.

Public Health, Workforce, Quality, and
Related Provisions in H.R. 3962

C. Stephen Redhead, Coordinator
Specialist in Health Policy
November 5, 2009
Congressional Research Service
7-5700
www.crs.gov
R40892
CRS Report for Congress
P
repared for Members and Committees of Congress
c11173008

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Public Health, Workforce, Quality, and Related Provisions in H.R. 3962

Summary
Health care reform is at the top of the domestic policy agenda for the 111th Congress, driven by
concerns about the growing ranks of the uninsured and the unsustainable growth in spending on
health care and health insurance. Improving access to care and controlling rising costs are seen to
require changes to both the financing and delivery of health care. Experts point to a growing body
of evidence of the health care system’s failure to consistently provide high-quality care to all
Americans.
The health reform debate has encompassed a number of proposals to address these challenges and
improve the delivery of health care services. They include initiatives to encourage individuals to
adopt healthier lifestyles, and to change the way that physicians and other providers treat and
manage disease. Delivery reform proposals focus on expanding the primary care workforce,
encouraging the use of clinical preventive services, and strengthening the role of chronic care
management. Health care delivery reform relies on putting mechanisms in place to drive change
in the systems of care. Key drivers include performance measurement and the public
dissemination of performance information, comparative effectiveness research, adoption of health
information technology, and, most important, the alignment of payment incentives with high-
quality care. In February 2009, Congress enacted the Health Information Technology for
Economic and Clinical Health (HITECH) Act to promote the widespread adoption of electronic
health records for sharing of clinical data among hospitals, physicians, and other health care
stakeholders.
On October 29, 2009, Representative Dingell introduced a comprehensive health reform bill, the
Affordable Health Care for America Act (H.R. 3962). The legislation is based on an earlier
measure, the America’s Affordable Health Choices Act of 2009 (H.R. 3200), which was jointly
developed and reported by the House Committees on Ways and Means, Energy and Commerce,
and Education and Labor. This report, one of a series of CRS products on H.R. 3962, summarizes
the bill’s workforce, prevention, quality, and related provisions.
H.R. 3962 includes numerous provisions intended to increase the primary care and public health
workforce, promote preventive services, and strengthen quality measurement, among other
things. The legislation would amend and expand on many of the existing health workforce
programs authorized under Title VII (health professions) and Title VIII (nursing) of the Public
Health Service Act (PHSA). It would create a Public Health Workforce Corps and establish a new
loan repayment program, modeled on the National Health Service Corps (NHSC), for individuals
who agree to practice in medically underserved areas with unmet health care needs. The bill also
would make a number of changes to the Medicare graduate medical education (GME) payments
to teaching hospitals, in part to encourage the training of more primary care physicians.
In addition, H.R. 3962 would bolster quality improvement activities, including performance
measurement, and broaden Medicare and Medicaid coverage of clinical preventive services. The
legislation would establish a multi-billion dollar Public Health Investment Fund to provide
additional funding for these and other new programs and activities.

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Public Health, Workforce, Quality, and Related Provisions in H.R. 3962

Contents
Introduction ................................................................................................................................ 1
Health Care Delivery Reform...................................................................................................... 1
Drivers of Reform................................................................................................................. 3
American Recovery and Reinvestment Act ............................................................................ 3
Overview of Report..................................................................................................................... 4
Public Health Investment Fund.................................................................................................... 4
Sec. 2002. Establishment, Authorization of Appropriations.............................................. 4
Sec. 2003. Deficit Neutrality ........................................................................................... 5
Health Centers ............................................................................................................................ 5
Background and Issues.......................................................................................................... 5
Sec. 2101. Increased Funding for Community Health Centers.......................................... 6
Sec. 2586. Liability Protection For Health Center Volunteers........................................... 6
Sec. 2511. School-Based Health Clinics .......................................................................... 6
Sec. 2512. Nurse-Managed Health Centers...................................................................... 7
Sec. 2534. Community-based Collaborative Care Networks ............................................ 7
Health Workforce........................................................................................................................ 8
Background and Issues.......................................................................................................... 8
National Health Service Corps .............................................................................................. 9
Sec. 2201. National Health Service Corps ....................................................................... 9
Sec. 2202. Authorization of Appropriations ................................................................... 10
Promotion of Primary Care and Dentistry............................................................................ 10
Sec. 2211. Frontline Health Providers............................................................................ 10
Sec. 2212. Primary Care Student Loans......................................................................... 11
Sec. 2213. Primary Care Training and Enhancement...................................................... 11
Sec. 2214. Training of Medical Residents in Community-Based Settings ....................... 11
Sec. 2215. Training in Dentistry .................................................................................... 12
Sec. 2216. Authorization of Appropriations ................................................................... 12
Sec. 2217. Study on Effectiveness of Scholarships and Loan Repayments ..................... 12
Nursing Workforce.............................................................................................................. 13
Sec. 2221. Amendments to the Public Health Service Act .............................................. 13
Sec. 2521. Grants for Nursing Training and Pipeline Programs ...................................... 14
Sec. 2536. Reducing Student-to-School Nurse Ratios .................................................... 14
Public Health Workforce ..................................................................................................... 14
Sec. 2231. Public Health Workforce Corps .................................................................... 15
Sec. 2232. Enhancing the Public Health Workforce ....................................................... 15
Sec. 2233. Public Health Training Centers..................................................................... 15
Sec. 2234. Preventive Medicine and Public Health Training Grant Program .................. 15
Sec. 2235. Authorization of Appropriations ................................................................... 15
Workforce Diversity, Cultural Competency, and Interdisciplinary Care................................ 16
Sec. 2241. Faculty Loan Repayments ............................................................................ 16
Sec. 2242. Nursing Workforce Diversity Grants ............................................................ 16
Sec. 2243. Coordination of Diversity and Cultural Competency Programs ..................... 16
Sec. 2251. Cultural and Linguistic Competency Training............................................... 16
Sec. 2252. Innovations in Interdisciplinary Care Training .............................................. 17
Health Workforce Evaluation and Assessment ..................................................................... 17
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Sec. 2261 and Sec. 2271. Health Workforce Evaluation and Assessment........................ 17
Authorization of Appropriations .......................................................................................... 18
Sec. 2281. Authorization of Appropriations ................................................................... 18
Medicare Graduate Medical Education Payments ................................................................ 18
Sec. 1501. Distribution of Unused Residency Positions ................................................. 19
Sec. 1502. Increasing Training in Non-Provider Settings ............................................... 19
Sec. 1503. Rules for Counting Resident Time for Non-Patient Care Activities ............... 19
Sec. 1504. Preservation of Resident Cap Positions from Closed Hospitals ..................... 20
Sec. 1505. Improving Accountability for Approved Medical Residency Training ........... 20
Other Workforce Provisions ................................................................................................ 20
Sec. 2533. Secondary School Health Sciences Training Program ................................... 20
Sec. 2589. Long-Term Care and Family Caregiver Support ........................................... 21
Sec. 2590. Web-Site on Health Care Labor Market ........................................................ 21
Sec. 2591. Online Health Workforce Training Programs ................................................ 21
Prevention and Wellness............................................................................................................ 22
Background and Issues........................................................................................................ 22
Coverage of Clinical Preventive Services ............................................................................ 22
Sec. 222. Essential Benefits Package Defined................................................................ 23
Sec. 1305. Medicare Coverage and Waiver of Cost-Sharing........................................... 23
Sec. 1306. Waiver of Medicare Deductible for Colorectal Cancer Screening.................. 23
Sec. 1310. Expanding Access to Vaccines Under Medicare............................................ 24
Sec. 1311. Expansion of Medicare Covered Preventive Services at FQHCs ................... 24
Sec. 1313. Certified Diabetes Educators as Certified Medicare Providers ...................... 24
Sec. 1711. Medicaid Coverage of Preventive Services ................................................... 24
Sec. 1712. Medicaid Coverage of Tobacco Cessation Products ...................................... 24
Sec. 1725. Including Public Health Clinics in the Vaccines for Children Program .......... 25
Provisions in the Public Health Service Act ......................................................................... 25
Sec. 2301. Prevention and Wellness............................................................................... 25
Sec. 2525. WISEWOMAN Program.............................................................................. 27
Sec. 2530. Grants to Promote Positive Health Behaviors and Outcomes ........................ 27
Sec. 2535. Community-Based Overweight and Obesity Prevention Program ................. 28
Employer-Provided Wellness Programs ............................................................................... 28
Sec. 112. Wellness Program Grants ............................................................................... 29
Other Provisions ................................................................................................................. 30
Sec. 2524. School Influenza Vaccination Centers........................................................... 30
Sec. 2594. Diabetes Screening Collaboration and Outreach Program ............................. 30
Maternal and Child Health ........................................................................................................ 30
Maternal and Early Childhood Home Visitation................................................................... 30
Sec. 1904. Home Visitation State Grant Program........................................................... 31
Postpartum Depression........................................................................................................ 32
Sec. 2529. Research and Screening ............................................................................... 32
Teen Pregnancy................................................................................................................... 32
Sec. 2526. Healthy Teen Initiative To Prevent Teen Pregnancy ...................................... 33
Infant Mortality................................................................................................................... 33
Sec. 2532. Pilot Program to Support Social, Education, and Clinical Services................ 33
Behavioral Health ..................................................................................................................... 34
Background and Issues........................................................................................................ 34
Sec. 214 and Sec. 222. Parity for Mental Health and Substance Abuse Benefits ............. 34
Sec. 2513. Federally Qualified Behavioral Health Centers ............................................. 34
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Sec. 2522. Mental and Behavioral Health Training ........................................................ 35
Sec. 2538. Behavioral Health Services in Primary Care Settings.................................... 35
Quality...................................................................................................................................... 36
Background and Issues........................................................................................................ 36
Quality Measurements ........................................................................................................ 36
Sec. 1441. Establishment of National Priorities for Quality Improvement ...................... 36
Sec. 1442. Development of New Quality Measures ....................................................... 37
Sec. 1443. Selection of Quality Measures ...................................................................... 37
Sec. 1444. Application of Quality Measures .................................................................. 38
Sec. 1445. Consensus-Based Entity Funding ................................................................. 38
Sec. 1446. Quality Indicators for Care of People with Alzheimer’s Disease ................... 38
Best Practices and Key Health Indicators ............................................................................ 38
Sec. 2401. Implementation of Best Practices in the Delivery of Health Care .................. 39
Sec. 2402. Assistant Secretary for Health Information ................................................... 39
Sec. 2403. Authorization of Appropriations ................................................................... 40
Public Reporting of Health Care-Associated Infections ....................................................... 40
Sec. 1461. Public Reporting of Health Care-Associated Infection .................................. 40
Comparative Effectiveness Research ................................................................................... 40
Sec. 1401. Center for Comparative Effectiveness Research ........................................... 40
Sec. 1802. Comparative Effectiveness Research Trust Fund .......................................... 41
Medicare and Medicaid Nursing Homes.............................................................................. 41
Secs. 1411-1432. Improving Transparency, Enforcement, and Staff Training ................. 41
Patient Navigators............................................................................................................... 42
Sec. 2537. Medical-Legal Partnerships .......................................................................... 42
Health Disparities ............................................................................................................... 42
Secs. 1221-1224. Medicare Beneficiaries with Limited English Proficiency .................. 43
Health Information Technology................................................................................................. 44
HIPAA Administrative Simplification.................................................................................. 44
Sec. 115. Administrative Simplification......................................................................... 45
Sec. 237 and Sec. 328. Application of Administrative Simplification Standards ............. 46
Electronic Health Records................................................................................................... 46
Sec. 263. Electronic Health Record Use Among Small Health Care Providers ............... 46
Telehealth ........................................................................................................................... 46
Sec. 2523. Telehealth Grant Programs ........................................................................... 47
Emergency Care........................................................................................................................ 47
Background and Issues........................................................................................................ 47
Sec. 2551. Trauma Care Centers.................................................................................... 48
Sec. 2552. Emergency Care Coordination...................................................................... 49
Sec. 2553. Regionalized Communication Systems for Emergency Care Response ......... 49
Sec. 2554. Emergency Medical Technician Training for Veterans .................................. 50
Sec. 2555. Dental Emergency Responders: Public Health and Medical Response........... 50
Sec. 2556. Dental Emergency Responders: Homeland Security ..................................... 50
Sec. 1908. Application of EMTALA.............................................................................. 50
Pain Care and Management ....................................................................................................... 50
Sec. 2561. Institute of Medicine Conference on Pain ..................................................... 51
Sec. 2562. Pain Research .............................................................................................. 51
Sec. 2563. Public Awareness Campaign on Pain Management ....................................... 51
Food and Drug Administration .................................................................................................. 52
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Background and Issues........................................................................................................ 52
Medical Devices ................................................................................................................. 52
Sec. 2571. National Medical Device Registry................................................................ 53
Sec. 552. Excise Tax on Medical Devices ...................................................................... 53
Nutrition Labeling............................................................................................................... 53
Sec. 2572. Chain Restaurant Menus and Vending Machines .......................................... 54
Generic Drugs..................................................................................................................... 54
Sec. 2573. Protecting Consumer Access to Generic Drugs ............................................. 55
Biosimilars.......................................................................................................................... 55
Sec. 2575. Licensure Pathway for Biosimilar Biological Products ................................. 56
Sec. 2576. Fees Relating to Biosimilar Biological Products ........................................... 57
Sec. 2577. Amendments to Certain Patent Provisions .................................................... 57
PHSA 340B Drug Pricing.......................................................................................................... 57
Background and Issues........................................................................................................ 57
Sec. 2501. Expanded Participation in 340B Program ..................................................... 58
Sec. 2502. Improvements to 340B Program Integrity..................................................... 58
Sec. 2503. Effective Date .............................................................................................. 59
Miscellaneous ........................................................................................................................... 59
Sec. 2527. National Autism Training Initiative .............................................................. 59
Sec. 2528. Medication Management Services for Treating Chronic Disease................... 60
Sec. 2531. State Alternative Medical Liability Laws ...................................................... 60
Sec. 2585. States Failing to Adhere to Certain Employment Obligations ........................ 61
Sec. 2587. Report on Parasitic and Other Diseases of Poor Americans ........................... 61
Sec. 2588. Offices of Women’s Health .......................................................................... 61
Sec. 2588A. Offices of Minority Health ........................................................................ 62
Sec. 2592. Access for Individuals with Disabilities ........................................................ 62
Sec. 2593. Duplicative Grant Programs ......................................................................... 62
Sec. 2595. Improvement of Vital Statistics Collection.................................................... 63

Appendixes
Appendix. Acronyms Used in the Report................................................................................... 64

Contacts
Author Contact Information ...................................................................................................... 66

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Introduction
Health care reform is at the top of the domestic policy agenda for the 111th Congress, driven by
concerns about the growing ranks of the uninsured and the unsustainable growth in spending on
health care and health insurance. Improving access to care and controlling rising costs are seen to
require changes to both the financing and delivery of health care. Experts point to a growing body
of evidence of the health care system’s failure to consistently provide high-quality care to all
Americans.
On October 29, 2009, Representative Dingell introduced a comprehensive health reform bill, the
Affordable Health Care for America Act (H.R. 3962).1 The legislation is based on an earlier
measure, the America’s Affordable Health Choices Act of 2009 (H.R. 3200), which was jointly
developed and reported by the House Committees on Ways and Means, Energy and Commerce,
and Education and Labor.2 This report, one of a series of CRS products on H.R. 3962,
summarizes the bill’s workforce, prevention, quality, and related provisions, including the
changes made by the Dingell manager’s amendment.3 It begins with some background on health
care delivery reform, followed by an overview of the report’s content and organization.
Health Care Delivery Reform
In a November 2008 report outlining its goals for health reform, the National Priorities
Partnership, representing 32 key stakeholder groups in the health sector, identified four major
challenges to the delivery of high-quality care.4 According to the Partnership, the first is to
improve patient safety by eliminating medical errors and other adverse events. These errors
mostly result from faulty systems, processes, and conditions that lead to mistakes. The second
challenge is to eradicate disparities in care. Racial and ethnic minorities and low-income groups
face disproportionately higher rates of disease, disability, and mortality, largely because of
variations in access to care, and quality of care. The third challenge is to reduce the burden of
chronic disease, which affects almost half of all Americans and accounts for three-quarters of
health care spending. The final challenge is to eliminate unnecessary and ineffective care that
compromises quality, drives up costs, and neglects the needs of patients. According to the
Institute of Medicine, an estimated 30%-40% of health care spending is wasted on unnecessary
and even unsafe care.5
While primarily focused on health care financing issues, the health reform debate has
encompassed a number of proposals to address these challenges and improve the delivery of

1 The full text of the bill is at http://www.congress.gov/cgi-lis/query/z?c111:H.R.3962:/.
2 In July, each of the three committees considered an amendment in the nature of a substitute to H.R. 3200, offered by
the chairman, and ordered the measure to be reported, as amended. The committees reported their respective versions
of the legislation on October 14, 2009 (H.Rept. 111-299, Parts I, II, and III).
3 The manager’s amendment is posted on the House Rules Committee website at http://www.rules.house.gov/.
4 National Priorities Partnership, National Priorities and Goals: Aligning Our Efforts to Transform America’s
Healthcare
. Washington, DC: National Quality Forum, 2008. For more information on the work of the Partnership, go
to http://www.nationalprioritiespartnership.org/.
5 Institute of Medicine, National Academy of Engineering, Building a Better Delivery System: A New
Engineering/Health Care Partnership.
Washington, DC: National Academies Press, 2005.
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health care services. They include initiatives to encourage individuals to adopt healthier lifestyles,
and to change the way that physicians and other providers treat and manage disease. Delivery
reform proposals focus on (1) expanding the primary care workforce, (2) encouraging the use of
clinical preventive services, and (3) strengthening the role of chronic care management. The
current system places a high value on specialty care, rather than primary care. Patients with
multiple chronic conditions often receive care from several providers in different settings. Among
other things, this can compromise patients’ understanding of their conditions and ways to manage
them. And the incomplete or inaccurate transfer of information among providers can lead to poor
outcomes. Care coordination is seen as an important aspect of health care that helps avoid waste,
and the over- and underuse of medications, diagnostic tests, and therapies.
Health workforce policy has emerged as an important component of the health reform debate.
Transforming the nation’s health care delivery system—from one that is focused on fragmented
specialty care for acute illness to one that places a greater emphasis on primary care, disease
prevention, and the coordination and management of care for chronic illness across settings—
would require significant changes in health professions education and training. While some
advisory groups have warned of a future physician shortage, based on the growing patient
demand for services, others caution that simply adding more physicians to the current health care
system will increase costs and not improve accessibility or quality. Currently, the number of
physicians per capita varies significantly across the country. But that variation is largely driven by
where physicians like to live and practice, rather than by patient need. Moreover, higher physician
supply is not associated with better patient outcomes or satisfaction, or improved quality of care.6
Instead of focusing on overall physician supply, many health policy analysts recommend a
workforce policy that couples the training of more primary care physicians (and other primary
care providers) with the promotion and development of integrated systems of care.
Expanding the use of clinical preventive services is a key goal of delivery reform and often touted
as having the potential to reduce health care costs. Such services include immunizations and other
interventions that prevent the onset of disease (known as primary prevention), and screening tests
that detect the presence of an incipient disease (known as secondary prevention). While there is
clear evidence that clinical preventive services can improve health and may be cost-effective (i.e.,
providing good value for their cost), few of these interventions are cost-saving.7
Proponents of delivery reform have also embraced the concept of a medical home, intended to
improve the quality of care through partnerships between patients and specially trained primary
care physicians. In this model, the physician helps the patient manage his or her own care and
coordinates services across settings (specialists’ offices, hospitals, and laboratories) and types of
care (acute, chronic, and preventive). Concern about the rising costs of treating chronic disease
and the lack of coordination of care also has generated keen interest in disease management
programs. These programs, typically focused on a specific disease such as diabetes, can help
patients manage their own care. Program elements include patient education, symptom
monitoring, and adherence to treatment plans. Disease management programs share similarities
with the medical home concept. But whereas the medical home is built around a physician-patient

6 David C. Goodman and Elliott S. Fisher, “Physician Workforce Crisis? Wrong Diagnosis, Wrong Prescription,” New
England Journal of Medicine
, vol. 358, no. 16 (April 17, 2008), pp. 1658-1661.
7 Joshua T. Cohen et al., “Does Preventive Care Save Money? Health Economics and the Presidential Candidates,”
New England Journal of Medicine, vol. 358, no. 7 (February 14, 2008), pp. 661-663.
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partnership, disease management programs typically are run by health plans or specialized
vendors.
Drivers of Reform
Health care delivery reform relies on putting in place mechanisms to drive change in the systems
of care. Key drivers include performance measurement and the public dissemination of
performance information, comparative effectiveness research, adoption of health information
technology, and, most important, alignment of payment incentives with high-quality care. Most
health policy experts concede that improvements in the quality of health care will not be fully
realized unless providers have financial incentives to change the way they deliver health care
services. Under fee-for-service, the predominant method of payment, physicians are paid based
on the volume of billable services, rather than the value or quality of care they provide.
Increasingly, public and private payers are linking a portion of provider payments to their
performance on a set of quality measures. Many policymakers are interested in expanding these
pay-for-performance initiatives to incentivize other changes to the health care delivery system.
The use of performance measures to track the quality of care is growing in both the private and
public health sectors, though concerns about the development and use of such data remain. The
public reporting of quality information is seen as a necessary step in helping patients make
informed choices about health care services and the organizations that provide them.
American Recovery and Reinvestment Act
Congress moved toward reforming the health care delivery system when it enacted the American
Recovery and Reinvestment Act (ARRA; P.L. 111-5) in February 2009. ARRA incorporated the
Health Information Technology for Economic and Clinical Health (HITECH) Act, which is
intended to promote the widespread adoption of health information technology (HIT) for the
electronic sharing of clinical data among hospitals, physicians, and other health care stakeholders.
It also included $2 billion to fund HIT grant programs authorized by the HITECH Act.8
HIT, which generally refers to the use of computer applications in medical practice, is widely
viewed as a necessary and vital component of health care reform. It encompasses interoperable
electronic health records (EHRs)—including computerized systems to order tests and
medications, and support systems to aid clinical decision making—and the development of a
national health information network to permit the secure exchange of electronic health
information among providers. The promise of HIT comes not from automating existing practices,
but rather its use as a tool to help overhaul the delivery of care. HIT has the potential to enable
providers to render care more efficiently; for example, by eliminating the use of paper-based
records and reducing the duplication of diagnostic tests. It can also improve the quality of care by
identifying harmful drug interactions and helping physicians manage patients with multiple
conditions. The widespread use of HIT could provide large amounts of clinical data for
comparative effectiveness research, performance measurement, and other activities aimed at
improving health care quality.

8 For more information, see CRS Report R40181, Selected Health Funding in the American Recovery and Reinvestment
Act of 2009
, coordinated by C. Stephen Redhead, and CRS Report R40161, The Health Information Technology for
Economic and Clinical Health (HITECH) Act
, by C. Stephen Redhead.
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Overview of Report
H.R. 3962 consists of four divisions. Division A addresses private health insurance. Its provisions
would mandate health insurance coverage, establish health insurance exchanges, and create a
public health insurance plan. Division B covers the Medicare and Medicaid programs. It would
substantially reduce the growth of Medicare’s payment rates for most covered services, relative to
the growth rates projected in current law, and significantly expand eligibility for Medicaid.
Division C, entitled “Public Health and Workforce Development,” includes a series of provisions
intended to increase the primary care and public health workforce, promote preventive services,
and strengthen quality measurement, among other things. Finally, Division D incorporates the
Indian Health Care Improvement Act Amendments of 2009 (H.R. 2708).
This report summarizes the workforce, prevention, quality, and related provisions in Division C.
Several provisions in Division A and B that directly relate to health care quality, prevention, and
some of the other topics covered under Division C are also included. Division C, Title V, Subtitle
D, which would establish a new national insurance program for purchasing community living
assistance services and supports (CLASS), is discussed in a separate CRS product. The report
groups the bill’s provisions under the following headings: (1) Public Health Investment Fund; (2)
health centers; (3) health workforce, including programs authorized under the Public Health
Service Act (PHSA) and under other statutes; (4) prevention and wellness; (5) maternal and child
health; (6) behavioral health; (7) quality; (8) health information technology; (9) emergency care;
(10) pain care and management; (11) Food and Drug Administration, including provisions
relating to medical devices, biological drugs, and food labeling; and (12) miscellaneous. In most
instances, each section begins with some background on current law and practice so as to provide
context for the subsequent brief descriptions of the bill’s provisions. Unless otherwise stated,
references to “the Secretary” refer to the Secretary of Health and Human Services (HHS). A list
of all the acronyms used in the report is in the Appendix.
Public Health Investment Fund
H.R. 3962 would amend numerous PHSA programs. While authorizations of appropriations for
many of these programs have expired, in most cases programs continue to receive an annual
appropriation. H.R. 3962 includes new authorizations of appropriations to fund most of these
programs, typically through FY2015. It also would create a multi-billion dollar Public Health
Investment Fund to provide additional funds for the programs. As described below, the legislation
includes several provisions authorizing the appropriation of amounts from the Fund for specified
PHSA programs. These amounts would be in addition to any amounts provided in annual
appropriations acts under regular procedures. To ensure that the Fund is used to supplement and
not supplant such annual appropriations, the authority to appropriate amounts from the Fund
would be contingent on maintaining a certain level of annual appropriations for the programs.
Sec. 2002. Establishment, Authorization of Appropriations
This section would establish a Public Health Investment Fund, into which the following amounts
would be deposited from general revenues of the Treasury: $4.6 billion for FY2011, $5.6 billion
for FY2012, $6.9 billion for FY2013, $7.8 billion for FY2014, and $9.0 billion for FY2015.
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Amounts in the Fund would be authorized to be appropriated for carrying out various designated
provisions in Division C, as described below, and would be in addition to any other amounts
authorized to be appropriated for such purposes. Amounts in the Fund would be authorized to be
appropriated only if the funding provided in annual appropriations for a given fiscal year are no
less than the funds appropriated in FY2008 for the following PHSA agencies and programs: (1)
Agency for Healthcare Research and Quality; (2) National Center for Health Statistics; (3)
National Health Service Corps, including the scholarship and loan repayment programs; (4)
community health centers; and (5) various designated workforce programs under PHSA Titles VII
and VIII.
Sec. 2003. Deficit Neutrality
Spending from the Fund would occur through subsequent enactment of annual appropriations
acts. Pursuant to a directed-scorekeeping provision in this section, the authorization of
appropriation levels in Sec. 2002 would be scored as direct spending and would be incorporated
by the Congressional Budget Office (CBO) into future budget baseline projections as
appropriated entitlements. In this way, the anticipated spending from the Fund for all covered
fiscal years is accounted for as part of the direct spending provided by H.R. 3962 and not as
discretionary spending in subsequent annual appropriations acts.9
Health Centers
Background and Issues
PHSA Sec. 330 authorizes the health center program, administered by the Health Resources and
Services Administration (HRSA), which provides grants to community health centers, migrant
health centers, health centers for the homeless, and health centers for residents of public housing.
Health centers are a key component of the nation’s health care safety net and provide primary
care and preventive services to many uninsured and underinsured. These centers are required to
accept all patients regardless of ability to pay and must offer sliding scale fee arrangements for
patients. Health centers are located in areas that are medically underserved and target populations
with insufficient health care access. PHSA Sec. 224 provides health centers that receive Sec. 330
funding with liability protection from medical malpractice claims under the Federal Tort Claims
Act (FTCA). FTCA coverage for health centers also applies to its employees, board members,
and certain contactors. However, it does not extend to health care providers who volunteer their
services at health centers. GAO found that the lack of medical malpractice coverage is a barrier to
such volunteerism, though not the only one. Other barriers to provider volunteerism include lack
of time to volunteer, licensure costs, misperceptions about litigiousness, and the limited capacity
of health centers to recruit, retain, and effectively use volunteers.10

9 In its preliminary assessment of the impact of H.R. 3962 on the federal budget deficit, CBO included as direct
spending the anticipated appropriations from the Public Health Investment Fund. CBO’s analysis, which scores the
budgetary impact of several other provisions discussed in this report, is at http://www.cbo.gov/ftpdocs/106xx/
doc10688/hr3962Rangel.pdf.
10 U.S. Government Accountability Office, Federal Torts Claims Act: Information Related to Implications of Extending
Coverage to Volunteers at HRSA-Funded Health Centers
, 09-693R, June 24, 2009.
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The health center program, which enjoys broad bipartisan support, has been expanded in recent
years. In 2002, there were approximately 3,500 health center sites; in 2009, there are an estimated
9,000 sites.11 The program was reauthorized by the Health Care Safety Net Act of 2008 (P.L. 110-
355).12 The Act also included the requirement that GAO study the economic costs and benefits of
school-based health clinics (SBHCs) and their impact on student health. SBHCs are not are not
explicitly authorized in the PHSA, but have been established pursuant to the general authority to
establish community health centers. Studies show that health centers increase access to primary
health care services, which helps reduce disparities and reduce costs by averting more expensive
emergency room visits.13
Sec. 2101. Increased Funding for Community Health Centers
This section would amend PHSA Sec. 330 by authorizing to be appropriated for the health center
program such sums as may be necessary (SSAN) for each of FY2013 through FY2015. The
section also would authorize to be appropriated from the Public Health Investment Fund, in
addition to any other amounts authorized to be appropriated for the program, the following
amounts: $1 billion for FY2011, $1.5 billion for FY2012, $2.5 billion for FY2013, $3 billion for
FY2014, and $4 billion for FY2015.
Sec. 2586. Liability Protection For Health Center Volunteers
This section would amend PHSA Sec. 224 by extending the FTCA liability protections against
medical malpractice to volunteer practitioners at Sec. 330-funded health centers.
Sec. 2511. School-Based Health Clinics
This section would create a new PHSA Sec. 399Z-1 requiring the Secretary to establish an SBHC
grant program. To receive a grant, an SBHC would have to meet certain specified criteria, match
20% of the grant amount from nonfederal sources, agree to use grant funds to supplement and not
supplant funds received from other sources, and demonstrate that grant funds will not be used
until funds from all payers, including private insurance, Medicaid, and CHIP, are used.
Additionally, SBHCs would not be permitted to use funds to provide abortions. The Secretary
would be required to give priority to qualified applicants based on their record of providing care
to at least one of the following: medically underserved children and adolescents, and of providing
care in communities where a high percentage of children and adolescents are uninsured,
underinsured, or eligible for Medicaid or CHIP. The section would authorize the appropriation of
$50 million for FY2011, and SSAN for FY2012 through FY2015.
The section also would amend P.L. 110-355 to strike language requiring GAO to conduct a study
on SBHCs.

11 An individual health center may operate multiple sites.
12 The health centers program is administered by HRSA. For more information, go to http://bphc.hrsa.gov.
13 J. Hadley and P. Cunningham, “Availability of Safety Net Providers and Access to Care of Uninsured Persons,”
Health Services Research, vol. 39, iss. 5 (August 2004), pp. 1527–46.
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Sec. 2512. Nurse-Managed Health Centers
This section would add a new PHSA Part S, Sec. 399FF, requiring the Secretary, acting through
the HRSA Administrator, to establish a program to award grants to entities to plan and develop
nurse-managed health centers (NMHCs) or to operate NMHCs. To receive a grant, eligible
entities would have to match 20% of the grant amount from nonfederal sources, agree to use grant
funds to supplement and not supplant federal and nonfederal funds received from other sources,
maintain expenditures of nonfederal amounts at levels not less than those expended in the fiscal
year prior to the entity’s receipt of the grant, and demonstrate that grant funds will not be used
until funds from all payers, including private insurance, Medicaid, and CHIP, are used.
The Secretary would be authorized to award NMHC planning grants only if the entity agrees to
assess the needs of the medically underserved population that the NMHC proposed to serve and
then design the services and operation of the NMHC based on the assessment. Further, the
Secretary would be authorized to award NMHC operating grants only if the entity assured that it
would provide primary care and other health care services deemed appropriate by the Secretary;
care to all patients regardless of insurance status or ability to pay; and services by advanced
practices nurses, other types of nurses and other specified providers. The section would authorize
to be appropriated SSAN for FY2011 through FY2015.
Sec. 2534. Community-based Collaborative Care Networks
This section would add a new PHSA Sec. 340H, authorizing HRSA to award grants to public and
nonprofit private entities, including federally qualified health centers (FQHCs) and public health
departments, to establish community-based collaborative care networks. The objectives of these
networks include (1) developing or strengthening the coordination of services, especially for
uninsured and low-income individuals, to improve the quality of care; (2) developing an
infrastructure for efficient and sustainable health care delivery; (3) developing or strengthening
chronic care coordination activities; and (4) reducing unnecessary use of emergency departments,
inpatient care, and other expensive resources where primary care provider services are
appropriate. Eligible collaborative care networks (CCNs) must be comprised of a consortium of
health care providers with a joint governance structure capable of delivering integrated health
care services to low-income populations or medically underserved individuals, irrespective of
health insurance status. Generally, a CCN would be expected to include all FQHCs located in the
geographic area served by the network and to have at least one safety net hospital that provides
services to a high volume of low-income patients. Other kinds of entities, such as critical access
hospitals, county departments of health, and community clinics, may be included in CCNs. One
single entity, such as an existing integrated health system may itself qualify as a CCN provided it
meets all of the criteria enumerated in the section.
The Secretary would be required to give priority to applicants that demonstrate the capacity to
provide the broadest array of health care services to low-income, vulnerable populations,
including providers that currently serve a high volume of low-income individuals. Permissible
uses of CCN funding would include assisting uninsured, underinsured, and low-income
individuals to: (1) access and appropriately use health services; (2) enroll in applicable public or
private health insurance programs; (3) obtain referrals to a primary care provider; and (4) get
appropriate care for chronic conditions. Permissible uses of funds also would include providing
case management, application assistance, and appropriate referrals through the use of HIT
networks and community outreach, and expanding the capacity to provide care at any provider
participating in the CCN through the use of telehealth, and by hiring additional staff and
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providing access to services after hours and on weekends. In order to comply with HRSA
requirements, the percentage of CCN funds that may be spent on direct care services may be
limited for members of networks who are also grantees of programs administered by HRSA.
No more than 7% of funds appropriated to carry out the section may be used by the Secretary for
providing technical assistance to grantees, obtaining the assistance of experts and consultants,
holding meetings, developing of tools, disseminating of information, and conducting evaluations.
Participation in a CCN would not alter an FQHC’s obligation to comply with the governance
requirements of PHSA Sec. 330. Conversely, participating FQHCs would only be required to
provide services that were required by their federal health center scope of project, as approved by
HRSA.
The Secretary would be permitted to conduct periodic audits and request periodic spending
reports from community-based CCNs. The Secretary would have the authority to terminate
funding for any CCN for good cause. Three years following an initial grant, each CCN would be
required to submit to the Secretary an evaluation of its activities detailing (at a minimum): the
number of patients served; the most common health problems treated; any reductions in
emergency department use; any improvements in access to primary care; an accounting of how
amounts received were used; and any quality measures or other performance measures as
specified by the Secretary. Beginning no later than six months after the first evaluations are
submitted, the Secretary would have to submit to Congress an annual evaluation including
information on the degree to which CCNs reduced emergency department utilization; the
prevalence of certain chronic conditions in various populations; and the health conditions of
persons presenting at the emergency departments of participating hospitals. There would be
authorized to be appropriated SSN for each of FY2011 through FY2015 to carry out the grant
program.
Health Workforce
Background and Issues
Existing health professions education and training programs authorized under PHSA Title VII
provide funding to medical schools and other facilities to promote community-based and rural
practice, primary care, and opportunities for minorities and disadvantaged students. In the early
1970s, annual funding for Title VII programs reached over $2.5 billion (in 2009 dollars); in recent
years, it has been about $200 million. PHSA Title VIII authorizes a comparable set of programs to
promote nursing education and training. Appropriations authority for most Title VII and VIII
programs has expired, though many of them continue to receive funding. The National Health
Service Corps (NHSC) program, authorized under PHSA Title III, provides scholarships and
student loan repayments for medical students, nurse practitioners, physician assistants, and others
who agree to a period of service as a primary care provider in a federally designated Health
Professional Shortage Area (HPSA). NHSC clinicians may fulfill their service commitments in
health centers, rural health clinics, public or nonprofit medical facilities, or within other
community-based systems of care. However, there is far more demand for NHSC clinicians and
there are many more clinicians interested in scholarships or loan repayment opportunities than
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can be met under the program’s budget. Currently, HHS estimates that the NHSC is filling only
8% of the total need for primary care practitioners in HPSAs.14
Medicare pays the costs of graduate medical education (GME) by making two types of payments
to teaching hospitals. First, direct graduate medical education (DGME) payments help cover the
costs of the residency training program, including resident salaries and benefits, supervisory
physician salaries, and administrative overhead expenses. DGME payments are calculated based
on the product of three factors: a hospital-specific per resident amount, a weighted count of full-
time equivalent (FTE) residents supported by the hospital, and the hospital’s Medicare patient
share. Second, indirect medical education (IME) payments, which vary with the intensity of a
hospital’s residency program, are intended to compensate hospitals for the higher costs of patient
care in teaching hospitals. Those costs are the result of such factors as having sicker patients and
the fact that inexperienced residents may order more tests. The IME adjustment is a percentage
add-on to a hospital’s Medicare payments for inpatient care and is based, in part, on the hospital’s
resident-to-bed ratio. Medicare includes the time that residents spend in both patient care and
non-patient care activities, including didactic activities, when calculating DGME payments.
When calculating IME payments, however, only the time spent in patient care activities is
included. In 2008, Medicare DGME and IME payments totaling an estimated $9 billion were paid
to more than 1,100 teaching hospitals to educate and train about 90,000 residents, equivalent to
approximately $100,000 per resident. Health policy analysts view Medicare GME payments as a
potentially important instrument for shaping future health workforce policy; for example, by
linking the subsidies to delivery system reform and by structuring them to encourage the training
of more generalists and to increase the amount of time residents spend in nonhospital settings
such as community health centers and rural health clinics.15
National Health Service Corps
Sec. 2201. National Health Service Corps
This section would amend PHSA Sec. 331, allowing the Secretary to waive certain requirements
of NHSC service so that the service obligation could be fulfilled on a half-time basis (i.e., a
minimum of 20 hours per week in clinical practice). Individuals fulfilling their service obligation
in this manner would have to agree to double the period of obligated service that would otherwise
be required, or, if receiving loan repayment, accept a minimum of two years of obligated service
and 50% of the amount that would otherwise be provided. It also would amend PHSA Sec. 337,
repealing the prohibition on reappointment of members to the NHSC National Advisory Council.
It would amend PHSA Sec. 338B, increasing the maximum annual NHSC loan repayment
amount from $35,000 to $50,000, adjusted annually for inflation beginning in FY2012. Finally,
the section would amend PHSA Sec. 338C, permitting teaching to be counted for up to 20% of
the NHSC service obligation.

14 For more information on the NHSC program, see CRS Report R40533, Health Care Workforce: National Health
Service Corps
, by Bernice Reyes-Akinbileje.
15 For a recent review of medical education in the United States and an analysis of the GME program and its potential
role in health care delivery reform, see the Medicare Payment Advisory Commission’s June 2009 Report to Congress:
Improving Incentives in the Medicare Program
, Chapter 1, at http://www.medpac.gov/chapters/Jun09_Ch01.pdf.
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Sec. 2202. Authorization of Appropriations
This section would amend PHSA Sec. 338 by (1) authorizing to be appropriated for NHSC
program operations SSAN through FY2015; and (2) authorizing to be appropriated from the
Public Health Investment Fund, in addition to any other amounts authorized to be appropriated
for NHSC program operations, the following amounts: $63 million for FY2011, $66 million for
FY2012, $70 million for FY2013, $73 million for FY2014, and $77 million for FY2015.
In addition, the section would amend PHSA Sec. 338H, by authorizing to be appropriated for the
NHSC scholarship and loan repayment programs SSAN for each of FY2013 through FY2015.
The section would add a new PHSA Sec. 338H-1 authorizing to be appropriated from the Public
Health Investment Fund, in addition to any other amounts authorized to be appropriated for
NHSC scholarships and loan repayments, the following amounts: $254 million for FY2011, $266
million for FY2012, $278 million for FY2013, $292 million for FY2014, and $306 million for
FY2015.
Promotion of Primary Care and Dentistry
PHSA Title VII, Part A, comprising Secs. 701-735, authorizes student loan programs for health
professions students. Sec. 735 establishes general provisions for the administration of the student
loan fund. Title VII, Part C, Sec.747, authorizes grants for health professions schools to develop
and operate training programs in family medicine, general internal medicine, general pediatrics,
physician assistants and general and pediatric dentistry. Funds may also be used to provide
financial assistance to medical students, interns, residents, and faculty who are participants in
such programs. Title VII, Part D, Sec. 751 authorizes the Area Health Education Centers (AHEC)
grant program. Among other activities, AHEC funds may be used to support community-based
primary care residency programs. There is no connection between AHEC-supported community-
based residency training and the Medicare GME program (described later in this report).
The House legislation includes the following seven sections that would establish or amend
existing programs to increase the supply of primary care providers. The first such provision
would create a new loan repayment program, analogous to the NHSC program, for individuals
who agree to practice in medically underserved areas whose health care needs are not being met
by the NHSC.
Sec. 2211. Frontline Health Providers
This section would amend the PHSA Title III, by adding at the end a new Subpart XI–Health
Professional Needs Areas, and creating in that subtitle four new sections as described below.
PHSA Sec. 340H would require the Secretary, acting through the HRSA Administrator, to
establish the Frontline Health Professional Loan Repayment Program. It would require the
Secretary to designate “health professional needs areas” (as defined), establish eligibility
requirements for loan repayors, and define “primary health services” as family medicine, internal
medicine, pediatrics, obstetrics and gynecology, dentistry, and mental health.
PHSA Sec. 340I would require the Secretary, acting through the HRSA Administrator, to contract
with individuals who agree to serve in a health professional needs area as either a full-time
primary health services provider, or as a part-time or full-time provider of other health services,
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for a period of two or more years. The Secretary would be required to pay, for each year of
service, an amount on the principal and interest of the educational loan of the individual that is
not more than 50% of the average award made under the NHSC Loan Repayment Program in that
year. Individuals would be allowed to satisfy the service requirement through employment at
specified practice settings. Statutory provisions for the NHSC Loan Repayment Program would
apply to the Frontline Health Professional Loan Repayment Program, where appropriate. Finally,
the section would require the Secretary to transfer all unobligated funds from this program to the
NHSC for the purpose of recruiting participants for the following year.
PHSA Sec. 340J would require the Secretary to submit an annual report to Congress on the
Frontline Health Professional Loan Repayment Program.
PHSA Sec. 340K would require the following allocation of funds obligated for each fiscal year
for loan repayments: (1) 90% must be allocated for physicians and other health professionals
providing primary health services, and (2) 10% must be allocated for non-physicians and non-
primary health professionals.
Sec. 2212. Primary Care Student Loans
PHSA Sec. 735 establishes general provisions for the administration of the student loan fund for
medical students and health professions students. Health professions schools are required to take
into account the expected financial contribution from parents or other family members when
considering student loan applications, regardless of the tax status of the student.
This section would amend PHSA Sec. 735, permitting the Secretary to require that loan
applicants submit information on their financial resources in order to determine the financial
resources available to them. It also would require the Secretary to take into account the extent to
which the applicant is financially independent in determining whether to require the submission
of financial information about an applicant’s family members.
Sec. 2213. Primary Care Training and Enhancement
This section would amend PHSA Sec. 747 to require the Secretary to award grants or enter into
contracts for a variety of activities to support training programs in primary care—defined as
family medicine, general internal medicine, general pediatrics, or geriatrics—and for capacity
building. Entities eligible for the training grants would include accredited public or nonprofit
hospitals, schools of medicine or osteopathic medicine, accredited physician assistant training
programs, public or private nonprofit entities, or a consortium of two or more of these entities.
However, only schools of medicine or osteopathic medicine would be eligible for capacity
building grants. The Secretary would be required to give preference to qualified applicants based
on an applicant’s record of (1) training primary care providers and individuals from minority
groups or disadvantaged backgrounds; (2) training individuals who provide care in underserved
areas or to populations experiencing health disparities including those eligible for Medicaid and
CHIP; and/or (3) supporting teaching programs targeting vulnerable populations.
Sec. 2214. Training of Medical Residents in Community-Based Settings
This section would redesignate current PHSA Sec. 748–Advisory Committee on Training in
Primary Care Medicine and Dentistry as Sec. 749A, and create a new PHSA Sec. 748, requiring
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the Secretary to award grants or contracts for planning and/or operating primary care residency
training programs in community-based settings. Eligible entities would be (1) Medicare GME-
eligible non-hospital providers; (2) teaching health centers as defined in Sec.1502(d) of this bill;16
or (3) an applicant for the designation described in (1) or (2) that meets certain specified criteria.
The Secretary would be required to give preference to qualified applicants that are an FQHC or a
rural health clinic, and to programs that would address the health care needs of vulnerable
populations, or that have a demonstrated record of training individuals from disadvantaged
backgrounds including those who are underrepresented in primary care, or who practice in
underserved areas or in areas experiencing health disparities.
Sec. 2215. Training in Dentistry
This section would amend PHSA Title VII, Part C by adding at the end a new PHSA Sec. 749,
described below. It also would add the newly created section to the list of programs—currently
Secs. 747 and 750—that are subject to the granting preference and other requirements under Sec.
791. That section specifies that the Secretary is required give preference to programs that have a
high or recently improved rate of placing graduates in settings that provide care to medically
underserved communities.
The new PHSA Sec. 749 would require the Secretary to award grants or contracts for a variety of
activities to support and develop oral health training programs for general, pediatric, and public
health dentists, and dental hygienists. Eligible entities would include accredited schools of
dentistry, training programs in dental hygiene, public or nonprofit private hospitals, or consortia
of these entities and a school of public health. The Secretary would have to give preference to
entities meeting similar criteria as for the grant program established in Sec. 2213 of this bill.
Sec. 2216. Authorization of Appropriations
This section would add a new PHSA Sec. 799C, authorizing to be appropriated from the Public
Health Investment Fund, in addition to any other amounts authorized to be appropriated for such
purposes, the following amounts to carry out PHSA Title III, Part D, Subpart XI (as established in
Sec. 2211 of this bill, regarding frontline health providers) and PHSA Secs. 747, 748, and 749, as
added or amended by this bill: $240 million for FY2011, $253 million for FY2012, $265 million
for FY2013, $278 million for FY2014, and $292 million for FY2015. The section also would
amend PHSA Sec. 747 by authorizing to be appropriated SSAN through FY2015.
Sec. 2217. Study on Effectiveness of Scholarships and Loan Repayments
This section would require GAO, within 12 months of enactment, to conduct and report the
findings of a study on the effectiveness of the NHSC and Frontline Health Provider programs, as
amended by this bill. The study must include an evaluation of whether scholarships or loan
repayments are more effective in (1) incentivizing physicians and other providers to pursue

16 Among other things, Sec. 1502(d) would amend the SSA to allow for Medicare GME payments to qualified teaching
health centers, such as federally qualified health centers and rural health centers that develop and operate an accredited
primary care residency program for which GME funding would be available if such program were operated by a
hospital. It also would establish a demonstration project to facilitate affiliations between teaching health centers and
teaching hospitals to encourage residency training in community-based settings. See the discussion of the bill’s GME
provisions.
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careers in primary care; (2) retaining primary care providers; and (3) encouraging them to
practice in underserved areas.
Nursing Workforce
PHSA Title VIII, comprising Secs. 801-855, authorizes several programs to support nursing
workforce development. These programs include funding for grant and scholarship programs for
graduate and undergraduate nursing education in specified areas of nursing, including cultural
competency, workforce diversity, nurse faculty members, advanced education nurses, and
geriatric nursing. The House legislation would modify and reauthorize several of these existing
programs, and delete the cultural and linguistic competency grant program. In addition, it would
authorize two new programs: a nursing training and retention program administered by the
Department of Labor, and a program administered by the Department of Education to help reduce
the student-to-nurse ratio in schools.
Sec. 2221. Amendments to the Public Health Service Act
This section would amend PHSA Sec. 801 to include “nurse-managed health centers” as eligible
entities for purposes of Title VIII’s nursing workforce development programs, and would insert a
definition for the term “nurse-managed health centers” into the section. It also would delete
PHSA Sec. 807, a grant program for cultural and linguistic competence training for nurses.
The section would add a new PHSA Sec. 809, requiring the Secretary to submit annual reports to
Congress on each of the loan and grant programs in Title VIII that do not already require an
annual report (i.e., Secs. 811, 821, 836, 846A, and 861, as redesignated). It would delete the 10%
limit on Advanced Education Nursing Grant awards to doctoral program traineeships in PHSA
Sec. 811
. It also would add to the list of eligible entities meriting special consideration those that
agree to expend the award to increase diversity among advanced education nurses.
The section would amend PHSA Sec. 831, regarding Nurse Education, Practice, and Retention
Grants, to restate grant activity priorities from managed care and quality improvement to
coordinated care, quality care, and other skills needed to practice nursing. It would delete a
subsection regarding preference for these grants.
The section would amend PHSA Sec. 836 to increase the maximum amount of loan funds a
recipient can receive per year from $2,500 to $3,300; increase the annual limit for the last two
academic years from $4,000 to $5,200; and increase the total loan amount that may be provided
to a student from $13,000 to $17,000. These limits would be annually adjusted for inflation
beginning in FY2012. PHSA Sec. 846 would be amended to include individuals in the Loan
Repayment and Scholarship Program who agree to serve for not less than two years as a faculty
member at an accredited nursing school. PHSA Sec. 846A would be amended to raise the Nurse
Faculty Loan Program limit from $30,000 to $35,000. These limits would be annually adjusted
for inflation beginning in FY2012.
The section would delete the current PHSA Title VIII, Part H, related to federal, state, and local
public service announcements to promote careers in nursing.
The section would redesignate PHSA Sec. 841 as PHSA Sec. 871 and amend it to authorize the
appropriation of SSAN for each fiscal year through FY2015 for PHSA Title VIII Parts B, C, and
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D (i.e., Sec. 811, Advanced Education Nursing Grants; Sec. 821, Workforce Diversity Grants; and
Sec. 831, Nurse Education, Practice, and Retention Grants). It also would authorize to be
appropriated SSAN through FY2015 for the following programs: Sec. 831 (Nurse Education and
Retention Grants); Sec. 846 (Student Loan Repayment and Scholarships); Sec. 846A (Nursing
Faculty Loans); and Sec. 861, as redesignated (Geriatric Education). Finally, the section would
add a new PHSA Sec. 872, authorizing to be appropriated out of monies in the Public Health
Investment Fund, in addition to any other amounts authorized to be appropriated for such
purposes, the following amounts for Title VIII programs: $115 million for FY2011; $122 million
for FY2012; $127 million for FY2013; $134 million for FY2014; and $140 million for FY2015.
Sec. 2521. Grants for Nursing Training and Pipeline Programs
This section would require the Secretary of Labor to establish a new partnership grant program to
support nurse education, practice, and retention. The program would provide matching grants to
eligible entities for qualified nursing training programs, including nurse “career ladder” programs
and nurse faculty development programs. Eligible entities would include partnerships of health
care providers and labor unions, trade associations, or groups that represent direct health workers.
In making awards, the Secretary of Labor would be required to give preference to programs that
improve nurse retention; increase the diversity of the nursing workforce; improve the quality of
nursing education; have demonstrated success for transitioning health care workers into nursing;
have established pilot programs to increase nurse faculty; or are modeled after or affiliated with
established transitioning and pilot programs mentioned above. Any awards made would require a
dollar-for-dollar match by the recipient. There would be authorized to be appropriated SSAN to
carry out this partnership grant program.
Sec. 2536. Reducing Student-to-School Nurse Ratios
This section would authorize the Secretary of Education (in consultation with HHS) to establish a
demonstration grant program for local education agencies to reduce the student-to-school nurse
ratio in public elementary and secondary schools. In making awards, the Secretary of Education
would be required to give special consideration to applicants that demonstrate high need, in part
by providing information about current student-to-school nurse ratios. Eligible local educational
agencies would be defined as those in which the student-to-school nurse ratio in the public
elementary and secondary schools they serve is 750 or more students to every school nurse. High-
need local educational agencies would mean those that serve at least 10,000 children from
families with incomes below the poverty line, or for which at least 20% of the children are from
families with incomes below the poverty line. The Secretary of Education could require non-
federal matching contributions from grant recipients. To carry out this section, there would be
authorized to be appropriated SSAN for each of FY2011 through FY2015.
Public Health Workforce
PHSA Title VII, Part E, Subpart 2, comprising Secs. 765-770, authorizes the Secretary to conduct
programs for public health workforce development by providing grants or contracts to schools,
state and local health agencies, and others to operate public health training and re-training
programs. Programs include grants for Public Health Training Centers; tuition, fees, and stipends
for traineeships in public health and in health administration; and residency programs in
preventive medicine and dental public health. Appropriations authority for these programs has
expired, though all except the health administration traineeships continue to receive funding.
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Sec. 2231. Public Health Workforce Corps
This section would add three new PHSA sections (340L, 340M, and 340N), requiring the
Secretary to establish within the U.S. Public Health Service a Public Health Workforce Corps
(PHWC), similar to the National Health Service Corps. The Secretary would be required to use
the PHWC to address critical public health workforce shortages and may designate as shortage
areas state, local, and tribal health departments, and FQHCs. In exchange for a postgraduate
period of service in a designated shortage area, members of the PHWC would be eligible for
scholarships while in training, and loan repayment while in service.
Sec. 2232. Enhancing the Public Health Workforce
This section would replace PHSA Sec. 765 with new language requiring the Secretary to
establish a grant program for certain health professions schools, state, local, or tribal health
departments, public or private nonprofit entities, or consortia of these entities, to develop public
health training programs and provide assistance to students. The Secretary would be required to
award grants preferentially to entities that train: (1) professionals who serve in underserved
communities; (2) individuals from minority groups or disadvantaged backgrounds; (3) individuals
in public health specialties experiencing shortages of public health professionals (as determined
by the Secretary); [and/or] (4) professionals serving in governmental public health.
Sec. 2233. Public Health Training Centers
This section would amend PHSA Sec. 766, which authorizes the Secretary to award grants for
Public Health Training Centers. Current law (1) defines these centers as accredited schools of
public health, or other public or nonprofit private accredited institutions, that provide graduate or
specialized training in public health and (2) authorizes grants for training activities that further the
decennial “Healthy People” national health goals developed and published by the Secretary. This
section would amend PHSA Sec. 766 to refer, instead of the Healthy People goals, to the National
Prevention and Wellness Strategy that would be required under Sec. 2301 of this bill.
Sec. 2234. Preventive Medicine and Public Health Training Grant Program
This section would replace the current PHSA Sec. 768, regarding preventive medicine residency
training, with new language requiring the Secretary to award grants or contracts for residency
training programs in preventive medicine and public health. Eligible applicants would include
schools of public health; state, local, or tribal health departments; schools of medicine or
osteopathic medicine; public or private hospitals; or consortia of the above entities.
Sec. 2235. Authorization of Appropriations
This section would amend new PHSA Sec. 799C (as established by Sec. 2216 of this bill) to
authorize appropriations through the Public Health Investment Fund for all of the public health
workforce provisions summarized above (i.e., new PHSA Secs. 340L, 340M, and 340N, and
amended PHSA Secs. 765, 766, and 768). For all of these activities, in addition to any other
amounts authorized to be appropriated for such purposes, there would be authorized to be
appropriated from the Fund the following amounts: $51 million for FY2011; $54 million for
FY2012; $57 million for FY2013; $59 million for FY2014; and $62 million for FY2015. In
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addition, this section would authorize or reauthorize the appropriation of SSAN for the following
PHSA sections through FY2015: Sec. 765 (public health workforce training grants), Sec. 766
(Public Health Training Centers), Sec. 767 (public health traineeships), Sec. 768 (preventive
medicine and public health training), and Sec. 769 (health administration traineeships and special
projects).
Workforce Diversity, Cultural Competency, and
Interdisciplinary Care

PHSA Title VII, Part B, comprising Secs. 736-741, authorizes several programs intended to
promote diversity in the health workforce. They include grants to establish Centers of Excellence
at health professions schools that recruit and train significant numbers of underrepresented
minority students, scholarships and other educational assistance for students from disadvantaged
backgrounds, and loan repayments and fellowships for individuals from disadvantaged
background who agree to serve as faculty members in health professions schools. Title VIII, Sec.
821 authorizes grants to increase nursing education opportunities for individuals from
disadvantaged backgrounds. Title VII, Part D, comprising Secs. 750-758, authorizes several grant
programs to support interdisciplinary, community-based health workforce training.
The House legislation includes the following five sections that would amend several of the
existing workforce diversity and interdisciplinary, community-based training programs.
Sec. 2241. Faculty Loan Repayments
This section would amend PHSA Sec. 738(a), increasing the annual limit on the loan repayment
amount from $20,000 to $35,000. Beginning in FY2012, that amount would be subject to an
annual adjustment for inflation.
Sec. 2242. Nursing Workforce Diversity Grants
This section would amend PHSA Sec. 821, eliminating the requirement that the Secretary, in
awarding nursing workforce diversity grants, take into account the recommendations of the three
Invitational Congresses for Minority Nurse Leaders that were convened in the 1990s.
Sec. 2243. Coordination of Diversity and Cultural Competency Programs
This section would add a new PHSA Sec. 739A, requiring the Secretary to coordinate the health
workforce diversity programs under Title VII, Part B and Title VIII (Sec. 821). It also would
amend PHSA Sec. 736, directing the Secretary to submit an annual report on the Centers of
Excellence program.
Sec. 2251. Cultural and Linguistic Competency Training
This section would amend PHSA Sec. 741, by replacing the existing grant program for training
health care professionals how to reduce disparities in outcomes and provide culturally competent
care with a new cultural and linguistic competency training grant program. The Secretary would
be required to award grants to health professions schools, academic health centers, and other
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entities to develop, test, and implement such training programs. Grantees would have to agree to
test and evaluate models of cultural and linguistic competence training.
Sec. 2252. Innovations in Interdisciplinary Care Training
This section would add a new PHSA Sec. 759, requiring the Secretary to award grants to health
professions schools, academic health centers, and other entities to develop, test, and implement
training programs that promote the delivery of health care services through interdisciplinary and
team-based models (e.g., patient-centered medical homes) of care.
Health Workforce Evaluation and Assessment
PHSA Title VII, Part E, Subpart 1, comprising Secs. 761-763, establishes various projects to
support health professions workforce information and analysis, including grants to entities in
order to develop analysis of and information on the health workforce, an Advisory Council on
Graduate Medical Education, and an evaluation of the number of pediatric rheumatologists.
The House legislation includes the following two sections that would replace existing PHSA
provisions with new language establishing an Advisory Committee on Health Workforce
Evaluation and Assessment and requiring certain health workforce data collection activities.
Sec. 2261 and Sec. 2271. Health Workforce Evaluation and Assessment
Sec. 2261 would add a new PHSA Sec. 764 requiring the Secretary, acting through the Assistant
Secretary for Health, to establish a permanent Advisory Committee on Health Workforce
Evaluation and Assessment. The Advisory Committee would be required to recommend
classifications, standardized methodologies, and procedures to enumerate the health workforce. In
addition, the Advisory Committee would have to submit recommendations regarding health
workforce supply, diversity, geographic distribution, retention, and expansion and to suggest
policies to carry out these recommendations. The Secretary would be required to consult with the
Secretary of Education and the Secretary of Labor in carrying out these activities.
Sec. 2271 would replace PHSA Sec. 761(a) and (b) with new language requiring the Secretary to
collect data on the health workforce, based on the work developed by the Advisory Committee,
and data on individuals participating in specified programs authorized by the bill. The Secretary
would be authorized to enter into grants or contracts with specified entities and collaborate with
federal agencies and other specified organizations for the purpose of carrying out these data
collection activities. Pending completion, the Secretary would be authorized to make a judgment
about the classifications, methodologies, and procedures developed by the Advisory Committee
with respect to their use for data collection under PHSA Sec. 761(a), as amended. Secs. 2261 and
2271 each require the Secretary to submit an annual report to Congress on activities of the
Advisory Committee and activities related to data collection, respectively.
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Authorization of Appropriations
Sec. 2281. Authorization of Appropriations
This section would amend new PHSA Sec. 799C (as established by Sec. 2216 of this bill) to
authorize to be appropriated from the Public Health Investment Fund, in addition to any other
amounts authorized to be appropriated for such purposes, the following amounts for activities in
specified PHSA sections: (1) health professions training and diversity (PHSA Secs. 736, 737,
738, 739, and 739A
): $90 million for FY2011; $97 million for FY2012; $100 million for
FY2013; $104 million for FY2014; $110 million for FY2015; and (2) interdisciplinary training
programs, the Advisory Committee on Health Workforce Evaluation and Assessment, and health
workforce assessment (PHSA Secs. 741, 759, 761, and 764): $87 million for FY2011; $97
million for FY2012; $103 million for FY2013; $105 million for FY2014; $113 million for
FY2015.
The section also would authorize to be appropriated SSAN through FY2015 for the following
PHSA health workforce programs: Sec. 736 regarding Centers of Excellence; Sec. 737 regarding
scholarships for disadvantaged students; Sec. 738 regarding faculty loan repayments and
fellowships; Sec. 739 regarding educational assistance for individuals from disadvantaged
backgrounds; Sec. 741 regarding grants for cultural and linguistic competency training for health
professionals; and Sec. 761 regarding health professions workforce information and analysis.
Medicare Graduate Medical Education Payments
With certain exceptions, Medicare caps the number of residents used to calculate GME payments
for individual teaching hospitals at the level reported at the end of 1996. The Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 permitted a one-time
redistribution of up to 75% of a teaching hospital’s unused resident position to hospitals seeking
to increase their medical residency programs, according to specific priorities. Medicare does not
set targets for the type or mix of resident physicians that a hospital trains, nor are Medicare GME
payments linked to promoting or fostering specific goals in medical education.
Medicare allows teaching hospitals to receive DGME and IME payments for the time residents
rotate in non-hospital settings provided (1) they are performing patient care, and (2) the hospital
pays all or substantially all (i.e., 90%) of the costs of the training at the non-hospital site, which
include the resident stipends and fringe benefits and the costs associated with supervising
physicians. Time spent in non-patient care activities in the non-hospital setting is not counted
when calculating either type of payment. A hospital that jointly operates a residency program with
another hospital cannot include the time spent by residents working at a non-hospital site if it
incurs all or substantially all of the costs for only a portion of the residents in that program at the
non-hospital site. Additional regulatory requirements discourage rotations in non-hospital
settings. Moreover, hospitals have a financial incentive to retain the often lower-cost clinical
labor that residents provide. While experts see value in having residents gain experience in
nonhospital settings such as community health centers and nursing facilities, residency programs
today are largely based in inpatient, acute-care teaching hospitals. H.R. 3962 includes the
following five sections, which collectively would make a number of changes to Medicare to
address these and related issues.
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Sec. 1501. Distribution of Unused Residency Positions
This section would, among other things, establish criteria to be used to reduce the otherwise
applicable resident limit for hospitals with unused residency positions, as defined, and direct the
Secretary to redistribute those unused positions and assign them to other qualifying facilities. A
facility that qualifies for an increase in residency positions would have to maintain its base level
of primary care residents and use the additional slots for training primary care residents.
Preference would be given to (1) hospitals that have demonstrated that they will fill the additional
positions in a timely manner; (2) hospitals that had a reduction in residency training slots under
this section; (3) hospitals that have a three-year primary care training program; (4) hospitals that
have a formal arrangement to train residents in health centers, other non-hospital settings, and
other specified settings; and (5) hospitals located in states with a low resident-to-population ratio,
among other criteria.
The section also would establish the criteria used to calculate DGME and IME payments for
hospitals that receive redistributed residency positions.
Sec. 1502. Increasing Training in Non-Provider Settings
This section would require that all time spent by a resident be counted towards the DGME
payment, regardless of the setting, provided the hospital continues to incur the costs of the
stipends and the fringe benefits of the resident during the time spent in that setting. In addition, all
time spent by a resident in patient care activities in a non-hospital setting would be counted
towards the IME payment, provided the hospital continues to incur those same costs. The HHS
Inspector General would be required to assess the extent to which there is an increase in time
spent by medical residents training in non-hospital settings.
The section also would establish a demonstration project, under which a teaching health center—
such as an FQHC or a rural health center that develops and operates an accredited primary care
residency program for which funding would be available if it were operated by a hospital—would
contract with a teaching hospital to provide primary care residency training. The center would be
responsible for payment of the hospital’s costs of the residents’ salary and benefits, and would be
eligible for DGME payments to cover those costs. Residents training at the center would not be
counted as the contracting hospital’s residents and thus would not count toward that hospital’s cap
on residents. In addition, the contracting hospital would not be permitted to reduce its number of
primary care residents.
Sec. 1503. Rules for Counting Resident Time for Non-Patient Care Activities
This section would require that resident time spent in certain non-patient care activities—
including attending conferences and seminars, but not research unless it is associated with the
treatment or diagnosis of a patient—in a non-hospital setting primarily engaged in furnishing
patient care be counted towards the DGME payment. In addition, Medicare would count all the
vacation, sick leave, and other approved leave spent by the resident as long as the leave time does
not extend the training program’s duration.
When calculating IME payments, Medicare would adopt the same rules for counting residents’
leave time. Resident time spent in hospital settings (as defined) on certain non-patient care
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activities—including attending conferences and seminars, but not research unless it is associated
with the treatment or diagnosis of a patient—would count towards the IME payment.
Sec. 1504. Preservation of Resident Cap Positions from Closed Hospitals
This section would direct the Secretary, by rulemaking, to establish a process to redistribute
medical residency slots from recently closed hospitals. Such residency slots would be
redistributed to other hospitals in the same state in a manner specified by the Secretary, taking
into account recommendations by the senior health official in the state.
Sec. 1505. Improving Accountability for Approved Medical Residency
Training

This section would establish certain goals for medical residency training programs. Specifically,
programs would have to train residents to (1) work in non-acute traditional settings; (2)
coordinate patient care within and across settings; (3) understand the relevant cost and value of
various diagnostic and treatment options; (4) work in multi-disciplinary teams; (5) identify
systematic errors in health care delivery and implement solutions for such errors; and (6) be
meaningful users of electronic health records.
GAO would be required to evaluate and, within 18 months of enactment, report on the extent to
which medical residency training programs are meeting the above workforce goals in a range of
residency programs, including primary care and specialties, and have the appropriate faculty
expertise to teach the topics required to achieve those goals. The study would include
recommendations on the development of curriculum requirements and an assessment of the
accreditation processes of the Accreditation Council for Graduate Medical Education and the
American Osteopathic Association.
Other Workforce Provisions
The following describes four workforce provisions that would address health sciences training in
secondary schools, the direct care workforce and family caregivers, and grants to establish online
health workforce information and training programs.
Sec. 2533. Secondary School Health Sciences Training Program
This section would permit the Secretary, acting through the HRSA Administrator, and in
consultation with the Secretary of Education, to establish a grants program for developing health
sciences curricula at the secondary school level. Grants would be awarded to local educational
agencies that are in partnerships with specified entities for the purpose of planning, developing or
implementing secondary school health sciences curricula to prepare students for health
professions or health professions-related degree programs and increase interest in applying to
these programs. The section would require the Secretary to submit an annual report on the
program to Congress. It would authorize to be appropriated SSAN for each of FY2011 through
FY2015.
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Sec. 2589. Long-Term Care and Family Caregiver Support
Title II, Sec. 202 of the Older Americans Act (OAA) authorizes various functions of the
Administration on Aging (AoA) and the Assistant Secretary for Aging. This section would amend
OAA Sec. 202(b)(1) to require the Assistant Secretary to make recommendations to other federal
entities regarding appropriate and effective means of identifying and implementing investments
in the direct care workforce and assisting states in developing state workforce development plans
with respect to such workforce. OAA Sec. 202 would be amended to include a new subsection
(g)(1)
requiring the Assistant Secretary to establish a Personal Care Attendant Workforce
Advisory Panel and pilot program to improve working conditions and training for long-term care
workers.
OAA Title III, Part E, the National Family Caregiver Support Program (NFCSP), provides direct
support to family caregivers primarily caring for the elderly through information and referral
assistance, respite care, and training and support. Sec. 303(e) authorizes funding to be
appropriated to the NFSCP for FY2007 through FY2011. OAA Sec. 303(e)(2) would be amended
to increase amounts authorized to be appropriated for the NFCSP to $250 million for each of
FY2011 through FY2013.
Sec. 2590. Web-Site on Health Care Labor Market
This section would require the Secretary of Labor, in consultation with HRSA’s Bureau of Health
Professions, National Center for Health Workforce Analysis (NCHWA), to establish and maintain
a website to serve as a comprehensive source of information on the health care labor market and
related educational and training opportunities.
Sec. 2591. Online Health Workforce Training Programs
The Workforce Investment Act (WIA) provides, in general, job training and related services to
unemployed and underemployed individuals. WIA programs are administered by the Department
of Labor (DOL), primarily through DOL’s Employment and Training Administration (ETA). WIA
Title I, Sec. 171 establishes pilot and demonstration programs to develop and evaluate innovative
approaches to providing employment and training services.17
This section would amend WIA Sec. 171 to add a new subsection (f) requiring the Secretary of
Labor, in consultation with the HHS Secretary, to award National Health Workforce Training
Grants to eligible entities who would carry out online workforce training for individuals to attain
or advance in health care occupations. The section also would require the Secretary of Labor to
award Online Health Professions Training Program Clearinghouse grants to eligible
postsecondary educational institutions to provide technical assistance and collect and disseminate
data to entities that receive National Health Workforce Training Grants, as well as disseminate
best practices identified by grantees. To carry out the National Health Workforce Training Grants,
the section would authorize to be appropriated $50 million for FY2011 through FY2020. To carry
out the Online Health Professions Training Program Clearinghouse, it would authorize to be
appropriated $1 million for FY2011 through FY2020.

17 For further information, see CRS Report RL33687, The Workforce Investment Act (WIA): Program-by-Program
Overview and Funding of Title I Training Programs
, by David H. Bradley.
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Prevention and Wellness
Background and Issues
Prevention interventions are of two key types: those provided to individuals in clinical settings
(e.g., cancer screenings) and those provided to communities (e.g., ad campaigns about exercise).
Employer-provided “wellness” programs often use both types of interventions. Evidence suggests
that many clinical and community-based prevention interventions can improve the health of
patients and populations. However, contrary to common belief, many clinical preventive services
(including cancer screenings) do not yield savings for the payer, but rather yield a net cost.18
Evidence is less clear, and there is more debate, about (1) whether clinical preventive services
may yield savings in a broader context (considering, for example, the value of lost workdays
prevented), and (2) what savings, if any, may accrue to the federal government or society as a
result of possible expansions of community-based prevention activities.
Beneficiary cost-sharing has been shown to decrease utilization of certain preventive services, in
some contexts. Based on an evidence review, the Task Force on Community Preventive Services
(which is administered by CDC) recommends reducing beneficiary cost-sharing in order to
increase utilization of screening mammography. However, the Task Force found insufficient
evidence to make the same recommendation for cervical or colorectal cancer screening.19
Current law addresses prevention in several ways, including through (1) coverage of certain
clinical preventive services under Medicare and Medicaid; (2) community-based research, disease
prevention, and health promotion programs, which may be funded through federal grants; (3)
support of evidence review processes to determine whether specific clinical and community-
based prevention interventions are effective;20 and (4) regulation of certain employer-provided
wellness programs, in order to strike a balance between flexibility and compliance with current
federal privacy, civil rights, and other laws.21
Coverage of Clinical Preventive Services
While federal law does not mandate coverage of preventive services for state and local
government and private health insurance plans, Medicare Part B covers a number of clinical
preventive services, including a one-time comprehensive examination, certain periodic cancer
screenings, and other services. Medicare Part B also covers vaccines against influenza,

18 See, for example, Louise B. Russell, “Preventing Chronic Disease: An Important Investment, But Don’t Count On
Cost Savings,” Health Affairs, vol. 28, no. 1 (January/February 2009), pp. 42-45; and Congressional Budget Office,
The Budgetary Effects of Expanding Governmental Support for Preventive Care and Wellness Services, Letter to the
Honorable Nathan Deal, August 7, 2009, http://www.cbo.gov/ftpdocs/104xx/doc10492/08-07-Prevention.pdf.
19 Task Force on Community Preventive Services, “Recommendations for Client- and Provider-directed Interventions
to Increase Breast, Cervical, and Colorectal Cancer Screening,” American Journal of Preventive Medicine, vol. 35,
suppl. 1 (2008), pp. S21-25. See also CDC, http://www.thecommunityguide.org/cancer/screening/client-oriented/
ReducingOutOfPocketCosts.html.
20 See the U.S. Preventive Services Task Force, established in Section 915(a) of the PHSA, http://www.ahrq.gov/clinic/
uspstfix.htm; and the Task Force on Community Preventive Services, not explicitly authorized but conducted under
general authorities in Title III of the PHSA, http://www.thecommunityguide.org/index.html.
21 CRS Report R40661, Wellness Programs: Selected Legal Issues, coordinated by Nancy Lee Jones.
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pneumococcus, and, for individuals at increased risk, hepatitis B. Medicare Part D covers any
FDA-licensed vaccine, when prescribed by a recognized provider. Congress has waived cost-
sharing for some, but not all, Medicare covered preventive services in Part B. Medicare
Advantage (Part C) is an alternative way for Medicare beneficiaries to receive covered benefits
through private health plans. Medicare Advantage plans must cover benefits covered under Part
B,22 but have considerable flexibility in how they apply or waive cost-sharing. Many of these
plans waive cost-sharing for preventive services.
State Medicaid plans must cover a package of preventive services under the Early and Periodic
Screening, Diagnostic, and Treatment Services program (EPSDT), for beneficiaries under 21
years of age. Current law does not explicitly require that Medicaid state plans cover preventive
services for adults, although coverage may be required if a service meets another applicable
requirement, such as a physician’s service.
Sec. 222. Essential Benefits Package Defined
Title II of Division A of this bill would establish requirements for “qualified health benefits
plans” (QHBPs), which are plans that provide private health insurance, as well as the public
insurance option, that meet new federal requirements regarding consumer protections and other
matters. QHBPs would be required to cover, at a minimum, a specified list of services
constituting an “essential benefits package.” This section would define the required elements of
this package to include preventive services, among others. Covered preventive services would
include services recommended (i.e., given a grade of A or B) by the Task Force on Clinical
Preventive Services (established by this bill) and vaccines recommended by the CDC. Cost-
sharing would be waived for these covered preventive services, as well as for required well-baby
and well-child care. Cost-sharing would apply, with certain stipulations, to other services in the
essential benefits package.
Sec. 1305. Medicare Coverage and Waiver of Cost-Sharing
This section would amend SSA Sec. 1861 to define “Medicare covered preventive services” as a
specified list of currently covered services, and any services subsequently covered under the
Secretary’s administrative authority. Coverage would be subject to conditions and limitations that
currently apply to each listed service, except that any cost-sharing (deductible and/or
coinsurance) that currently applies would be waived.
Sec. 1306. Waiver of Medicare Deductible for Colorectal Cancer Screening
This section would amend SSA Sec. 1833 to clarify that coinsurance and the deductible would be
waived for colorectal cancer screening services regardless of the code applied, of the
establishment of a diagnosis, or of the removal of tissue or other matter or other procedure that is
performed in connection with and as a result of the screening test.

22 Medicare Advantage plans must also cover all Part A services, except hospice care. CRS Report R40374, Medicare
Advantage
, by Paulette C. Morgan.
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Sec. 1310. Expanding Access to Vaccines Under Medicare
This section would provide Medicare Part B coverage for all federally recommended vaccines,
defined as any approved vaccine that is recommended by the CDC upon advice from the
Advisory Committee on Immunization Practices.
Sec. 1311. Expansion of Medicare Covered Preventive Services at FQHCs
This section would amend SSA Sec. 1861 to provide that FQHCs may receive Medicare
reimbursement for Medicare covered preventive services, as defined in Sec. 1305 of this bill.
Sec. 1313. Certified Diabetes Educators as Certified Medicare Providers
This section would amend SSA Sec. 1861 to designate certain certified diabetes educators as
Medicare-certified providers of covered diabetes self-management training (DSMT) services. A
“certified diabetes educator” would be defined as an individual who meets specified criteria,
including certification by a “recognized certifying body,” which also would be defined.
Sec. 1711. Medicaid Coverage of Preventive Services
This section would amend SSA Sec. 1905 to require Medicaid state plans to cover, for all
beneficiaries, preventive services that the Secretary determines are (1) services recommended by
the Task Force on Clinical Preventive Services (established by this bill), or vaccines
recommended by the CDC; and (2) appropriate for Medicaid beneficiaries.23 Beneficiary cost-
sharing would not be required.24
Sec. 1712. Medicaid Coverage of Tobacco Cessation Products
Federal Medicaid law requires states that cover outpatient drugs (which all states do) to cover all
drugs for which manufacturers have rebate agreements in place with the federal Medicaid
program. SSA Sec. 1927 lists 11 drug categories, including smoking cessation products, that
states are permitted to exclude from their coverage of outpatient drugs. This section would
remove smoking cessation products from the list of excluded drugs, thereby requiring state
Medicaid plans to cover prescription and non-prescription FDA-approved smoking cessation
products for which rebate agreements are in effect.

23 In addition, this section would clarify that vaccines covered under the Vaccines for Children (VFC) program are
those recommended by the CDC Director, rather than an advisory committee to the Director. Under the VFC program,
Medicaid assumes the costs for certain low-income children who receive recommended vaccinations. SSA Sec. 1928(g)
provides that Sec. 1928 (and, therefore, the VFC program) would cease to be in effect if federal law were to provide for
immunization services for all children as part of a broad-based reform of the national health care system. This section
of the bill would also strike SSA Sec. 1928(g).
24 For more information about cost-sharing in Medicaid, see CRS Report RS22578, Medicaid Cost-Sharing Under the
Deficit Reduction Act of 2005 (DRA)
, by Elicia J. Herz.
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Sec. 1725. Including Public Health Clinics in the Vaccines for Children
Program

This section would amend SSA Sec. 1928 to add public health clinics to the list of providers that
may administer vaccines to eligible children under the Vaccines for Children (VFC) program.25
SSA Sec. 1928 authorizes the VFC program, under which Medicaid assumes the costs for
providing certain low-income children with recommended vaccinations. Medicaid law currently
defines VFC-eligible children as those who are eligible for Medicaid; who are uninsured; who do
not have health insurance coverage for vaccines and receive vaccines purchased through VFC and
administered at a FQHC or rural health clinic; or who are Indians.
Provisions in the Public Health Service Act
Sec. 2301. Prevention and Wellness
This provision would create a new PHSA Title XXXI–Prevention and Wellness, consisting of
several new PHSA subtitles and sections, as described below.
Subtitle A, Sec. 3111–Prevention and Wellness Trust would establish a Prevention and
Wellness Trust and authorize the appropriation to the Trust of funds from the Public Health
Investment Fund as established in Sec. 2002 of this bill, as follows: $2.400 billion for FY2011;
$2.845 billion for FY2012; $3.100 billion for FY2013; $3.455 billion for FY2014; and $3.600
billion for FY2015. Amounts in the Trust would be available for carrying out this title as provided
in advance in appropriation acts. The provision would authorize the appropriation from the Trust
of specified amounts for specified subtitles or sections in this title for each of FY2011 through
FY2015. (These amounts are provided with the summaries of each provision, below.)
Subtitle B, Sec. 3121–National Prevention and Wellness Strategy would require the Secretary
to submit to Congress, and update biennially, a National Prevention and Wellness Strategy (“the
Strategy”) to improve the nation’s health through evidence-based clinical and community-based
prevention and wellness activities, including public health infrastructure improvements. The
strategy would include goals and priorities, and identify health disparities in prevention, among
other things.
Subtitle C, Secs. 3131 and 3132–Prevention Task Forces would require the Secretary to
establish two task forces: a Task Force on Clinical Preventive Services, to be administered by the
Agency for Healthcare Research and Quality (AHRQ), and a Task Force on Community
Preventive Services, to be administered by CDC.26 Each task force would be required, among
other things, to review evidence regarding the benefits, effectiveness, appropriateness, and costs
of clinical or community preventive services, respectively, and to develop and disseminate
recommendations for the use of such services. Each task force would also be required to convene
an advisory stakeholders board and would, in general, be subject to the Federal Advisory

25 “Public health clinic” is not defined in the SSA or in this bill.
26 In effect, this section would reauthorize or codify two existing task forces: the U.S. Preventive Services Task Force,
authorized in PHSA Sec. 915 (see http://www.ahrq.gov/clinic/uspstfix.htm for more information), and the Task Force
on Community Preventive Services, which is not explicitly authorized (see http://www.thecommunityguide.org for
more information).
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Committee Act (FACA). For carrying out this section, Sec. 3111 would authorize the
appropriation from the Trust of $30 million for each of FY2011 through FY2015. (See also new
Subtitle G below, regarding the transition of functions from the existing task forces to the task
forces established under this section.)
Subtitle D, Secs. 3141, 3142, and 3143–Prevention and Wellness Research. Sec. 3141 would
require the Directors of the CDC and NIH, in conducting or supporting research on prevention
and wellness, to take into consideration the Strategy and the recommendations of the Task Forces
on Clinical and Community Preventive Services.
Sec. 3142 would require the Secretary, through the CDC Director, to conduct, or award grants for,
research in prevention and wellness priority areas identified in the Strategy, or by the Task Forces.
Sec. 3143 would require the Secretary to fund research and demonstration projects on the use of
incentives to encourage individuals and communities to promote wellness, adopt healthy
behaviors, and use evidence-based preventive services. Projects would focus on tobacco use,
obesity, and other priorities identified in the Strategy under PHSA Sec. 3121, as established by
this bill. If, on the basis of project findings, the Task Force on Clinical Preventive Services
determines that an incentive is effective and should be recommended, the Secretary would be
required to ensure that it is included in the essential benefits package under Sec. 222 of this bill.
Similarly, if the Task Force on Community Preventive Services determines that an incentive is
effective, the Secretary would be required to ensure that it is an allowable use of grant funds
under PHSA Sec. 3151, as established by this bill. The Secretary would also be required to ensure
that any incentive does not have a discriminatory effect on the basis of any personal characteristic
extraneous to the provision of health care or related services, and is not tied to premiums or cost-
sharing under any qualified health benefits plan, as defined in Sec. 100 of this bill.
For carrying out this subtitle, Sec. 3111 would authorize the appropriation from the Trust of the
following amounts: $155 million for FY2011; $205 million for FY2012; $255 million for
FY2013; $305 million for FY2014; and $355 million for FY2015.
Subtitle E, Sec. 3151–Delivery of Community Prevention and Wellness Services would
require the Secretary, through the CDC Director, to award grants for programs to deliver
prevention and wellness services that address priority areas identified in the Strategy. Program
requirements would emphasize services intended to reduce health disparities. Funds could not be
used for construction, or to fund services that would otherwise be covered by public or private
health care programs. For carrying out this section, Sec. 3111 would authorize the appropriation
from the Trust of the following amounts: $1.065 billion for FY2011; $1.260 billion for FY2012;
$1.365 billion for FY2013; $1.570 billion for FY2014; and $1.600 billion for FY2015.
Subtitle F, Secs. 3161 and 3162–Core Public Health Infrastructure. Sec. 3161 would require
the Secretary to award grants to each state health department, and authorize the Secretary to
award competitive grants to state, local, and tribal health departments, to address core public
health infrastructure needs. A specified funding formula would apply to the mandatory grant
program; specified maintenance of effort requirements would apply to both grant programs. In
addition, the Secretary, acting through the CDC Director, would be required to develop and
implement a program of voluntary accreditation of state or local health departments and public
health laboratories. For carrying out this section, Sec. 3111 would authorize the appropriation
from the Trust of the following amounts: $800 million for FY2011; $1.000 billion for FY2012;
$1.100 billion for FY2013; $1.200 billion for FY2014; and $1.265 billion for FY2015.
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Sec. 3162 would require the Secretary to expand and improve the core public health infrastructure
and activities of the CDC to address unmet and emerging public health needs. For carrying out
this section, Sec. 3111 would authorize the appropriation from the Trust of $350 million for each
of FY2011 through FY2015.
Subtitle G, Sec. 3171–General Provisions would provide certain definitions applicable to this
new title, and procedures for the transition of the functions of the existing U.S. Preventive
Services Task Force and Task Force on Community Preventive Services to the Task Force on
Clinical Preventive Services and the Task Force on Community Preventive Services, established
under Secs. 3131 and 3132 of this bill.
Sec. 2525. WISEWOMAN Program
This section would amend PHSA Sec. 1509 to reauthorize the WISEWOMAN program. This
CDC grant program funds demonstration programs to provide preventive services (such as blood
pressure and cholesterol screening) and appropriate follow-up to low-income women. Only states
that receive funding to provide breast and cervical cancer screening services to low-income
women (authorized under PHSA Sec. 1501) are eligible for these grants. Appropriations authority
for the WISEWOMAN program expired at the end of FY2003, but the program has continued to
receive funding. Although PHSA Sec. 1509 authorizes grants to no more than 3 states, currently
19 states and 2 tribal organizations receive funding, under the Secretary’s general authority to
award grants for public health and disease prevention programs in PHSA Title III.
This section would remove the 3-state limit and authorize the appropriation of the following
amounts for the WISEWOMAN program: $70.0 million for FY2011, $73.5 million for FY2012,
$77.0 million for FY2013, $81.0 million for FY2014, and $85.0 million for FY2015.
Sec. 2530. Grants to Promote Positive Health Behaviors and Outcomes
This section would amend PHSA Title III, Part P by adding a new Sec. 399V authorizing the
Secretary, in collaboration with CDC and other federal officials as appropriate, to award grants to
public and nonprofit private entities (including FQHCs and public health departments) to promote
positive health behaviors for populations in medically underserved communities through the use
of community health workers. Grants would be used to provide training support to community
health workers, subject to federal guidelines. Those workers, in turn, would provide education,
guidance, and outreach to communities regarding: health problems that are prevalent in the
medically underserved; effective strategies to promote positive health behaviors; enrollment in
health insurance programs, including CHIP and Medicaid; referral to appropriate health care
agencies and community-based programs and organizations; and access to home visitation
services to promote maternal health and prenatal care.
The Secretary would be required to give priority to grant applicants that propose to target
geographic areas with a high percentage of residents who are eligible for health insurance but are
uninsured or underinsured, a high percentage of residents who suffer from chronic diseases, and a
high infant mortality rate. The Secretary also would be required to prioritize applicants with
experience in providing health and social services to underserved individuals and engaging
community health workers.
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The Secretary would be required to encourage funded programs to implement an outcome-based
payment system that rewards community health workers for connecting underserved populations
with the most appropriate and timely services. Finally, the Secretary would have to report to
Congress regarding specified aspects of the program not later than four years after grants are first
awarded. There would be authorized to be appropriated $30 million to carry out the grant
program for each of FY2011 through FY2015.
Sec. 2535. Community-Based Overweight and Obesity Prevention Program
This section would amend PHSA Title III, Part Q by adding a new Sec. 399W-1, requiring the
Secretary to award grants and contracts for an evidence-based, community-based overweight and
obesity prevention program. Funds would be awarded for five year periods (renewable for
demonstrated performance) to community partnerships that demonstrate broad stakeholder
involvement. Awardees would be required to match $1 for every $9 of federal funds, and meet
specified maintenance of effort requirements. Funds could not be used to provide health care
services that could be covered through existing public or private programs. Preference would be
given to entities that serve communities with high levels of overweight and obesity and related
chronic diseases, or that plan to implement programs in school or workplace settings. There
would be authorized to be appropriated $10 million for FY2011 and SSAN for each of FY2012
through FY2015.
Employer-Provided Wellness Programs
Increasingly, employers are offering incentives to encourage their employees to participate in
worksite health and wellness programs. Employer-sponsored wellness programs are subject to
Health Insurance Portability and Accountability Act’s (HIPAA’s) nondiscrimination rules and,
depending on their design, may also be affected by other statutes such as the Americans with
Disabilities Act (ADA).27 Generally, HIPAA prohibits an employer-sponsored health plan from
denying enrollment or increasing an individual’s premium contribution based on the individual’s
health status. However, the law provides an exception for plans that offer financial incentives
(e.g., premium rebates, lower deductibles) to join a wellness program. A program that provides an
incentive simply to encourage participation is considered nondiscriminatory under HIPAA (e.g.,
reimbursing the cost of a gym membership, or offering an incentive to participate in a smoking
cessation clinic, regardless of outcome). But a wellness program that provides an incentive based
on achieving a specified health-related outcome, such as giving up smoking or reaching a stated
weight loss goal, must meet certain requirements in order to be considered nondiscriminatory.
Those requirements include having a program that is reasonably designed to promote health or
prevent disease, offering the program to all eligible employees, and providing a reasonable
alternative to individuals for whom it would be unreasonably difficult or medically inadvisable to
attempt to satisfy the goal.28

27 42 U.S.C. §§ 12101 et seq.
28 Nondiscrimination and Wellness Programs in Health Coverage in the Group Market, 71 Fed. Reg. 75014 (Dec. 13,
2006). See also CRS Report R40661, Wellness Programs: Selected Legal Issues, coordinated by Nancy Lee Jones; and
CRS Report R40791, Employer Wellness Programs: Health Reform and the Genetic Information Nondiscrimination
Act
, by Amanda K. Sarata.
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The ADA, which in part prohibits an employer from discriminating against an individual with a
disability with regard to employment and benefits, specifically exempts health programs from its
requirements if (1) participation in the program is voluntary and (2) the health information is
treated confidentially, kept separate from other employment records, and not used to limit health
insurance coverage. However, according to Equal Employment Opportunity Commission (EEOC)
guidance on ADA enforcement, offering an incentive may render a wellness program involuntary
if it is required in order to participate in an employer’s insurance program.29
Employer-sponsored wellness programs also are subject to federal health privacy laws. Generally,
individually identifiable health information acquired through a wellness program is protected
under the HIPAA privacy rule if (1) the program is considered a part of the health plan, (2) the
program provides and bills for health care services, or (3) the program is operated outside of the
health plan by an entity that has a HIPAA-compliant business associate contract with the plan.
ARRA strengthened the privacy rule’s business associate requirements, making such entities
criminally liable if they violate the HIPAA privacy protections. The HIPAA privacy rule allows
health plans to disclose health information to employers, subject to certain conditions that include
prohibiting the use of such information for employment-related actions.
Sec. 112. Wellness Program Grants
This section would require the Secretaries of HHS and Labor jointly to establish a grant program
to help small employers (to be defined) cover 50% of the costs of providing employee wellness
programs. Allowable costs would be those attributable to the wellness program (excluding the
cost of food), and not to the health plan or health insurance coverage offered in connection with
such a plan. Grants for a given plan year would be capped at $150 per employee. Grants could be
provided for up to three years and would be capped at $50,000, in total, for an employer.
A qualified wellness program would be jointly certified by the Secretaries of HHS and Labor as
meeting several criteria, including (1) being consistent with current evidence-based research and
best practices; (2) being culturally appropriate, and accessible for individuals with disabilities and
with limited English proficiency, among others; (3) having a number of required components,
including health awareness, health education, periodic screenings, employee engagement, and
listed behavioral change activities (including smoking cessation and weight reduction); and (4)
having supportive work policies regarding tobacco use, food choices, stress management, and
physical activity. A program could not be certified unless each required program component were
available to all employees. Employee participation could not be mandated. Qualified programs
could provide incentives for participation provided such incentives are not tied to the premium or
cost-sharing of the individual under the health benefits plan. Any employee health information
collected through the wellness program would be confidential and could not be used for purposes
other than administration of the program.
There would be authorized to be appropriated SSAN to carry out this section.

29 http://www.eeoc.gov/foia/letters/2009/ada_disability_medexam_healthrisk.html. For a more detailed discussion see
CRS Report R40661, Wellness Programs: Selected Legal Issues, coordinated by Nancy Lee Jones.
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Other Provisions
Sec. 2524. School Influenza Vaccination Centers
This section would require the Secretary to award grants for demonstration programs to study the
feasibility of using elementary and secondary schools as influenza vaccination centers. The
Secretary would be required to coordinate with the Secretaries of Labor and Education, state
Medicaid agencies, state insurance agencies, and private insurers, to ensure that children have
coverage for the costs of influenza vaccinations, including purchasing and administering the
vaccine outside of the physician’s office in a school or other related setting. The participation of
any school or individual would be voluntary.
The grant program would cover the costs of influenza vaccine and its administration for children
who are not otherwise covered by an existing federal program or private insurance. Children
eligible to receive influenza vaccines under existing federal programs would not be covered under
this program. The Secretary would be required to ensure that this program adheres to the HIPAA
privacy rule, which addresses the use and disclosure of personal health information, and Sec. 444
of the Family Educational Rights and Privacy Act of 1974 (FERPA), which addresses the use and
disclosure of information in students’ education records. The Secretary would be required to
award: (1) a minimum of 10 grants in 10 different states to eligible partnerships that each include
one or more public schools serving primarily low-income students (as defined); and (2) a
minimum of 5 grants in 5 different states to eligible partnerships that each include one or more
public schools located in a rural local education agency.
Within 90 days of its completion, the Secretary would be required to report to Congress on the
effect of the program on influenza vaccination rates, including an assessment of the utility of
using elementary and secondary school vaccination programs to respond to seasonal influenza
and an influenza pandemic. There would be authorized to be appropriated SSAN to carry out the
program for each of FY2011 through FY2015.
Sec. 2594. Diabetes Screening Collaboration and Outreach Program
This section would require the Secretary, in consultation with specified government agencies and
private groups, to review and report to Congress regarding the utilization of benefits for
recommended diabetes screening and any problems with utilization or associated data collection,
and to establish an outreach program to increase awareness among seniors and providers of
diabetes screening benefits.
Maternal and Child Health
Maternal and Early Childhood Home Visitation
Home visiting is used to deliver support and services to families or individuals in their homes.
Early childhood home visitation programs typically seek to improve maternal and child health;
early childhood social, emotional, and cognitive development; and family/parent functioning.
Depending on the particular model of early home visitation being used, the visitors may be
specially trained nurses, other professionals, or paraprofessionals. Visits may occur on a weekly
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basis, may begin during a woman’s pregnancy or some time after the birth of a child, and may
continue until the child reaches his/her second birthday (in some cases) or enters kindergarten.
Participation of families is voluntary. Early childhood home visitation programs are in operation
in all 50 states and the District of Columbia. No federal program provides funds exclusively for
early childhood home visitation programs. However, in addition to private and state and local
public funds, several federal programs have been tapped to support home visitation. Among
others, these include Medicaid, the Temporary Assistance for Needy Families block grant, the
Social Services Block Grant, Community-Based Grants to Prevent Child Abuse and Neglect, the
Promoting Safe and Stable Families Program, the Maternal and Child Health (MCH) block grant,
Healthy Start, and Early Head Start. For more information, see CRS Report R40705, Home
Visitation for Families with Young Children.

Title IV-B of the Social Security Act (SSA) authorizes formula grants to states, territories and
tribes for the provision of a range of child and family services. Those services are generally
intended to ensure the safety of children and the well-being of children and their families, and to
enable and ensure that children have a permanent family to call their own. Subpart 1 authorizes
the Stephanie Tubbs Jones Child Welfare Services program. Subpart 2 authorizes the Promoting
Safe and Stable Families program. Both programs are administered at the federal level by the
Administration for Children and Families, (ACF) within HHS. There is no current law provision
for formula grants to states to support home visitation programs for families with young children
and those expecting children.
Sec. 1904. Home Visitation State Grant Program
This section would add a new SSA Title IV-B, Subpart 3 to provide funds to states, territories
and tribes for the establishment and expansion of voluntary home visitation programs for families
with young children (under school age) and families expecting children and is intended to
improve the well-being, health, and development of children. States would need to conduct a
statewide needs assessment to determine current services and capacity of home visitation
programs; sources of and amounts of funding for these programs; families and individuals served
and gaps in the services; and training and technical assistance offered to support the goals of
current programs. The results of the assessment would need to be submitted in the state’s grant
application. That application would further need to describe the home visitation programs the
state plans to support, outcomes intended to be achieved, and evidence to support the
effectiveness of those programs. It would further need to provide assurances, including the state’s
commitment to identifying and prioritizing support to home visitation programs serving high-
need communities; reserving 5% of the grant fund for training and technical assistance; and
providing annual reports to the Secretary on the programs funded with the grant, including
characteristics of programs funded and families served as well as outcomes achieved and other
information.
The Secretary would be required to make an allotment of funds to each state that successfully
applied and met the maintenance of effort requirement. Beginning with FY2011, a state would not
be eligible for these funds unless the Secretary determined its combined spending from state and
local sources for early childhood home visitation programs was no less in the immediately
preceding fiscal year than in the fiscal year prior to that. Each state’s allotment amount would be
based on its relative share of children living in families with incomes at or below 200% of the
federal poverty level. To receive its full allotment a state would need to provide non-federal
funding of no less than 15% of the total dollars spent under the early childhood home visitation
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program in FY2010; no less than 20% of that spending in FY2011; and no less than 25% in
FY2012 and succeeding fiscal years.
To be counted as spending under this program, services would need to be provided on a voluntary
basis to families expecting children or those with children under the age of entry to school, and
they must delivered under a home visitation program that adheres to a clear, evidence-based
service delivery model with demonstrated positive effects on child and parent outcomes (such as
reducing child abuse and neglect and improving child health and development) and meet other
criteria that would be specified in law. States would be permitted to use part of the program
funding, declining over time, on home visitation programs that do not meet the “strongest
evidence of effectiveness.” The Secretary would be required to provide an interim report on an
independent evaluation of the home visitation program within three years of enactment and a final
report on the evaluation within five years. Further, HHS would be required to submit a report to
Congress, annually, on activities carried out with funds provided under the home visitation
program.
The section would appropriate a total of $750 million for the early childhood home visitation
program over five years, as follows: $50 million for FY2010; $100 million for FY2011; $150
million for FY2012; $200 million for FY2013; and $250 million for FY2014. Of these amounts,
5% must be reserved for federal evaluation, training and technical assistance related to the
program and, after that reservation, 3% of the remaining funds must be used to support tribal
home visitation programs.
Postpartum Depression
Sec. 2529. Research and Screening
This section would encourage the Secretary to expand and intensify research on the causes of, and
treatments for, postpartum depression and other conditions, including conducting basis research
and epidemiological studies, improving screening and diagnostic techniques, and developing
information and education programs. The Secretary would be required to study and, within two
years of enactment, report to Congress on the benefits of screening for postpartum conditions. It
would be the sense of Congress that the Director of the National Institute of Mental Health may
conduct a nationally representative longitudinal study, between FY2011 and FY2020, on the
relative mental health consequences for women of resolving a pregnancy (intended and
unintended) in various ways. There would be authorized to be appropriated to carry out this
section, in addition to any other amounts authorized to be appropriated for such purpose, SSAN
for FY2011 through FY2013.
Teen Pregnancy
PHSA Title XX, Adolescent Family Life Demonstration Projects, authorizes a number of
voluntary teen pregnancy prevention, counseling, and related programs. The Secretary may award
demonstration grants to public or nonprofit private entities to provide care and/or prevention
services (including educational services) according to specified requirements. Grantees are
required to evaluate program results and report to the Secretary, and the Secretary is authorized to
support research on teen pregnancy prevention. PHSA Title X, Population Research and
Voluntary Family Planning Programs, authorizes grants for comprehensive voluntary family
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planning services, education, and research, including such activities regarding adolescents. There
are several other federal programs that provide information about contraceptives, provide
contraceptive services to teens, and provide referral and counseling services related to
reproductive health. They include Medicaid family planning, the MCH block grant, the Title XX
Social Services block grant, and the Temporary Assistance for Needy Families (TANF) block
grant.
In addition, SSA Sec. 510 authorizes a state formula grant program to support abstinence
education programs for adolescents. Funds are awarded to states based on the proportion of low-
income children in each state compared to the national total, and may only be used for teaching
abstinence. Funds must be requested by states when they solicit MCH block grant funds. To
receive funding, a state must match every $4 in federal funds with $3 in state funds. Sec. 510
provided $50 million for each of the fiscal years FY1998 through FY2003. Although the program
has not been reauthorized, the latest of several extensions, included in the Medicare
Improvements for Patients and Providers Act of 2008, continued funding through June 30, 2009.
For more information, see CRS Report RS20873, Reducing Teen Pregnancy: Adolescent Family
Life and Abstinence Education Programs.

Sec. 2526. Healthy Teen Initiative To Prevent Teen Pregnancy
This section would add a new PHSA Sec. 317U, creating a state grant program for evidence-
based education programs to reduce teen pregnancy or sexually transmitted diseases. The amount
of funding provided to each state would be based on the proportion of the nation’s low-income
children residing in that state. States would be required to provide $1 in matching funds or in-
kind contributions for each $4 of grants funds, and use no more than 10% of the grant funds for
an independent evaluation of the program.
The Secretary would be required, within 180 days of enactment, to develop and periodically
update a registry of evidence-based, medically and scientifically accurate, age-appropriate
programs, from which the states would choose the programs they intend to use. The section
would authorize an appropriation of $50 million for each of FY2011 through FY2015.
Infant Mortality
Sec. 2532. Pilot Program to Support Social, Education, and Clinical Services
This section would require the Secretary, acting through the CDC Director, to award five-year
grants to state, county, city, territorial, or tribal health departments to create, implement and
oversee infant mortality programs that the Secretary deems likely to reduce infant mortality rates.
The pilot program would allow grantees to use the funds for a range of activities including
community need identification and strategy planning; outreach to at-risk mothers, including those
in rural areas; development and implementation of standardized systems to improve access,
utilization, and quality of social, education, and clinical services to promote healthy pregnancies,
full-term births, and healthy infancies; establishment of regional public education campaigns; and
provision of other activities, programs, or strategies as identified by the community plan. Each
pilot program would be allowed to use not more than 10% of the grant for program evaluation.
The Secretary would be required to give preference to applications regarding areas in the United
States with the highest rates of infant mortality. The section would authorize to be appropriated
$10 million for each of FY2011 through FY2015.
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Behavioral Health
Background and Issues
Existing behavioral health programs authorized under PHSA Title V and Title IX provide funding
for prevention and treatment of mental health and substance abuse problems. These programs are
administered by the Substance Abuse and Mental Health Services Administration (SAMHSA).
Appropriations authorities for most of the Title V programs have expired, though many of them
continue to receive funding.30 PHSA Title XXVII, Sec. 2705 requires insurers who choose to
offer coverage for behavioral health to provide it on par with their coverage for physical health
conditions.
In 2007, about 11% of Americans aged 18 or older (i.e., 23.7 million individuals) experienced
serious psychological distress, such as anxiety and mood disorders, that resulted in functional
impairment that impeded one or more major life activities. During the same year, an estimated
8% of Americans aged 12 or older (i.e., 19.9 million individuals) were current users of illicit
drugs.31 The behavioral health care system has numerous issues including access to and
availability of services, quality of care, insurance coverage and payment, and coordination of
care.32
The House legislation includes the following four sections that address behavioral health issues.
They focus on mental health parity, federally qualified behavioral health centers, training
programs, and postpartum depression.
Sec. 214 and Sec. 222. Parity for Mental Health and Substance Abuse Benefits
Under Sec. 214, QHBPs (including the public health insurance option) would be required to
comply with the existing parity rules regarding the amount, duration, and scope of mental health
and substance abuse benefits. Those rules do not mandate that plans provide behavioral health
coverage. However, Sec. 222 requires the essential benefits package, offered as part of the public
health insurance option, to include behavioral health services. Thus, the public health insurance
option would be required to offer full parity mental health and substance abuse treatment benefits.
Sec. 2513. Federally Qualified Behavioral Health Centers
This section would amend PHSA Sec. 1913 to establish federally qualified behavioral health
centers as part of SAMHSA’s Community Mental Health Services block grant. It would modify
the Secretary’s authority to waive the statutory requirement for states to maintain their efforts to
provide services to children with serious emotional disturbance at a certain level. The section

30 For more information on SAMHSA, see CRS Report RL33997, Substance Abuse and Mental Health Services
Administration (SAMHSA): Reauthorization Issues
, by Ramya Sundararaman.
31 Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, National
Survey on Drug Use and Health
, 2007, at http://www.oas.samhsa.gov/NSDUHlatest.htm. A “current user” is defined as
someone who used an illicit drug during the month prior to the survey interview.
32 For more information on issues related to the mental health care delivery system, see CRS Report R40536, The U.S.
Mental Health Delivery System Infrastructure: A Primer
, by Ramya Sundararaman.
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would delete the term “community mental health services” and insert the term “behavioral health
services.” In addition, it would replace the term “community mental health centers” with
“federally qualified behavioral health centers” in existing requirements for the venue where these
health services are provided. The section would require that services be provided through either
appropriate, qualified community programs or federally qualified behavioral health centers. The
section also would require an entity to be certified as a federally qualified behavioral health
center by the SAMHSA Administrator at least every five years, based on certain specified criteria.
The Administrator would be required to issue regulations for certifying these centers within 18
months of enactment.
Sec. 2522. Mental and Behavioral Health Training
This section would amend PHSA Title VII, Part E by adding at the end a new PHSA Sec. 775,
requiring HRSA to, among other things, establish a grant program to support interdisciplinary
mental and behavioral health training programs. Eligible entities would include (1) accredited
schools or programs of psychology, psychiatry, social work and other disciplines as specified; (2)
an accredited public or nonprofit private hospital; (3) a public or private nonprofit entity; or (4) a
consortium of two or more such entities. The Secretary would give preference to applicants who
have a demonstrated record of (1) training health professionals who serve in underserved
communities; (2) supporting teaching programs that address the health care needs of vulnerable
populations; (3) training individuals who are from underserved areas, minority groups or
disadvantaged backgrounds; (4) training individuals who serve geriatric populations; and (5)
training individuals who serve pediatric populations.
The Secretary would be required to submit an annual report to Congress on this program. There
would be authorized to be appropriated for this program $60 million for each of FY2011 through
FY2015. Of the amounts appropriated for each fiscal year, at least 15% would be required to be
used for psychology training programs.
Sec. 2538. Behavioral Health Services in Primary Care Settings
This section would add a new PHSA Sec. 544, requiring the Secretary to establish a program to
fund mental health and substance abuse screening, brief intervention, referral, and recovery
services in primary care settings. Eligible entities would include those that (1) provide primary
care services, (2) seek to integrate behavioral health into their services, (3) have working
relationships with behavioral health providers, (4) demonstrate the need to integrate behavioral
health into their services, and (5) agree to certain reporting requirements. The Secretary would
give preference to applicants who provide services in rural or frontier settings; school, college, or
university-based settings; or those who provide services to certain special needs populations. The
funding period would not exceed five years.
The Secretary would be required to submit an annual report to Congress on evaluation results and
performance measures of this program within four years of when funds are first appropriated for
it. There would be authorized to be appropriated for this program $30 million for FY2011 and
SSAN for FY2012 through FY2015. Of the amounts appropriated for each fiscal year, no more
than 5% would be used for program management.
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Quality
Background and Issues
Numerous stakeholders, including policymakers, have engaged in a wide range of efforts to try to
address the issue of health care quality. These efforts have generally focused on improving and
refining metrics for measuring the quality of care delivered in a number of settings; publicly
reporting comparative information on quality performance; and, in some cases, using metrics as
the basis for payment policies to demand provider accountability (value-based purchasing).
However, these efforts have not generally been guided by a single strategy, entity, or set of
priorities or goals, nor have they benefitted from a coordinated infrastructure specifically devoted
to improving health care quality.
Quality Measurements
There are no provisions in current law that require the development of national priorities for
performance improvement (directed either at the Secretary or AHRQ). However, the Secretary is
required by law to have in effect a contract with a consensus-based entity to perform a number of
duties, including to synthesize evidence and convene stakeholders to make recommendations on
an integrated national strategy and priorities for health care performance measurement in all
applicable settings.
AHRQ has significant existing statutory authorities under PHSA Title IX with respect to the
development of quality measures. This includes promoting health care quality improvement by
conducting and supporting research that develops and presents scientific evidence regarding all
aspects of health care, including methods for measuring quality and strategies for improving
quality. In addition, AHRQ’s role includes the ongoing development, testing, and dissemination
of quality measures, including measures of health and functional outcomes, and the compilation
and dissemination of health care quality measures developed in the private and public sector.
Current law does not set forth a process for, or require, multi-stakeholder input into the selection
of quality measures by the Secretary for use in CMS’s quality programs, such as Medicare’s
Physician Quality Reporting Initiative (PQRI) or the Reporting Hospital Quality Data for Annual
Payment Update (RHQDAPU) program.
H.R. 3962 includes the following sections, which together would require the development of an
explicit national effort to prioritize quality improvement activities; develop a comprehensive
repertoire of quality measures; formalize the role of multi-stakeholder input into the selection of
quality measures for use in health care programs; create a mechanism for evaluating the processes
used to collect quality data by the Secretary; and harmonize requirements across settings for the
use of endorsed measures (and instances in which non-endorsed measures may be selected).
Sec. 1441. Establishment of National Priorities for Quality Improvement
This section would amend SSA Title XI by adding a new Part E–Quality Improvement:
Establishment of National Priorities for Performance Improvement, and by creating a new SSA
Sec. 1191. It would require the Secretary to establish national priorities for performance
improvement and to solicit and consider recommendations from multiple outside stakeholders
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when establishing and updating these national priorities. When establishing the national priorities,
the Secretary would be required to give priority to care delivery areas that contribute to a large
burden of disease, have the greatest potential to decrease morbidity and mortality, and will
address health disparities, among others. For the purposes of carrying out this section, the
Secretary would be required to provide for the transfer, from the Medicare Part A and Part B trust
funds, of $2 million for each of FY2010 through FY2014. The section also would authorize the
appropriation of $2 million, for each of FY2010 through FY2014, from any funds in the Treasury
not otherwise appropriated.
Sec. 1442. Development of New Quality Measures
This provision would add two new sections to SSA Title XI, Part E (as established by Sec. 1441
of this bill). SSA Sec. 1192 would require the Secretary to enter into agreements with qualified
entities to develop quality measures for the delivery of health care services in the United States.
The Secretary would be required, as specified, to determine areas in which quality measures for
assessing health care services in the United States are needed. The section would require the
Secretary to make proposed quality measures available to the public and it would authorize the
Secretary to fund the testing of proposed quality measures by qualified entities and the updating,
by consensus-based entities, of quality measures that have been previously endorsed by such an
entity as new evidence is developed. For purposes of carrying out this section, the Secretary
would be required to provide for the transfer, from the Medicare Part A and Part B trust funds, of
$25 million for each of FY2010 through FY2014. In addition, the section would authorize the
appropriation of $25 million, for each of the FY2010 through FY2014, from any funds in the
Treasury not otherwise appropriated.
SSA Sec. 1193 would require GAO to periodically evaluate the implementation of the data
collection processes for quality measures used by the Secretary and to report to Congress and to
the Secretary on the findings and conclusions of the results of each such evaluation.
Sec. 1443. Selection of Quality Measures
This section would amend SSA Sec. 1808 to establish a process whereby multi-stakeholder
groups would formally provide input into the selection of Medicare quality measures.
Specifically, it would require the Secretary to make public quality measures being considered for
selection in rulemaking, and require the consensus-based entity that has entered into a contract
with the Secretary under SSA Sec. 1890 (i.e., National Quality Forum, NQF) to convene multi-
stakeholder groups to provide recommendations on the selection of individual or composite
quality measures for use in public reporting of performance information or in public health care
programs. The consensus-based entity, in convening multi-stakeholder groups, would be required
to provide for an open and transparent process for the activities conducted pursuant to such
convening. The section would further require the proposed rule to contain a summary of the
recommendations made by the multi-stakeholder groups, as well as other comments received
regarding the proposed measures, and the extent to which the proposed rule follows such
recommendations and the rationale for not following such recommendations.
For purposes of carrying out this section, the Secretary would be required to provide for the
transfer, from the Medicare Part A and Part B trust funds, of $1 million for each of FY2010
through FY2014. In addition, the section would authorize the appropriation of $1 million for each
of FY2010 through FY2014 from any funds in the Treasury not otherwise appropriated.
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Sec. 1444. Application of Quality Measures
Generally, this section would place requirements on the Secretary when selecting quality
measures for use in existing quality programs for inpatient hospital, outpatient hospital, physician
and renal dialysis services. These requirements relate to the endorsement of quality measures and
specifically amend relevant sections of the SSA33 to (1) require the Secretary to select endorsed
quality measures for the purposes of reporting quality data; (2) authorize the Secretary to select a
non-endorsed measure, if feasible and practical measures are not available, providing the
Secretary gives due consideration to endorsed or adopted measures; and (3) require the Secretary
to submit non-endorsed measures to NQF for consideration for endorsement, and if NQF were
not to endorse the measure, and the Secretary were to continue to use the measure, require the
Secretary to include the rationale for its continued use in rulemaking.
The section would, by amending SSA Sec. 1890(b)(2), require NQF to explain the reasons
underlying non-endorsement of a given measure, and to provide suggestions about changes to
such measure that might make such a measure potentially endorsable.
Sec. 1445. Consensus-Based Entity Funding
This section would amend SSA Sec. 1890(d) to provide for the transfer from the Medicare Part A
and Part B trust funds of $10 million for FY2009, and $12 million for each of FY2010 through
FY2012 to fund the activities of the consensus-based entity under contract in this section.
Sec. 1446. Quality Indicators for Care of People with Alzheimer’s Disease
This section would require the Secretary to develop quality indicators for the provision of medical
services to people with Alzheimer’s disease and other dementias and develop a plan for
implementing the indicators to measure the quality of care provided to individuals with these
conditions. Within 24 months of enactment, the Secretary would be required to report to Congress
on the status of the implementation of the requirements of this section.
Best Practices and Key Health Indicators
PHSA Title IX provides AHRQ with broad general authority to conduct and support research on
health care quality, including ways in which patients, consumers, purchasers, and practitioners
acquire new information about best practices and health benefits, and the determinants and impact
of their use of this information. In addition, AHRQ has the authority to provide financial
assistance for meeting the costs of planning and establishing new centers for multidisciplinary
health services research, demonstration projects, evaluations, training, and policy analysis.
There are a number of current efforts, some required by law, to collect and disseminate health
statistics on the U.S. population. Those activities are primarily directed by AHRQ and the CDC
National Center for Health Statistics (NCHS). AHRQ is required to submit two annual reports to
Congress: one on national trends in the quality of health care provided to the American people,

33 Specifically, this section would amend: (1) SSA Sec. 1886(b)(3)(B) for hospital inpatient services; (2) SSA Sec.
1833(t)(17) for outpatient hospital services; (3) SSA Sec. 1848(k)(2)(C)(ii) for physician services; and (4) SSA Sec.
1881(h)(2)(B)(ii) for renal dialysis services.
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and the other on prevailing disparities in health care delivery as they relate to racial and
socioeconomic factors in priority populations. NCHS conducts and supports statistical and
epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality
of health services in the United States. NCHS collects statistics on (1) the extent and nature of
illness and disability in the U.S. population; (2) the impact of illness and disability of the
population on the U.S. economy; (3) environmental, social, and other health hazards; (4)
determinants of health; (5) health resources; (6) utilization of health care; (7) health care costs
and financing; and (8) family formation, growth, and dissolution.
Sec. 2401. Implementation of Best Practices in the Delivery of Health Care
This section would amend PHSA Title IX by adding a new Part D–Implementation of Best
Practices in the Delivery of Health Care, which would establish within AHRQ a Center for
Quality Improvement. The Center would be required to prioritize areas for the identification,
development, evaluation, and implementation of best practices for quality improvement activities
in the delivery of health care services. In prioritizing these areas, the Center would have to
consider the national priorities for performance improvement established pursuant to SSA Sec.
1191 (as added by this bill) and key health indicators identified by the HHS Assistant Secretary
for Health Information (discussed below).
The section would require the Center to provide for the public dissemination of information with
respect to best practices and activities, and to submit an annual report to the Congress and the
Secretary on the activities conducted under this section. Until such time as initial national
priorities have been established, priority in initial quality improvement activities and initiatives
would have to be given to the following five areas: health care-associated infections, surgery,
emergency room, obstetrics, and pediatrics.
Sec. 2402. Assistant Secretary for Health Information
This section would amend PHSA Title XVII by adding a new PHSA Sec. 1709 to create an HHS
Assistant Secretary for Health Information. The Assistant Secretary would have a number of
responsibilities, mostly related to the collection, reporting, and publishing of information on key
health indicators; ensuring the sharing of relevant health data between federal departments; and
developing standards for the collection of health data; among others.
This section would require the Assistant Secretary to identify key health indicators and publish
statistics on such indicators not less than annually. The review, release, and dissemination of key
health indicators would be subject to the same OMB regulations, rules, processes, and procedures
that govern the review, release, and dissemination of Principal Federal Economic Indicators by
the Bureau of Labor Statistics. This section would require the Assistant Secretary to coordinate
with public and private entities that collect and disseminate information on health care and with
the National Coordinator for Health Information Technology (ONCHIT). The Assistant Secretary
would be required to submit an annual report to the Secretary and to Congress with an analysis of
and recommendations based on the health indicator data collected pursuant to this section, as
specified.
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Sec. 2403. Authorization of Appropriations
This section would amend new PHSA Sec. 799C (as established by Sec. 2216 of this bill),
authorizing to be appropriated from the Public Health Investment Fund, in addition to any other
amounts authorized to be appropriated for such purposes, $300 million for each of FY2011
through FY2015 to carry out PHSA Title IX, Part D and Sec. 1709.
Public Reporting of Health Care-Associated Infections
Current federal law does not, in general, require the reporting of health care-associated infections
(HAIs), although such reporting is required in a number of states. Provisions in current federal
law attempt to incentivize the reduction of some specific types of health-care acquired catheter-
associated infections (which are only one type of HAI) in two ways: through withholding of
Medicare reimbursement under certain circumstances, and through incentives for voluntary
physician and hospital reporting.
Sec. 1461. Public Reporting of Health Care-Associated Infection
This section would add a new SSA Sec. 1138A requiring the Secretary to provide, by regulation,
that in order to participate in Medicare and Medicaid, hospitals (including critical access
hospitals) and ambulatory surgical centers would have to report certain HAIs that develop in the
facility. The Secretary would be required to establish procedures regarding the validity of
reported data to ensure appropriate comparisons between facilities, and to post information online
in a manner that permits comparisons by facility and by patient demographic characteristics. The
section also would provide that it should not be construed as preempting or otherwise affecting
applicable state reporting laws.
Comparative Effectiveness Research
ARRA provided $1.1 billion for comparative effectiveness research and created the Federal
Coordinating Council for Comparative Effectiveness Research, an interagency advisory group
that is required to report to the President and Congress annually.34
Sec. 1401. Center for Comparative Effectiveness Research
This section would add a new SSA Sec. 1181, establishing a Center for Comparative
Effectiveness Research within the AHRQ, as well as an independent Comparative Effectiveness
Research Commission, to oversee and evaluate the activities carried out by the Center. The
Commission would represent broad constituencies of stakeholders, including clinicians, patients,
researchers, third-party payers, and consumers of federal and state beneficiary programs. Nothing
in the section would be construed to permit the Commission or the Center to mandate coverage,
reimbursement or other policies for any public or private payer. In no case could any research
conducted, supported, or developed by the Center, the Commission, or the Federal Coordinating
Council for Comparative Effectiveness Research be used by the federal government to deny or

34 For more information, see CRS Report R40181, Selected Health Funding in the American Recovery and
Reinvestment Act of 2009
, coordinated by C. Stephen Redhead.
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ration care. In addition, CMS could not use federally funded clinical comparative effectiveness
research data to make coverage determinations for medical treatments, services, or items under
the Medicare program on the basis of cost.
Sec. 1802. Comparative Effectiveness Research Trust Fund
This section would amend the Internal Revenue Code (IRC) by adding a new IRC Sec. 9511,
establishing the Health Care Comparative Effectiveness Research Trust Fund (CERTF) to fund
comparative effectiveness research activities. While activities in the initial years (2010-2012)
would be funded entirely from transfers from the Medicare trust funds, the CERTF would
eventually receive both public funds (from the Medicare trust funds) as well as monies from the
private sector through a fee imposed on health insurance and self-insured plans.
Medicare and Medicaid Nursing Homes
Secs. 1411-1432. Improving Transparency, Enforcement, and Staff Training
H.R. 3962 includes a number of provisions that would enhance a range of accountability
requirements for Medicare certified skilled nursing (SNF) and Medicaid certified nursing
facilities (NF). These provisions would require SNFs and NFs to maintain and make available
additional information on ownership and organizational structure, as well as to establish new staff
compliance and ethics training programs. GAO would be required to conduct a study and report
to Congress on SNF and NF undercapitalization.
The Secretary would be required to enhance the information available on the Medicare Nursing
Home Compare website for SNFs and NFs, and to make that information more easily accessible
to long-term care (LTC) consumers. SNFs would be required to report expenditures for wages and
benefits for direct care staff on facility cost reports. The Secretary would be required to consult
with government and private sector cost report experts to assist in categorizing by functional area
SNF expenditure data, as well as in making it publicly available. A new standardized complaint
form would be developed, and facilities and states would be required to make this form available
to all stakeholders and consumers. The new complaint form would be accompanied by whistle-
blower protections for SNF and NF staff who reported quality of care problems.
The Secretary would have to establish a process to require SNFs and NFs regularly to report
staffing data, including agency and contract staff, by staff position categories (based on payroll
and other verifiable and auditable data). The Secretary also would be required to submit a report
to Congress on staff accountability and would be required to establish a nationwide program for
national and state background checks on direct patient access employees of certain LTC facilities
or providers and provide federal matching funds to states to conduct these activities.
Additional civil money penalties would be established that both the Secretary and states could
impose on nursing facilities found to have quality of care and other deficiencies that jeopardized
residents’ safety. The Secretary would be required to develop, test, and implement a national
independent monitoring program for large interstate and intrastate SNF and NF chains. Further,
new requirements would be established for SNF and NF administrators to inform residents and
their representatives, as well as the Secretary, states, and other stakeholders of planned facility
closures. In addition, SNFs and NFs would be required to add additional staff training in the areas
of dementia and abuse prevention, and the Secretary would be required to study and report to
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Congress on the content of additional staff training for certified nurse aides and supervisors.
Finally, Medicare and Medicaid law would be amended to require the full-time director of food
services of a nursing facility, if not a qualified dietician, to be a Certified Dietary Manager or a
Registered Dietetic Technician or have equivalent military, academic, or other qualifications (as
specified by the Secretary).
Patient Navigators
PHSA Sec. 340A authorizes the Secretary to make grants to eligible entities for the development
and operation of demonstration programs to provide patient navigator services. Patient navigators
must have direct knowledge of the communities they serve, and perform the following duties,
among others: (1) facilitate involvement of community organizations in assisting individuals with
chronic diseases to receive better access to high-quality health care services; (2) help patients to
overcome barriers in the health care system to ensure prompt resolution of an abnormal finding of
a chronic disease; and (3) coordinate with relevant health insurance entities to provide
information to individuals with chronic diseases about health coverage.
Sec. 2537. Medical-Legal Partnerships
This section would require the Secretary to establish a nationwide demonstration project that
would award grants to medical-legal partnerships to assist patients in the navigation of health-
related programs and for the evaluation of the effectiveness of these partnerships. The
partnerships awarded funds under this section would be required to enhance access, improve
health outcomes, reduce disparities and prevent chronic conditions. The Secretary would be
required to submit a report to Congress on the results of this demonstration project. A medical-
legal partnership is defined as an entity that is a collaboration between a provider of health
services to a significant number of low-income beneficiaries and one or more attorneys, and
whose primary mission is the assistance of patients and their families with the navigation of
health care-related programs and activities. The section would authorize the appropriation of
SSAN for each of FY2011 through FY2015.
Health Disparities
Federal civil rights policy requires most health care providers to make interpretation services
available to patients with limited English proficiency (LEP). HHS regulations promulgated under
the Civil Rights Act require recipients of HHS financial assistance to provide meaningful access
by LEP persons. Recipients of HHS assistance include hospitals; nursing homes; home health
agencies; managed care organizations; universities; state, county, and local health agencies;
Medicaid agencies; public and private contractors; vendors; physicians; and other providers.
Providers who only receive Medicare Part B payments are not considered recipients of HHS
assistance.
Research has demonstrated that Medicare beneficiaries with LEP have a harder time accessing
health care than LEP seniors covered by Medicaid. Some authors have argued that this difference
may be attributed to the fact that federal civil rights policies require Medicaid health care
providers to offer language assistance, while physicians serving only Medicare patients are not
subject to the same requirements. Although all providers are bound by the Civil Rights Act, which
obligates health care professionals to make interpreters available to LEP patients, studies suggest
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that a lack of reimbursement for language services and poor enforcement of the Act has
sometimes made it difficult for LEP Medicare beneficiaries to access translation services.
Secs. 1221-1224. Medicare Beneficiaries with Limited English Proficiency
These sections would require the Secretary to conduct a study to examine the extent to which
Medicare providers utilize, offer, or make available language services for LEP, and the ways that
Medicare should develop payment systems for language services. The study would include an
analysis of ways to develop and structure appropriate payment systems for language services for
Medicare providers; the feasibility of adopting a payment methodology for on-site interpreters;
the feasibility of Medicare contracting directly with agencies that provide off-site interpretation,
including telephonic and video interpretation; the feasibility of modifying the existing Medicare
resource-based relative value scale (RBRVS) by using adjustments for LEP patients; and how
each of these options would be funded. It also would examine the nature and type of language
services provided to Medicaid beneficiaries, and whether these services could be used by
Medicare beneficiaries and providers. The potential payment systems included in the analysis
could allow variations based on types of service providers, available delivery methods, and costs
for providing language services. The Secretary would be authorized to apply sanctions, such as
civil money penalties, suspension of enrollment, and suspension of payments, to Medicare
Advantage organizations that fail to provide required language services to LEP beneficiaries
enrolled in their plans.
Within six months of the completion of the study, the Secretary would be required to carry out a
demonstration program under which the Secretary would award no fewer than 24 three-year
grants to eligible Medicare providers to improve effective communication between providers and
Medicare beneficiaries living in communities where racial and ethnic minorities, including
populations that face language barriers, are underserved with respect to such services. Grantees
would be required to provide the Secretary with annual reports, which would include (1) the
number of Medicare beneficiaries to whom language services are provided, (2) the languages of
those Medicare beneficiaries, (3) the types of language services provided, (4) the type of
interpretation, (5) the methods of providing language services, (6) the length of time for each
interpretation encounter, and (7) the costs of providing language services. No grant under this
program could exceed $500,000 for the three-year period.
The Secretary would be required to conduct an evaluation of the demonstration program and
submit a report to Congress not later than one year after the completion of the program. An
amount of $16 million would be authorized to be appropriated for each fiscal year of the
demonstration program.
The Secretary would be required to contract a study on the impact of language access services on
the health and health care of LEP populations and report the findings within three years of
enactment. The Secretary would be authorized to use $2 million from the Medicare Trust Fund to
pay for the study and report. Based on the study’s findings, the Secretary, in consultation with
patients, providers, and organizations representing the interests of LEP individuals, may opt to
designate one or more training or accreditation organizations to oversee translation services being
provided to Medicare beneficiaries.
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Health Information Technology
HIPAA Administrative Simplification
To promote the growth of electronic record keeping and claims processing in the nation’s health
care system, HIPAA’s Administrative Simplification provisions (SSA Secs. 1171-1179) instructed
the Secretary to adopt electronic format and data standards for nine specified administrative and
financial transactions between health care providers and health plans. Those transactions include
patient eligibility inquiry and response, reimbursement claims, claims status inquiry and response,
and payment and remittance advice. In addition, HIPAA directed the Secretary to adopt a standard
for transferring standard data elements among health plans for the coordination of benefits and
the sequential processing of claims. In 2000, CMS issued an initial set of standards for seven of
the nine transactions and for the coordination of benefits. As required under HIPAA, the Secretary
published updated standards in early 2009 to replace the versions currently is use. The
compliance deadline for the updated standards is January 1, 2012.
The health care payment and remittance advice transaction is a communication from a health plan
to a provider that includes an explanation of the claim and payment for that claim. The HIPAA
standard for this transaction can accommodate an electronic funds transfer (EFT), in which
payment is electronically deposited into a designated bank account. EFT is common in the health
care sector—health plan contracts often require it—but there is no EFT mandate in federal law for
Medicare, Medicaid, or private health insurance. In September 2005, CMS proposed a standard
for health care claims attachments, one of the two remaining transactions standards that must be
adopted. A claims attachment transaction is used to request and provide additional clinical data
necessary to adjudicate a claim.
HIPAA does not mandate that providers conduct the transactions electronically, though health
plans increasingly require it. However, providers that elect to submit one or more of the HIPAA
transactions electronically must comply with the standard for those transactions. In 2001,
Congress enacted the Administrative Simplification Compliance Act, which mandated that
Medicare claims be submitted electronically in the HIPAA standard format, with the exception of
those from small providers and in other limited circumstances.
The HIPAA electronic transactions standards, which are the result of a consensus-based
development process, include optional data/content fields that can accommodate plan-specific
information. Providers often are faced with a multiplicity of companion guides and plan-specific
requirements and must customize transactions on a plan-by-plan basis.
HIPAA instructed the Secretary to adopt unique identifiers for health care providers, health plans,
employers, and individuals for use in standard transactions. Unique identifiers for providers and
employers have been adopted, while the health plan identifier is still under review. Congress has
blocked the development of a unique individual identifier through language added to the annual
Labor-HHS appropriations bill.
HIPAA’s Administrative Simplification provisions also instructed the Secretary to develop
security standards to safeguard electronic health information from unauthorized access, use, and
disclosure, and to issue standards to protect the privacy of patient information. The HIPAA
privacy rule, which took effect in 2003, established a set of patient rights, including the right of
access to one’s medical information, and placed certain limitations of when and how health plans
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and health care providers may use and disclose patient information. The HITECH Act included a
series of privacy and security provisions that amended and expanded the current HIPAA
requirements. The HIPAA Administrative Simplification standards do not apply to the use and
disclosure of information by financial institutions that are responsible for authorizing, processing,
clearing, billing, transferring or collecting payments for premiums or health care.
Sec. 115. Administrative Simplification
This section would amend the HIPAA Administrative Simplification provisions by adding a new
SSA Sec. 1173A, requiring the Secretary, within two years of enactment, to adopt an additional
set of financial and administrative transactions standards to help clarify, complete, and expand the
existing standards. The goal would be for the standards to be unique (with no conflicting or
redundant standards), authoritative, and comprehensive, requiring minimal augmentation by
paper transactions. In addition, the standards would describe all data elements in unambiguous
terms and not permit optional fields. They would enable real-time (or near real-time)
determination of a patient’s financial responsibility at the point of service and adjudication of
claims, and harmonize all common data elements across transactions standards. Finally, the
standards would have to support electronic funds transfers as well as timely and transparent claim
and denial management processes, enable providers to quickly and efficiently enroll with a health
plan so as to conduct other electronic transactions, and provide for other requirements related to
administrative simplification as identified by the Secretary.
In developing the standards, the Secretary would be required to build upon existing and planned
standards and regularly update the new standards. Within six months of enactment, the Secretary
would be required to submit to Congress a plan for implementing and enforcing the new
standards within five years of enactment. The plan would have to include a timetable for
developing and regularly updating the new standards, implementation programs to help rural and
other providers, an estimate of the funding needed to ensure timely completion of the
implementation plan, and an enforcement process including timely investigation of complaints,
random audits, and a fair and reasonable appeals process. The Secretary would have to ensure that
all data collected pursuant to the new standards meets the HIPAA privacy and security
requirements, as modified by the HITECH Act.
In addition, the section would add a new SSA Sec. 1173B, requiring the Secretary to adopt an
interim companion guide (including operating rules) for each HIPAA electronic transaction to be
effective until the new standards, pursuant to Sec. 1173A, are adopted. In adopting the companion
guides the Secretary would be required to comply with the existing HIPAA requirements for
standards adoption and consult with a nonprofit entity that (1) is focused on administrative
simplification; (2) has an established multi-stakeholder, consensus-based process for creating
such rules; (3) employs a public set of guiding principles; (4) coordinates its activities with the
HIT Policy Committee and the HIT Standards Committee; (5) uses existing market research and
proven best practices; (6) employs a set a measures that allow for the evaluation of their market
impact and public reporting of aggregate stakeholder impact; (7) supports nondiscrimination and
conflict of interest policies; and (9) allows for public reviews and upgrades of the operating rules.
Companion guides for eligibility and claims status transactions must be adopted by October 1,
2011, and take effect no later than January 1, 2013. Companion guides for the remaining HIPAA
transactions must be adopted by October 1, 2012, and take effect no later than January 1, 2014.
The section would require the Secretary, within one year of enactment, to issue a final rule to
establish a standard for health claims attachment transactions and coordination of benefits. It
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would clarify that the HIPAA standards do not apply to the use and disclosure of information by
financial institutions that process payments unless they are business associates of health plans and
health care providers. Also, the Secretary would be required, within two years of enactment, to
issue a final rule to establish a unique health plan identifier. The rule could be an interim final
rule, effective not later than October 1, 2012. Finally, beginning January 1, 2015, the Secretary
would be prohibited from paying Medicare Part A and B claims other than by EFT, provided he
Secretary has adopted an EFT standard pursuant to Sec. 1173A. The electronic claims exemption
for small providers and in other limited circumstances would remain in effect.
Sec. 237 and Sec. 328. Application of Administrative Simplification Standards
HIPAA’s Administrative Simplification standards for electronic transactions, and health
information privacy and security would apply to QHBPs (Sec. 237) and to the public health
insurance option (Sec. 328).
Electronic Health Records
Congress enacted the HITECH Act to encourage the use of electronic health records (EHRs).
Among its provisions, the Act authorized Medicare and Medicaid bonus payments for eligible
professionals and hospitals participating in these programs as an incentive to become meaningful
users of certified EHR systems. Meaningful use is defined as using certified EHR technology for
the purpose of exchanging clinical information to improve the coordination and quality of care,
and using such technology to report clinical quality measures. For the Medicare incentives, an
eligible professional means a physician, dentist, podiatrist, optometrist, or chiropractor. For the
Medicaid incentives, an eligible professional is defined as (1) a non-hospital physician, dentist,
certified nurse mid-wife or nurse practitioner with at least a 30% Medicaid patient volume
(pediatricians must have at least a 20% Medicaid patient volume); (2) physician assistants that
meet certain specified requirements; and (3) FQHCs and rural health clinics with at least a 30%
patient volume made up of needy individuals, as defined.
ARRA provided $2 billion to fund activities and grant programs authorized by the HITECH Act.
They include the Health Information Technology Extension Program, which will establish a
national Health Information Technology Research Center and fund regional extension centers
around the country to offer technical and other assistance to health care providers.
Sec. 263. Electronic Health Record Use Among Small Health Care Providers
This section would authorize the Secretary to conduct a study of potential methods to increase the
use of EHRs among small health care providers, including providing higher reimbursement rates,
promoting low-cost EHR software, and offering training and technical assistance. By December
31, 2013, the Secretary would be required to report to Congress with recommendations for
increasing EHR use among small providers.
Telehealth
PHSA Sec. 330I authorizes four-year grants for telehealth networks and for telehealth resource
centers. PHSA Sec. 330L authorizes grants to provide incentives to coordinate telemedicine
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licensure among states. Appropriations authority for the two programs, which are administered by
HRSA’s Office for the Advancement of Telehealth (OAT), expired at the end of FY2006.
Sec. 2523. Telehealth Grant Programs
This section would amend PHSA Sec. 330I by reauthorizing grants for telehealth networks and
telehealth resource centers. The section would permit OAT to award such grants for projects that
demonstrate how telehealth technologies may be used to reduce health disparities, and it would
add skilled nursing facilities, among others, to the list of facilities that are eligible to participate in
a network. It also would expand the list of activities for which funds may be used to include
developing projects to use telehealth technology to facilitate collaboration between health care
providers, support telenursing services, and promote patient understanding and adherence to
national guidelines for personal health care. In addition, the section would establish new criteria
for giving funding preference to eligible applicants for both the telehealth network grants and the
telehealth recource center grants. Finally, it would amend existing reporting requirements to
require an annual report on the progress and accomplishments of the telehealth grant programs.
The section would authorize the appropriation of the following amounts for each of the two Sec.
330I telehealth grant programs: $10 million for FY2011, and SSAN for each of FY2012 through
FY2015. It also would amend PHSA Sec. 330L by authorizing the appropriation of $10 million
for FY2011, and SSAN for each of FY2012 through FY2015 for the telehealth licensure grants.
Emergency Care
Background and Issues
PHSA Title XII authorizes the Secretary, acting through HRSA, to fund trauma care research,
training, evaluations, and demonstration projects. Title XII, Part D, comprising Secs. 1241-1245,
authorizes grants to trauma centers operating in areas severely affected by drug-related violence
that have incurred substantial costs for providing uncompensated care. PHSA Title XXVIII
addresses preparedness for and response to bioterrorism and other public health emergencies.
Many trauma experts consider the first 60 minutes after an injury to be a so-called “golden hour”
when trauma care is most effective in saving lives. Given that the risk of death for severely
injured patients rises significantly after one hour, trauma systems strive to offer access within that
time period, from receipt of the initial emergency call to arrival at a trauma center. The
geographic distribution of trauma centers varies widely across states and regions. Many areas of
the country are not well served by trauma centers, while other areas may have a surplus of
centers, possibly leading to inefficiencies, lower patient volumes per center, and reduced quality
of care. More than 84% of U.S. residents can reach level I or II trauma center within an hour, but
access lags in rural areas.35
The Emergency Medical Treatment and Labor Act (EMTALA; SSA Sec. 1867) requires hospital
emergency departments to examine and treat any individual who comes to the hospital with an

35 Charles C. Branas, No Time to Spare: Improving Access to Trauma Care, University of Pennsylvania, Leonard
David Institute of Health Economics, September 2005, at http://www.upenn.edu/ldi/issuebrief11_1.pdf.
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emergency medical condition, and any woman who is in labor. EMTALA further requires
hospitals to offer treatment, within their capacity and with the individual’s consent, to stabilize
the emergency condition, or transfer the individual to another medical facility, subject to certain
restrictions. EMTALA does not preempt state or local laws unless they directly conflict with its
specific requirements. In addition, the Act prohibits discrimination and delay in examining or
treating emergency patients, and provides protections to whistleblowers who report violations of
its provisions.
Sec. 2551. Trauma Care Centers
This section would amend PHSA Secs. 1241-1245 by replacing the existing language with the
following new provisions.
Sec. 1241–Grants for Certain Trauma Centers would require the Secretary to establish a grant
program to fund (1) existing trauma centers to further their core missions or to provide
emergency relief to those at risk of closing or in need of financial assistance; and (2) grants to
local government and public or private nonprofit entities to establish new trauma centers in urban
areas with a substantial degree of trauma due to violent crimes. In states with a trauma care
system, a trauma center would not be eligible for such a grant unless it is part of the trauma care
component of the state plan for the provision of emergency care. The grantee trauma center
would have to be designated as a trauma center by the American College of Surgeons (ACS) or
the applicable state health or emergency medical services authority.
Sec. 1242–Preferences in Making Grants would require that when making grants to existing
centers the Secretary (1) reserve at least 25% for level III and IV trauma centers in rural and
underserved areas, (2) reserve at least 25% for level I and II trauma centers in urban areas, and (3)
give preference to areas with unmet needs for trauma services, centers receiving state or political
subdivision funding, centers with at least one graduation medical education fellowship program
in a specified trauma-related area, and those with a substantial commitment to serving vulnerable
populations. The section would require states and local entities to use nonfederal funds to
demonstrate financial support for the trauma center. It also would designate trauma center levels
for states that do not have trauma centers at designated levels, defining levels I and II as the
highest levels of trauma centers. The Secretary would be required to give preference, based on
geography and need, to certain applicants for grants made to new and existing trauma centers.
Sec. 1243–Certain Agreements would require grantee trauma centers to participate in a
professional trauma care system, where available, and maintain access to trauma services at
comparable levels to the prior year during the grant program. Moreover, these trauma centers
would be required to agree to provide data to a national and centralized registry of trauma centers,
in accordance with guidelines developed by the ACS and other requirements.
Sec. 1244–General Provisions would limit grants to three years (with a specific exception).
Receipt of a grant would not preclude a trauma center from being eligible for other grants
established by PHSA Sec. 1241(a), as amended. The section also would establish that of the total
amount appropriated for these grants in a fiscal year, 90% be used for core mission grants to
existing centers, and 10% be used to provide emergency relief to existing centers and to fund new
centers. The Secretary would be required to report biennially to Congress on the grant program.
Sec. 1245–Authorization of Appropriations would authorize to be appropriated for the trauma
care center grant program, in addition to any other authorization of appropriations for such
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purpose, $100 million for FY2011, and SSAN for each of FY2012 through FY2015. The
Secretary would be required to reallocate funds not used for providing emergency relief and for
establishing new trauma centers to fund the core mission of existing trauma centers.
Sec. 2552. Emergency Care Coordination
This section would amend PHSA Title XXVIII, Subtitle B by adding a new PHSA Sec. 2816,
establishing an Emergency Care Coordination Center within the Office of the Assistant Secretary
for Preparedness and Response (ASPR). The Secretary, acting through the Center Director, would
be required to coordinate with the Federal Interagency Committee on Emergency Medical
Services to promote and fund research in emergency medicine and trauma care, promote regional
partnerships in the emergency medical systems, and promote emergency medical systems’
preparedness. The section would establish the Council of Emergency Care, consisting of specified
experts, to advise the Director. The Secretary would be required to submit a report to Congress on
activities carried out under this section, including the issues of emergency department crowding
and delays in care. There would be authorized to be appropriated SSAN to carry out this section
for each of FY2010 through FY2014. All functions, personnel, assets, liabilities of, and
administrative actions applicable to, the existing Center would be transferred to the new Center
established by this section.
Sec. 2553. Regionalized Communication Systems for Emergency Care
Response

This section would amend PHSA Title III, Part B by adding a new PHSA Sec. 315, requiring the
Secretary, acting through the ASPR, to establish at least four multi-year demonstration projects to
design, implement and evaluate innovative models of regionalized, comprehensive, and
accountable emergency care systems. Entities eligible for funding would be partnerships between
one or more states and one or more local governments. The demonstration projects would: (1)
coordinate services across certain public agencies and medical facilities; (2) coordinate access to
the emergency medical and dispatch system; (3) include a mechanism to ensure that patients are
transported to medically appropriate facilities in a timely manner; (4) allow for tracking of
resources such as capacity at emergency departments and coordinate this information with
regional communications and hospital destination decisions; and (5) include a consistent region-
wide data management system, which complies with the National EMS Information System, the
National Trauma Data Bank and other specified registries, and can be used for evaluation.
Eligible entities would be required to submit an application, including certain required
information on appropriate coordination, systems compatibility, oversight, and surge capacity,
and also make nonfederal matching financial contributions to the activities as specified. Grantees
would be required to submit an evaluation report to the Secretary within 90 days of completion of
the demonstration project. The Secretary would be required to give funding priority to an eligible
entity that serves a medically underserved population as defined in PHSA 330(b)(3). The
Secretary also would be required to contract with an entity to independently evaluate the
demonstration programs and to make publicly available the findings of the evaluation.
There would be authorized to be appropriated to carry out this section $12 million for each of
FY2011 through FY2015. Three percent of the appropriated amount would be reserved to conduct
the independent evaluation.
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Sec. 2554. Emergency Medical Technician Training for Veterans
This section would further amend PHSA Title III by adding a new PHSA Sec. 315A, requiring
the Secretary to establish a state grant program to assist veterans who have received and
completed military emergency medical training during their active duty service in the U.S. Armed
Forces to become state licensed or certified emergency medical technicians (EMTs) upon their
discharge or release from active duty service. The grants could be used to fund training,
reimburse costs associated with training or when applying for EMT licensure, and expedite the
licensure process. To be eligible for a grant, a state would be required to demonstrate that the state
has a shortage of EMTs. There would be authorized to be appropriated to carry out the grant
program SSAN for each of FY2011 through FY2015.
The section would require the Secretary to submit to Congress an annual report on the program.
GAO would be required to conduct a study on the barriers experienced by veterans who received
medical training while serving on active duty service and, upon their discharge from active duty,
sought to become licensed as civilian health professionals. Within two years of enactment, GAO
would be required to report on the results of the study, including recommendations on expansion
of this EMT training program to other health professions.
Sec. 2555. Dental Emergency Responders: Public Health and Medical Response
This section would amend PHSA Sec. 2802 to clarify that dental health facilities and assets are to
be included in the development of national public health emergency preparedness goals in the
National Health Security Strategy, regarding matters of preparedness for and response to public
health emergencies. It also would amend PHSA Sec. 319F to clarify that emergency curricula and
training programs could be carried out at federal dental health facilities.
Sec. 2556. Dental Emergency Responders: Homeland Security
This section would amend Sec. 2 of the Homeland Security Act (HSA) to add emergency dental
personnel, agencies, and authorities to the definition of emergency response providers. It also
would amend Sec. 653 of the Post-Katrina Emergency Management Reform Act of 2006
(PKEMRA, Title VI of P.L. 109-295) to require that federal agency operational plans address the
“[t]he preparedness and deployment of public health, medical and dental resources.... ” Finally, it
would amend Sec. 516 of the HSA to state that the Chief Medical Officer of the Department of
Homeland Security serves as the Department’s primary point of contact with the medical and
dental communities.
Sec. 1908. Application of EMTALA
This section would clarify that nothing in the bill relieves any health care provider from providing
emergency services as required by federal and state laws, including EMTALA.
Pain Care and Management
Under general authorities in PHSA Title III and Title IV, NIH established the Pain Consortium to
enhance pain research and promote collaboration among researchers across various NIH Institutes
and Centers that have programs and activities addressing pain. In addition, PHSA Sec. 403
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requires the NIH Director to submit to the President and Congress a biennial report that includes,
among other things, a summary of the research activities throughout the agency organized by
category; the chronic disease category includes pain and palliative care.
The House legislation includes the following three sections that would address pain research,
education, and awareness for the purposes of recognizing pain as a national public health
problem.
Sec. 2561. Institute of Medicine Conference on Pain
This section would require the Secretary to seek an agreement with the Institute of Medicine
(IOM), or another appropriate entity if the IOM declines, to convene a Conference on Pain for the
purposes of increasing the recognition of pain as a significant public health problem in the United
States, among other purposes. It also would require a report summarizing the Conference’s
findings to be submitted to Congress. For the purpose of carrying out this section, the bill would
authorize to be appropriated $500,000 for each of FY2011 and FY2012.
Sec. 2562. Pain Research
This section would amend PHSA Title IV, Part B to add a new Sec. 409J, which would encourage
the NIH Director to continue and expand an aggressive program of research on the causes of and
potential treatment for pain through the Pain Consortium. The Pain Consortium, no less than
annually, would develop and submit to the NIH Director recommendations on appropriate pain
research initiatives that could be undertaken with funds reserved under the PHSA Common Fund
or otherwise available for such initiatives. The Secretary also would be required to establish, and
as necessary maintain, the Interagency Pain Research Coordinating Committee to coordinate all
efforts within HHS and other federal agencies that relate to pain research.
Sec. 2563. Public Awareness Campaign on Pain Management
This section would amend PHSA Title II, Part B to add a new Sec. 249 requiring the Secretary to
establish and implement a national pain care education outreach and awareness campaign to
educate consumers, patients, their families, and other caregivers about various issues with respect
to pain as a national public health problem. The Secretary would be authorized to make awards to
public agencies and private nonprofit organizations to assist with the development and
implementation of the public awareness campaign. For the purposes of carrying out this section,
there would be authorized to be appropriated $2 million for FY2011 and $4 million for each of
FY2012 and FY2015.
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Food and Drug Administration
Background and Issues
The Food and Drug Administration (FDA) is responsible for the safety of most foods, as well as
the safety and the effectiveness of human drugs, biologics (e.g., vaccines, blood, and blood
components), and medical devices, among other things.36
FDA’s regulation of medical products affects aspects of the cost, quality, and accessibility of
health care. Medical products comprise a large percentage—over 15%—of health care costs.37
The products’ effectiveness, which FDA evaluates, is a major component of health care quality.
Their availability to consumers, which FDA regulates, is one component of access to health care.
In the context of health care, adding regulatory requirements may increase the quality of medical
products that reach the market, but may also raise the cost of those products or delay consumer
access to them.
FDA’s regulation of food, in particular its nutrition labeling requirements, may have an effect on
the health of individuals as well. This is particularly relevant given links between obesity and
chronic diseases that may drive up health care costs.
H.R. 3962 contains seven FDA-related provisions that would affect the agency’s regulation of
four types of products. For medical devices, one provision would create a national medical device
registry, and a second would impose a tax on certain device sales. For foods, a third provision
would require nutrition labeling at certain restaurants and vending machines. For drugs, a fourth
provision would prohibit activities that can delay FDA’s approval of generics. For biologics, a
fifth, sixth, and seventh provision would create a licensure pathway for biosimilars (generic
biologics) and authorize the agency to collect associated fees. Each of these is described in more
detail below.
Medical Devices
Concern about the safety of certain high-risk medical devices has led Congress to consider
various tracking and postmarket surveillance mechanisms. Sec. 519(e) of the Federal Food Drug
and Cosmetic Act (FFDCA) permits the Secretary to order a medical device manufacturer to
adopt a method of tracking for certain devices that may create risks for patients.38 The FDA
Amendments Act of 2007 (P.L. 110-85) added a new Sec. 519(f), yet to be implemented, which

36 For further information about FDA, see CRS Report RS22946, Food and Drug Administration (FDA): Overview and
Issues
, by Erin D. Williams.
37 This percentage is based upon CMS data from 2007. It was generated by dividing $289 billion (Retail Outlet Sales of
Medical Products) by $1,878 billion (Personal Health Care). The number does not reflect all of the costs of FDA
regulated medical product involved in health care spending, because it does not include those purchased by hospitals
(such as pacemakers and other implantable devices), dentist’s offices (such as fillings), or other health care facilities.
“Table 4 - National Health Expenditures, by Source of Funds and Type of Expenditure: Calendar Years 2002 - 2007,”
CMS website, at http://www.cms.hhs.gov/NationalHealthExpendData/downloads/tables.pdf.
38 For background information about the medical device approval system, see CRS Report RL32826, The Medical
Device Approval Process and Related Legislative Issues
, by Erin D. Williams
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requires medical devices to bear a unique identifier.39 There are currently no special taxes
imposed on the sale of medical devices or on device manufacturers. However since 2002, medical
device manufacturers have been subject to certain fees collected by the FDA.40
Sec. 2571. National Medical Device Registry
This section would add a new FFDCA Sec. 519(g), requiring the Secretary to establish a public
national medical device registry to facilitate analysis of postmarket safety and outcomes data on
certain implantable, life-sustaining, and other types of medical devices. The Secretary would be
required to establish a procedure to link specified medical device data from manufacturers with
patient safety and outcomes data from disparate sources, and integrate the registry activities with
certain other postmarket risk and safety activities required by the FFDCA. In addition, acting
through ONCHIT, the Secretary would be required to adopt standards for the electronic exchange
and use in certified electronic health records of a unique device identifier.
Sec. 552. Excise Tax on Medical Devices
This section would amend Chapter 31 of the Internal Revenue Code by adding a new
Subchapter D, Medical Devices, imposing a tax of 2.5% of a price determined as specified, on the
first taxable sale (including certain leases and uses) of a medical device. The tax would not apply
to devices sold to (or of the type and quantity typically sold to) consumers by retail
establishments. Certain tax exemptions similar to those in IRC Sec. 4221 and 4222 would apply.
These concern devices sold for export, and devices for use by the purchaser for further
manufacture. (Other tax exemptions listed under IRC Sec. 4221(a)(3)-(6) would not apply,
including those for state and local governments, nonprofit educational entities, and certain
others.) Under specified circumstances involving contractually negotiated sales prices, sellers
would be entitled to recover the amount of taxes paid from device producers, manufacturers, or
importers. The tax would apply to sales made after December 31, 2012.
Nutrition Labeling
Concern about the rising rates of obesity and the resulting effect on individuals’ health and health
care costs have prompted Congress to consider options for promoting healthy eating. One option
is to require nutrition labeling for some foods currently exempted from such regulations. (See
FFDCA Secs. 301(a) and 403). Food served in restaurants is currently among the types exempted
from FDA’s nutrition labeling requirements.
FFDCA Sec. 403 lists the circumstances that would cause a food to be deemed misbranded,
which include the failure to adhere to the Act’s nutrition labeling requirements. FFDCA Sec.
403A prohibits states and localities from establishing their own nutrition labeling that is not
identical to the Act’s requirements. States and localities may petition the Secretary of HHS for an
exemption from the preemption clause in FFDCA Sec. 403A.

39 For information on the implementation status of the unique device identifier, go to http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentifiers/default.htm.
40 See CRS Report RL34571, Medical Device User Fees and User Fee Acts, by Erin D. Williams.
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Sec. 2572. Chain Restaurant Menus and Vending Machines
This section would insert a new paragraph H into FFDCA Sec. 403(q)(5), requiring nutrition
labeling for standard menu items offered for sale in chain restaurants or similar retail food
establishments with 20 or more locations. These establishments would be required, for standard
menu items, to disclose as specified: (1) the number of calories contained in the item; and (2) the
suggested daily caloric intake, as specified by the Secretary by regulation. Such establishments
would also be required to make available, at the premises upon request, certain detailed written
nutritional information.
The establishments would be required to have a reasonable basis for their nutrient content
disclosures. The Secretary would be required to establish by regulation standards for determining
and disclosing the nutrient content for standard menu items that come in different flavors,
varieties, or combinations, but which are listed as a single menu item.
The section would require certain vending machine operators that own or operate 20 or more
machines to provide specified signs disclosing the number of calories contained in each article of
food, so that the information is accessible to consumers before they make their purchases.
The Secretary would be required to promulgate proposed regulations as specified to carry out the
requirements of the section, and to provide quarterly reports to Congress describing progress
toward promulgating final regulations.
The section would amend FFDCA Sec. 403A to preempt states and localities from establishing or
continuing in effect any requirement for nutrition labeling of a food that is not identical to the
requirements of FFDCA Sec. 403(q), including the new requirements for foods served in certain
restaurants and retail food. The section also would prohibit the amendments it made from being
construed as: (1) preempting any provision of state or local law unless the state or local law
creates or continues nutrition disclosures of the type that would be required by this section and
those disclosures would be expressly preempted; (2) applying to any state or local requirement
about food labeling that provides for safety warnings concerning the food or a component of the
food; or (3) applying to any restaurant or similar retail food establishment other than those
described in this proposal and offering for sale substantially the same menu items.
Generic Drugs
Congressional interest in generic drugs has been piqued by recent reports suggesting that brand
name manufacturers have paid generic drug manufacturers to delay the introduction of their
generic drugs into the marketplace. Generic drugs may help control health care costs because they
typically have lower prices than their brand-name counterparts. This is the case because the
research and development costs associated with developing a new drug (the brand name), are
greater than those associated with producing a generic copy of an existing drug. While generics
provide a cost-saving option for consumers, they also reduce brand name manufacturers’ revenue,
which may diminish manufacturers’ capacity and incentive to develop additional new drugs.41

41 For further information, see CRS Report RL33605, Authorized Generic Pharmaceuticals: Effects on Innovation, by
John R. Thomas.
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Companies seek FDA approval to market generic drugs by filing an Abbreviated New Drug
Application (ANDA) under FFDCA Sec. 505(j). The filing of an ANDA may trigger patent
infringement litigation between the owner of a relevant patent and the ANDA applicant. The
FFDCA currently does not restrict the ability of these parties to resolve their patent dispute
through settlement. The MMA of 2003 required that certain of these settlements be filed with the
Department of Justice (DOJ) and Federal Trade Commission (FTC).
Requirements for FTC actions (and those by other agencies), such as rulemaking and
adjudication, are described in the Administrative Procedure Act (APA). APA Sec. 553 covers
informal rulemaking procedures and mandates that all agencies publish a notice of proposed
rulemaking in the Federal Register, with some exceptions. After an agency publishes such notice,
interested persons may then comment on the proposed rule through written submissions with
data, views, or arguments, hence the term notice-and-comment rulemaking. Such comments may
affect the resulting final rule.
Sec. 2573. Protecting Consumer Access to Generic Drugs
This section would add a new paragraph (w) to FFDCA Sec. 505, declaring unlawful any
agreement resolving or settling a patent infringement claim in which an ANDA applicant receives
anything of value and agrees to limit or forgo research, development, manufacturing, marketing,
or sales, for any period of time, of the drug that is the subject of the ANDA and the patent.
Agreements under which the ANDA applicant receives no more than the right to sell the drug that
is the subject of the ANDA and the patent, along with the waiver of past damages for patent
infringement, would remain permissible. The FTC would be authorized to enforce these
provisions under Sec. 5 of the FTC Act.
The section also would amend the MMA so that any patent litigation settlement covered by this
proposal must also be filed with the DOJ and FTC. The chief executive officer or company
official responsible for negotiating the agreement must certify that the filing constitutes the
complete, final, and exclusive agreement between the parties. The section would require GAO to
conduct a series of studies regarding the practice and impact of pharmaceutical patent litigation.
Finally, it would allow the FTC to issue informal rulemakings under APA Sec. 553 to exempt
certain agreements from the proposal’s requirements if the FTC finds that such agreements are “in
furtherance of market competition and for the benefit of consumers.” The proposal states that
such rules can include interpretive rules and general statements of policy.
Biosimilars
A biosimilar, often called a “follow-on” biologic, is similar to a brand-name biologic while a
generic drug is the same as a brand-name chemical drug. Chemical drugs are small molecules for
which the equivalence of chemical structure between the brand-name drug and a generic version
is relatively easy to determine. In contrast, comparing the structure of a biosimilar and the brand-
name biologic is far more scientifically challenging. A biologic is a preparation, such as a drug or
a vaccine, that is made from living organisms. Most biologics are complex proteins that require
special handling (such as refrigeration) and are usually administered to patients via injection or
infused directly into the bloodstream. In many cases, current technology will not allow complete
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characterization of biological products. Additional clinical trials may be necessary before the
FDA would approve a biosimilar.42
Congress is interested in creating an expedited pathway for the approval of biosimilars for the
same reasons it was interested in allowing access to generic chemical drugs in 1984: cost savings.
The pathway for biosimilars would be analogous to the FDA’s authority for approving generic
chemical drugs under the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L.
98-417). Often referred to as the Hatch-Waxman Act, this law allows the generic company to
establish that its drug product is chemically the same as the already approved innovator drug, and
thereby relies on the FDA’s previous finding of safety and effectiveness for the approved drug.
The generic drug industry achieves cost savings by avoiding the expense of clinical trials, as well
as the initial drug research and development costs that were incurred by the brand-name
manufacturer. The cost of brand-name biologics is often prohibitively high. For example, the
rheumatoid arthritis and psoriasis treatment Enbrel costs $16,000 per year. It is thought that a
pathway enabling the FDA approval of biosimilars will allow for market competition and
reduction in prices, though perhaps not to the same extent as occurred with generic chemical
drugs under Hatch-Waxman.
Sec. 2575. Licensure Pathway for Biosimilar Biological Products
This section would amend PHSA Sec. 351 by opening a pathway for the approval of biosimilars.
A biosimilar is defined as a biological product that is highly similar to the reference (brand-name)
product such that there is no clinically meaningful difference between the biological product and
the reference product. A biological product is defined as a protein (except any chemically
synthesized polypeptide).
The section would allow the Secretary to determine that elements (such as clinical studies) in the
application for the licensure of a biological product as biosimilar or interchangeable may be
unnecessary. The Secretary would determine that the reference product and a biological product
are interchangeable according to specified criteria. Interchangeable means that the biological
product may be substituted for the reference product without the intervention of the health care
provider who prescribed the reference product. Special requirements would apply to certain
biosimilars that might present a greater risk (e.g., toxins or controlled substances).
The section would allow for a period of exclusive marketing for the biological product that is the
first to be established as interchangeable with the reference product. The provision also would
provide a 12-year data exclusivity period (from the date on which the reference product was first
approved) for the reference product and would provide an additional six months of exclusivity if
pediatric studies show health benefits in that population.43
The Secretary may publish proposed guidance as specified for public comment prior to
publication of final guidance on the licensure of a biological product. If guidance is to be
developed, a process must be established to allow for public input regarding priorities for issuing

42 For additional information, see CRS Report RL34045, FDA Regulation of Follow-On Biologics, by Judith A.
Johnson.
43 For more information on exclusivity and patents, see CRS Report RL33901, Follow-On Biologics: Intellectual
Property and Innovation Issues
, by Wendy H. Schacht and John R. Thomas.
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guidance. The issuance or non-issuance of guidance would not preclude the review of, or action
on, an application. The provision also would require the Secretary to ensure that the labeling and
packaging of each biological product bears a unique name that distinguishes it from the reference
product and any other biological products that are evaluated against the reference product.
The section would set forth a process governing patent infringement claims against an applicant
or prospective applicant for a biological product license. It also would establish new processes for
identifying patents that might be disputed between the reference product company and the
company submitting a biosimilar application.
Finally, this section would require reference product and biosimilar product sponsors to file with
the Assistant Attorney General and Federal Trade Commission copies of the text of any
agreement they reach regarding the manufacture, marketing, or sale of either product. Agreements
that solely concern purchase orders for raw materials, equipment and facility contracts,
employment or consulting contracts, or packaging and labeling contracts are excluded. Failure to
comply with this filing requirement may result in civil fines and other relief as the courts deem
appropriate. With the concurrence of the Assistant Attorney General, the Federal Trade
Commission may engage in rulemaking regarding the filing requirement.
Sec. 2576. Fees Relating to Biosimilar Biological Products
This section would amend FFDCA Sec. 735(1) to allow for the collection of user fees for the
review of applications for approval of biosimilars.
Sec. 2577. Amendments to Certain Patent Provisions
This section would amend the Patent Act to stipulate that the filing of a statement by a biosimilar
applicant regarding patents identified by the reference product sponsor and other interested
parties may be considered an act of patent infringement. It would require reference product
sponsors, and allow other interested parties, to identify patents that relate to the proposed
biosimilar product. The biosimilar applicant would then be afforded the opportunity to state its
position regarding those patents. If the biosimilar applicant responds by asserting that one or
more of these patents are invalid, unenforceable, or would not be infringed by the proposed
biosimilar product, the biosimilar applicant would be deemed to have committed an act of patent
infringement that would be immediately actionable in the courts.
PHSA 340B Drug Pricing
Background and Issues
Under PHSA Sec. 340B, pharmaceutical drug manufacturers that participate in the Medicaid drug
rebate program are required to enter into pharmaceutical pricing agreements (PPA) that provide
discounts on covered outpatient drugs purchased by certain public health facilities (covered
entities). HRSA, the agency that administers the 340B program, indicates that approximately
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14,000 covered entities and 800 pharmaceutical manufacturers participate in the program.44
Covered entities are eligible to receive discounts on outpatient prescription drugs from
participating manufacturers. These entities include hospitals owned or operated by state or local
government that serve a higher percentage of Medicaid beneficiaries, as well as federal grantees
such as FQHCs, FQHC look-alikes, family planning clinics, state-operated AIDS drug assistance
programs, Ryan White CARE Act grantees, family planning and sexually transmitted disease
clinics, and others, as identified in the PHSA. Covered entities may not receive discounts on
inpatient drugs under the 340B program.
Under the 340B program, covered entities are prohibited from diverting drugs purchased under
the program to other organizations and from obtaining multiple discounts, including participation
in outpatient group purchasing arrangements. The 340B discount is based on the average
manufacturer price (AMP) reduced by the Medicaid rebate percentage of 15.1% for single source
and innovator multiple source drugs, and 11% for non-innovator multiple source drugs. AMP is
defined in Medicaid statute as the average price paid to the manufacturer by wholesalers for drugs
distributed to the retail pharmacy class of trade. Manufacturers are required to report AMP and
their best price to the Secretary, but subject to verification, manufacturers calculate the maximum
price (“ceiling price”) they may charge 340B entities. Manufacturers are permitted to audit
covered entity records if they suspect product diversion or multiple discounts are taking place.
Sec. 6004 of the Deficit Reduction Act of 2005 added children’s hospitals that are exempt from
the Medicare prospective payment system to the list of covered entities, provided that these
facilities meet other 340B participation requirements. Proposed rules to implement the expansion
of covered entities to children’s hospitals were issued by HRSA on July 9, 2007. A final rule for
participation of children’s hospitals in the 340B program was issued September 1, 2009.
Sec. 2501. Expanded Participation in 340B Program
This section would amend PHSA Sec. 340B to add the following to the list of covered entities
that would be entitled to discounted drug prices under the 340B program: (1) certain children’s
and free-standing cancer hospitals excluded from the Medicare prospective payment system, (2)
critical access hospitals, (3) certain maternal and child health grantees, (4) certain community
mental health service grantees, (5) substance abuse prevention and treatment grantees, (6)
Medicare-dependent, small rural hospitals, (7) sole community hospitals, and (8) rural referral
centers. These new 340B-eligible facilities also would need to meet specified 340B participation
requirements. However, the prohibition on hospital participation in outpatient drug group
purchasing agreements would remain.
Sec. 2502. Improvements to 340B Program Integrity
This section would amend PHSA Sec. 340B to require the Secretary to develop systems to
improve compliance and program integrity activities for manufacturers and covered entities, as
well as administrative procedures to resolve disputes. The systems would include a number of
specifications to increase transparency and strengthen the monitoring, oversight, and investigation
of the prices manufacturers charge covered entities, as well as additional improvements to ensure

44 See HRSA “2009 Quarter 3 Statistics for 340B Covered Entities, Record Counts as of 7/01/2009” at
ftp://ftp.hrsa.gov/bphc/pdf/opa/Stats_2009_QTR_3.pdf.
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covered entities are not diverting drugs or obtaining multiple discounts. The Secretary would
have new authority to impose monetary penalties on manufactures and covered entities for
violations. The administrative dispute resolution process would mediate and provide final
resolution to covered entity overpayment claims and manufacturer claims against covered entities
for drug diversion or multiple discounts. When supply of a drug was limited, manufacturers
would be required to report to the Secretary their plans to ensure that covered entities were not
discriminated against in the allocation of available supplies. Manufacturers would be required to
report to the Secretary quarterly ceiling prices for each covered drug and to offer these drugs to
covered entities at or below these prices.
Sec. 2503. Effective Date
Changes made by this section would take effect upon enactment and would apply to drugs
dispensed beginning with that date. In addition, the changes in this section would be used as the
basis for determining if prescription drug manufacturers’ met 340B and Medicaid requirements.
Miscellaneous
Sec. 2527. National Autism Training Initiative
PHSA Title III, Part R, comprising Secs. 399AA-399EE, authorizes several programs related to
autism spectrum disorder (ASD) and other developmental disabilities. Sec. 399AA authorizes
grants for the collection, analysis, and reporting of state epidemiological data on ASD and other
developmental disabilities, and directs the Secretary to establish regional centers of excellence in
ASD epidemiology. Sec. 399BB requires the Secretary to establish and evaluate activities to
increase public awareness of ASD and other developmental disabilities, research and promote
early screening, and support evidence-based interventions. The Secretary is further directed to
provide culturally competent information about ASD and other developmental disabilities to meet
the needs of individuals with these conditions and their families through federal health, education
and welfare programs.
Sec. 399CC requires the Secretary to establish an Interagency Autism Coordinating Committee to
track ASD-related research, monitor federal ASD activities, make recommendations to the
Secretary, and submit an annual ASD research plan to Congress. Sec. 399DD requires the
Secretary to submit to Congress a progress report on activities related to ASD and other
developmental disabilities, as outlined in the Combating Autism Act of 2006, no later than four
years after its enactment. Sec. 399EE authorizes appropriations for the activities authorized under
Secs. 399AA, 399BB, and 399CC through FY2011.
This section would amend Title I of the Developmental Disabilities Assistance and Bill of Rights
Act by adding at the end a new Subtitle F, National Training Initiative on Autism Spectrum
Disorders. Within that subtitle, a new Sec. 171 would require the Secretary, in consultation with
the Interagency Autism Coordinating Committee, to award training grants to qualifying
University Centers for Excellence in Developmental Disabilities Education, Research, and
Service, or other comparable entities. These grants would be used to (1) expand and develop
interdisciplinary training and continuing education initiatives for parents, health, allied health,
vocational, educational, and other professionals for the purpose of improving services provided to
children and adults with ASD; and (2) develop model services and supports that demonstrate
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evidence-based practices, among other activities. The Secretary also would be required to reserve
up to 2% of the appropriated funds to make a grant to a qualified national organization for
providing training and technical assistance to the University Centers for Excellence. This
organization would assist in the national dissemination of evidence-based best practices from the
interdisciplinary training programs; compile and disseminate technical assistance materials; assist
in the coordination of grantees under this section; and serve as a research-based resource for
policymakers, among other activities. There would be authorized to be appropriated $17 million
for FY2011, and SSAN for each of FY2012 through FY2015 to carry out the training grant
program.
In addition, the section would require the Secretary to award grants to establish up to four new
University Centers for Excellence in Developmental Disabilities Education, Research, and
Service. Priority would be given to minority institutions and facilities located in a state with one
or more underserved populations. The section would authorize to be appropriated $2 million for
each of FY2011 through FY2015 for these grants.
Sec. 2528. Medication Management Services for Treating Chronic Disease
This section would require the Secretary, acting through the Director of AHRQ, to provides grants
to support medication management (MTM) services provided by licensed pharmacists. Currently,
Medicare Part D sponsors are required to establish MTM programs, in cooperation with licensed
pharmacists, to ensure that covered Part D drugs are used appropriately and reduce adverse drug
interactions. Part D plans have significant flexibility in structuring their MTM programs and
deciding which targeted populations are appropriate for MTM services. In a July 2008 study,
CMS examined the attributes and features of MTM models currently in use and concluded that it
is too soon to tell how the various MTM models contribute to clinical outcomes.
The section would require AHRQ to establish an MTM grant program by May 1, 2011. Grantees
would have to provide various specified MTM services to targeted individuals such as (1)
assessing patients’ health and functional status; (2) formulating a medical treatment plan; (3)
administering appropriate medication therapy; (4) monitoring and evaluating patient response to
therapy; (5) documenting the care delivered and communicating essential aspects to appropriate
care providers; (6) providing education and training to enhance the appropriate use of
medications; and (7) coordinating and integrating MTM services in broader health care
management. MTM services provided by licensed pharmacists under this program would be
targeted at individuals who take four or more prescribed medications, take high-risk medications,
have two or more chronic diseases, or have undergone a transition of care or other factors that are
likely to create a high risk of medication-related problems. The Secretary would be required to
assess and evaluate specified aspects of the program and report to Congress.
Sec. 2531. State Alternative Medical Liability Laws
This section would authorize the Secretary to make incentive payments to states that enact and
implement effective alternative medical liability laws that include litigation alternatives such as
certificate of merit, early offer, or both, and that do not limit attorneys’ fees or impose caps on
damages. In determining the effectiveness of such a law, the Secretary must consider whether it
(1) makes the medical liability system more reliable through the prevention of, or prompt
resolution of, disputes; (2) encourages the disclosure of health care errors; and (3) maintains
access to affordable liability insurance. Nothing in the section would preempt or modify existing
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state laws that limit attorneys’ fees or cap damage awards, impair a state’s authority to establish
such laws, or restrict the eligibility of a state for an incentive payment on the basis of such laws
provided they are not established or implemented as part of an alternative medical liability law
that meets the requirements described above. The Secretary would be required to submit to
Congress an annual report on the progress states are making in enacting and implementing
alternative medical liability laws and the effectiveness of such laws. The section would authorize
to be appropriated SSAN for the incentive payments, which would be used to improve health care
in the state.
Sec. 2585. States Failing to Adhere to Certain Employment Obligations
This section says that a state would be eligible for federal funds authorized under the PHSA only
if it agrees, as an employer, to adhere to the requirements in Division A of this bill, and assures
that all political subdivisions in the state do the same.
Sec. 2587. Report on Parasitic and Other Diseases of Poor Americans
This section would require the Secretary to report to Congress, within one year of enactment, on
the epidemiology of, impact of, and appropriate funding required to address neglected diseases of
poverty, including a number of specified parasitic diseases. The report should provide the
information necessary to enhance health policy to accurately evaluate and address the threat of
those diseases.
Sec. 2588. Offices of Women’s Health
This section would create a new PHSA Sec. 229, establishing in the Office of the Secretary an
Office on Women’s Health, for the establishment of goals and objectives, expert consultation, and
other specified duties. Among them, the Secretary would be required to establish a National
Women’s Health Information Center and an HHS Coordinating Committee on Women’s Health.
The Secretary would be authorized to provide funding and make interagency agreements as
necessary to carry out these duties, and would be required to conduct evaluations of such
activities and provide periodic reports to Congress. The section would transfer to this new office
all functions of the existing Office on Women’s Health of the Public Health Service.
In addition, the section would establish new offices of women’s health, with specified duties, in
CDC (new PHSA Sec. 310A), AHRQ (new PHSA Sec. 927), HRSA (new PHSA Sec. 713), and
the Food and Drug Administration (FDA, new Federal Food, Drug, and Cosmetic Act, FFDCA
Sec. 1011
). For the AHRQ office, there would be authorized to be appropriated SSAN for
FY2011 through FY2015. The section would also amend current authority for offices of women’s
health at NIH and SAMHSA, to establish that the director of each office would report to the
senior official of the respective agency.
This section and amendments made by it would not alter existing regulatory authority; terminate,
reorganize, or transfer authority away from women’s health offices in existence as of enactment
without the approval of Congress; or change existing administrative activities at HHS regarding
women’s health.
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Sec. 2588A. Offices of Minority Health
This section would amend PHSA Sec. 1707(a) to strike language establishing an Office of
Minority Health within the Office of Public Health and Science and replace it with new language
establishing the office within the Office of the Secretary.
The section also would add a new PHSA Sec. 1707A requiring the Secretary to establish an
Office of Minority Health in each of the following agencies: CDC, SAMHSA, AHRQ, HRSA,
and FDA. Each office would be headed by a director that would be appointed by and report
directly to the senior official of the respective agency. The section and amendments made by it
would not establish or alter existing regulatory authority; or terminate, reorganize, or transfer
authority away from a minority health office or federal appointive position with primary
responsibility over minority health issues in HHS in existence as of enactment without the
approval of Congress.
Sec. 2592. Access for Individuals with Disabilities
This section would add a new Sec. 510 of the Rehabilitation Act, requiring the Architectural and
Transportation Barriers Compliance Board to issue guidelines for minimal technical criteria for
new medical diagnostic equipment (as specified) used in medical settings.45 The guidelines must
ensure that individuals with disabilities can use, enter, and exit such equipment independently, to
the maximum extent possible. The Board would be required periodically to review the guidelines
and amend them as necessary.
Within six months of the issuance of the guidelines, each federal agency authorized to promulgate
regulations under the Rehabilitation Act or the ADA would be required to prescribe regulations to
carry out the provisions of each Act with respect to accessibility standards that are consistent with
the guidelines, and to ensure that health care providers and health care plans covered under this
bill meet the requirements of Section 504 of the Rehabilitation Act and the ADA, including
ensuring that individuals with disabilities receive equal access to all aspects of the health care
delivery system.
Sec. 2593. Duplicative Grant Programs
This section would require the Secretary to conduct a study to determine whether any newly
established grant program under Division C of this bill is duplicative of one or more HHS federal
grant programs specifically authorized in the PHSA or receiving appropriations. If determined to
be duplicative, the Secretary would be required to attempt to integrate the new program with the
duplicative programs. And, if integration is not appropriate or not successful, the Secretary would
be required to promulgate a rule eliminating the duplication, including terminating one or more
programs, if appropriate. Any funds appropriated to carry out a program that is terminated would
remain available for obligation for the one or more programs that (1) were determined to be
duplicative of such program and (2) remain in effect. The section would require the Secretary to
submit a report to Congress and make the results of the study publicly available.

45 Section 502 of the Rehabilitation Act established the Architectural and Transportation Barriers Compliance Board to
develop design standards for, and to assure compliance by, facilities designed, built, altered, or leased with federal
funds, in order to improve access for people with disabilities.
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Sec. 2595. Improvement of Vital Statistics Collection
This section would require the Secretary, acting through the CDC Director, to promote the
education and training of physicians on the importance of birth and death certificate data,
encourage state adoption of the latest standard revisions of birth and death certificates, and work
with states to re-engineer their vital statistics systems. The section also would allow the Secretary
to promote improvements to the collection of diabetes mortality data.

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Appendix. Acronyms Used in the Report
ACF
Administration for Children and Families
ACS
American College of Surgeons
ADA
Americans with Disabilities Act
AHEC
Area Health Education Center
AHRQ
Agency for Healthcare Research and Quality
AMP
average manufacturer price
ANDA
Abbreviated New Drug Application
APA
Administrative Procedures Act
ARRA
American Recovery and Reinvestment Act
ASD
Autism Spectrum Disorder
ASPR
Assistance Secretary for Preparedness and Response
CBO
Congressional Budget Office
CCN
Collaborative Care Network
CDC
Centers for Disease Control and Prevention
CERTF
Comparative Effectiveness Research Trust Fund
CHIP
Children’s Health Insurance Program
CMS
Centers for Medicare and Medicaid Services
DGME
Direct Graduate Medical Education
DOJ
Department of Justice
DOL
Department of Labor
EEOC
Equal Employment Opportunities Commission
EFT
electronic funds transfer
EHR
electronic health record
EMT
Emergency Medical Technician
EMTALA
Emergency Medical Treatment and Labor Act
EPSDT
Early and Periodic Screening, Diagnostic and Treatment Services
FACA
Federal Advisory Committee Act
FDA
Food and Drug Administration
FERPA
Family Educational Rights and Privacy Act
FFDCA
Federal Food, Drug, and Cosmetic Act
FQHC
Federally Qualified Health Center
FTC
Federal Trade Commission
FTCA
Federal Tort Claims Act
FTE
full-time equivalent
GAO
Government Accountability Office
GME
Graduate Medical Education
HAI
Health Care-Associated Infection
HHS
Health and Human Services
HIPAA
Health Insurance Portability and Accountability Act
HIT
Health Information Technology
HITECH
Health Information Technology for Economic and Clinical Health
HRSA
Health Resources and Services Administration
HPSA
Health Professional Shortage Area
HSA
Homeland Security Act
IME
Indirect Medical Education
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IOM
Institute of Medicine
LEP
limited English proficiency
LTC
long term care
MCH
maternal and child health
NCHS
National Center for Health Statistics
NCHWA
National Center for Health Workforce Analysis
NFCSP
National Family Caregiver Support Program
NHSC
National Health Service Corps
NIH
National Institutes of Health
NMHC
Nurse-Managed Health Center
NQF
National Quality Forum
OAA
Older Americans Act
OMB
Office of Management and Budget
ONCHIT
Office of the National Coordinator for Health Information Technology
PHSA
Public Health Service Act
PHWC
Public Health Workforce Corps
PQRI
Physician Quality Reporting Initiative
QHBP
Qualified Health Benefits Plan
RHQDAPU
Reporting Hospital Quality Data for Annual Payment Update
SAMHSA
Substance Abuse and Mental Health Services Administration
SBHC
School-Based Health Clinic
SNF
skilled nursing facilities
SSA
Social Security Act
SSAN
such sums as may be necessary
TANF
Temporary Assistance for Needy Families
VFC
Vaccines for Children
WIA
Workforce Investment Act


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Author Contact Information

C. Stephen Redhead, Coordinator
Ramya Sundararaman
Specialist in Health Policy
Analyst in Public Health
credhead@crs.loc.gov, 7-2261
rsundararaman@crs.loc.gov, 7-7285
Kirsten J. Colello
Cliff Binder
Specialist in Health and Aging Policy
Analyst in Health Care Financing
kcolello@crs.loc.gov, 7-7839
cbinder@crs.loc.gov, 7-7965
Elayne J. Heisler
Jim Hahn
Analyst in Health Services
Analyst in Health Care Financing
eheisler@crs.loc.gov, 7-4453
jhahn@crs.loc.gov, 7-4914
Sarah A. Lister
Judith A. Johnson
Specialist in Public Health and Epidemiology
Specialist in Biomedical Policy
slister@crs.loc.gov, 7-7320
jajohnson@crs.loc.gov, 7-7077
Bernice Reyes-Akinbileje
Amalia K. Corby-Edwards
Analyst in Health Resources and Services
Analyst in Public Health and Epidemiology
breyes@crs.loc.gov, 7-2260
acorbyedwards@crs.loc.gov, 7-0423
Amanda K. Sarata
Emilie Stoltzfus
Analyst in Health Policy and Genetics
Specialist in Social Policy
asarata@crs.loc.gov, 7-7641
estoltzfus@crs.loc.gov, 7-2324
Erin D. Williams
Carmen Solomon-Fears
Specialist in Public Health and Bioethics
Specialist in Social Policy
ewilliams@crs.loc.gov, 7-4897
csolomonfears@crs.loc.gov, 7-7306
Andrew R. Sommers

Analyst in Public Health and Epidemiology
asommers@crs.loc.gov, 7-4624




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