Unified agenda of regulations--Department of Health and Human Services. Publication of unified agenda of regulations

The President's February 17, 1981, Executive Order (12291) and the Regulatory Flexibility Act of 1980 require the Department to publish an agenda of significant regulations being developed and an indication of those regulatory actions that are being analyzed for their effect on small businesses. The Department published its last agenda on April 30, 1982.     

The Department of Health and Human Services issues proposed regulations on physician incentive payments by hospitals

Hospitals tempted to operate their own physician incentive plans are reminded that, under OBRA 1986, they are precluded from paying physician incentives of any kind to reduce or limit Medicare or Medicaid covered services. In light of the proposed regulations and the guidance of the preamble, hospitals should review their incentive plans to determine whether physicians providing direct patient care are receiving prohibited payments. Further, supervising physicians who are receiving incentives for certain hospital departments may not influence direct care over patients served by those departments, even through other physicians. Some risk may also exist if incentives are based on a formula that considers patients of the supervising physician's medical group. Finally, it may be useful to develop a utilization and quality of care review program specifically designed to assure that patient undertreatment does not occur as a result of any supervising physician incentive program.     

Food and Drug Administration-Redesignation of the Department of Health, Education, and Welfare as the Department of Health and Human Services. Final rule

The agency is amending Chapter I of Title 21 of the Code of Federal Regulations to reflect the redesignation of the Department of Health, Education, and Welfare as the Department of Health and Human Services.     

Department of Health and Human Services Public Health Services. Notification of a new system of records: Three Mile Island mental health survey, respondent records

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new system of records entitled "Three Mile Island Mental Health Survey, Respondent Records, HHS/ADAMHA/NIMH." The Disaster Assistance and Emergency Mental Health Section, Division of Special Mental Health Programs, National Institute of Mental Health, is responsible for the system. The purpose of the system is to enable the Government to arrange followup study to the currently-funded research project entitled "The Mental Health of Residents Near the Three Mile Island Reactor: A Comparative Study of Selected Groups." PHS invites interested persons to submit comments on the proposed routine uses on or before November 3, 1980.     

State Vocational Rehabilitation Services Program. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary amends the regulations governing the State Vocational Rehabilitation Services Program (VR program) by revising the scope of employment outcomes under the VR program. These regulations redefine the term "employment outcome" (as it applies to the VR program) to mean outcomes in which an individual with a disability works in an integrated setting. This action is necessary to reflect the purpose of Title I of the Rehabilitation Act of 1973, as amended (Act), which is to enable individuals with disabilities who participate in the VR program to achieve an employment outcome in an integrated setting.     

State Vocational Rehabilitation Services Program. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary amends the regulations governing the State Vocational Rehabilitation Services Program. These amendments implement changes to the Rehabilitation Act of 1973 made by the Rehabilitation Act Amendments of 1998 that were contained in Title IV of the Workforce Investment Act of 1998 (WIA), enacted on August 7, 1998, and as further amended in 1998 by technical amendments in the Reading Excellence Act and the Carl D. Perkins Vocational and Applied Technology Education Act Amendments of 1998 (hereinafter collectively referred to as the 1998 Amendments).     

Protection of human research subjects. Department of Health and Human Services (DHHS). Final rule

The Department of Health and Human Services (DHHS) is amending its human subjects protection regulations. These regulations provide additional protections for pregnant women and human fetuses involved in research and pertains to human in vitro fertilization. The rule continues the special protections for pregnant women and human fetuses that have existed since 1975. The rule enhances the opportunity for participation of pregnant women in research by promoting a policy of presumed inclusion, by permitting the pregnant woman to be the sole decision maker with regard to her participation in research, and by exempting from the regulations six categories of research. The rule also provides a mechanism for the Secretary of HHS to conduct or fund research not otherwise approvable after consultation with an expert panel and public review and comment.     

The State Vocational Rehabilitation Services Program. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary amends the regulations governing The State Vocational Rehabilitation Services Program (VR program). These amendments are needed to implement changes in the Rehabilitation Act of 1973, as amended (Act). These changes establish evaluation standards and performance indicators for the VR program.     

Special demonstration programs. Office of Special Education and Rehabilitative Services, Department of Education. Final regulations

The Secretary issues regulations governing the Special Demonstration Programs. These regulations are needed to implement changes in the Rehabilitation Act Amendments of 1998. The regulations provide definitions and requirements for grants and contracts under the expanded authority of the Special Demonstration Programs.     

Interim polio vaccine information materials. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

The Centers for Disease Control and Prevention has modified its recommendation for use of the two polio vaccines to discourage use of oral poliovirus vaccine (OPV) for the first two doses administered, except in limited circumstances. This revised recommendation necessitates a revision of the vaccine information statement entitled, "Polio Vaccines: What You Need to Know" (dated February 6, 1997), which was developed by the CDC as required by the National Childhood Vaccine Injury Act of 1986 (NCVIA). To ensure that up-to-date information is available regarding this revised recommendation, CDC is distributing the following interim polio vaccine information statement for use pending completion of the formal revision process mandated by the NCVIA.     

DHHS wisely proposed to remove the "consent" requirement from the HIPAA privacy standards. Department of Health and Human Services

The author contends that requiring advance written consent to use and disclose health information interferes with patient care, is unnecessary in view of other rigorous privacy protections, and imposes an unwarranted burden on healthcare providers. Consequently, the author commends DHHS for taking the "practical and apolitical step" of removing this requirement.     

National Vaccine Injury Compensation Program: addition of vaccines against rotavirus to the program. Department of Health and Human Services (HHS), Public Health Service (PHS), Health Resources and Services Administration (HRSA). Final rule

This final rule amends the existing regulations governing the National Vaccine Injury Compensation Program (VICP) by adding vaccines against rotavirus to the Table of Injuries, which lists the vaccines covered under the VICP. This action is taken under section 2114(e) of the Public Health Service Act (the Act). The VICP provides a system of no-fault compensation for certain individuals who have been injured by specific childhood vaccines. The two prerequisites for adding vaccines against rotavirus to the VICP have been satisfied. An excise tax of 75 cents per dose was enacted on October 21, 1998, and took effect for sales of the vaccines after October 21, 1998. The Centers for Disease Control and Prevention (CDC) has recommended to the Secretary of HHS that this vaccine be routinely administered to children. Thus, vaccines against rotavirus are now included in the VICP.     

Health maintenance organizations--Public Health Service. Final regulations

These rules amend the Public Health Service (PHS) regulations on health maintenance organizations (HMOs) by implementing certain changes made by the Health Maintenance Organization Amendments of 1981. The provision governing repayment of grant funds under certain circumstances is also amended. In addition, this rule amends the requirements for the award of loans or loan guarantees to qualified HMOs for the acquisition or construction of ambulatory health care facilities and the acquisition of equipment for those facilities (Subpart J). The amendments to Subpart J are made as a result of public comments on the interim regulations published on April 9, 1980.     

Department of Health and Human Services--Grants and subgrants to for-profit organizations. Proposed rules

This rule proposed to remove regulatory bars to grants to for-profit organizations under three HHS grant programs in which the for-profit organizations are not barred by statute from receiving grants. It also proposes (1) to make HHS's Department-wide grants administration regulations, 45 CFR Part 74, apply automatically to grants and subgrants to for-profit organizations and (2) to add to those regulations additional provisions for grants and subgrants to for-profit organizations. These actions reflect a reversal of the Department's generally policy of not making for-profit organizations eligible for grants in those few programs where they are not statutorily barred from receiving grants.     

Health maintenance organizations--PHS. Final regulations

This rule amends the Public Health Service regulations on qualification of health maintenance organizations (HMOs). Changes are made in the procedural requirements for entities to obtain qualification as federally qualified HMOs. These changes include requirements relating to Freedom of Information requests and deletion of the fair hearing provision. Adoption of these amendments will update the requirements for HMOs seeking Federal qualification.     

Quality mammography standards. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments are intended to incorporate changes required by the Mammography Quality Standards Reauthorization Act (MQSRA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event that the agency withdraws the direct final rule.