[House Report 111-44] [From the U.S. Government Publishing Office] 111th Congress Report HOUSE OF REPRESENTATIVES 1st Session 111-44 ====================================================================== EARLY HEARING DETECTION AND INTERVENTION ACT OF 2009 _______ March 23, 2009.--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. 1246] [Including cost estimate of the Congressional Budget Office] The Committee on Energy and Commerce, to whom was referred the bill (H.R. 1246) to amend the Public Health Service Act regarding early detection, diagnosis, and treatment of hearing loss, having considered the same, report favorably thereon without amendment and recommend that the bill do pass. CONTENTS Page Purpose and Summary.............................................. 1 Background and Need for Legislation.............................. 2 Hearings......................................................... 2 Committee Consideration.......................................... 2 Committee Votes.................................................. 3 Committee Oversight Findings..................................... 3 Statement of General Performance Goals and Objectives............ 3 New Budget Authority, Entitlement Authority, and Tax Expenditures 3 Earmarks and Tax and Tariff Benefits............................. 3 Committee Cost Estimate.......................................... 3 Congressional Budget Office Estimate............................. 4 Federal Mandates Statement....................................... 5 Advisory Committee Statement..................................... 6 Constitutional Authority Statement............................... 6 Applicability to Legislative Branch.............................. 6 Section-by-Section Analysis of the Legislation................... 6 Changes in Existing Law Made by the Bill, as Reported............ 7 Purpose and Summary The purpose of H.R. 1246, the ``Early Hearing Detection and Intervention Act of 2009'', is to amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated follow-up care once newborn screening has been conducted, to reauthorize programs under part A of title III of such act, and for other purposes. Background and Need for Legislation Each year in the United States, more than 12,000 babies are born with hearing loss. The cause of hearing loss for many babies is not known, and hearing loss can go undetected for years. Studies have shown that children who have hearing loss can have delays in speech, language, and cognitive development. When a child's hearing loss is identified soon after birth, the child's family and doctors can seek services he or she needs at an early age, increasing the likelihood of mitigating or preventing those delays. H.R. 1246 reauthorizes the Early Hearing Detection and Intervention (EHDI) program within the U.S. Department of Health and Human Services (HHS) by authorizing the appropriation of such sums as may be necessary for the 6-year period FY 2010 through FY 2015. The original legislation, which was enacted in 2000, directed federal agencies to work with states to develop newborn infant hearing screening and early intervention programs. EHDI programs include screening (the initial test of infants for hearing loss), diagnostic evaluations (to confirm hearing loss), and early intervention (including medical services, early intervention programs, and family support) to enhance language, communication, and cognitive and social skill development. When the EHDI program was first implemented, 44% of newborns were screened for hearing loss. With increased congressional funding, this increased to 67% by the end of 2001, and 87% by the end of 2002. Today, more than 93% of all newborns are screened, and each year there are thousands of infants with hearing loss who benefit from early identification. Despite the success of the EHDI program, much work remains to be done. Many infants do not receive timely follow-up and referrals due to shortages in properly trained healthcare providers, limited access to early intervention programs, and poor EHDI program integration with existing public healthcare systems. Hearings The Committee on Energy and Commerce has not held hearings on the legislation. Committee Consideration The Committee on Energy and Commerce met in open markup session on Wednesday, March 4, 2009, and, pursuant to a motion by Mr. Waxman, agreed by unanimous consent to consider and approve H.R. 1246 and several other bills en bloc. H.R. 1246 was ordered favorably reported to the House by a voice vote. No amendments were offered during full Committee consideration of H.R. 1246. Committee Votes Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion to report legislation and amendments thereto. There were no recorded votes taken during consideration or ordering H.R. 1246 reported to the House. Committee Oversight Findings Regarding clause 3(c)(1) of rule XIII of the Rules of the House of Representatives, the oversight findings of the Committee are reflected in this report. Statement of General Performance Goals and Objectives The objective of H.R. 1246 is to expand the EHDI program to include diagnostic services among services provided and to require the Secretary of HHS, acting through the Administrator of the Health Resources and Services Administration (HRSA), to assist in the recruitment, retention, education, and training of qualified personnel and healthcare providers. The bill provides that the purposes of the EHDI program include award of grants by the Secretary of HHS to develop efficient models to ensure follow-up care for newborns, infants, and young children identified with a hearing loss through screening, and to ensure an adequate supply of qualified personnel to meet the screening, evaluation, and early intervention needs of children. It also requires the Director of the National Institutes of Health (NIH) to establish a postdoctoral fellowship program to foster research and development in the area of early hearing detection and intervention. H.R. 1246 further requires that families be given the opportunity to obtain the full range of early intervention services, educational and program placements, and other options for their child. New Budget Authority, Entitlement Authority, and Tax Expenditures In compliance with clause 3(c)(2) of rule XIII of the Rules of the House of Representatives, the Committee finds that H.R. 1246 would result in no new or increased budget authority, entitlement authority, or tax expenditures. Earmarks and Tax and Tariff Benefits In compliance with clause 9 of rule XXI of the Rules of the House of Representatives, H.R. 1246 does not contain any congressional earmarks, limited tax benefits, or limited tariff benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI. Committee Cost Estimate The Committee adopts as its own the cost estimate prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974. Congressional Budget Office Estimate Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House of Representatives, the following is the cost estimate provided by the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974: U.S. Congress, Congressional Budget Office, Washington, DC, March 20, 2009. 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. 1246, the Early Hearing Detection and Intervention Act of 2009. If you wish further details on this estimate, we will be pleased to provide them. The CBO staff contact is Jamease Kowalczyk. Sincerely, Douglas W. Elmendorf, Director. Enclosure. H.R. 1246--Early Hearing Detection and Intervention Act of 2009 Summary: H.R. 1246 would amend the Public Health Service Act to authorize and expand research and public health activities related to the early detection, diagnosis, and treatment of hearing loss in newborns and infants. CBO estimates that implementing the bill would cost $151 million over the 2010-2014 period, assuming the appropriation of the necessary amounts. Enacting H.R.1246 would not affect direct spending or federal revenues. H.R. 1246 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. 1246 is shown in the following table. The costs of this legislation fall within budget function 550 (health). ---------------------------------------------------------------------------------------------------------------- By fiscal year, in millions of dollars-- -------------------------------------------------- 2010 2011 2012 2013 2014 2010-2014 ---------------------------------------------------------------------------------------------------------------- CHANGES IN SPENDING SUBJECT TO APPROPRIATIONS HRSA: Estimated Authorization Level........................... 12 12 12 12 12 61 Estimated Outlays........................................ 6 11 12 12 12 53 CDC: Estimated Authorization Level............................ 11 11 11 11 11 55 Estimated Outlays........................................ 4 9 11 11 11 46 NIH: Estimated Authorization Level............................ 13 13 13 13 13 64 Estimated Outlays........................................ 3 11 12 13 13 51 Total Changes: Estimated Authorization Level............................ 36 36 36 36 36 180 Estimated Outlays........................................ 14 30 35 36 36 151 ---------------------------------------------------------------------------------------------------------------- Note: CDC = Centers for Disease Control and Prevention. HRSA = Health Resources and Services Administration. NIH = National Institutes of Health. Basis of estimate: H.R. 1246 would authorize funding for early hearing loss detection and intervention activities at the Health Resources and Services Administration (HRSA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) for fiscal years 2010 through 2015. It also would require the Director of the National Institutes of Health to establish a postdoctoral research program to foster research and development in the area of early hearing detection and intervention. CBO estimates that those activities would require the appropriation of $180 million over the 2010-2014 period. Based on historical spending patterns for similar activities and assuming the appropriation of necessary amounts, CBO estimates that implementing H.R. 1246 would cost $151 million over the 2010-2014 period. HRSA administers the Universal Newborn Screening program, which makes grants to states to support testing of infants prior to hospital discharge, audiologic evaluation by three months of age, and early intervention activities. CBO estimates that those activities would require the appropriation of $61 million over the 2010-2014 period. Assuming the appropriation of the necessary amounts, CBO estimates that implementing that grant program would cost $53 million over the 2010-2014 period. H.R. 1246 would authorize CDC to make grants to states and provide technical assistance to states to promote screening, surveillance, and research into the causes of hearing loss among newborns and infants. To fund that grant program, CBO estimates that the CDC would require the appropriation of $55 million over the 2010-2014 period. Assuming the appropriation of the necessary amounts, CBO estimates that implementing the program would cost $46 million over the 2010-2014 period. H.R. 1246 would authorize the NIH to conduct research on early detection and treatment of hearing loss. The bill would direct the NIH to establish a postdoctoral fellowship program to train researchers in the field of detecting and intervening in early hearing loss. Based on information provided by the NIH, CBO expects that the new postdoctoral program would fund three postdoctoral fellows at an annual cost of approximately $120,000 per fellow. Based on that information, historical program expenditures at NIH, and adjustments for inflation, CBO estimates that NIH would require the appropriation of $64 million over the 2010-2014 period. CBO estimates that implementing those programs would cost $51 million over the 2010-2014 period, assuming appropriation of the necessary amounts. Intergovernmental and private-sector impact: H.R. 1246 contains no intergovernmental or private-sector mandates as defined in UMRA. States that participate in programs to detect, diagnose, and treat hearing loss in newborns and infants would benefit from activities and grants authorized in the bill. Estimate prepared by: Federal Costs: Jamease Kowalczyk, Stephanie Cameron, and Lisa Ramirez-Branum; Impact on State, Local, and Tribal Governments: Lisa Ramirez-Branum; Impact on Private Sector: Patrick Bernhardt. Estimate approved by: Peter H. Fontaine, Assistant Director for Budget Analysis. Federal Mandates Statement The Committee adopts as its own the estimate of federal mandates regarding H.R. 1246 prepared by the Director of the Congressional Budget Office pursuant to section 423 of the Unfunded Mandates Reform Act. Advisory Committee Statement No advisory committees within the meaning of section 5(b) of the Federal Advisory Committee Act were created by H.R. 1246. 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 this legislation is provided in Article I, section 8, clause 1, that relates to expending funds to provide for the general welfare of the United States. Applicability to Legislative Branch The Committee finds that H.R. 1246 does not relate to the terms and conditions of employment or access to public services or accommodations within the meaning of section 102(b)(3) of the Congressional Accountability Act. Section-by-Section Analysis of the Legislation Section 1. Short title Section 1 establishes the short title of the Act as the ``Early Hearing Detection and Intervention Act of 2009''. Section 2. Early detection, diagnosis, and treatment of hearing loss Section 2 of this legislation amends Section 399M of the Public Health Service Act (42 U.S.C. 280g-1). In the Section 399M heading, H.R. 1246 strikes ``infants'' and inserts ``newborns and infants.'' Section 2 expands the purpose of the grant program to say that grants and cooperative agreements will be given to: (1) develop statewide newborn, infant hearing screening, evaluation, diagnosis, and intervention programs and systems; (2) assist in the recruitment, retention, education, and training of qualified personnel and healthcare providers; (3) ensure the prompt evaluation of children referred from screening programs; (4) provide appropriate educational, audiological, and medical interventions for children identified with hearing loss; (5) establish and foster family-to-family support mechanisms; (6) develop efficient models to ensure that newborns and infants who are identified with a hearing loss through screening receive follow-up by a qualified health care provider; and (7) ensure an adequate supply of qualified personnel to meet the screening, evaluation, diagnosis, and early intervention needs of children. Section 2 directs the Director of the NIH, acting through the Director of the National Institute on Deafness and Other Communication Disorders to establish a postdoctoral fellowship program to foster research and development in the area of early hearing detection and intervention. Section 2 amends the definition of the term ``early intervention''. As amended by H.R. 1246, the term ``early intervention'' ensures that families of the child are provided comprehensive, consumer-oriented information about the full range of family support, training, information services, and language and communication options and are given the opportunity to consider and obtain the full range of such appropriate services, educational and program placements, and other options for their child from highly qualified providers. Finally, Section 2 updates the authorization of appropriation sections to strike ``fiscal year 2002'' everywhere that such term appears and replace it with ``fiscal years 2010 through 2015''. 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 (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed is shown in roman): SECTION 399M OF THE PUBLIC HEALTH SERVICE ACT SEC. 399M. EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING HEARING LOSS IN [INFANTS] NEWBORNS AND INFANTS. (a) Statewide Newborn and Infant Hearing Screening, Evaluation and Intervention Programs and Systems.--The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make awards of grants or cooperative agreements to develop statewide newborn and infant hearing [screening, evaluation and intervention programs and systems] screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the recruitment, retention, education, and training of qualified personnel and health care providers, for the following purposes: [(1) To develop and monitor the efficacy of state- wide newborn and infant hearing screening, evaluation and intervention programs and systems. Early intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act, which offer programs specifically designed to meet the unique language and communication needs of deaf and hard of hearing newborns, infants, toddlers, and children.] (1) To develop and monitor the efficacy of statewide programs and systems for hearing screening of newborns and infants; prompt evaluation and diagnosis of children referred from screening programs; and appropriate educational, audiological, and medical interventions for children identified with hearing loss. Early intervention includes referral to and delivery of information and services by schools and agencies, including community, consumer, and parent- based agencies and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act, which offer programs specifically designed to meet the unique language and communication needs of deaf and hard of hearing newborns, infants, toddlers, and children. Programs and systems under this paragraph shall establish and foster family-to-family support mechanisms that are critical in the first months after a child is identified with hearing loss. * * * * * * * (3) To develop efficient models to ensure that newborns and infants who are identified with a hearing loss through screening receive follow-up by a qualified health care provider. These models shall be evaluated for their effectiveness, and State agencies shall be encouraged to adopt models that effectively increase the rate of occurrence of such follow-up. (4) To ensure an adequate supply of qualified personnel to meet the screening, evaluation, diagnosis, and early intervention needs of children. (b) Technical Assistance, Data Management, and Applied Research.-- (1) Centers for disease control and prevention.--The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall make awards of grants or cooperative agreements to provide technical assistance to State agencies to complement an intramural program and to conduct applied research related to newborn and infant hearing screening, evaluation and intervention programs and systems. The program shall develop standardized procedures for data management and program effectiveness and costs, such as-- (A) to ensure quality monitoring of newborn and infant [hearing loss screening, evaluation, and intervention programs] hearing loss screening, evaluation, diagnosis, and intervention programs and systems; * * * * * * * (2) National institutes of health.--The Director of the National Institutes of Health, acting through the Director of the National Institute on Deafness and Other Communication Disorders, shall [for purposes of this section, continue] for purposes of this section-- (A) continue a program of research and development on the efficacy of new screening techniques and technology, including clinical studies of screening methods, studies on efficacy of intervention, and related research[.]; and (B) establish a postdoctoral fellowship program to foster research and development in the area of early hearing detection and intervention. (c) Coordination and Collaboration.-- (1) * * * (2) Policy development.--The Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and collaborate on recommendations for policy development at the Federal and State levels and with the private sector, including consumer, medical and other health and education professional-based organizations, with respect to newborn and infant [hearing screening, evaluation and intervention programs] hearing screening, evaluation, diagnosis, and intervention programs and systems. (3) State early detection, diagnosis, and intervention programs and systems; data collection.-- The Administrator of the Health Resources and Services Administration and the Director of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States to establish newborn and infant [hearing screening, evaluation and intervention programs] hearing screening, evaluation, diagnosis, and intervention programs and systems under subsection (a) and to develop a data collection system under subsection (b). * * * * * * * (e) Definitions.--For purposes of this section: (1) * * * * * * * * * * (3) The term ``early intervention'' refers to providing appropriate services for the child with hearing loss, including nonmedical services, and [ensuring that families of the child are provided comprehensive, consumer-oriented information about the full range of family support, training, information services, communication options and are given the opportunity to consider the full range of educational and program placements and options for their child.] ensuring that families of the child are provided comprehensive, consumer-oriented information about the full range of family support, training, information services, and language and communication options and are given the opportunity to consider and obtain the full range of such appropriate services, educational and program placements, and other options for their child from highly qualified providers. * * * * * * * (6) The term ``newborn and infant hearing screening'' refers to objective physiologic procedures to detect possible hearing loss and to identify newborns and infants who[, after rescreening,] require further audiologic and medical evaluations. (f) Authorization of Appropriations.-- (1) Statewide newborn and infant hearing screening, evaluation and intervention programs and systems.--For the purpose of carrying out subsection (a), there are authorized to be appropriated to the Health Resources and Services Administration such sums as may be necessary for [fiscal year 2002] fiscal years 2010 through 2015. (2) Technical assistance, data management, and applied research; centers for disease control and prevention.--For the purpose of carrying out subsection (b)(1), there are authorized to be appropriated to the Centers for Disease Control and Prevention such sums as may be necessary for [fiscal year 2002] fiscal years 2010 through 2015. (3) Technical assistance, data management, and applied research; national institute on deafness and other communication disorders.--For the purpose of carrying out subsection (b)(2), there are authorized to be appropriated to the National Institute on Deafness and Other Communication Disorders such sums as may be necessary for [fiscal year 2002] fiscal years 2010 through 2015. * * * * * * *