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").     

Refugee resettlement program and Cuban/Haitian entrant program: cash and medical assistance policies. Social Security Administration. Interim final rule

This interim final regulation amends the refugee resettlement program regulations (45 CFR Part 400) and establishes new policies on cash and medical assistance available to refugees and Cuban and Haitian entrants who are ineligible for Aid to Families with Dependent Children (AFDC), Supplemental Security Income (SSI), adult assistance (OAA, AB, APTD, and AABD) in the Territories and medicaid. The Refugee Resettlement Program (RRP) provides Federal reimbursement to States for 100 percent of the costs of cash and medical assistance provided, during the first 36 months after entry into the United States, to such refugees in accordance with applicable program rules and requirements and the administrative costs of providing such assistance. Cash assistance provided to such refugees under the RRP is termed "refugee cash assistance" (RCA); and medical assistance provided to such refugees under the RRP is termed "refugee medical assistance" (RMA). This regulation permits 100 percent Federal reimbursement for RCA and RMA for an eligible refugee for the first 18 months that a refugee is in the United States. For a refugee who has been in the U.S. more than 18 months but less than 36 months, the regulation permits a State, at its option, to seek RRP reimbursement for the cost of General Assistance (GA) provided to such a refugee.     

Medical use of byproduct material; policy statement, revision. Nuclear Regulatory Commission. Final policy statement; revision

The Nuclear Regulatory Commission (NRC) is revising its 1979 policy statement on the medical use of byproduct material. These revisions are one component of the Commission's overall program for revising its regulatory framework for medical use, including its regulations that govern the medical use of byproduct material. The overall goals of this program are to focus NRC regulation of medical use on those medical procedures that pose the highest risk and to structure its regulations to be risk-informed and more performance-based, consistent with NRC's "Strategic Plan for Fiscal Year 1997-Fiscal Year 2002." The policy informs NRC licensees, other Federal and State agencies, and the public of the Commission's general intentions in regulating the medical use of byproduct material.     

Medical devices; refurbishers, rebuilders, reconditioners, servicers, and "as is" remarketers of medical devices; review and revision of compliance policy guides and regulatory requirements; request for comments and information--FDA. Advance notice of proposed rulemaking

The Food and Drug Administration (FDA) is announcing its intention to review and, as necessary, to revise or to amend its compliance policy guides and regulatory requirements relating to the remarketing of used medical devices and the persons who refurbish, recondition, rebuild, service, or remarket such devices. The agency is considering these actions because it believes evolving industry practices warrant reevaluation of current policy and the application of certain regulatory requirements in order to ensure that particular remarketed devices meet suitable performance requirements for their intended uses, and are as safe as the originally marketed finished device. FDA is soliciting comments, proposals for alternative regulatory approaches, and information on these issues. In a future issue of the Federal Register, FDA will announce an open meeting of the Good Manufacturing Practices (GMP) Advisory Committee concerning these matters.     

Obligated service for mental health traineeships; interim rule--Public Health Service. Interim rule with request for comments

This rule adds a new Part 64a to Title 42 of the Code of Federal Regulations which: (1) governs the length and type of service payback required of individuals who have received clinical traineeships in psychology, psychiatry, social work, or nursing section 303 of the Public Health Service Act. as amended by section 803 of the Mental Health Systems Act; and (2) in connection with this payback obligation, imposes certain notice and other requirements upon institutions receiving training grants under section 303 of the Public Health Service Act.     

Medical use of byproduct material; draft policy statement--NRC. draft policy statement

The Nuclear Regulatory Commission (NRC) is proposing, for formal comment, revisions of its 1979 policy statement on the medical use of byproduct material. These proposed revisions are one component of the Commission's overall program, as previously announced in the Federal Register, for revising its regulatory framework for medical use, including its regulations that govern the medical use of byproduct material. The overall goals of this program are to focus NRC regulation of medical use on those medical procedures that pose the highest risk and to structure its regulations to be risk-informed and performance-based, where appropriate, consistent with NRC's "Strategic Plan for Fiscal Year 1970 Fiscal Year 2002".     

Federal support for hospital construction in overbedded areas

This memorandum established policies and procedures to limit Federal financial support for the construction of hospitals in overbedded areas. The policy for Federal hospitals is that no new or replacement hospitals will be built in an overbedded area unless suitable, existing, non-Federal facilities cannot reasonably be acquired through purchase or lease. The policy for non-Federal facilities is that no Federal grants, loans, loan subsidies, or loan guarantees will be provided for hospital construction or renovation in an overbedded area, unless the proposed project is consistent with an approved local hospital facility plan or the Secretary of Health and Human Services (HHS) determines that it is necessary. In addition, legislation and regulations will be proposed to revise the current Medicare and Medicaid reimbursement policies for costs related to hospital construction or renovation. Finally, legislation will be proposed to revise Federal tax exempt bond financing for hospital construction and renovation in overbedded areas. This memorandum also prescribes agency responsibilities and procedures for implementing these policies.     

Is it lawful to use Medicaid to pay for circumcision?

Since 1965, tens of millions of boys have been circumcised under the Medicaid program, most at birth, at a cost to the United States Federal Government, the States and taxpayers of billions of dollars. Although 18 States have ended coverage since 1982, the United States Government and 32 States continue to pay for non-therapeutic circumcision, even though no medical association in the world recommends it. Many cite American medical association policy that the procedure has potential medical benefits as well as disadvantages, and that the circumcision decision should be left to parents. This article shows that Medicaid coverage of circumcision is not a policy issue because it is prohibited by federal and State law. As American medical associations concede, non-therapeutic circumcision is unnecessary, elective, cosmetic surgery on healthy boys, usually performed for cultural, personal or religious reasons. The fundamental principle of Medicaid law is that Medicaid only covers necessary medical treatments after the diagnosis of a current medical condition. Physicians and hospitals face severe penalties for charging Medicaid for circumcisions. Medicaid officials and the Federal and State Governments are also required to end coverage. It is unlawful to circumcise and to allow the circumcision of healthy boys at the expense of the government and taxpayers.     

Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy.     

An end to a consensus on health care in the Federal Republic of Germany?

Over the past fifteen years the national government in the Federal Republic of Germany has animated the political debate about rising health care expenditures. However, it has only provided health policy leadership by shifting the burden of financing health and medical care to others. This paper presents three cases that illustrate the political and institutional constraints inherent in the German policy process that limit the proposal and implementation of appropriate policy solutions to rising health care costs. Cost controls have been inhibited because of the near-universal entitlement of national health insurance, the access all social groups have to advanced medical care, and policies targeted at providers rather than users of health services. The paper also underscores the past and future importance of regional policy coalitions in shaping national health policy.     

Federal Employees Health Benefits Program; benefits for medically underserved areas--Office of Personnel Management. Final rule

The Office of Personnel Management (OPM) is amending its regulations pertaining to benefits under the Federal Employees Health Benefits (FEHB) Program for individuals in medically underserved areas. These regulations are necessary to implement the FEHB law, as amended, which mandates special consideration for enrollees of certain FEHB plans who receive covered health service in States with critical shortages of primary care physicians.     

Federal Employees Health Benefits Program; benefits for medically underserved areas--Office of Personnel Management. Final rule

The Office of Personnel Management (OPM) is amending its regulations pertaining to benefits under the Federal Employees Health Benefits (FEHB) Program for individuals in medically underserved areas, these regulations are necessary to implement the FEHB law, as amended, which mandates special consideration for enrollees of certain FEHB plans who receive covered health service in States with critical shortages of primary care physicians.     

Solicitation of new safe harbors and special fraud alerts--Office of Inspector General, HHS. Notice of intent to develop regulations

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal and State health care programs' anti-kickback statute, as well as developing new OIG Special Fraud Alerts. The purpose of developing these documents is to clarify OIG enforcement policy with regard to program fraud and abuse.     

Medicare and Medicaid programs; preadmission screening and annual resident review--HCFA. Final rule; correction

In the November 30, 1992 issue of the Federal Register, we established requirements for preadmission and annual review of individuals with mental illness or mental retardation who are applicants to or residents of nursing facilities that are certified for Medicaid. We also established an appeals system for individuals who may be transferred or discharged from facilities or who wish to dispute a determination made in the preadmission screening and annual review process. This notice corrects typographical errors made in that document.     

Court sets aside immigration employment authorization containing HIV-related job restrictions

In an order issued on 30 May 2003, the Federal Court-Trial Division set aside an employment authorization that prohibited an HIV-positive man from working in childcare, primary and secondary school teaching, health services, and agriculture. The court directed immigration medical officers to decide whether a new medical examination is required. This is a significant case for HIV-positive immigrants and refugees who are required to hold an employment authorization if they intend to work in Canada while their applications for permanent residence are decided, a process that can take years.     

美国医疗器械立法嬗变及其动因

1938年《联邦食品药品及化妆品法》和1976年《医疗器械法》是两个具有里程碑意义的法律。某种程度上，每一部法律的制定都是灾难性事件的杰作。而在立法进程中，立法者都在促进医疗器械安全与鼓励新医疗器械的发展上进行着一种平衡，美国联邦食品药品管理局在执行这些立法过程中更追求这种平衡。中国医疗器械安全立法及侵权法都忽视了这一点，一味追求对医疗器械生产商和医疗机构课以责任。     

Physician agreements to control medical prepayment plans: Federal Trade Commission. Adoption and publication of enforcement policy with respect to physician agreements to control medical prepayment plans

The Federal Trade Commission has adopted, and is publishing with this notice, a statement of enforcement policy with respect to physician agreements to control medical prepayment plans. The statement sets forth the general approach the Commission intends to use in its case-by-case enforcement program for evaluating physician agreements to form, operate, or control such plans and for evaluating the practices of plans that are controlled by a group of physicians.     

Sovereign Immunity in an Economic Theory of Government Behavior

The Federal Tort Claims Act of 1946 put government on an equal footing in tort law with private individuals. It also provides a very broadly defined immunity for any public function of a discretionary nature. While economists argue that immunity does not minimize social costs, this analysis outlines a theoretically optimal mix of liability and immunity. Discretionary governmental policy must be immune as it establishes principles of government conduct. Tort liability then insures cost-minimizing policy execution. This theory of state behavior links a number of leading/controversial immunity cases that otherwise exhibit no consistent thought.     

Medicare program; special enrollment period and Medicare premium changes. Final rule

This final rule provides a special enrollment period (SEP) for Medicare Part B and premium Part A for certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and who have health insurance that covers them while outside the United States. Under the SEP provision, qualifying volunteers can delay enrollment in Part B and premium Part A, or terminate such coverage, for the period of service outside of the United States and reenroll without incurring a premium surcharge for late enrollment or reenrollment. This final rule also codifies provisions that require certain beneficiaries to pay an income-related monthly adjustment amount (IRMAA) in addition to the standard Medicare Part B premium, plus any applicable increase for late enrollment or reenrollment. The income-related monthly adjustment amount is to be paid by beneficiaries who have a modified adjusted gross income that exceeds certain threshold amounts. It also represents the amount of decreases in the Medicare Part B premium subsidy, that is, the amount of the Federal government's contribution to the Federal Supplementary Medicare Insurance (SMI) Trust Fund.