II 110th CONGRESS 1st Session S. 1459 IN THE SENATE OF THE UNITED STATES May 23, 2007 Mr. Menendez (for himself and Mr. Lautenberg) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To strengthen the Nation’s research efforts to identify the causes and cure of psoriasis and psoriatic arthritis, expand psoriasis and psoriatic arthritis data collection, study access to and quality of care for people with psoriasis and psoriatic arthritis, and for other purposes.

1.

Short title

This Act may be cited as the Psoriasis and Psoriatic Arthritis Research, Cure, and Care Act of 2007.

2.

Table of contents

The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Sec. 3. Findings. Sec. 4. Expansion of biomedical research. Sec. 5. National patient registry. Sec. 6. National summit. Sec. 7. Study and report by the Institute of Medicine.

3.

Findings

The Congress finds as follows: (1)Psoriasis and psoriatic arthritis are autoimmune-mediated, chronic, inflammatory, painful, disfiguring, and life-altering diseases that require life-long sophisticated medical intervention and care and have no cure. (2)Psoriasis and psoriatic arthritis affect as many as 7.5 million men, women, and children of all ages and have an adverse impact on the quality of life for virtually all affected. (3)Psoriasis often is overlooked or dismissed because it does not cause death. Psoriasis is commonly and incorrectly considered by insurers, employers, policymakers, and the public as a mere annoyance, a superficial problem, mistakenly thought to be contagious and due to poor hygiene. Treatment for psoriasis often is categorized, wrongly, as life-style and not medically necessary. (4)Psoriasis goes hand-in-hand with a myriad of co-morbidities such as Crohn’s disease, diabetes, metabolic syndrome, obesity, hypertension, heart attack, cardiovascular disease, liver disease, and psoriatic arthritis, which occurs in 10 to 30 percent of people with psoriasis. (5)The National Institute of Mental Health funded a study that found that psoriasis may cause as much physical and mental disability as other major diseases, including cancer, arthritis, hypertension, heart disease, diabetes, and depression. (6)Psoriasis is associated with elevated rates of depression and suicidal ideation. (7)Each year the people of the United States lose approximately 56 million hours of work and spend $2 billion to $3 billion to treat psoriasis. (8)Early diagnosis and treatment of psoriatic arthritis may help prevent irreversible joint damage. (9)Treating psoriasis and psoriatic arthritis presents a challenge for patients and their health care providers because no one treatment works for everyone, some treatments lose effectiveness over time, many treatments are used in combination with other treatments, and all treatments may cause a unique set of side effects. (10)Although new and more effective treatments finally are becoming available, too many people do not yet have access to the types of therapies that may make a significant difference in the quality of their lives. (11)Psoriasis and psoriatic arthritis constitute a significant national health issue that deserves a comprehensive and coordinated response by State and Federal governments with involvement of the health care provider, patient, and public health communities.

4.

Expansion of biomedical research

(a)

In general

The Secretary of Health and Human Services (in this Act referred to as the Secretary), acting through the Director of the National Institutes of Health, shall expand and intensify research and related activities of the Institutes with respect to psoriasis and psoriatic arthritis. (b)

Research by NIAMS

(1)

In general

The Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases shall conduct or support research to expand understanding of the causes of, and to find a cure for, psoriasis and psoriatic arthritis. Such research shall include the following: (A)Basic research to discover the pathogenesis and pathophysiology of the disease. (B)Expansion of molecular genetics and immunology studies, including additional animal models. (C)Global association mapping with single nucleotide polymorphisms. (D)Identification of environmental triggers and autoantigens in psoriasis. (E)Elucidation of specific immune receptor cells and their products involved. (F)Pharmcogenetic studies to understand the molecular basis for varying patient response to treatment. (G)Identification of genetic markers of psoriatic arthritis susceptibility. (H)Research to increase understanding of joint inflammation and destruction in psoriatic arthritis. (I)Clinical research for the development and evaluation of new treatments, including new biological agents. (J)Research to develop improved diagnostic tests. (K)Research to increase understanding of co-morbidities and psoriasis, including shared molecular pathways. (2)

Coordination with other institutes

In carrying out paragraph (1), the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases shall coordinate the activities of the Institute with the activities of other national research institutes and other agencies and offices of the National Institutes of Health relating to psoriasis or psoriatic arthritis.

5.

National patient registry

(a)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in collaboration with an eligible national organization, shall establish a national psoriasis and psoriatic arthritis patient registry. (b)

Cooperative agreements

In carrying out subsection (a), the Secretary shall enter into cooperative agreements with an eligible national organization and appropriate academic health institutions to develop, implement, and manage a system for psoriasis and psoriatic arthritis patient data collection and analysis, including the creation and use of a common data entry and management system. (c)

Longitudinal data

In carrying out subsection (a), the Secretary shall ensure the collection and analysis of longitudinal data related to individuals of all ages with psoriasis and psoriatic arthritis, including infants, young children, adolescents, and adults of all ages including older Americans. (d)

Eligible national organization

In this section, the term eligible national organization means a national organization that— (1)has expertise in the epidemiology of psoriasis and psoriatic arthritis; and (2)maintains an established patient registry or biobank. (e)

Authorization of appropriations

To carry out this section, there are authorized to be appropriated $1,000,000 for fiscal year 2008 and $500,000 for each of fiscal years 2009 through 2012.

6.

National summit

(a)

In general

Not later than one year after the date of enactment of this Act, the Secretary shall convene a summit on the current activities of the Federal Government to conduct or support research, treatment, education, and quality-of-life activities with respect to psoriasis and psoriatic arthritis, including psoriasis and psoriatic arthritis related co-morbidities. The summit shall include researchers, public health professionals, representatives of voluntary health agencies and patient advocacy organizations, representatives of academic institutions, and Federal and State policymakers. (b)

Focus

The summit convened under this section shall focus on— (1)a broad range of research activities relating to biomedical, epidemiological, psychosocial, and rehabilitative issues; (2)clinical research for the development and evaluation of new treatments, including new biological agents; (3)translational research; (4)information and education programs for health care professionals and the public; (5)priorities among the programs and activities of the various Federal agencies involved in psoriasis and psoriatic arthritis and psoriasis and psoriatic arthritis related co-morbidities; and (6)challenges and opportunities for scientists, clinicians, patients, and voluntary organizations. (c)

Report to Congress

Not later than 180 days after the first day of the summit convened under this section, the Secretary shall submit to Congress and make publicly available a report that includes a description of— (1)the proceedings at the summit; and (2)the research, treatment, education, and quality-of-life activities conducted or supported by the Federal Government with respect to psoriasis and psoriatic arthritis, including psoriasis and psoriatic arthritis related co-morbidities. (d)

Authorization of appropriations

To carry out this section, there are authorized such sums as may be necessary for each of fiscal years 2008 through 2010.

7.

Study and report by the Institute of Medicine

(a)

In general

The Secretary shall enter into an agreement with the Institute of Medicine to conduct a study on the following: (1)The extent to which public and private insurers cover prescription medications and other treatments for psoriasis and psoriatic arthritis. (2)The payment structures, such as deductibles and co-payments, and the amounts and duration of coverage under health plans and their adequacy to cover the costs of providing ongoing care to patients with psoriasis and psoriatic arthritis. (3)Health plan and insurer coverage policies and practices and their impact on the access of such patients to the best regimen and most appropriate care for their particular disease state. (b)

Report

The agreement entered into under subsection (a) shall provide for the Institute of Medicine to submit to the Secretary and Congress, not later than 18 months after the date of the enactment of this Act, a report containing a description of the results of the study conducted under this section and the conclusions and recommendations of the Institutes of Medicine regarding each of the issues described in paragraphs (1) through (3) of subsection (a).