SEC. 2566. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS. Subparagraph (B) of section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended by inserting ", including licensure of a biological product under section 351(k) of such Act" before the period at the end. Subtitle D-Community Living Assistance SEC. 2571. ESTABLISHMENT OF NATIONAL VOLUNTARY INSURANCE PROGRAM FOR PURCHASING COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS. (a) IN GENERAL.-The Public Health Service Act (42 U.S.C. 201 et seq.), as amended, is amended by adding at the end the following: "TITLE XXXII-COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS "SEC. 3201. IN GENERAL. "The Secretary shall establish a national voluntary insurance program to be known as the CLASS Independence Benefit Plan for purchasing community living assistance services and supports. Such program shall "(1) provide individuals who have functional limitations with tools that will allow them “(A) to maintain their personal and financial independence; and "(B) to live in the community through a new financing strategy for community living assistance services and supports; "(2) establish an infrastructure that will help address the Nation's community living assistance services and supports needs; "(3) alleviate burdens on family caregivers; and "(4) address institutional bias by providing a financing mechanism that supports personal choice and independence to live in the community. "SEC. 3202. DEVELOPMENT AND MANAGEMENT OF PROGRAM. "The Secretary shall develop the CLASS Independence Benefit Plan in an actuarially sound manner and "(1) set criteria for participation in the CLASS Independence Benefit Plan that do not restrict eligibility based on underwriting; “(2) establish criteria for eligibility for benefits; "(3) establish benefit levels; "(4) establish mechanisms for collecting and distributing payments; "(5) provide mechanisms to assist beneficiaries in the use of benefits; "(6) promulgate such regulations as are necessary to carry out the CLASS program in accordance with this title; and "(7) take any other action appropriate to develop, manage, and maintain the CLASS Independence Benefit Plan, including making adjustments to benefits paid out and premiums collected in order to "(A) maintain program solvency; and "(B) ensure the program remains deficit neutral. "SEC. 3203. REPORT. "The Secretary shall submit to the Congress an annual report on the program under this title." (b) EFFECTIVE DATE.-Title XXXII of the Public Health Service Act, as added by subsection (a), shall take effect on the effective date of a statute establishing a voluntary payroll deduction under the Internal Revenue Code of 1986 to support the program authorized by such title. Subtitle E-Miscellaneous SEC. 2581. STATES FAILING TO ADHERE TO CERTAIN EMPLOYMENT OBLIGATIONS. A State is eligible for Federal funds under the provisions of the Public Health Service Act (42 U.S.C. 201 et seq.) only if the State (1) agrees to be subject in its capacity as an employer to each obligation under division A of this Act and the amendments made by such division applicable to persons in their capacity as an employer; and (2) assures that all political subdivisions in the State will do the same. SEC. 2582. STUDY, REPORT, AND TERMINATION OF DUPLICATIVE GRANT PROGRAMS. (a) STUDY.-The Secretary of Health and Human Services (in this section referred to as the "Secretary") shall conduct a study to determine if any grant program established by this division, or any amendment made by this division, is duplicative of one or more other Federal grant programs under the authority of the Secretary in existence as of the date of the enactment of this Act. (b) REPORT.-Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress and make available to the public a report that contains the results of the study required under subsection (a). (c) TERMINATION OF DUPLICATIVE GRANT PROGRAMS.-If the Secretary determines under subsection (a) that any grant program established by this division, or any amendment made by this division, is duplicative of one or more other Federal grant programs under the authority of the Secretary, the Secretary shall, to maximum extent appropriate, terminate such other Federal grant programs not later than 180 days after the date of the submission of the report under subsection (b). SEC. 2583. HEALTH CENTERS UNDER PUBLIC HEALTH SERVICE ACT; LIABILITY PROTECTIONS FOR VOLUNTEER PRACTITIONERS. (a) IN GENERAL.-Section 224 (42 U.S.C. 233) is amended— (1) in subsection (g)(1)(A) (A) in the first sentence, by striking "or employee" and inserting "employee, or (subject to subsection (k)(4)) volunteer practitioner"; and (B) in the second sentence, by inserting "and subsection (k)(4)" after "subject to paragraph (5)"; and (2) in each of subsections (g), (i), (j), (1), and (m), by striking the term "employee, or contractor" each place such term appears and inserting "employee, volunteer practitioner, or contractor"; (3) in subsection (g)(1)(H), by striking the term "employee, and contractor" each place such term appears and inserting "employee, volunteer practitioner, and contractor"; (4) in subsection (1), by striking the term "employee, or any contractor" and inserting "employee, volunteer practitioner, or contractor"; and (5) in subsections (h)(3) and (k), by striking the term "employees, or contractors" each place such term appears and inserting "employees, volunteer practitioners, or contractors". (b) APPLICABILITY; DEFINITION.-Section 224(k) (42 U.S.C. 233(k)) is amended by adding at the end the following paragraph: "(4)(A) Subsections (g) through (m) apply with respect to volunteer practitioners beginning with the first fiscal year for which an appropriations Act provides that amounts in the fund under paragraph (2) are available with respect to such practitioners. "(B) For purposes of subsections (g) through (m), the term 'volunteer practitioner' means a practitioner who, with respect to an entity described in subsection (g)(4), meets the following conditions: "(i) The practitioner is a licensed physician, a licensed clinical psychologist, or other licensed or certified health care practitioner. "(ii) At the request of such entity, the practitioner provides services to patients of the entity, at a site at which the entity operates or at a site designated by the entity. The weekly number of hours of services provided to the patients by the practitioner is not a factor with respect to meeting conditions under this subparagraph. "(iii) The practitioner does not for the provision of such services receive any compensation from such patients, from the entity, or from third-party payors (including reimbursement under any insurance policy or health plan, or under any Federal or State health benefits program).”. SEC. 2584. REPORT TO CONGRESS ON THE CURRENT STATE OF PARASITIC DISEASES THAT HAVE BEEN OVERLOOKED AMONG THE POOREST AMERICANS. Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall report to Congress on the epidemiology of, impact of, and appropriate funding required to address neglected diseases of poverty, including neglected parasitic diseases identified as Chagas Disease, cysticercosis, toxocariasis, toxoplasmosis, trichomoniasis, the soil-transmitted helminths, and others. The report should provide the information necessary to enhance health policy to accurately evaluate and address the threat of these diseases. SEC. 2585. STUDY OF IMPACT OF OPTOMETRISTS ON ACCESS TO HEALTH CARE AND ON AVAILABILITY OF SUPPORT UNDER FEDERAL HEALTH PROGRAMS FOR OPTOM ETRY. (a) IN GENERAL.-The Secretary of Health and Human Services (in this section referred to as the "Secretary") shall conduct a study with respect to optometrists and optometry to determine (1) whether there is a current and projected role for, and the impact of, optometrists in increasing access to primary eye and vision care to underserved, rural, and senior populations; (2) the role and impact of optometrists in the early diagnosis and treatment of glaucoma, cataract, diabetes, and other conditions; (3) whether there is a need for optometrists to be recognized and supported as primary care providers; (4) whether there is an existence of, and the extent of, any barriers to recruitment and participation of underrepresented minorities in optometry, including the potential role played by the lack of eligibility of optometrists, optometry students, and facilities for certain Federal health programs; and (5) the scope of Federal support for clinical optometric education and options for enhancing that support (A) to address barriers to underrepresented minority recruitment and participation in optometry; and (B) to improve access to primary eye and vision care, especially in underserved and rural areas. (b) COMMENT ON MATTERS STUDIED.-In carrying out the study under subsection (a), the Secretary shall seek the comments of appropriate public and private entities. (c) REPORT TO CONGRESS.-Not later than 18 months after the date of the enactment of this Act, the Secretary shall submit to the Congress a report containing— (1) the results of the study under subsection (a); (2) a summary of comments received from public and private entities under subsection (b); and (3) recommendations for such legislation and administrative action as the Secretary determines to be appropriate regarding the issues studied under subsection (a). PURPOSE AND SUMMARY The purpose of H.R. 3200, the "America's Affordable Health Choices Act of 2009", is to provide affordable, quality health care for all Americans and to reduce the growth in health care costs. It does that in a manner consistent with President Obama's principles for health reform: building on what works in today's healthcare system while repairing aspects that are broken. It provides for comprehensive reform in three key areas: • Affordable Health Care Choices • Public Health and Workforce Development AFFORDABLE HEALTH CARE CHOICES H.R. 3200 reforms the health system by ensuring more affordable health care choices for all Americans. It provides for: • Strong insurance market reforms: Pre-existing condition exclusions are prohibited; guarantee issue and renewal is required of all health insurance; and discrimination in coverage and premium rating based on health status, gender, or any other personal characteristics is prohibited. Premiums can vary only by geographic area and by age, with a limit of 2:1 variation in rate variation by age. There are limits on the maximum out-of-pocket payments for covered benefits, and no annual or lifetime limits on benefits. • A new national health insurance exchange: Individuals and small groups can purchase health benefits, with a choice among private insurers and a new public option competing on a level playing field. • Affordability: Medicaid coverage expansions and new sliding scale affordability credits make premiums and cost sharing more affordable for those with income below 400% of the federal poverty level. • Shared responsibility among individuals, employers and government: Individuals are required to have health coverage; employers (except for small employers) are required to either offer qualified health benefits or make a contribution toward the costs of health care; and new insurance reforms and oversight by the federal and state governments create a marketplace to foster choice and competition, while ensuring that coverage is affordable for those who need assistance. MEDICARE AND MEDICAID IMPROVEMENTS H.R. 3200 improves and strengthens Medicare and Medicaid, provides for substantial savings and fosters long-term delivery system reforms through those programs. It provides for: • Modernization of Medicare: Major delivery system reforms include innovative concepts such as accountable care organizations, medical homes, and bundling of acute and post-acute care services. Payment incentives decrease preventable hospital readmissions. Physician payments are improved, with a complete reform of the sustainable growth rate formula (eliminating the prospect of immediate, deep cuts in physician payments), along with payment improvements for primary care services. Benefit improvements: The Medicare Part D "donut hole" is phased out, financed by re-imposing rebates on the drugs purchased for individuals eligible for both Medicare and Medicaid; cost-sharing on preventive services is eliminated, and the low income subsidy programs in Medicare improved. Fraud and abuse protections: New tools are provided to combat waste, fraud, and abuse in Medicare and Medicaid, as well as in the new public option. • Payment accuracy: Overpayments to Medicare Advantage plans are phased out, and payment systems and updates are made more accurate for providers in Medicare, following the recommendations of the Medicare Payment Advisory Commission and the President's budget. In total, the changes in Medicare will put the program on a much more solid financial growth pattern in the future and extend the life of the Medicare Hospital Insurance Trust Fund by five years. • Medicaid improvements: In addition to the Medicaid coverage expansion, primary care payments are phased up to Medicare levels to enhance beneficiary access to services, and recommended preventive services are covered without cost-sharing. PUBLIC HEALTH AND WORKFORCE DEVELOPMENT H.R. 3200 addresses critical health care access, public health, and enhancements in the health care workforce. It provides for: • Community health centers: A significant expansion in community health centers to foster access to needed services. • Workforce investments: Increased funding for the National Health Service Corps, and for training for primary care physicians, nurses, and public health professionals, with special attention to workforce diversity and the needs of health care shortage areas. • Preventive services: Improvements in research and adoption of policy improvements in both clinical and community preventive services, including elimination of cost-sharing on recommended preventive services. • Public health and wellness: Investments in state, territorial, and local public health infrastructure. BACKGROUND AND NEED FOR LEGISLATION Rising costs, declining insurance coverage and suboptimal quality are evident in the U.S. healthcare system. National healthcare spending now is approximately $2.4 trillion, or about 17% of the gross domestic product (GDP). The U.S. Census Bureau estimates that more than 45.7 million people were uninsured in 2007, representing more than one-seventh of the population. Although the United States spends substantially more on health care per person than other industrialized countries, it scores only average or somewhat worse on many quality-of-care indicators. HEALTH CARE COSTS Escalating healthcare costs are a significant public policy concern and key driver of calls to reform the healthcare system. The United States spends a large and growing share of national income on health care. In 2008, national health spending was approximately $2.4 trillion and accounted for nearly 17% of GDP. We spend substantially more than other developed countries on health care, both per capita and as a share of GDP. That strains the budgets of families, business, and government. Health insurance coverage is expensive and premiums have been growing rapidly. For private-sector employer plans in 2008, the average premium for self-only and family coverage was $4,386 and $12,298, respectively. Moreover, from 1996 to 2006, health insurance premiums grew a cumulative 107% for self-only coverage and 130% for family coverage. In contrast, workers' earnings have grown more slowly. For example, over the same time period, the average weekly earnings of private-sector workers increased by 47%. To attract and maintain a qualified workforce, many businesses provide health benefits for their employees. As the cost of insurance rises, employers face a growing challenge paying for health benefits while managing labor costs to succeed in a competitive market. Given that health insurance premiums have been rising and employers on average pay a majority of those costs, the amount that employers pay for health insurance has been increasing both absolutely and as a share of labor costs. For example, in 1996, private-sector employers contributed an average of $1,650 towards the premium for self-only coverage. By 2006, that average had grown to $3,330; a 102% increase. In response to such conditions, some employers offer insurance to fewer workers or stop of fering it altogether; ask employees to pay more for coverage; and reduce benefits. In addition, health care costs place significant pressure on the federal and state budgets-both directly, through spending on |