II 110th CONGRESS 2d Session S. 3387 IN THE SENATE OF THE UNITED STATES July 31, 2008 Mr. Hatch (for himself and Mr. Dodd) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act with respect to pain care.

1.

Short title; table of contents

(a)

Short title

This Act may be cited as the National Pain Care Policy Act of 2008. (b)

Table of contents

The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings. Sec. 3. Institute of Medicine Conference on Pain. Sec. 4. Pain Consortium at National Institutes of Health. Sec. 5. Pain care education and training. Sec. 6. Public awareness campaign on pain management.

2.

Findings

The Congress finds that— (1)pain is the most common reason Americans access the health care system and is a leading contributor to health care costs; (2)most painful conditions can be relieved with proper treatment, and providing adequate pain management is a crucial component of improving and maintaining quality of life for patients, survivors, and their loved ones; (3)pain is a leading cause of lost productivity, temporary disability, and permanent disability in the American workforce; (4)pain affects Americans across all ages, including children. It can occur at any stage of disease, affecting patients in active treatment, survivors who have completed treatment, and those at the end of life; (5)in some cases pain is the disease itself and in others it is caused by or related to other diseases and conditions; (6)either acute or chronic pain may accompany other health conditions that are prevalent in the Medicare and Medicaid populations, including cancer, arthritis, diabetes, and cardiovascular disease; (7)pain is often improperly assessed, misdiagnosed, mistreated, or undertreated; (8)disparities in the assessment, diagnosis, and treatment of pain across racial and ethnic groups, particularly at the end of life, are well documented; (9)pain research funding represents less than 2 percent of the annual research expenditures of the National Institutes of Health; (10)pain research needs better planning and coordination across the many institutes, centers, and programs of the National Institutes of Health; (11)many health care professionals are inadequately trained in the proper assessment, diagnosis, treatment, and management of pain; (12)patients in pain face significant barriers that can prevent proper assessment, diagnosis, treatment, and management of their pain; and (13)improving pain care research, education, access, and care are national health care priorities of the United States.

3.

Institute of Medicine Conference on Pain

(a)

Convening

Not later than June 30, 2009, the Secretary of Health and Human Services shall seek to enter an agreement with the Institute of Medicine of the National Academies to convene a Conference on Pain (in this section referred to as the Conference). (b)

Purposes

The purposes of the Conference shall be to— (1)increase the recognition of pain as a significant public health problem in the United States; (2)evaluate the adequacy of assessment, diagnosis, treatment, and management of acute and chronic pain in the general population, and in identified racial, ethnic, gender, age, and other demographic groups that may be disproportionately affected by inadequacies in the assessment, diagnosis, treatment, and management of pain; (3)identify barriers to appropriate pain care, including— (A)lack of understanding and education among employers, patients, health care providers, regulators, and third-party payors; (B)barriers to access to care at the primary, specialty, and tertiary care levels, including barriers— (i)specific to those populations that are disproportionately undertreated for pain; (ii)related to physician concerns over regulatory and law enforcement policies applicable to some pain therapies; and (iii)attributable to benefit, coverage, and payment policies in both the public and private sectors; and (C)gaps in basic and clinical research on the symptoms and causes of pain, and potential assessment methods and new treatments to improve pain care; and (4)establish an agenda for action in both the public and private sectors that will reduce such barriers and significantly improve the state of pain care research, education, and clinical care in the United States. (c)

Other appropriate entity

If the Institute of Medicine declines to enter into an agreement under subsection (a), the Secretary of Health and Human Services may enter into such agreement with another appropriate entity. (d)

Report

A report summarizing the Conference’s findings and recommendations shall be submitted to the Congress not later than June 30, 2010. (e)

Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2009 and 2010.

4.

Pain Consortium at National Institutes of Health

Section 401(c)(2) of the Public Health Service Act (42 U.S.C. 281(c)(2)) is amended— (1)by redesignating subparagraph (B) as subparagraph (C); and (2)by inserting after subparagraph (A) the following: (B)

Pain consortium

(i)

Establishment

The Director of NIH shall establish within the Division an office to be known as the Pain Consortium (referred to in this subparagraph as the Consortium). (ii)

Purposes

The purposes of the Consortium shall be to— (I)establish and maintain a national agenda for basic and clinical research on the causes and effective treatments for pain; (II)coordinate and promote the pain research, research training, and other pain-related activities being carried out in and across the institutes, centers, and programs of the National Institutes of Health; (III)convene an annual conference of prominent intramural and extramural experts in pain research, treatment, and management to assess and make recommendations with respect to the pain research activities and programs of the National Institutes of Health; and (IV)take such other actions as may be appropriate with respect to research on the causes and effective treatments for pain. (iii)

Representation of institutes

The Consortium shall include the heads of the institutes, centers, and programs of the National Institutes of Health involved in pain research, as determined by the Director of NIH. (iv)

Chair

The Consortium shall be chaired by the Director of the National Institute of Neurological Disorders and Stroke, and shall have such co-chairs as the Director of NIH shall determine. (v)

Advisory committee

(I)

Establishment

The Director of NIH shall establish an advisory committee to the Consortium to be known as the National Pain Care Research Advisory Committee (in this section referred to as the Advisory Committee). (II)

Establishment

The Advisory Committee shall be established and maintained in accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix). (III)

Membership

The members of the Advisory Committee shall consist of voting appointed members and nonvoting ex officio members as follows: (aa)The voting appointed members of the Advisory Committee shall be appointed by the Director of NIH and shall include representatives of the broad range of medical, health, and scientific disciplines involved in pain research and pain care, including individuals with expertise and training in pain medicine, pain management, neuroscience, psychology, social work, pharmacy and pharmacology, nursing, dentistry, and physical and occupational therapy, and patient representatives. (bb)The nonvoting ex officio members of the Advisory Committee shall be the Chair of the Consortium and such officials as the Director of NIH shall designate. (IV)

Duties

The Advisory Committee shall advise, assist, consult with, and make recommendations to the Consortium regarding the matters set forth in clause (ii). .

5.

Pain care education and training

(a)

Pain care research and quality

Part A of title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) is amended by adding at the end the following:

904.

Program for pain care research and quality

(a)

In general

The Director shall carry out a program— (1)to collect protocols and evidence-based practices regarding pain care at all stages of life; and (2)to disseminate such information to Federal, State, and local regulatory and enforcement agencies, public and private health care programs, payors and providers, health professions schools, hospices, and the general public. (b)

Consultation

In carrying out this section, the Secretary shall consult with organizations representing patients in pain and other consumers, employers, physicians including physicians specializing in pain care, other pain management professionals, medical device manufacturers, and pharmaceutical companies. (c)

Definition

For purposes of this section, the term pain care means the assessment, diagnosis, treatment, or management of acute or chronic pain regardless of causation or body location.

. (b)

Education and training in pain and palliative care

Part D of title VII of the Public Health Service Act (42 U.S.C. 294 et seq.) is amended— (1)by redesignating sections 754 through 758 as sections 755 through 759, respectively; and (2)by inserting after section 753 the following:

754.

Program for education and training in pain care

(a)

In general

The Secretary, in consultation with the Director of the Agency for Healthcare Research and Quality, may make awards of grants, cooperative agreements, and contracts to health professions schools, hospices, and other public and private entities for the development and implementation of programs to provide education and training to health care professionals in pain care. (b)

Priorities

In making awards under subsection (a), the Secretary shall give priority to awards for the implementation of programs under such subsection. (c)

Certain topics

An award may be made under subsection (a) only if the applicant for the award agrees that the program carried out with the award will include information and education on— (1)recognized means for assessing, diagnosing, treating, and managing pain and related signs and symptoms, including the medically appropriate use of controlled substances; (2)applicable laws, regulations, rules, and policies on controlled substances, including the degree to which misconceptions and concerns regarding such laws, regulations, rules, and policies, or the enforcement thereof, may create barriers to patient access to appropriate and effective pain care; (3)interdisciplinary approaches to the delivery of pain care, including delivery through specialized centers providing comprehensive pain care treatment expertise; (4)cultural, linguistic, literacy, geographic, and other barriers to care in underserved populations; and (5)recent findings, developments, and improvements in the provision of pain care. (d)

Program sites

Education and training under subsection (a) may be provided at or through health professions schools, residency training programs, and other graduate programs in the health professions, entities that provide continuing education related to health professions, and such other programs or sites as the Secretary determines to be appropriate. (e)

Evaluation of programs

The Secretary shall (directly or through grants or contracts) provide for the evaluation of programs implemented under subsection (a) in order to determine the effect of such programs on knowledge and practice of pain care. (f)

Peer review groups

In carrying out section 799(f) with respect to this section, the Secretary shall ensure that the membership of each peer review group involved includes individuals with expertise and experience in pain care. (g)

Definitions

For purposes of this section the term pain care means the assessment, diagnosis, treatment, or management of acute or chronic pain regardless of causation or body location.

. (c)

Authorization of appropriations

Subparagraph (C) of section 758(b)(1) of the Public Health Service Act (as redesignated by subsection (a)(1) of this section) is amended— (1)by striking sections 753, 754, and 755 and inserting section 753, 754, 755, and 756; and (2)by striking not less than $22,631,000 and inserting such sums as may be necessary. (d)

Technical Amendment

Paragraph (2) of section 757(b) of the Public Health Service Act (as redesignated by subsection (a)(1)) is amended by striking 754(3)(A), and 755(b) and inserting 755(3)(A), and 756(b).

6.

Public awareness campaign on pain management

Part B of title II of the Public Health Service Act (42 U.S.C. 238 et seq.) is amended by adding at the end the following:

249.

National education outreach and awareness campaign on pain management

(a)

Establishment

Not later than June 30, 2009, the Secretary shall establish and implement a national pain care education outreach and awareness campaign described in subsection (b). (b)

Requirements

The Secretary shall design the public awareness campaign under this section to educate consumers, patients, their families, and other caregivers with respect to— (1)the incidence and importance of pain as a national public health problem; (2)the adverse physical, psychological, emotional, societal, and financial consequences that can result if pain is not appropriately assessed, diagnosed, treated, or managed; (3)the availability, benefits, and risks of all pain treatment and management options; (4)having pain promptly assessed, appropriately diagnosed, treated, and managed, and regularly reassessed with treatment adjusted as needed; (5)the role of credentialed pain management specialists and subspecialists, and of comprehensive interdisciplinary centers of treatment expertise; (6)the availability in the public, nonprofit, and private sectors of pain management-related information, services, and resources for consumers, employers, third-party payors, patients, their families, and caregivers, including information on— (A)appropriate assessment, diagnosis, treatment, and management options for all types of pain and pain-related symptoms; and (B)conditions for which no treatment options are yet recognized; and (7)other issues the Secretary deems appropriate. (c)

Consultation

In designing and implementing the public awareness campaign required by this section, the Secretary shall consult with organizations representing patients in pain and other consumers, employers, physicians including physicians specializing in pain care, and other pain management professionals. (d)

Coordination

(1)

Lead official

The Secretary shall designate one official in the Department of Health and Human Services to oversee the campaign established under this section. (2)

Agency coordination

The Secretary shall ensure the involvement in the public awareness campaign under this section of the Surgeon General of the Public Health Service, the Director of the Centers for Disease Control and Prevention, and such other representatives of offices and agencies of the Department of Health and Human Services as the Secretary determines appropriate. (e)

Underserved areas and populations

In designing the public awareness campaign under this section, the Secretary shall— (1)take into account the special needs of geographic areas and racial, ethnic, gender, age, and other demographic groups that are currently underserved; and (2)provide resources that will reduce disparities in access to appropriate diagnosis, assessment, and treatment. (f)

Grants and contracts

The Secretary may make awards of grants, cooperative agreements, and contracts to public agencies and private nonprofit organizations to assist with the development and implementation of the public awareness campaign under this section. (g)

Authorization of appropriations

For purposes of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2009, 2010, and 2011.

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