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Thursday, September 30, 2010

Stem Cell Research: Science, Federal Research Funding, and Regulatory Oversight

Judith A. Johnson
Specialist in Biomedical Policy 

Erin D. Williams
Specialist in Public Health and Bioethics

On August 23, 2010, a federal district court issued a preliminary injunction in the case of Sherley v. Sebelius enjoining the Department of Health and Human Services (HHS) from “funding research involving human embryonic stem cells.” The plaintiffs in the case, two researchers of adult stem cells, argued that funding such research violated the Dickey Amendment. HHS appealed and the Court of Appeals for the D.C. Circuit issued a stay of the preliminary injunction pending its consideration of the merits of the government’s appeal. The Sherley opinion would have effectively precluded the award of federal funding for such research if it had not been stayed by the D.C. Circuit; research is permitted to continue while the stay is effective.

Since FY1996, the Dickey amendment in appropriation acts has prohibited the use of federal funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed. At the time, the Dickey amendment halted the development of guidelines by the National Institutes of Health (NIH) on the broad field of human embryo research and has each year since 1996 prohibited federal funding for human embryo research and related topics, including in vitro fertilization (IVF) and human embryonic stem cells. These cells have the ability to develop into virtually any cell in the body, and may have the potential to treat injuries as well as illnesses, such as diabetes and Parkinson’s disease. Currently, most human embryonic stem cell lines used in research are derived from embryos produced via IVF. Because the process of removing these cells destroys the embryo, some individuals believe the derivation of stem cells from human embryos is ethically unacceptable.

In August 2001, President George W. Bush announced that for the first time, federal funds would be used to support research on human embryonic stem cells, but funding would be limited to “existing stem cell lines.” NIH established a registry of such cell lines eligible for use in federally funded research; 21 lines were available due to technical reasons and other limitations. Over time, scientists became increasingly concerned about the quality and longevity of these 21 stem cell lines. These scientists believe that research advancement requires access to new human embryonic stem cell lines. Those concerned about the ethical implications of deriving stem cells from human embryos argue that researchers should use alternatives, such as induced pluripotent stem (iPS) cells or adult stem cells (from bone marrow or umbilical cord blood). However, many scientists believe research should focus on all types of stem cells.

On March 9, 2009, President Barack Obama signed an executive order that reversed the nearly eight-year-old Bush Administration restriction on federal funding for human embryonic stem cell research. The Obama decision directed NIH to issue new guidelines for the conduct of embryonic stem cell research. Draft guidelines were released on April 23, 2009, and final guidelines were issued on July 6, 2009. In December 2009, NIH created a new registry of human embryonic stem cell lines that are eligible for use in research supported by federal funds under the 2009 guidelines. As of August 19, 2010, a total of 75 stem cell lines are listed in the new registry.

In the 111
th Congress, five bills have been introduced to codify the Obama stem cell policy: H.R. 873 (DeGette), the Stem Cell Research Enhancement Act of 2009; H.R. 872 (DeGette), the Stem Cell Research Improvement Act of 2009; S. 487 (Harkin), Stem Cell Research Enhancement Act of 2009; H.R. 4808 (DeGette), the Stem Cell Research Advancement Act of 2009; and S. 3766 (Specter), the Stem Cell Research Advancement Act of 2010. In general, these bills would allow federal support of research that utilizes human embryonic stem cells regardless of the date on which the stem cells were derived from a human embryo, and stem cell lines must meet certain ethical guidelines. Other stem cell bills introduced in the 111th Congress include H.R. 877, H.R. 1654, H.R. 2107, S. 99, and three bills that reauthorize the Stem Cell Therapeutic and Research Act of 2005 (S. 3751, H.R. 6081, and H.R. 6083).


Date of Report: September 15, 2010
Number of Pages: 29
Order Number: RL33540
Price: $29.95

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Stem Cell Research: Ethical and Legal Issues


Erin D. Williams
Specialist in Public Health and Bioethics

Edward C. Liu
Legislative Attorney

Judith A. Johnson
Specialist in Biomedical Policy


Recent court decisions in the case of Sherley v. Sebelius have called into question whether federal law prohibits the award of federal funding for embryonic stem cell research (ESR). As explained in the next paragraph, but for a brief period, federal funding has been available for research using established embryonic stem cell (ES) lines, but not for the establishment of ES lines. Neither the Sherley case nor the affected federal policy restricts or regulates ESR conducted solely with private, local, and/or state government funding, or with funding from other non-federal sources.

Since 1996, federal funding for research that involves the creation or destruction of human embryos has been prohibited. This prohibition is due to the Dickey Amendment, a rider placed on Health and Human Services’ (HHS) annual appropriation each year since FY1997. Federal policy allowing research on established ES lines was based on an interpretation of Dickey, issued in 1999 by then-HHS General Counsel Harriet Rabb (HHS 1999 Opinion). The HHS 1999 Opinion concluded that Dickey prohibited the use of HHS funds to establish ES lines (which involves embryo destruction), but not to conduct research using ES from established lines (on the theory that ES themselves are not embryos). In the context of the HHS 1999 Opinion, the Obama Administration created its ES policy, which permits federal funding for research using established ES lines that meet certain ethical requirements. The Obama ES policy is articulated in two 2009 documents: Executive Order 13505 (Obama EO), and National Institutes of Health guidelines issued pursuant to the EO (NIH 2009 Guidelines). In Sherley, the court issued a preliminary injunction, enjoining HHS from “implementing, applying, or taking any action whatsoever pursuant to” the NIH 2009 Guidelines “or otherwise funding research involving human embryonic stem cells as contemplated in the Guidelines,” holding that they violate Dickey. HHS appealed and the Court of Appeals for the D.C. Circuit issued a stay of the preliminary injunction, temporarily permitting federal funding of ESR to continue under the NIH 2009 Guidelines.

While the D.C. Circuit considers the appeal, Congress has four policy options. First, it could sanction or expand federal funding for ESR by eliminating or modifying the Dickey Amendment, or by passing other legislation (for example, H.R. 872, H.R. 873, S. 487, H.R. 4808, and S. 3766). (Note that the effect of such legislation could be questioned if Dickey and the Sherley holding are affirmed.) Second, Congress could encourage possible alternatives to ESR through research funding or tax incentives for activities that that do not involve the destruction of human embryos (S. 99, S. 3751, H.R. 877, H.R. 1230, H.R. 1654, H.R. 2107, H.R. 6081, and H.R. 6083). Third, it could restrict or eliminate ESR by prohibiting federal research funding, banning certain cloning techniques, or giving embryos a constitutional right to life (H.R. 110, H.R. 227, S. 346, H.R. 881, and H.R. 1050). (Enactment of a law banning federal ESR funding would preclude such funding even if Sherley were overturned or Dickey were eliminated.) Fourth, it could take no action, which would permit federal ESR funding unless or until the Sherley case is affirmed.

Many opinions about the ethics of ESR have been published. The positions could be broadly categorized as for or against ESR; however, there is an array of finer distinctions that reveal more subtle variation in ethical, moral, and factual beliefs. Breaking down ESR arguments according to these finer distinctions demonstrates both the complexity of the issues and the points of resonance among the opinions. The broadest discussion involves the balance of embryo destruction and relief of human suffering. More subtle issues focus on the relative importance of embryo viability, the purpose of embryo creation, new versus existing ES lines, donor consent, egg procurement, possible alternatives, and federal funding. This report presents background concepts, outlines legal arguments related to Sherley, and details the ethical arguments that surround ESR.



Date of Report: September 15, 2010
Number of Pages: 24
Order Number: RL33554
Price: $29.95

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Wednesday, September 29, 2010

The Americans with Disabilities Act (ADA): Final Rule Amending Title II and Title III Regulations


Nancy Lee Jones
Legislative Attorney

The Americans with Disabilities Act (ADA) has as its purpose “to provide a clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities.” On July 26, 2010, the 20th anniversary of the passage of the ADA, the Department of Justice (DOJ) issued final rules amending the existing regulations under ADA title II (prohibiting discrimination against individuals with disabilities by state and local governments) and ADA title III (prohibiting discrimination against individuals with disabilities by places of public accommodations). The new regulations for title II and title III are similar. They both adopt accessibility standards consistent with the minimum guidelines and requirements issued by the Architectural and Transportation Barriers Compliance Board (Access Board). In addition, the regulations include more detailed standards for service animals and power-driven mobility devices, ticketing, effective communication, and provide for an element-by-element “safe harbor” in certain circumstances. The regulations take effect March 15, 2011, but compliance with the 2010 standards for accessible design is not required until March 15, 2012. These final regulations only address issues that were in the 2008 notice of proposed rulemaking. DOJ has noted that it intends to engage in additional rulemaking in certain areas, including equipment and furniture, next generation 9-1-1, movie captioning and video description, and accessibility of websites operated by public entities or places of public accommodation.


Date of Report: September 16, 2010
Number of Pages: 9
Order Number: R41376
Price: $19.95

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Appropriations and Fund Transfers in the Patient Protection and Affordable Care Act (PPACA)

C. Stephen Redhead
Specialist in Health Policy

On March 23, 2010, President Obama signed into law a comprehensive health care reform bill, the Patient Protection and Affordable Care Act (PPACA; P.L. 111-148). The following week, on March 30, 2010, the President signed the Health Care and Education Reconciliation Act of 2010 (HCERA; P.L. 111-152), which amended various health care and revenue provisions in PPACA.

Among its many provisions, PPACA (as amended by HCERA) restructures the private health insurance market, sets minimum standards for health coverage, creates a mandate for most U.S. residents to obtain health insurance, and provides for the establishment by 2014 of insurance exchanges through which certain individuals and families will be able to receive federal subsidies to reduce the cost of purchasing that coverage. The new law expands eligibility for Medicaid; amends the Medicare program in ways that are intended to reduce the growth in Medicare spending that had been projected under preexisting law; imposes an excise tax on insurance plans found to have high premiums; and makes other changes to the tax code, Medicare, Medicaid, and numerous other federal programs.

In some instances, PPACA mandates appropriations or requires the Secretary to transfer from the Medicare Part A and Part B trust funds billions of dollars to support new or existing grant programs and other activities. This report summarizes those mandated appropriations and fund transfers. They include funding for a temporary insurance program for individuals who have been uninsured for several months and have a preexisting condition, as well as funding for states to plan and establish exchanges. PPACA also provides funding for various Medicare and Medicaid demonstration programs, for the creation of a Center for Medicare and Medicaid Innovation to test and implement innovative payment and service delivery models, and for an independent board to provide Congress with proposals for reducing Medicare cost growth and improving quality of care for Medicare beneficiaries.

Among other provisions, the new health reform law appropriates funding for health workforce and maternal and child health programs, and establishes three multi-billion dollar funds. The first fund will provide a total of $11 billion over five years in supplementary funding for community health centers and the National Health Service Corps. (A separate appropriation provides $1.5 billion for health center construction and renovation.) The second fund will support comparative effectiveness research through FY2019 with a mixture of appropriations and fund transfers. The third fund, which is funded in perpetuity, is to support prevention, wellness, and other public health-related programs and activities authorized under the Public Health Service Act (PHSA).

In addition to the mandated appropriations and fund transfers discussed in this report, PPACA authorizes new funding for numerous existing discretionary grant and other programs and activities, primarily ones authorized under the PHSA. It also creates a number of new discretionary grant programs and activities and provides for each an authorization of appropriations. Funding for all of these discretionary programs and activities is subject to action by congressional appropriators. A companion product, CRS Report R41390, Discretionary Funding in the Patient Protection and Affordable Care Act (PPACA), summarizes all the provisions in PPACA for which appropriations are authorized.



Date of Report: September 13, 2010
Number of Pages: 14
Order Number: R41301
Price: $29.95

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Monday, September 27, 2010

Self-Insured Health Insurance Coverage


Bernadette Fernandez
Specialist in Health Care Financing

Private health insurance can be provided to groups of people that are drawn together by an employer or other organization. Such groups are generally formed for some purpose other than obtaining insurance, like employment. When insurance is provided to a group, it is referred to as “group coverage” or “group insurance.” A common distinction made between private health coverage offered to groups is how such coverage is funded. That is, the plan sponsor may either purchase group health insurance from a state-licensed insurance carrier, or fund the health benefits directly. The former refers to fully insured plans; the latter, self-insured plans.

Self-insurance refers to coverage that is provided by the organization seeking coverage for its members. Such organizations set aside funds and pay for health benefits directly. (Enrollees may still be charged a premium.) Under self-insurance, the organization itself bears the risk for covering medical expenses. Because self-insured plans are not purchased from an insurance carrier licensed by the state, they are exempt from state requirements and subject only to federal regulation. With fully insured plans, the insurance carrier charges the plan sponsor a fee for providing coverage for the benefits specified in the insurance contract. The fee typically is in the form of a monthly premium. (In turn, the sponsor may decide that each person or family who wishes to enroll must pay part of the premium cost.) Under the fully insured scenario, the private insurer bears the insurance risk; that is, the insurer is responsible for covering the applicable costs associated with covered benefits. Insurance purchased from a state-licensed insurer is subject to both federal and state regulation.

A majority of individuals with private health insurance coverage are enrolled in self-insured plans. In 2008, 55% of private-sector enrollees were in such plans. This proportion differs when comparing small firms and large firms. In 2008, of the private-sector workers who were employed at small firms with health coverage, 12% were enrolled in self-insured health plans. In contrast, of private-sector workers employed at large firms, 65% were enrolled in self-insured plans. Consistent with these findings is the share of private-sector firms that offer at least one self-insured plan. In 2008, while 34% of all private-sector firms that offered insurance had at least one self-insured plan, only 13% of small firms had such a plan, compared with 63% of large firms.

To assist individuals, families, and employers in obtaining health coverage, the 111
th Congress passed major health reform legislation. The Patient Protection and Affordable Care Act (P.L. 111- 148, PPACA) was signed into law on March 23, 2010, and later amended by the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152). PPACA imposes new requirements on individuals, employers, and health plans; restructures the private health insurance market; sets minimum standards for health coverage; and provides financial assistance to certain individuals and, in some cases, small employers. Among the provisions in PPACA are ones that would have a major impact on private health insurance coverage, including self-insured plans.


Date of Report: September 13, 2010
Number of Pages: 11
Order Number: R41069
Price: $29.95

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