effective care;
(2) factors, if any, that may contribute to the underuse of
pain medications, including opiods;
(3) the identification of State legal and regulatory
barriers, if any, that may impact patient access to medications
used for pain and symptom management; and
(4) strategies to assure the aggressive use of pain
medications, including opiods, regardless of health care
setting.
(b) Report.--Not later than 18 months after the date of enactment
of this Act, the Secretary shall prepare and submit to the appropriate
committees of Congress a report concerning the findings described in
subsection (a).
SEC. 403. CONFERENCE ON PAIN RESEARCH AND CARE.
Not later than December 31, 2007, the Secretary, acting through the
National Institutes of Health, shall convene a national conference to
discuss the translation of pain research into the delivery of health
services including mental health services to chronic pain patients and
those needing end-of-life care. The Secretary shall use unobligated
amounts appropriated for the Department of Health and Human Services to
carry out this section.
TITLE V--DEMONSTRATION PROJECTS
SEC. 501. PROVIDER PERFORMANCE STANDARDS FOR IMPROVEMENT IN PAIN AND
SYMPTOM MANAGEMENT.
(a) In General.--The Secretary, acting through the Health Resources
Services Administration, shall award grants for the establishment of
not less than 5 demonstration projects to determine effective methods
to measure improvement in the skills, knowledge, and attitudes and
beliefs of health care personnel in pain and symptom management as such
skill, knowledge, and attitudes and beliefs apply to providing services
to chronic pain patients and those patients requiring pain and symptom
management at the end of life.
(b) Evaluation.--Projects established under subsection (a) shall be
evaluated to determine patient and caregiver knowledge and attitudes
toward pain and symptom management.
(c) Application.--To be eligible to receive a grant under
subsection (a), an entity shall prepare and submit to the Secretary an
application at such time, in such manner and containing such
information as the Secretary may require.
(d) Termination.--A project established under subsection (a) shall
terminate after the expiration of the 2-year period beginning on the
date on which such project was established.
(e) Authorization of Appropriations.--There is authorized to be
appropriated such sums as may be necessary to carry out this section.
SEC. 502. END OF LIFE CARE DEMONSTRATION PROJECTS.
The Secretary, acting through the Health Resources and Services
Administration, shall--
(1) not later than January 1, 2006, carry out not less than
5 demonstration and evaluation projects that implement care
models for individuals at the end of life, at least one of
which shall be developed to assist those individuals who are
terminally ill and have no family or extended support, and each
of which may be carried out in collaboration with domestic and
international entities to gain and share knowledge and
experience on end of life care;
(2) conduct 3 demonstration and evaluation activities
concerning the education and training of clinicians in end of
life care, and assist in the development and distribution of
accurate educational materials on both pain and symptom
management and end of life care;
(3) in awarding grants for the training of health
professionals, give priority to awarding grants to entities
that will provide training for health professionals in pain and
symptom management and in end-of-life care at the undergraduate
level;
(4) shall evaluate demonstration projects carried out under
this section within the 5-year period beginning on the
commencement of each such project; and
(5) develop a strategy and make recommendations to Congress
to ensure that the United States health care system--
(A) has a meaningful, comprehensive, and effective
approach to meet the needs of individuals and their
caregivers as the patient approaches death; and
(B) integrates broader supportive services.
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