II 114th CONGRESS 1st Session S. 586 IN THE SENATE OF THE UNITED STATES February 26, 2015 Mrs. Shaheen (for herself, Ms. Collins , Mr. Brown , Mr. Markey , Mr. Kirk , Ms. Ayotte , Mrs. Boxer , Mr. Nelson , Mr. Donnelly , Mr. Carper , Mr. Booker , Mr. Grassley , and Mr. Peters ) 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 foster more effective implementation and coordination of clinical care for people with pre-diabetes, diabetes, and the chronic diseases and conditions that result from diabetes.

1. Short title This Act may be cited as the National Diabetes Clinical Care Commission Act . 2. Findings Congress finds the following: (1) The Centers for Disease Control and Prevention report that nearly 29,000,000 Americans have diabetes in addition to an estimated 86,000,000 American adults that have pre-diabetes, an increase of 3,000,000 Americans with diabetes and 7,000,000 American adults with pre-diabetes since 2011. (2) Diabetes affects 9.3 percent of Americans of all ages and 12.3 percent of adults age 20 and older. Adults age 20 and older of racial and ethnic minorities continue to have higher rates of diabetes than individuals not of such minorities, as demonstrated by the following: 15.9 percent of all adult American Indians and Alaskan Natives have diabetes; 13.2 percent of all adult African-Americans have diabetes; 12.8 percent of all adult Hispanics have diabetes; and 9.0 percent of all adult Asian-Americans have diabetes, while 7.6 percent of all non-Hispanic Whites have diabetes. (3) Diabetes is the seventh leading cause of death in the United States. (4) People with diabetes are more likely than people without diabetes to also have chronic diseases and conditions that are complications of diabetes, including cardiovascular disease, strokes, high blood pressure, kidney disease, including dialysis, blindness, neuropathy, and leg and feet amputations. (5) Adults with diabetes have an elevated risk of heart disease and stroke. Adults with diabetes have death rates from heart disease that are nearly twice as high as adults without the disease. (6) Diabetes is the leading cause of kidney failure. Each year, nearly 100,000 individuals in the United States are diagnosed with kidney failure, and diabetes accounts for 44 percent of these new cases. (7) Diabetic neuropathies are a family of nerve disorders caused by diabetes and are prevalent in nearly 60 to 70 percent of individuals with diabetes. (8) Diabetes is the leading cause of new cases of blindness among adults aged 20 to 74. (9) About 60 percent of all non-traumatic lower limb amputations in the United States occur in individuals with diabetes. (10) Total national costs associated with diabetes in 2012 exceeded $245,000,000,000, according to the Centers for Disease Control and Prevention. (11) One in three Medicare dollars is currently spent on people with diabetes. (12) The Centers for Disease Control and Prevention projects that as many as 1 in 3 American adults could have diabetes by 2050 if current trends continue. (13) There are 35 Federal departments, agencies, and offices involved in the implementation of Federal diabetes activities. 3. Establishment of the National Diabetes Clinical Care Commission Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ) is amended by adding at the end the following new section: 399V–6. National Diabetes Clinical Care Commission (a) Establishment There is hereby established within the Department of Health and Human Services a National Diabetes Clinical Care Commission (in this section referred to as the Commission ) to evaluate and recommend solutions regarding better coordination and the leveraging of programs within the Department of Health and Human Services and other Federal agencies that relate in any way to supporting appropriate clinical care (such as any interactions between physicians and other health care providers and their patients) related to the treatment and care management for people with pre-diabetes, diabetes, and the chronic diseases and conditions that are complications of or caused by diabetes. (b) Membership (1) In general The Commission shall be composed of the following voting members: (A) The heads (or their designees) of the following Federal agencies and departments that conduct programs that could impact the clinical care of people with pre-diabetes, diabetes, and the chronic diseases and conditions that are complications of or caused by diabetes: (i) The Centers for Medicare and Medicaid Services. (ii) The Agency for Healthcare Research and Quality. (iii) The Centers for Disease Control and Prevention. (iv) The Indian Health Service. (v) The Department of Veterans Affairs. (vi) The National Institutes of Health. (vii) The Food and Drug Administration. (viii) The Health Resources and Services Administration. (ix) The Department of Defense. (x) Other governmental or nongovernmental agency heads, at the discretion of the agency, that impact clinical care of individuals with pre-diabetes and diabetes. (B) Twelve additional voting members appointed under paragraph (2). (2) Additional members The Commission shall include additional voting members appointed by the Comptroller General of the United States, in consultation with national medical societies and patient advocate organizations with expertise in diabetes and the care of patients with diabetes and the diseases it causes, including one or more from each of the following categories: (A) Clinical endocrinologists. (B) Physician specialties (other than as described in subparagraph (A)) that play a role in diabetes care, such as cardiologists, nephrologists, and eye care professionals. (C) Primary care physicians. (D) Non-physician health care professionals, such as certified diabetes educators, registered dieticians and nutrition professionals, nurses, nurse practitioners, and physician assistants. (E) Patient advocates. (F) National experts in the duties listed under subsection (c). (3) Chairperson The voting members of the Commission shall select a chairperson from the members described in paragraph (2)(A). (4) Meetings The Commission shall meet at least twice, and not more than 4 times, a year. (5) Board terms Members of the Commission, including the chairperson, shall serve for a 3-year term. A vacancy on the Commission shall be filled in the same manner as the original appointments. (c) Duties The Commission shall— (1) evaluate programs of the Department of Health and Human Services regarding the utilization of diabetes screening benefits, annual wellness visits, and other preventive health benefits that may reduce the risk of diabetes and the chronic diseases and conditions that are complications of diabetes, addressing any existing problems regarding such utilization and related data collection mechanisms; (2) identify current activities and critical gaps in Federal efforts to support clinicians in providing integrated, high-quality care to people with pre-diabetes, diabetes, and the chronic diseases and conditions that are complications of diabetes; (3) make recommendations regarding the coordination of clinically based activities that are being supported by the Federal Government; (4) make recommendations regarding the development and coordination of federally funded clinical practice support tools for physicians and other health care professionals in caring for and managing the care of people with pre-diabetes, diabetes, and the chronic diseases and conditions that are complications of diabetes, specifically with regard to the implementation of new treatments and technologies; (5) evaluate programs in existence as of the date of the enactment of this section and determine if such programs are meeting the needs identified in paragraph (2) and, if such programs are determined to not be meeting such needs, recommend programs that would be more appropriate; (6) recommend clinical pathways for new technologies and treatments, including future data collection activities, and how they may be developed and then used to evaluate and develop various care models and methods and the impact of such models and methods on quality of care and diabetes management as measured by appropriate care parameters (such as A1C, blood pressure, and cholesterol levels); (7) evaluate and expand education and awareness to physicians and other health care professionals regarding clinical practices for the prevention of diabetes and the chronic diseases and conditions that are complications of diabetes; (8) review and recommend appropriate methods for outreach and dissemination of educational resources that regard diabetes prevention and treatments, are funded by the Federal Government, and are intended for health care professionals and the public; and (9) include other activities, such as those relating to the areas of public health and nutrition, that the Commission deems appropriate. (d) Operating plan (1) Initial plan Not later than 90 days after its first meeting, the Commission shall submit to the Secretary and the Congress an operating plan for carrying out the activities of the Commission as described in subsection (c). Such operating plan may include— (A) a list of specific activities that the Commission plans to conduct for purposes of carrying out the duties described in each of the paragraphs in subsection (c); (B) a plan for completing the activities; (C) a list of members of the Commission and other individuals who are not members of the Commission who will need to be involved to conduct such activities; (D) an explanation of Federal agency involvement and coordination needed to conduct such activities; (E) a budget for conducting such activities; (F) a plan for evaluating the value and potential impact of the Commission's work and recommendations, including the possible continuation of the Commission for the purposes of overseeing their implementation; and (G) other information that the Commission deems appropriate. (2) Updates The Commission shall periodically update the operating plan under paragraph (1) and submit such updates to the Secretary and the Congress. (e) Final report and sunset of the commission By not later than 3 years after the date of the Commission’s first meeting, the Commission shall submit a report containing all of the findings and recommended actions of the Commission to the Secretary and Congress. Not later than 120 days after the submission of the final report, the Secretary shall review the evaluation required under subsection (d)(1)(F) to determine the continuation of the Commission. (f) Authorization of appropriations Appropriations are authorized to be made available to the Commission for each of fiscal years 2016, 2017, and 2018, from amounts otherwise made available to the Department of Health and Human Services for such fiscal years, to carry out this section. .