OBRA regulations: a violation of the Administrative Procedures Act?
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Facility Regulation and Control↗
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Results for “Administrative Procedure Act”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Legal functions of the Kansas State Board of Nursing ... after the Administrative Procedures Act.
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Humans↗
Administrative practices and procedures; promulgation of regulations for the efficient enforcement of law--FDA. Final rule.
The Food and Drug Administration (FDA) is amending its regulation governing notice-and-comment (informal) rulemaking by removing from the regulation the requirement that the agency issue interpretative rules and rules of agency practice and procedure by informal rulemaking. As amended, the regulation provides that informal rulemaking procedures by followed to the extent required by the Administrative Procedure Act.
Decision Making, Organizational↗
The Freedom of Information Act and Medicare costs reports.
Health care providers must submit cost reports to the Department of Health and Human Services or its designated intermediary before they can be reimbursed for their services by the Medicare system. These reports closely detail the financial operations of the provider. Whenever third parties have requested copies of the cost reports pursuant to the Freedom of Information Act and the Department of Health, Education and Welfare (now HHS) has declared its intention to comply with the request, the providers have sued to enjoin disclosure. This Note evaluates whether the cost reports are confidential and therefore exempt from mandatory disclosure under Exemption 4 of the Freedom of Information Act. It concludes that they should not be exempt, but that even if they are, disclosure is mandated by a validly promulgated HEW regulation. This regulation was enacted in compliance with the Administrative Procedure Act, and should not be considered on abuse of the HEW Secretary's discretion.
Confidentiality↗
Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration--FDA. Tentative final rule.
The Food and Drug Administration (FDA) is issuing a tentative final rule to require that device user facilities and distributors, including importers, submit reports to FDA and to the manufacturers, of deaths, serious illnesses and serious injuries related to medical devices. FDA is authorized to issue regulations implementing reporting requirements for user facilities and distributors by certain provisions of the Safe Medical Devices Act of 1990 (the SMDA). This tentative final rule also amends existing reporting requirements for manufacturers to conform them with the proposed reporting requirements for user facilities and distributors, and requires distributors and manufacturers to report certain malfunctions that may cause a death, serious illness or serious injury. The tentative final rule also requires foreign manufacturers to be subject to the same reporting requirements as domestic manufacturers. FDA is designating this document a tentative final rule, although under the Administrative Procedure Act it is a proposed rule. Because of the statutory deadlines discussed below, this "tentative final rule" alerts the public not only to the agency's interest in receiving comments, but also to the need for device user facilities, distributors, and other affected persons to begin preparing for compliance.
Costs and Cost Analysis↗
Critical assessment of carcinogenic risk policy.
Fact. Cancer is a relatively common yet greatly feared disease. Belief. The concept that cancer is largely preventable is widely held by advocate groups, the press, and Congress. Belief. The concept that carcinogens at any level of exposure pose a significant cancer risk to human is widely believed by the public. Fact. In contrast to this belief, carcinogens are now known to be widespread in the environment and that virtually all substances are contaminated with carcinogens at some albiet low level. Fact. The solution to the ubiguitous presence of carcinogens cannot be solved by regulatory fiat. Fact. Often the only viable solution to regulating carcinogens is setting maximum levels of acceptable exposure (tolerances). Belief. In U.S. society, the process of establishing tolerances must be conducted in the open, providing adequate opportunity for public comment. Fact. The courts will sustain regulatory agency decisions about risks only if the administrative procedures used comply with the Administrative Procedures Act and if the technical methodology used is in good standing. Fact. For the method to be in good standing it cannot be a recent invention created after the fact to solve the issue at hand but must instead be a procedure that is claimed to be generally applicable to determining or estimating cancer risk. Belief. QRA should be an orderly procedure or process by which cancer risk estimations are conducted in an unbiased manner. As such it is fundamentally acceptable to the courts for resolving disputes. Fact. However, because QRA is dependent upon a large number of assumptions and because regulatory agencies feel compelled to act in a conservative, risk-adverse manner, risk estimates are often criticized for being over stated. Belief. To make risk estimates more realistic, data or facts must substitute for worst case assumptions. Fact. This process of substituting scientific facts for assumptions is occurring but it is expensive, time consuming, and not always possible. Nevertheless, it constitutes a major opportunity for improving the process by which risk estimates are made.
Animals↗
Complete decay of radionuclides: implications for low-level waste disposal in municipal landfills.
The time required for the complete decay of a radioactive source can be quantified by specifying an acceptable probability and using an original derivation. The physical phenomenon of complete decay may be used as the technical basis to change regulations and permit, with public acceptance, the inexpensive disposal of short half-lived radioactive waste into municipal landfills. Current regulations require isolation of trash from the biosphere for 30 years during the post-closure control period for municipal landfills. Thirty years is sufficient time for complete decay of significant quantities of short-lived radionuclides, and there is a large decay capacity in the nation's landfills. As the major generators of low-level radioactive waste with relatively short half-lives, the academic, medical, and research communities likely would benefit most from such regulatory relief. Disposal of such waste is prohibited or costly. The waste must be specially packaged, stored, transported, and disposed in designated repositories. Regulatory relief can be initiated by citizens since the Administrative Procedures Act gives citizens the right to petition for regulatory change.
Radioactive Waste↗
Improved standards for laboratory animals?
In February 1993, Judge Charles R. Richey of the United States District Court issued a summary judgment in the case of Animal Legal Defense Fund, et al. v. The Secretary of Agriculture, et al. The decision, which was in favor of the Animal Legal Defense Fund, requires the U.S. Department of Agriculture to withdraw its current regulations governing exercise for dogs and the psychological well-being of nonhuman primates used for biomedical research and to issue new regulations containing only minimum, measurable standards. Both plaintiffs and defendants contended that they were seeking the best interests of the laboratory animals. The issue at stake is whether animals are better protected if the government establishes limited minimal standards or is allowed to require institutions to provide additional standards, which will be judged on the basis of their effectiveness in maintaining healthy animals. The Court avoided this dispute, however, by placing primary emphasis on applying the Administrative Procedures Act and stating that it was merely interpreting the "plain meaning" of the Animal Welfare Act, as amended. In this article, arguments are presented for interpreting the law in a far more flexible way than Judge Richey did. The conclusion is also reached that there were no winners in the Animal Legal Defense Fund case and that the real losers are the laboratory animals.
Animal Experimentation↗
Home health benefits of federally qualified HMOs likely to increase.
There are differing opinions as to whether the Program Memorandum simply expresses HCFA's interpretation of existing law or whether the Program Memorandum adds new requirements for federally qualified HMOs. If the Program Memorandum is "additive," then the procedures by which it was issued may be subject to legal challenge for failure to comply with the federal Administrative Procedure Act applicable to formal rulemaking.
Centers for Medicare and Medicaid Services, U.S.↗
Administrative practices and procedures--Office of the Secretary, HHS. Proposed rule.
These proposed rules would reaffirm the Department's policy ordinarily to use notice and comment procedures in the development of rules relating to public property, loans, grants, benefits, and contracts, even though such action is not required by the Administrative Procedure Act, and would set forth the circumstances for such use. The Secretary believes that public comment serves an important purpose in bringing the expertise and views of interested parties to the attention of the Department.
Financing, Government↗
Medicare program; invalidation of the wage index in the schedule of limits on Hospital per diem inpatient general routine operating costs for cost reporting periods beginning on or after July 1, 1981 and ending with cost reporting periods beginning on or before September 30, 1982--HCFA. Notice.
This notice announces the April 29, 1983 decision of the United States District Court for the District of Columbia in the case of District of Columbia Hospital Association, et al. v. Heckler, et al. (No. 82-2520 D.D.C.). In its decision, the court ordered us to publish a notice in the Federal Register stating that the 1981 schedule of limits on hospital per diem inpatient general routine operating costs has been declared invalid with regard to the wage index for cost reporting periods beginning on or before July 1, 1981 and ending with cost reporting periods beginning on or before September 30, 1982. The District Court held that the decision to exclude Federal government hospital wage data from the computation of the wage index used in the 1981 Medicare hospital cost limits, without providing prior notice and an opportunity for comment, was in violation of the rulemaking requirements of the Administrative Procedure Act. The decision of the District Court does not apply to cost reporting periods beginning on or after October 1, 1982. The cost limits for periods beginning on or after October 1, 1982 are contained in the interim final notice with comment period published in the Federal Register on September 30, 1982 (47 FR 43296).
Centers for Medicare and Medicaid Services, U.S.↗
Medicare program; reissuance of the wage index in the 1981 schedule of limits on hospital per diem inpatient general routine operating costs--HCFA. Proposed notice.
We are reissuing for public comment the change in the types of data that were used to calculate the wage index that was contained in the schedules of limits on hospital per diem inpatient general routine operating costs reimbursable under Medicare that were applicable to cost reporting periods beginning on or after July 1, 1981 and for cost reporting periods ending after September 30, 1981. The cost limits for cost reporting periods beginning on or after October 1, 1982 are governed by the notice published in the Federal Register on September 30, 1982 (47 FR 43296) and August 30, 1983 (48 FR 39426) and are not affected by this reissuance. The wage index was originally issued as part of the schedule of limits published on June 30, 1981 (46 FR 33637) and September 30, 1981 (46 FR 48010) and is being reissued as the result of the April 29, 1983 decision of the United States District Court for the District of Columbia in the case of District of Columbia Hospital Association, et al. v Heckler, et al. (No. 82-2520 DDC). The District Court held that the 1981 schedule of hospital cost limits was invalid for failure to comply with the Administrative Procedure Act insofar as the schedule incorporated or was formulated by using a wage index that was calculated by excluding Federal government hospital wage data.
Centers for Medicare and Medicaid Services, U.S.↗
Currently effective Indian Health Service eligibility regulations. Indian Health Service, HHS. Republication of currently effective Indian Health Service eligibility regulations.
The HHS is publishing in the Federal Register, final regulations governing eligibility for services from the Indian Health Service. The eligibility regulations currently codified at 42 CFR part 36 are under a congressional moratorium. Republishing the regulations that are currently in effect while the codified regulations are under moratorium is being done for the convenience of the public and in conformance with the requirement of the Administrative Procedure Act, 5 U.S.C. 552(a)(1), that the Code of Federal Regulations (CFR) must contain currently effective regulations.
Delivery of Health Care↗
Processing complaints and disciplining nurses. An overview of the investigative process by the Kansas State Board of Nursing.
This is a brief review of the process the Kansas State Board of Nursing would utilize when investigating a complaint and determining discipline against a licensee, and does not include all points of law that could apply. Although the Kansas Administrative Procedures Act was discussed, there are many sections of the statute that were not addressed. The Board of Nursing has published two pamphlets "Your Rights Before the Kansas State Board of Nursing" and "The Investigative Process" which are valuable to the nurse in understanding the process. These are available on the KSBN's website www.ksbn.org or by mail.
Data Collection↗
FDA regulation of human cloning: usurpation or statesmanship?
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Cloning, Organism↗
Human tissues and reproductive cloning: new technologies challenge FDA.
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Biomedical Technology↗
Complexities in ETS-domain transcription factor function and regulation: lessons from the TCF (ternary complex factor) subfamily. The Colworth Medal Lecture.
The ETS-domain transcription factor family can be divided into a series of subfamilies. Elk-1 represents the founding member of the ternary complex factor (TCF) subfamily. By focusing on the TCF subfamily, we can demonstrate the complexities that exist in the function and regulation of ETS-domain transcription factors. This article focuses on Elk-1 in detail and summarizes the functions of other TCFs. The key themes covered include the domain structure of the TCFs, the mechanisms of complex formation with serum response factor, regulation of TCFs by mitogen-activated protein kinase cascades, and transcriptional regulatory properties of the TCFs. Finally, the emerging role of the TCFs in vivo is discussed. A picture is developing indicating that, while these proteins exhibit significant sequence and functional conservation, key differences in their structure and regulation are being identified which may relate to unique functions of these proteins in vivo.
Amino Acid Sequence↗