[House Report 111-633] [From the U.S. Government Publishing Office] 111th Congress Report HOUSE OF REPRESENTATIVES 2d Session 111-633 ====================================================================== GESTATIONAL DIABETES ACT OF 2010 _______ September 28, 2010.--Committed to the Committee of the Whole House on the State of the Union and ordered to be printed _______ Mr. Waxman, from the Committee on Energy and Commerce, submitted the following R E P O R T [To accompany H.R. 5354] [Including cost estimate of the Congressional Budget Office] The Committee on Energy and Commerce, to whom was referred the bill (H.R. 5354) to establish an Advisory Committee on Gestational Diabetes, to provide grants to better understand and reduce gestational diabetes, and for other purposes, having considered the same, report favorably thereon with amendments and recommend that the bill as amended do pass. CONTENTS Page Amendment........................................................ 2 Purpose and Summary.............................................. 4 Background and Need for Legislation.............................. 4 Committee Consideration.......................................... 4 Committee Votes.................................................. 4 Committee Oversight Findings and Recommendations................. 5 New Budget Authority, Entitlement Authority, and Tax Expenditures 5 Statement of General Performance Goals and Objectives............ 5 Constitutional Authority Statement............................... 5 Earmarks and Tax and Tariff Benefits............................. 5 Federal Advisory Committee Statement............................. 5 Applicability of Law to the Legislative Branch................... 5 Federal Mandates Statement....................................... 5 Committee Cost Estimate.......................................... 6 Congressional Budget Office Cost Estimate........................ 6 Section-by-Section Analysis of the Legislation................... 7 Explanation of Amendment......................................... 8 Changes in Existing Law Made by the Bill, as Reported............ 8 Amendment The amendments are as follows: Strike all after the enacting clause and insert the following: SECTION 1. SHORT TITLE. This Act may be cited as the ``Gestational Diabetes Act of 2010'' or the ``GEDI Act''. SEC. 2. GESTATIONAL DIABETES. Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by adding after section 317H the following: ``SEC. 317H-1. GESTATIONAL DIABETES. ``(a) Understanding and Monitoring Gestational Diabetes.-- ``(1) In general.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in consultation with the Diabetes Mellitus Interagency Coordinating Committee established under section 429 and representatives of appropriate national health organizations, shall develop a multisite gestational diabetes research project within the diabetes program of the Centers for Disease Control and Prevention to expand and enhance surveillance data and public health research on gestational diabetes. ``(2) Areas to be addressed.--The research project developed under paragraph (1) shall address-- ``(A) procedures to establish accurate and efficient systems for the collection of gestational diabetes data within each State and commonwealth, territory, or possession of the United States; ``(B) the progress of collaborative activities with the National Vital Statistics System, the National Center for Health Statistics, and State health departments with respect to the standard birth certificate, in order to improve surveillance of gestational diabetes; ``(C) postpartum methods of tracking women with gestational diabetes after delivery as well as targeted interventions proven to lower the incidence of type 2 diabetes in that population; ``(D) variations in the distribution of diagnosed and undiagnosed gestational diabetes, and of impaired fasting glucose tolerance and impaired fasting glucose, within and among groups of women; and ``(E) factors and culturally sensitive interventions that influence risks and reduce the incidence of gestational diabetes and related complications during childbirth, including cultural, behavioral, racial, ethnic, geographic, demographic, socioeconomic, and genetic factors. ``(3) Report.--Not later than 2 years after the date of the enactment of this section, and annually thereafter, the Secretary shall generate a report on the findings and recommendations of the research project including prevalence of gestational diabetes in the multisite area and disseminate the report to the appropriate Federal and non-Federal agencies. ``(b) Expansion of Gestational Diabetes Research.-- ``(1) In general.--The Secretary shall expand and intensify public health research regarding gestational diabetes. Such research may include-- ``(A) developing and testing novel approaches for improving postpartum diabetes testing or screening and for preventing type 2 diabetes in women with a history of gestational diabetes; and ``(B) conducting public health research to further understanding of the epidemiologic, socioenvironmental, behavioral, translation, and biomedical factors and health systems that influence the risk of gestational diabetes and the development of type 2 diabetes in women with a history of gestational diabetes. ``(2) Authorization of appropriations.--There is authorized to be appropriated to carry out this subsection $5,000,000 for each fiscal year 2012 through 2016. ``(c) Demonstration Grants to Lower the Rate of Gestational Diabetes.-- ``(1) In general.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants, on a competitive basis, to eligible entities for demonstration projects that implement evidence-based interventions to reduce the incidence of gestational diabetes, the recurrence of gestational diabetes in subsequent pregnancies, and the development of type 2 diabetes in women with a history of gestational diabetes. ``(2) Priority.--In making grants under this subsection, the Secretary shall give priority to projects focusing on-- ``(A) helping women who have 1 or more risk factors for developing gestational diabetes; ``(B) working with women with a history of gestational diabetes during a previous pregnancy; ``(C) providing postpartum care for women with gestational diabetes; ``(D) tracking cases where women with a history of gestational diabetes developed type 2 diabetes; ``(E) educating mothers with a history of gestational diabetes about the increased risk of their child developing diabetes; ``(F) working to prevent gestational diabetes and prevent or delay the development of type 2 diabetes in women with a history of gestational diabetes; and ``(G) achieving outcomes designed to assess the efficacy and cost-effectiveness of interventions that can inform decisions on long-term sustainability, including third-party reimbursement. ``(3) Application.--An eligible entity desiring to receive a grant under this subsection shall submit to the Secretary-- ``(A) an application at such time, in such manner, and containing such information as the Secretary may require; and ``(B) a plan to-- ``(i) lower the rate of gestational diabetes during pregnancy; or ``(ii) develop methods of tracking women with a history of gestational diabetes and develop effective interventions to lower the incidence of the recurrence of gestational diabetes in subsequent pregnancies and the development of type 2 diabetes. ``(4) Uses of funds.--An eligible entity receiving a grant under this subsection shall use the grant funds to carry out demonstration projects described in paragraph (1), including-- ``(A) expanding community-based health promotion education, activities, and incentives focused on the prevention of gestational diabetes and development of type 2 diabetes in women with a history of gestational diabetes; ``(B) aiding State- and tribal-based diabetes prevention and control programs to collect, analyze, disseminate, and report surveillance data on women with, and at risk for, gestational diabetes, the recurrence of gestational diabetes in subsequent pregnancies, and, for women with a history of gestational diabetes, the development of type 2 diabetes; and ``(C) training and encouraging health care providers-- ``(i) to promote risk assessment, high-quality care, and self-management for gestational diabetes and the recurrence of gestational diabetes in subsequent pregnancies; and ``(ii) to prevent the development of type 2 diabetes in women with a history of gestational diabetes, and its complications in the practice settings of the health care providers. ``(5) Report.--Not later than 4 years after the date of the enactment of this section, the Secretary shall prepare and submit to the Congress a report concerning the results of the demonstration projects conducted through the grants awarded under this subsection. ``(6) Definition of eligible entity.--In this subsection, the term `eligible entity' means a nonprofit organization (such as a nonprofit academic center or community health center) or a State, tribal, or local health agency. ``(7) Authorization of appropriations.--There is authorized to be appropriated to carry out this subsection $5,000,000 for each fiscal year 2012 through 2016. ``(d) Postpartum Follow-up Regarding Gestational Diabetes.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall work with the State- and tribal-based diabetes prevention and control programs assisted by the Centers to encourage postpartum follow-up after gestational diabetes, as medically appropriate, for the purpose of reducing the incidence of gestational diabetes, the recurrence of gestational diabetes in subsequent pregnancies, the development of type 2 diabetes in women with a history of gestational diabetes, and related complications.''. Amend the title so as to read: A bill to provide grants to better understand and reduce gestational diabetes, and for other purposes. Purpose and Summary H.R. 5354, the ``Gestational Diabetes Act of 2010'' or the ``GEDI Act,'' was introduced on May 20, 2010, by Rep. Eliot L. Engel (D-NY) and referred to the Committee on Energy and Commerce. The goal of H.R. 5354 is to expand and intensify research on gestational diabetes and to provide grants to better understand and reduce the incidence of this disease. Background and Need for Legislation Gestational Diabetes Mellitus (GDM)--generally known as gestational diabetes--is high blood sugar that starts or is first diagnosed during pregnancy. According to the Centers for Disease Control and Prevention (CDC) gestational diabetes affects between 3% and 7% of all pregnancies in the United States. It can have negative health effects on both mothers and their babies--an estimated 40% to 60% of women with gestational diabetes will develop type 2 diabetes within 10 years; babies born to mothers with the disease are at risk for having a high birth weight. Gestational diabetes also disproportionately affects minority populations. Gestational diabetes represents less than 1% of the diabetes burden in the United States, yet its impact on maternal and child health is significant, and federal support for research on the disease has been limited. Increased research is needed to better understand the risk factors for the disease and to develop evidence-based intervention strategies. Committee Consideration H.R. 5354, the ``Gestational Diabetes Act of 2010'' or the ``GEDI Act,'' was introduced by Mr. Engel of New York on May 20, 2010, and referred to the Committee on Energy and Commerce. The bill was subsequently referred to the Subcommittee on Health on May 21, 2010. On September 15, 2010, the Subcommittee held a legislative hearing on the bill. The Subcommittee met in open markup session to consider H.R. 5354 on September 16, 2010. An amendment in the nature of a substitute (manager's amendment) by Mr. Engel was adopted by a voice vote. Subsequently, H.R. 5354 was favorably forwarded to the full Committee, amended, by a voice vote. On September 23, 2010, the Committee on Energy and Commerce met in open markup session to consider H.R. 5354, as approved by the Subcommittee on Health. There were no amendments offered in full Committee and subsequently the Committee ordered H.R. 5354 favorably reported to the House, as amended by the Subcommittee on Health, by a voice vote. Committee Votes Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list each record vote on the motion to report legislation and amendments thereto. A motion by Mr. Waxman ordering H.R. 5354 reported to the House, as amended, was approved by a voice vote. There were no record votes taken during consideration of this bill. Committee Oversight Findings and Recommendations In compliance with clause 3(c)(1) of rule XIII and clause (2)(b)(1) of rule X of the Rules of the House of Representatives, the oversight findings and recommendations of the Committee are reflected in the descriptive portions of this report, including the finding that increased research is needed to better understand the risk factors for gestational diabetes and to develop evidence-based intervention strategies. New Budget Authority, Entitlement Authority, and Tax Expenditures Regarding compliance with clause 3(c)(2) of rule XIII of the Rules of the House of Representatives, the Committee finds that H.R. 5354 would result in no new budget authority, entitlement authority, or tax expenditures or revenues. Statement of General Performance Goals and Objectives In accordance with clause 3(c)(4) of rule XIII of the Rules of the House of Representatives, the performance goals and objectives of the Committee are reflected in the descriptive portions of this report, including the goal to support increased research on gestational diabetes. Constitutional Authority Statement Pursuant to clause 3(d)(1) of rule XIII of the Rules of the House of Representatives, the Committee finds that the constitutional authority for H.R. 5354 is provided under article I, section 8, clauses 3 and 18 of the Constitution of the United States. Earmarks and Tax and Tariff Benefits H.R. 5354 does not contain any congressional earmarks, limited tax benefits, or limited tariff benefits as defined in clause 9 of rule XXI of the Rules of the House of Representatives. Federal Advisory Committee Statement The Committee finds that the legislation does not establish or authorize the establishment of an advisory committee within the definition of 5 U.S.C. App., section 5(b) of the Federal Advisory Committee Act. Applicability of Law to the Legislative Branch Section 102(b)(3) of Public Law 104-1 requires a description of the application of this bill to the legislative branch where the bill relates to terms and conditions of employment or access to public services and accommodations. H.R. 5354 contains no such provisions. Federal Mandates Statement Section 423 of the Congressional Budget and Impoundment Control Act of 1974 (as amended by section 101(a)(2) of the Unfunded Mandates Reform Act, Public Law 104-4) requires a statement on whether the provisions of the report include unfunded mandates. In compliance with this requirement the Committee adopts as its own the analysis of federal mandates prepared by the Director of the Congressional Budget Office regarding H.R. 5354. Committee Cost Estimate Pursuant to clause 3(d)(2) of rule XIII of the Rules of the House of Representatives, the Committee adopts as its own the cost estimate of H.R. 5354 prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974. Congressional Budget Office Cost Estimate With respect to the requirements of clause (3)(c)(3) of rule XIII of the Rules of the House of Representatives and section 402 of the Congressional Budget Act of 1974, the Committee has received the following cost estimate for H.R. 5354 from the Director of Congressional Budget Office: September 24, 2010. Hon. Henry A. Waxman, Chairman, Committee on Energy and Commerce, House of Representatives, Washington, DC. Dear Mr. Chairman: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 5354, the Gestational Diabetes Act of 2010. If you wish further details on this estimate, we will be pleased to provide them. The CBO staff contact is Mindy Cohen. Sincerely, Douglas W. Elmendorf. Enclosure. H.R. 5354--Gestational Diabetes Act of 2010 Summary: H.R. 5354 would require the Secretary of the Department of Health and Human Services (HHS) to develop research projects and award grants for the purposes of tracking and reducing the prevalence of gestational diabetes. Assuming appropriation of the specified amounts, CBO estimates that implementing H.R. 5354 would cost $32 million over the 2011- 2015 period. Enacting H.R. 5354 would not affect direct spending or revenues; therefore, pay-as-you-go procedures do not apply. H.R. 5354 contains no intergovernmental or private-sector mandates as defined in the Unfunded Mandates Reform Act (UMRA). Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 5354 is shown in the following table. The costs of this legislation fall within budget function 550 (health). ---------------------------------------------------------------------------------------------------------------- By fiscal year, in millions of dollars-- ----------------------------------------------------------- 2011- 2011 2012 2013 2014 2015 2015 ---------------------------------------------------------------------------------------------------------------- CHANGES IN SPENDING SUBJECT TO APPROPRIATION Authorization Level................................. 0 10 10 10 10 40 Estimated Outlays................................... 0 4 8 10 10 32 ---------------------------------------------------------------------------------------------------------------- Basis of estimate: H.R. 5354 would require the Secretary of HHS, acting through the Director of the Center for Disease Control and Prevention (CDC), to conduct research and grant activities relating to gestational diabetes. For example, the bill would require CDC to expand surveillance data and public health research, to test approaches for screening for the disease, and to award grants to entities that implement interventions to reduce the incidence of the disease. H.R. 5354 would authorize appropriations for fiscal years 2012 through 2016 of $5 million a year for the research activities and $5 million a year for the grant activities. Based on historical spending patterns for similar activities, and assuming appropriation of the specified amounts, CBO estimates that implementing H.R. 5354 would cost $32 million over the 2012-2015 period, and an additional $18 million after 2015. Pay-As-You-Go considerations: None. Intergovernmental and private-sector impact: H.R. 5354 contains no intergovernmental or private-sector mandates as defined in UMRA. Grant funds authorized in the bill would benefit states that implement programs to reduce the incidence of gestational diabetes. Estimate prepared by: Federal costs: Mindy Cohen; Impact on state, local, and tribal governments: Lisa Ramirez-Branum; Impact on the private sector: Sarah Axeen. Estimate approved by: Holly Harvey, Deputy Assistant Director for Budget Analysis. Section-by-Section Analysis of the Legislation Section 1. Short title Section 1 designates that the short title may be cited as the ``Gestational Diabetes Act of 2010'' or the ``GEDI Act.'' Section 2. Gestational Diabetes Section 2 establishes a new section 317H-1 in the Public Health Service Act (PHSA) on gestational diabetes. This section includes the following provisions: Subsection (a) requires the Secretary of Health and Human Services (HHS), acting through the Director of the Centers for Disease Control and Prevention (CDC), and in consultation with the HHS Diabetes Mellitus Interagency Coordinating Committee (DMICC) (established under section 429 of the Public Health Service Act), to develop a multisite, gestational diabetes research project at CDC to expand and enhance surveillance data and public health research on gestational diabetes. Subsection (b) requires the Secretary to expand and intensify public health research on gestational diabetes research. Such research may include (1) the development and testing of new approaches for improving postpartum diabetes screening and for preventing type 2 diabetes in women with a history of gestational diabetes; and (2) research to further understand various factors that influence the risk of gestational diabetes and the development of type 2 diabetes in women with a history of gestational diabetes. The Act authorizes $5 million to support these research activities in each of FY2012 through FY2016. Subsection (c) requires the Secretary, acting through the CDC Director, to award grants to non-profit organizations or state or local health agencies for demonstration projects to support various activities designed to implement evidence-based interventions to reduce the incidence of gestational diabetes and its recurrence and to prevent type 2 diabetes after pregnancy. The Act authorizes $5 million to fund these grants in each of FY2012 through FY2016. Subsection (d) requires the Secretary, acting through the CDC Director, to work with state and tribal-based diabetes prevention and control programs to encourage postpartum screenings after a diagnosis of gestational diabetes to reduce (1) the incidence of gestational diabetes and its recurrence; and (2) the progression to type 2 diabetes and its related complications. Explanation of Amendment During the Subcommittee on Health markup, Mr. Engel of New York offered an amendment in the nature of a substitute (manager's amendment), which was adopted by a voice vote. The substance of the substitute amendment is reflected in the section-by-section analysis contained in this report. Changes in Existing Law Made by the Bill, as Reported In compliance with clause 3(e) of rule XIII of the Rules of the House of Representatives, changes in existing law made by the bill, as reported, are shown as follows (new matter is printed in italic and existing law in which no change is proposed is shown in roman): PUBLIC HEALTH SERVICE ACT * * * * * * * TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE * * * * * * * Part B--Federal-State Cooperation * * * * * * * SEC. 317H-1. GESTATIONAL DIABETES. (a) Understanding and Monitoring Gestational Diabetes.-- (1) In general.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in consultation with the Diabetes Mellitus Interagency Coordinating Committee established under section 429 and representatives of appropriate national health organizations, shall develop a multisite gestational diabetes research project within the diabetes program of the Centers for Disease Control and Prevention to expand and enhance surveillance data and public health research on gestational diabetes. (2) Areas to be addressed.--The research project developed under paragraph (1) shall address-- (A) procedures to establish accurate and efficient systems for the collection of gestational diabetes data within each State and commonwealth, territory, or possession of the United States; (B) the progress of collaborative activities with the National Vital Statistics System, the National Center for Health Statistics, and State health departments with respect to the standard birth certificate, in order to improve surveillance of gestational diabetes; (C) postpartum methods of tracking women with gestational diabetes after delivery as well as targeted interventions proven to lower the incidence of type 2 diabetes in that population; (D) variations in the distribution of diagnosed and undiagnosed gestational diabetes, and of impaired fasting glucose tolerance and impaired fasting glucose, within and among groups of women; and (E) factors and culturally sensitive interventions that influence risks and reduce the incidence of gestational diabetes and related complications during childbirth, including cultural, behavioral, racial, ethnic, geographic, demographic, socioeconomic, and genetic factors. (3) Report.--Not later than 2 years after the date of the enactment of this section, and annually thereafter, the Secretary shall generate a report on the findings and recommendations of the research project including prevalence of gestational diabetes in the multisite area and disseminate the report to the appropriate Federal and non-Federal agencies. (b) Expansion of Gestational Diabetes Research.-- (1) In general.--The Secretary shall expand and intensify public health research regarding gestational diabetes. Such research may include-- (A) developing and testing novel approaches for improving postpartum diabetes testing or screening and for preventing type 2 diabetes in women with a history of gestational diabetes; and (B) conducting public health research to further understanding of the epidemiologic, socioenvironmental, behavioral, translation, and biomedical factors and health systems that influence the risk of gestational diabetes and the development of type 2 diabetes in women with a history of gestational diabetes. (2) Authorization of appropriations.--There is authorized to be appropriated to carry out this subsection $5,000,000 for each fiscal year 2012 through 2016. (c) Demonstration Grants to Lower the Rate of Gestational Diabetes.-- (1) In general.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants, on a competitive basis, to eligible entities for demonstration projects that implement evidence-based interventions to reduce the incidence of gestational diabetes, the recurrence of gestational diabetes in subsequent pregnancies, and the development of type 2 diabetes in women with a history of gestational diabetes. (2) Priority.--In making grants under this subsection, the Secretary shall give priority to projects focusing on-- (A) helping women who have 1 or more risk factors for developing gestational diabetes; (B) working with women with a history of gestational diabetes during a previous pregnancy; (C) providing postpartum care for women with gestational diabetes; (D) tracking cases where women with a history of gestational diabetes developed type 2 diabetes; (E) educating mothers with a history of gestational diabetes about the increased risk of their child developing diabetes; (F) working to prevent gestational diabetes and prevent or delay the development of type 2 diabetes in women with a history of gestational diabetes; and (G) achieving outcomes designed to assess the efficacy and cost-effectiveness of interventions that can inform decisions on long-term sustainability, including third-party reimbursement. (3) Application.--An eligible entity desiring to receive a grant under this subsection shall submit to the Secretary-- (A) an application at such time, in such manner, and containing such information as the Secretary may require; and (B) a plan to-- (i) lower the rate of gestational diabetes during pregnancy; or (ii) develop methods of tracking women with a history of gestational diabetes and develop effective interventions to lower the incidence of the recurrence of gestational diabetes in subsequent pregnancies and the development of type 2 diabetes. (4) Uses of funds.--An eligible entity receiving a grant under this subsection shall use the grant funds to carry out demonstration projects described in paragraph (1), including-- (A) expanding community-based health promotion education, activities, and incentives focused on the prevention of gestational diabetes and development of type 2 diabetes in women with a history of gestational diabetes; (B) aiding State- and tribal-based diabetes prevention and control programs to collect, analyze, disseminate, and report surveillance data on women with, and at risk for, gestational diabetes, the recurrence of gestational diabetes in subsequent pregnancies, and, for women with a history of gestational diabetes, the development of type 2 diabetes; and (C) training and encouraging health care providers-- (i) to promote risk assessment, high- quality care, and self-management for gestational diabetes and the recurrence of gestational diabetes in subsequent pregnancies; and (ii) to prevent the development of type 2 diabetes in women with a history of gestational diabetes, and its complications in the practice settings of the health care providers. (5) Report.--Not later than 4 years after the date of the enactment of this section, the Secretary shall prepare and submit to the Congress a report concerning the results of the demonstration projects conducted through the grants awarded under this subsection. (6) Definition of eligible entity.--In this subsection, the term ``eligible entity'' means a nonprofit organization (such as a nonprofit academic center or community health center) or a State, tribal, or local health agency. (7) Authorization of appropriations.--There is authorized to be appropriated to carry out this subsection $5,000,000 for each fiscal year 2012 through 2016. (d) Postpartum Follow-up Regarding Gestational Diabetes.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall work with the State- and tribal-based diabetes prevention and control programs assisted by the Centers to encourage postpartum follow-up after gestational diabetes, as medically appropriate, for the purpose of reducing the incidence of gestational diabetes, the recurrence of gestational diabetes in subsequent pregnancies, the development of type 2 diabetes in women with a history of gestational diabetes, and related complications. * * * * * * *