S 966

112th CONGRESS
1st Session

S. 966

To amend the Public Health Service Act to provide for osteoporosis and related bone disease education, research, and surveillance, and for other purposes.

IN THE SENATE OF THE UNITED STATES

May 12, 2011

Mrs. GILLIBRAND 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 to provide for osteoporosis and related bone disease education, research, and surveillance, 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.

    This Act may be cited as the `Bone Health Promotion and Research Act of 2011'.

SEC. 2. FINDINGS.

    Congress makes the following findings:

      (1) Bone health is critical to the overall health and quality of life of Americans. Bone provides mobility, support, and protection for the body and acts as a storehouse for essential minerals.

      (2) Osteoporosis is a condition in which the bones become weak and can break from a minor fall or, in serious cases, from simple actions such as sneezing. An estimated 34,000,000 Americans have low bone mass or osteopenia, which puts them at risk for osteoporosis and bone fractures. In addition, 10,000,000 Americans have osteoporosis.

      (3) Eight million of those with osteoporosis are women, and an estimated 2,000,000 American men have osteoporosis. The United States Surgeon General says that by 2020 one in two Americans over age 50 is expected to have or to be at risk of developing osteoporosis of the hip; even more will be at risk of developing osteoporosis at any site in the skeleton.

      (4) According to estimated figures, osteoporosis was responsible for more than 2,000,000 fractures in 2005, including hip, spine, wrist, and other fractures. The number of fractures due to osteoporosis is expected to rise to more than 3,000,000 by 2025. Approximately 1 in 2 women and up to 1 in 4 men over age 50 will break a bone because of osteoporosis.

      (5) An average of 24 percent of hip fracture patients age 50 and older die in the year following their fracture.

      (6) Osteoporosis costs our health care system an estimated $19,000,000,000 each year. By 2025, experts predict that osteoporosis will account for $25,300,000,000 in costs.

      (7) Individuals with certain diseases are at higher risk of developing osteoporosis. For example, diabetes patients are at increased risk for developing an osteoporosis-related fracture. Cancer patients are also at increased risk because many cancer therapies, such as chemotherapy and corticosteroids, have direct negative effects on bone. Also, certain cancers, including prostate and breast cancer, may be treated with hormonal therapy, which can cause bone loss.

      (8) Osteogenesis imperfecta is characterized by fragile bones and frequent fractures. It is estimated to afflict an estimated 40,000 people.

      (9) Paget's disease of the bone, a geriatric disorder that results in enlarged and deformed bones in one or more parts of the body, afflicts an estimated 700,000 Americans over the age of 60.

      (10) Lifestyle factors can affect bone health. For example, the chemicals in cigarette smoke are harmful to bone cells and smoking may make it harder to absorb calcium. Heavy drinking can reduce bone formation and may also affect the body's calcium supply.

      (11) The 2004 Surgeon General's Report, `Bone Health and Osteoporosis: A Report of the Surgeon General', said that Americans must be encouraged to: get enough calcium and vitamin D; engage in regular weight-bearing and muscle-strengthening exercise; avoid smoking and excessive alcohol; and talk to their healthcare providers about bone health.

      (12) The Nation's annual direct and indirect costs for bone and joint health are $849,000,000,000--7.7 percent of the United States gross domestic product.

      (13) Greater efforts and commitments are needed from Congress, the States, providers, and patients to lessen the burden of osteoporosis and related bone diseases on Americans.

SEC. 3. NATIONAL BONE HEALTH PROGRAM.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 314 the following:

`SEC. 315. NATIONAL BONE HEALTH PROGRAM.

    `(a) Establishment of Program- The Secretary may develop and implement a National Bone Health Program (in this section referred to as the `Program') consistent with this section.

    `(b) Control, Prevention, and Surveillance-

      `(1) IN GENERAL- Under the Program, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may, directly or through competitive grants to eligible entities, conduct, support, and promote the coordination of research, investigations, demonstrations, training, and studies relating to the control, prevention, and surveillance of osteoporosis and related bone diseases.

      `(2) TRAINING AND TECHNICAL ASSISTANCE- With respect to the planning, development, and operation of any activity carried out under paragraph (1), the Secretary may provide training, technical assistance, supplies, equipment, or services, and may assign any officer or employee of the Department of Health and Human Services to a State or local health agency, or to any public or nonprofit entity designated by a State health agency, in lieu of providing grant funds under this subsection.

      `(3) OSTEOPOROSIS AND RELATED BONE DISEASE PREVENTION RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION- The Secretary may provide additional grant support under this subsection to encourage the expansion of research related to the prevention and management of osteoporosis and related bone diseases at the Centers for Disease Control and Prevention.

      `(4) ELIGIBLE ENTITY- For purposes of this subsection, the term `eligible entity' means a national public or private nonprofit entity that demonstrates to the satisfaction of the Secretary, in the application described in subsection (e), the ability of the entity to carry out the activities described in paragraph (1).

    `(c) Education and Outreach-

      `(1) IN GENERAL- Under the Program, the Secretary may coordinate and carry out national education and outreach activities, directly or through the provision of grants to eligible entities, to support, develop, and implement education initiatives and outreach strategies appropriate for osteoporosis and related bone diseases.

      `(2) INITIATIVES AND STRATEGIES- Initiatives and strategies implemented under paragraph (1) may include public awareness campaigns, public service announcements, and community partnership workshops, as well as programs targeted at businesses and employers, managed care organizations, and health care providers.

      `(3) PRIORITY- In carrying out paragraph (1), the Secretary--

        `(A) may emphasize prevention, early diagnosis, and appropriate management of osteoporosis and related bone disease, and opportunities for effective patient self-management; and

        `(B) may give priority to reaching high-risk or underserved populations.

      `(4) COLLABORATION- In carrying out this subsection, the Secretary shall consult and collaborate with the Advisory Committee established in subsection (g).

      `(5) ELIGIBLE ENTITY- For purposes of this subsection, the term `eligible entity' means a national public or private nonprofit entity that demonstrates to the satisfaction of the Secretary, in the application described in subsection (e), the ability of the entity to carry out the activities described in paragraph (1).

    `(d) Comprehensive State Grants-

      `(1) IN GENERAL- Under the Program, the Secretary may award grants to eligible entities to provide support for comprehensive osteoporosis and related bone disease control and prevention programs and to enable such entities to provide public health surveillance, prevention, and control activities related to osteoporosis and related bone diseases.

      `(2) ELIGIBILITY- To be eligible to receive a grant under this subsection, an entity shall be a State or Indian tribe.

      `(3) APPLICATION- To be eligible to receive a grant under this subsection, an entity shall submit to the Secretary an application at such time, in such manner, and containing such agreements, assurances, and information as the Secretary may require, including a comprehensive osteoporosis and related bone disease control and prevention plan that--

        `(A) is developed with the advice of stakeholders from the public, private, and nonprofit sectors that have expertise relating to osteoporosis and related bone disease control, prevention, and treatment that increase the quality of life and decrease the level of disability;

        `(B) is intended to reduce the morbidity of osteoporosis and related bone diseases, with priority on preventing and controlling osteoporosis and related bone diseases in at-risk populations and reducing disparities in osteoporosis and related bone disease prevention, diagnosis, management, and quality of care in underserved populations;

        `(C) describes the osteoporosis and related bone disease services and activities to be undertaken or supported by the entity; and

        `(D) demonstrates the relationship the entity has with the community and local entities and how the entity plans to involve such community and local entities in carrying out the activities described in paragraph (1).

      `(4) USE OF FUNDS- An eligible entity may use amounts received under a grant awarded under this subsection to conduct, in a manner consistent with the comprehensive osteoporosis and related bone disease control and prevention plan submitted by the entity in the application under paragraph (3)--

        `(A) public health surveillance and epidemiological activities relating to the prevalence of osteoporosis and related bone disease and assessment of disparities in osteoporosis and related bone disease prevention, diagnosis, management, and care;

        `(B) public information and education programs; and

        `(C) education, training, and clinical skills improvement activities for health professionals, including allied health personnel.

    `(e) General Application- To be eligible to receive a grant under this section, except under subsection (d), an entity shall submit to the Secretary an application at such time, in such manner, and containing such agreements, assurances, and information as the Secretary may require, including a description of how funds received under a grant awarded under this section will supplement or fulfill unmet needs identified in a comprehensive osteoporosis and related bone disease control and prevention plan of the entity.

    `(f) Definitions- For purposes of this section:

      `(1) INDIAN TRIBE- The term `Indian tribe' has the meaning given such term in section 4(e) of the Indian Self-Determination and Education Assistance Act.

      `(2) STATE- The term `State' means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, Guam, and the Northern Mariana Islands.

    `(g) Advisory Committee-

      `(1) ESTABLISHMENT- Not later than 90 days after the date of the enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a committee to be known as the Osteoporosis and Related Bone Disease Advisory Committee (referred to in this section as the `Advisory Committee'). The Advisory Committee shall be composed of at least one member, to be appointed by the Secretary, acting through the Director of the Centers for Disease Control and Prevention, representing each of the following:

        `(A) National voluntary health organizations that focus on issues relating to osteoporosis or other bone diseases.

        `(B) Professional societies that focus on issues relating to osteoporosis or other bone diseases.

        `(C) The Centers for Disease Control and Prevention, to include, upon the recommendation of the Director of the Centers, representatives of the Coordinating Center for Health Promotion, the Coordinating Center for Health Information and Service, and the Coordinating Center for Environmental Health and Injury Prevention.

        `(D) State public health departments.

        `(E) The National Institutes of Health, to include, upon the recommendation of the Director of the National Institutes of Health, representatives of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Cancer Institute, the National Institute of Biomedical Imaging and Bioengineering, the National Institute of Child Health and Human Development, the National Institute of Dental and Craniofacial Research, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, the Office of Dietary Supplements, the Office of Rare Diseases, and the Office of Research on Women's Health.

        `(F) Patients with osteoporosis or related bone diseases or their family members.

        `(G) The Office on Women's Health in the Department of Health and Human Services.

        `(H) Clinicians with expertise on osteoporosis or related bone diseases.

        `(I) Other stakeholders from the public, private, and nonprofit sectors with expertise relating to osteoporosis or other bone disease control, prevention, and treatment.

      `(2) DUTIES- The Advisory Committee shall advise the Secretary and the Assistant Secretary for Health regarding the manner in which such officials can--

        `(A) ensure interagency coordination and communication and minimize overlap regarding efforts to address osteoporosis and related bone diseases;

        `(B) conduct and support national education and outreach activities;

        `(C) identify opportunities to coordinate efforts with other Federal and State agencies and private organizations addressing such diseases;

        `(D) ensure that public health policy decisions and information disseminated to the public and physicians are evidence-based and population-focused;

        `(E) advise relevant Federal agencies on priorities related to osteoporosis and related bone diseases;

        `(F) conduct surveillance and data collection and disseminate epidemiological information in accordance with section 32OB; and

        `(G) expand and intensify research on osteoporosis and related bone diseases in accordance with section 404I.

    `(h) Authorization of Appropriations- There are authorized to be appropriated to carry out this section $22,000,000 for each of fiscal years 2011 through 2013.'.

SEC. 4. HHS RESEARCH ACTIVITIES WITH RESPECT TO OSTEOPOROSIS AND RELATED BONE DISEASES.

    Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:

`SEC. 404I. BONE HEALTH INITIATIVE.

    `(a) Expansion and Intensification of Activities-

      `(1) IN GENERAL- The Director of NIH shall expand and intensify programs of the National Institutes of Health with respect to research and related activities concerning osteoporosis and related bone diseases, including osteogenesis imperfecta, Paget's disease of bone, and rare bone diseases.

      `(2) COORDINATION; CONSULTATION- The Director of NIH shall carry out paragraph (1)--

        `(A) in coordination with the directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Cancer Institute, the National Institute of Biomedical Imaging and Bioengineering, the National Institute of Child Health and Human Development, the National Institute of Dental and Craniofacial Research, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, the Office of Rare Diseases, the Office of Research on Women's Health, and any other national research institutes or offices, as appropriate; and

        `(B) in consultation with additional Federal officials, the advisory committee established under section 315(g), and any national voluntary health organizations, professional societies, and private entities, as appropriate.

    `(b) Planning Grants and Contracts for Innovative Research in Osteoporosis and Related Bone Diseases-

      `(1) IN GENERAL- In carrying out subsection (a)(1), the Director of NIH shall award planning grants or contracts for the establishment of new research programs, or enhancement of existing research programs, that focus on osteoporosis and related bone diseases, including osteogenesis imperfecta, Paget's disease of bone, and rare bone diseases.

      `(2) RESEARCH-

        `(A) TYPES OF RESEARCH- In carrying out this subsection, the Secretary shall encourage basic, clinical, and translational research that focuses on osteoporosis and related bone diseases, including osteogenesis imperfecta, Paget's disease of bone, and rare bone diseases.

        `(B) PRIORITY- In awarding planning grants or contracts under paragraph (1), the Director of NIH may give priority to collaborative partnerships, which may include academic health centers, private sector entities, and nonprofit organizations.

        `(C) NEW AND EARLY STAGE INVESTIGATORS- The Director of NIH shall make an effort to fund research by new and early stage investigators under paragraph (1).

    `(c) Authorization of Appropriations- For the purpose of carrying out this section, there is authorized to be appropriated $250,000,000 for each of fiscal years 2011 through 2013. Such authorization shall be in addition to any authorization of appropriations under any other provision of law to carry out research activities on osteoporosis or related bone diseases.'.

SEC. 5. SURVEILLANCE ACTIVITIES RELATED TO BONE DISEASES AT THE CENTERS FOR DISEASE CONTROL AND PREVENTION.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 320A the following:

`SEC. 320B. SURVEILLANCE REGARDING OSTEOPOROSIS AND RELATED BONE DISEASES.

    `(a) In General- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to and enter into cooperative agreements with public or nonprofit private entities for the collection, analysis, and reporting of data on osteoporosis and related bone diseases, including osteogenesis imperfecta and Paget's disease of bone.

    `(b) Technical Assistance- In awarding grants and entering into agreements under subsection (a), the Secretary may provide direct technical assistance in lieu of cash.

    `(c) Coordination With Advisory Committee and NIH- The Secretary shall ensure that epidemiological and other types of information obtained under subsection (a) is made available to the National Institutes of Health. The advisory committee established under section 315(g) shall advise the Secretary in the coordination of epidemiological efforts and in the expansion and intensification of programs for conducting surveillance and data collection activities under this section.

    `(d) Authorization of Appropriations- For the purpose of carrying out this section, there is authorized to be appropriated $25,000,000 for each of fiscal years 2011 through 2015.'.

END