Control of communicable diseases; apprehension and detention of persons with specific diseases; transfer of regulations. Food and Drug Administration and Centers for Disease Control and Prevention, HHS. Final rule

The Secretary of Health and Human Service (the Secretary) is transferring a portion of the Food and Drug Administration (FDA) "Control of Communicable Diseases" regulations to the Centers for Disease Control and Prevention (CDC). In general, these regulations provide the Secretary with the authority to apprehend, detain, or conditionally release individuals to prevent the spread of specified communicable diseases. The regulations implement the provisions of the Public Health Service Act (PHS Act) to prevent the introduction, transmission, or spread of communicable diseases from one State or possession into any other State or possession. CDC will have authority for interstate quarantine over persons, while FDA will retain regulatory authority over animals and other products that may transmit or spread communicable diseases. The Secretary is taking this action to consolidate regulations designed to control the spread of communicable diseases, thereby increasing the agencies' efficiency and effectiveness.     

Current good manufacturing practices for blood and blood components: notification of consignees receiving blood and blood components at increased risk for transmitting HIV infection--FDA. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations to require that blood establishments (including plasma establishments) prepare and follow written procedures for appropriate action when it is determined that Whole Blood, blood components (including recovered plasma), Source Plasma and Source Leukocytes at increased risk for transmitting human immunodeficiency virus (HIV) infection have been collected. This final rule requires that when a donor who previously donated blood is tested on a later donation in accordance with the regulations and tests repeatedly reactive for antibody to HIV, the blood establishment shall perform more specific testing using a licensed test, if available, and notify consignees who received Whole Blood, blood components, Source Plasma or Source Leukocytes from prior collections so that appropriate action is taken. Blood establishments and consignees are required to quarantine previously collected Whole Blood, blood components, Source Plasma and Source Leukocytes from such donors, and if appropriate, notify transfusion recipients. The Health Care Financing Administration (HCFA) is also issuing a final rule, published elsewhere in this Federal Register, which requires all transfusion services subject to HCFA's conditions of Medicare participation for hospitals to notify transfusion recipients who have received Whole Blood or blood components from a donor whose subsequent donation test results are positive for antibody to HIV (hereinafter referred to as HCFA's final rule). FDA is requiring transfusion services that do not participate in Medicare and are, therefore, not subject to HCFA's final rule, to take steps to notify transfusion recipients. FDA is taking this action to help ensure the continued safety of the blood supply, and to help ensure that information is provided to consignees of Whole Blood, blood components, Source Plasma and Source Leukocytes and to recipients of Whole Blood and blood components from a donor whose subsequent donation tests positive for antibody to HIV.     

Waiver of the two-year home country physical presence requirement for certain foreign medical graduates--INS. Interim rule with request for comments

This rule amends the Immigration and Naturalization Service (Service) regulations by allowing certain foreign medical graduates who entered the United States in J-1 status, or who acquired J-1 status after arrival in the United States, to obtain a waiver of the 2-year home country residence and physical presence requirement under section 212(e)(iii) of the Immigration and Nationality Act (Act) pursuant to a request by a State Department of Public Health, or its equivalent. The waiver is intended to permit these foreign medical graduates to work at a health care facility in an area designated by the Secretary, Health and Human Services (HHS), as having a shortage of health care professionals ("HHS-designated shortage area"). This interim rule also contains provisions which will permit these foreign medical graduates to change their nonimmigrant status in the United States from J-1 exchange visitor to H-1B specialty occupation worker.     

Supplemental security income for the aged, blind, and disabled; federal administration of State supplementary payments to individuals in Medicaid facilities--SSA. Final rule

These final regulations reflect section 12201(b) of Public Law 99-272 (the Consolidated Omnibus Budget Reconciliation Act of 1985, enacted April 7, 1986). Section 12201(b) permits Federal administration of optional State supplementary payments to individuals in medical facilities that receive little XIX (Medicaid) funds at a level exceeding 50 percent of the cost of their care (Medicaid facilities). Currently, the regulations prohibit Federal administration of optional State supplementary payments to a person who, throughout any month, is in a Medicaid facility. Under these regulations States will have the option of having the Social Security Administration (SSA) administer optional State supplementary payments to these individuals. States will be limited to one State supplementary payment level variation for residents of Medicaid facilities (Federal living arrangement "D").     

The donor-conceived child's "Right to Personal Identity": the public debate on donor anonymity in the United Kingdom

On 1 April 2005, with the implementation of the Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004, United Kingdom law was changed to allow children born through gamete donation to access details identifying the donor. Drawing on trends in adoption law, the decision to abolish donor anonymity was strongly influenced by a discourse that asserted the ‘child's right to personal identity’. Through examination of the donor anonymity debate in the public realm, while adopting a social constructionist approach, this article discusses how donor anonymity has been defined as a social problem that requires a regulative response. It focuses on the child's ‘right to personal identity’ claims, and discusses the genetic essentialism behind these claims. By basing its assumptions on an adoption analogy, United Kingdom law ascribes a social meaning to the genetic relatedness between gamete donors and the offspring.     

Control of communicable diseases. Interim final rule with comment period

The Public Health Service Act authorizes the Secretary, in consultation with the Surgeon General, to make and enforce regulations as are necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. The existing regulations are outdated and do not address communicable diseases that currently pose a substantial public health threat. As of April 2, 2003, the World Health Organization (WHO) has reported 2236 cases and 78 deaths related to outbreaks of a severe form of pneumonia of unknown origin in Hong Kong SAR, Vietnam, Guangdong province in southern China, Canada, Singapore, and Thailand, which appears to have spread rapidly. For this reason, the Director General of the World Health Organization (WHO) issued a global alert about cases of atypical pneumonia and recommended that travelers with atypical pneumonia who may be related to these outbreaks be placed into isolation and assessed by quarantine officials. The Centers for Disease Control and Prevention (CDC) is currently investigating 85 suspected cases of the disease in the United States. This is being issued as an interim final rule because this newly-detected disease is likely spread in person-to-person fashion and may have an adverse public health impact if further introduced into the United States.     

Public education and organ donation: untested assumptions and unexpected consequences

While the number of individuals able to benefit from transplantation increases with technological developments, donation rates remain insufficient to cater for demand. A universal response to the insufficient number of donor organs has been public education to increase knowledge about donation and transplantation, and to encourage individuals to register their wishes about donation. Although education appears to have increased knowledge and encouraged individuals to register their wishes, it has not increased the number of organs available for transplantation. In fact, there is some evidence that encouraging people to register their wishes may be detrimental to increasing net donation rates. The failure of education programs to increase organ donation rates may be due in part to a failure to recognise that attitudes to donation are influenced by complex socio-cultural and personal beliefs, and not simply by knowledge. Research aiming to increase the rate at which organs are procured for donation must recognise that some individuals do not support transplantation and have their own personal reasons for maintaining this position. Educational interventions should not assume that increasing knowledge or simply encouraging individuals to declare a decision about donation will increase consent to donation.     

Medicare and Medicaid; resident assessment in long term care facilities--HCFA. Final rule

This final rule establishes a resident assessment instrument for use by long term care facilities participating in the Medicare and Medicaid programs when conducting a periodic assessment of a resident's functional capacity. The resident assessment instrument (RAI) consists of a minimum data set (MDS) of elements, common definitions, and coding categories needed to perform a comprehensive assessment of a long term care facility resident. A State may choose to use the Federally established resident assessment instrument or an alternate instrument that is designed by the State and approved by us. These regulations establish guidelines for use of the data set and designation of the assessment instrument. The provisions contained in these regulations implement statutory requirements. The resident assessment instrument is intended to produce a comprehensive, accurate, standardized, reproducible assessment of each long term care facility resident's functional capacity.     

Medicaid program; home and community-based services waivers for individuals age 65 or older--HCFA. Interim final rule with comment period

This interim final rule amends current Medicaid regulations to permit States to offer, under a Secretarial waiver, a wide array of home and community-based services to individuals age 65 or older who are determined, but for the provision of these services, to be likely to require the level of care furnished in a skilled nursing facility (SNF) or intermediate care facility (ICF) (nursing facility (NF) effective October 1, 1990). The rule allows Federal payment for these and other long term care services, up to an amount specified in section 1915(d)(5)(B) of the Social Security Act, subject to HCFA's approval of the States' requests for waivers and certain assurances made by the States. Once granted, waivers are in effect for 3 years, unless terminated by the State with notice to the Secretary, and are renewable for periods of 5 years. Periodic evaluation, assessment, and review of the care furnished under the waivers is required. This rule implements section 4102 of the Omnibus Budget Reconciliation Act of 1987, as modified by section 411(k) of the Medicare Catastrophic Coverage Act of 1988, section 8432 of the Technical and Miscellaneous Revenue Act of 1988, and section 4741(b) of the Omnibus Budget Reconciliation Act of 1990. This rule is being issued in final and, for the most part, without a delay in the effective date for the reasons explained in section IV, "Waiver of Proposed Rulemaking and Delay in the Effective Date."     

Public Health Service--health systems agencies and state health planning and development agencies; certificate of need reviews. Notice regarding certificate of need programs

This Notice sets forth advance information regarding amendments to the regulations governing certificate of need reviews by health systems agencies and State health planning and development agencies. This Notice is intended to provide early guidance to States prior to publication of interim final regulations implementing the amendments to certificate of need provisions of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub. L 96-79). This early guidance will assist the States in beginning to revise their certificate of need laws. Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. The Secretary intends to publish these interim final regulations within a few weeks. Following consideration of comments which will be solicited with regard to the interim regulations, the Secretary will publish an analysis of the comments and will revise those regulations as appropriate.     

Medicare and Medicaid programs; hospital conditions of participation; identification of potential organ, tissue, and eye donors and transplant hospitals' provision of transplant-related data--HCFA. Final rule

This final rule addresses only provisions relating to organ donation and transplantation. It imposes several requirements a hospital must meet that are designed to increase organ donation. One of these requirements is that a hospital must have an agreement with the Organ Procurement Organization (OPO) designated by the Secretary, under which the hospital will contact the OPO in a timely manner about individuals who die or whose death is imminent in the hospital. The OPO will then determine the individual's medical suitability for donation. As well, the hospital must have an agreement with at least one tissue bank and at least one eye bank to cooperative in the retrieval processing, preservation, storage, and distribution of tissue and eyes, as long as the agreement does not interfere with organ donation. The final rule requires a hospital to ensure, in collaboration with the OPO with which it has an agreement, that the family of every potential donor is informed of its opinion to donate organs or tissues or not to donate. Under the final rule, hospital must work with the OPO and at least one tissue bank and one eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of organs and tissues take place. In addition, transplant hospitals must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide, if requested, such data directly to the Department.     

Religious perspectives on umbilical cord blood banking

Umbilical cord blood is a valuable source of haematopoietic stem cells. There is little information about whether religious affiliations have any bearing on attitudes to and decisions about its collection, donation and storage. The authors provided information about umbilical cord blood banking to expert commentators from six major world religions (Catholicism, Anglicanism, Islam, Judaism, Hinduism and Buddhism) and asked them to address a specific set of questions in a commentary. The commentaries suggest there is considerable support for umbilical cord blood banking in these religions. Four commentaries provide moral grounds for favouring public donation over private storage. None attach any particular religious significance to the umbilical cord or to the blood within it, nor place restrictions on the ethnicity or religion of donors and recipients. Views on ownership of umbilical cord blood vary. The authors offer a series of general points for those who seek a better understanding of religious perspectives on umbilical cord blood banking.     

Tax-exempt bonds and sponsored research

"Sponsored research," wherein a business corporation or the government pays a portion of the cost of research activities carried out by a university or hospital, is increasingly important both for state institutions and for Section 510(c)(3) organizations. Sponsored research arrangements that are not properly structured can jeopardize the status of tax-exempt bonds issued to finance the facility at which the sponsored research occurs. While these rules have been difficult to apply in practice, properly structured agreements can provide funding for research without undue risk. This Article discusses the multiple pieces of guidance put forth by the Internal Revenue Service to clarify the many issues and tiers of analysis necessary to ensure a properly-structured sponsored research agreement.     

Tax policy as a lifeline: encouraging blood and organ donation through tax credits

This article, the second concerning the organ donation crisis, proposes the use of tax policy to encourage blood and organ donation. After critiquing the ethical and logistical problems posed by other commercial and non-commercial solutions, the author demonstrates how tax credits can be used as an effective and ethical solution to address the shortage of donors. The author also offers two model statutes that provide guidance as to how a nonrefundable tax credit for blood and organ donation might operate in the tax code.     

COBRA's draconian penalties.

In June 1987 the Internal Revenue Service issued proposed regulations clarifying the penalties to be imposed for noncompliance with the Consolidated Omnibus Budget Reconciliation Act (COBRA). These regulations met with ardent objections from employers because of the scope of the sanctions. Not only does a noncomplying employer lose its tax deduction for health plan contributions, for example, but so does any successor employer or member of a multiemployer plan to which the offending employer belongs. The IRS has also been criticized for neglecting to differentiate in the regulations between significant and minor violations and for neglecting to define what it means when it refers to a violation being corrected. In the following article the author explores these problems and their effect on employers as well as Congress's recent efforts to ease the COBRA penalty burden.     

Tax-deductible alcohol: an issue of public health policy and prevention strategy

In 1982 U.S. businesses will spend over $10 billion (12 percent of the total retail alcohol market) on alcoholic beverages which will be consumed by top executives, professionals, and other white-collar employees in a variety of business and personal settings. The Internal Revenue Service, through a series of vaguely defined tax deduction categories, permits these expenditures to be deducted from corporate and individual taxes as "ordinary and necessary" to the conduct of business, costing U.S. taxpayers between $3 and $5 billion annually in lost tax receipts. This article examines the scope and legal underpinnings of the IRS tax expenditure policy; its impact on drinking habits and drinking problems among the nation's business and professional elite; the arguments for permitting the subsidization of corporate drinking habits; reform measures that are available to policymakers; and the barriers to effective implementation.     

Public Health Service--Health systems agency and state health planning and development agency reviews: certificate of need programs. Final regulation

These rules amend the Public Health Service regulations on health systems agency and State health planning and Development agency (State Agency) certificate of need reviews. These final regulations implement changes to Title XV of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub L. 96-79). Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth the minimum requirements for satisfactory certificate of need programs.     

HIPAA Mental Health Parity Act--IRS. Notice of proposed rulemaking by cross-reference to temporary regulations

Elsewhere in this issue of the Federal Register, the IRS is issuing temporary regulations relating to mental health parity requirements imposed on group health plans. These requirements were added to the Internal Revenue Code by section 1532 of the Taxpayer Relief Act of 1997. The IRS is issuing the temporary regulations at the same time that the Pension and Welfare Benefits Administration of the U.S. Department of Labor and the Health Care Financing Administration of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations relating to mental health parity requirements added by the Mental Health Parity Act of 1996 to the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The temporary regulations provide guidance to employers and group health plans relating to the new mental health parity requirements. The text of those temporary regulations also serves as the text of these proposed regulations.     

Tax administration as health policy: hospitals, the Internal Revenue Service, and the courts

Since 1969 federal tax policy has permitted nonprofit hospitals to turn away indigent patients or to transfer them to public hospitals. The Internal Revenue Service made health policy, but its officials remain convinced that they were not making policy at all. Convinced that it was reasoning from legal principles, the Revenue Service accepted the hospital industry's view of the history and purpose of hospitals. The federal courts further obscured the problem. Moreover, the Revenue Service took no interest in the effects of its ruling on the services provided by tax-exempt hospitals until 1989. We describe these events and seek to explain them by linking the recent history of health policy to the assumptions that govern the making of tax policy. We conclude that the making of health policy by tax officials who are not accountable for it and who believe that they are not making policy at all is not in the public interest.     

Standards applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities: liability requirements. Environmental Protection Agency. Revised interim final rule

The Environmental Protection Agency is today revising regulations of January 12, 1981, on liability coverage requirements for hazardous waste facility owners or operators. Under these requirements, owners or operators must demonstrate liability coverage for bodily injury and property damage to third parties resulting from facility operations. The major revisions are: addition of the option of a financial test as a means of demonstrating liability coverage to satisfy the requirements; addition of the option of submitting a certificate of insurance as evidence of insurance; and changes in the requirements for the endorsement and certificate. In a future document, EPA will propose to delete two provisions of the January 12, 1981 regulations. These provisions are: the procedure to obtain a variance for liability coverage requirements; and the provision allowing an owner or operator to use State assumption of legal responsibility for liability coverage to satisfy the liability requirements. The January 12, 1981, regulations were issued under an accelerated schedule imposed by a court order. The revisions that are being made today are necessary to eliminate unworkable aspects of the previous regulations, improve their effectiveness, and allow reasonable flexibility in satisfying the requirements.