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.     

Administration of grants to states other than block grants or open-end grants--HHS. Proposed rule

For most of its categorical grants to States, HHS proposes to replace its general grants administration regulations (45 CFR Part 74) by reduced and simplified regulations. This proposal is part of the Department's efforts to provide regulatory relief to States and to place greater reliance on States to administer their Federally-assisted programs.     

Requirements and procedures applicable to appeals before the Departmental Grant Appeals Board--Department of Health and Human Services. Notice of proposed rulemaking

The Department of Health and Human Services (HHS) proposes to delete the material currently set forth in 45 CFR Part 16, and substitute new requirements and procedures applicable to disputes arising under certain HHS grants and other programs. HHS also proposes to add certain related provisions to 45 CFA Part 74, which contains general requirements applicable to all HHS grants and cooperative agreements. These proposed provisions are intended to improve the Department's capability to provide a fair, quick and flexible process for appeal from final written decisions.     

Nondiscrimination on the basis of age in programs or activities receiving federal financial assistance from HHS. Final rules

These final regulations implement provisions of the Age Discrimination Act of 1975, and the general, governmentwide regulation published in the Federal Register on June 12, 1979, codified at 45 CFR Part 90. The Age Discrimination Act of 1975 prohibits discrimination on the basis of age in programs or activities receiving federal financial assistance. The Act also contains certain exceptions that permit, under limited circumstances, use of age distinctions or factors other than age that may have a disproportionate effect on the basis of age. The Act applies to persons of all ages. These final regulations are designed to guide the actions of recipients of financial assistance from HHS. The regulations incorporate the basic standards for determining what is age discrimination that were set forth in the general regulations. They discuss the responsibilities of HHS recipients and the investigations, conciliation and enforcement procedures HHS will use to ensure compliance with the Act.     

Medicare, Medicaid, and Maternal and Child Health Services Block Grant programs; civil money penalties and assessments for false or improper claims--Department of Health and Human Services. Notice of proposed rulemaking

These proposed regulations are intended to strengthen the Department's ability to protect the health care financing programs against persons and organizations who defraud and abuse those programs. The regulations would specify procedures for implementing the authority provided to the Department by section 2105 of the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), as amended by section 137(b)(26) of the Tax Equity and Fiscal Responsibility Act of 1982 (Pub. L. 97-248), to impose civil money penalties and assessments administratively for the filing of false or certain other improper claims in the Medicare, Medicaid, or Maternal and Child Health Services Block Grant programs. The statute also permits an individual upon whom the Department imposes a civil money penalty or assessment to be suspended from participation in the Medicare and Medicaid programs. Until enactment of the civil money penalties legislation, the federal government had to rely upon litigation under the False Claims Act or criminal proceedings in order to compel restitution of funds falsely or improperly claimed under HHS health care financing programs.     

HIPAA privacy: the compliance challenges ahead

This Article reviews the HIPAA Privacy Standards' impact on healthcare organizations. It discusses whether a healthcare organization is a "Covered Entity" under the regulations, what information the Privacy Standards protect, what restrictions the regulations place on the use and disclosure of protected health information, what individual rights the Privacy Standards create, and what agreements they require between healthcare organizations and their business associates. The author provides relatively extensive guidance to organizations that are embarking upon their voyage of compliance with these broadly applicable regulations, but notes that the full extent of necessary compliance remains unclear, pending DHHS issuance of the next iteration of the rulemaking in this area. The Article was finalized in January 2002, before HHS issued any modifications to the Privacy Standards.     

Grants to for-profit organizations; implementing amendments--Public Health Service. Final rule

This issuance amends 42 CFR Part 52 applicable to grants made for research projects under sections 301 and 356 of the Public Health Service Act to delete the prohibition on eligibility for research awards to entities that are organized or operated for profit. Elsewhere in this issue of the Federal Register is a final rule which, among other things, amends 42 CFR Part 87 to allow for-profit organizations to apply for health research and demonstration grants under section 20 of the Occupational Safety and Health Act and section 501 of the Federal Mine Safety and Health Act.     

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--DHHS. Notice of proposed rulemaking

The Department of Health and Human Services (the Department or HHS) is proposing to include among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects), research and demonstration projects conducted under the Social Security Act and other Federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. This proposed amendment to the revised final regulations for protection of human research subjects (published January 26, 1981) would, in effect, restore to the regulations an exemption included in the initial notice of proposed rulemaking (NPRM) (published August 14, 1979). These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an IRB would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of an unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation.     

Equipment acquired under public assistance programs--HHS. Final rule

This rule revises and consolidates current HHS regulations concerning Federal financial participation in the cost of equipment under HHS supported public assistance programs. The rule also revises and consolidates current regulations on the management and disposition of equipment under these programs. The rule would permit State public assistance agencies to claim the cost of most of their equipment acquired at the time of purchase rather than depreciating the equipment over its useful life as required by the current regulations. This change would allow these agencies to claim Federal financial participation in the cost of the equipment at an earlier date than under the current regulations and would simplify the accounting requirements associated with the equipment.     

National Library of Medicine programs--PHS. Notice of proposed rulemaking

The Public Health Service, HHS, proposes to revise the regulations for the programs of the National Library of Medicine. The proposed revisions would: (1) Permit the Regional Medical Libraries to recover part or all of the costs of providing photocopies of biomedical materials, (2) improve readability of the regulations, (3) update references to statutory authorities and uniform administrative requirements, and (4) revoke Part 63 (Traineeships) which is obsolete.     

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.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals and other non-profit organizations, and with commercial organizations, foreign governments, organizations under the jurisdiction of foreign governments, and international organizations--DOL. Final rule

The Department of Labor is issuing these regulations pursuant to the requirements of the Office of Management and Budget (OMB) Circular No. A-110 (Revised), which provides standards for obtaining consistency and uniformity among Federal agencies in the administration of grants and agreements with institutions of higher education, hospitals, and other non-profit organizations. This rule also applies to the Department of Labor's grants to commercial organizations, foreign governments, organizations under the jurisdiction of foreign governments and international organizations. OMB issued Circular A-110 in 1976 and, except for a minor revision in February 1987, the Circular remained unchanged until revised in 1993. To update the Circular, OMB established an interagency task force to review the Circular. The task force solicited suggestions for changes to the Circular from university groups, non-profit organizations and other interested parties and compared for consistency the provisions of similar provisions applied to State and local governments. The revised Circular and these regulations reflect the results of these efforts.     

Playing by the rules: Impact and implementation of children's educational television regulations among local broadcasters

This study explores the institutional process involved in the implementation of the 1997 Federal Communications Commission regulations regarding educational programs for children. Through open‐ended interviews with representatives from twenty‐eight stations, this study assessed local broadcasters' reactions to these new rules in the early stages of policy implementation, examining their understanding of the new regulations; the implementation strategies and structural constraints that guide the selection of educational programs and the implications of these strategies for the success of the rules in achieving their goals as stated explicitly by the FCC. All respondents indicated that they would comply with the regulations by providing the minimum three hours of educational programming per week, along with other reporting and public file obligations. However, the ultimate effectiveness of these rules in ensuring better television for children seems complicated by the institutional constraints on local broadcasters and the widespread belief among broadcasters that educational programs are not viable in the market. The authors argue that future research on national policy evaluation should consider the implementation of the policy within a complex web of institutional and social structures.     

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.     

Grants for residency training in general internal medicine or general pediatrics--PHS. Amendments to final regulations

This rule amends the regulations implementing grants for residency training programs in general internal medicine or general pediatrics to conform with statutory changes made by the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35) and the Commonwealth-Covenant to Establish-Northern Mariana Islands (Pub. L. 94-241). These changes are nondiscretionary in nature. Additional amendments are for clarification.     

Public Health Service--Grants for allied health projects. Final rule

These regulations set forth requirements for grants to: (a) Establish regional or State systems to assure that allied health and nursing personnel needs in the area are met by coordinating and managing allied health professions and nursing education and training within and among educational institutions and their clinical affiliates; (b) Establish or improve recruitment, training, and retraining programs for allied health personnel; and (c) Establish career ladders and advancement programs for practicing allied health personnel. These regulations implement section 796 of the Public Health Service Act.     

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.     

Physicians' conflicts of interest in Japan and the United States: lessons for the United States

Japanese health policy shows that even with physician ownership and the absence of for-profit, investor-owned health care, physicians' conflicts of interest thrive. Physician dispensing of drugs and ownership of hospitals and clinics were justified in Japan as ways to avoid commercialization of medicine. Instead, they create physicians' conflicts and fuel patient overuse of services. Japan's Ministry of Health and Welfare (MHW) has responded by introducing per-diem payment, thereby creating incentives to decrease services in ways similar to those of American managed care organizations, but with none of their benefits, such as coordination of care, oversight of physicians practices, and quality assurance. Although the United States and Japanese health care systems are organized and financed differently there is convergence in the source of their physicians' conflicts and the way they are addressed. The United States is starting to integrate institutional and physician payment and align their incentives, in a traditional Japanese way. In so doing, the United States creates new physicians' conflicts and reduces the role of countervailing incentives and power, an advantage of previous policy. Japan, in turn, has combined incentives to increase and decrease services, thus moving closer to the U.S. policy.     

Bicameralism and Geographic Politics: Allocating Funds in the House and Senate

Because they represent different kinds of constituencies—states versus parts of states—senators and House members have different incentives in constructing federal distributive programs. In order to claim credit for providing particularized benefits, House members need to use policy tools—earmarks and narrow categorical programs—that target funds to their constituencies. Senators, by contrast, are able to claim credit for the large formula grants that distribute the bulk of intergovernmental grant money. Examining House‐Senate interactions in one of the largest distributive programs, federal aid to states for surface transportation, I show that the different bases of representation in the House and Senate structure the chambers' preferences on distributive programs and affect the outcomes of interchamber conflicts.