Office of Inspector General; Medicare and state health care programs: fraud and abuse; issuance of advisory opinions by the OIG. Final rule

OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.     

The Policymaking Role of State Supreme Courts in Education Policy

In this article, I examine the relationship between courts and legislatures from a comparative perspective. Specifically, I discuss how (1) the ideological composition of the bench, (2) the propensity of court involvement in a given policy area, and (3) the presence of an advisory opinion affect the number of bill introductions and policy enactments by state legislatures. Examination of education policy in the American states reveals that ideologically distant courts limit the number of bill introductions and bill enactments in state legislatures. Alternatively, the presence of an advisory opinion increases policy introduction and enactment in state legislatures. A fundamental implication of these findings is that courts exert the greatest impact on policy during the introduction stage of the legislative process. Previous studies have not examined the introduction stage and have therefore marginalized the real impact of court influence on policy.     

Medicare and state health care programs: fraud and abuse; issuance of advisory opinions by the OIG--HHS. Interim final rule with comment period

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule establishes a new part 1008 in 42 CFR chapter V to address the new OIG advisory opinion process. Specifically, these regulations set forth the specific procedures by which the Office of Inspector General, in consultation with the Department of Justice, will issue advisory opinions to outside parties regarding the interpretation and applicability of certain statutes relating to the Medicare and State health care programs.     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule; correction--FDA. Proposed rule; correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of June 16, 1998 (63 FR 32772). The document proposed to amend the FDA regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The document was published with an error. This document corrects that error.     

Administrative practices and procedures; internal agency review of decisions; companion document to direct final rule--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. The agency is taking this action to clarify the availability of review of scientific controversies by such advisory panels or committees. This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. If FDA receives any significant adverse comment, the direct final rule will be withdrawn, and the comments will be considered in the development of a final rule using usual notice and comment rulemaking based on this proposed rule.     

Administrative practices and procedures; internal review of agency decisions---FDA. Direct final rule

The Food and Drug Administration (FDA) is amending its regulations governing the review of agency decisions by inserting a statement that sponsors, applicants, or manufacturers of drugs (including biologics) or devices may request review of a scientific controversy by an appropriate scientific advisory panel, or an advisory committee. This action is being taken to clarify the availability of review of scientific controversies by such advisory panels and committees. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule. If any significant adverse comment is received, FDA will withdraw the direct final rule and will follow its usual procedures for notice-and-comment rulemaking based on the companion proposed rule.     

Obligations and Liability of Sponsoring States Concerning Activities in the Area: Reflections on the Itlos Advisory Opinion of 1 February 2011

Netherlands International Law Review - On 1 February 2011, the Seabed Disputes Chamber of the International Tribunal for the Law of the Sea handed down its frst advisory opinion, namely,...     

Medicare and state health programs: fraud and abuse; issuance of advisory opinions by the OIG--HHS. Final rule

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996, this final rule sets forth the specific procedures by which the Department, through the Office of the Inspector General (OIG), in consultation with the Department of Justice (DoJ), will issue advisory opinions to outside parties regarding the interpretation and applicability of certain statutes relating to the Federal and State health care programs. The procedures for submitting a request and obtaining an advisory opinion from the OIG were established through interim final regulations published in the Federal Register on February 19, 1997. In response to public comments received on these interim final regulations, this final rule revises and clarifies various aspects of the earlier rulemaking.     

A Court as the Process of Signification: Legal Semiotics of the International Court of Justice Advisory Opinion on the Legality of the Threat or Use of Nuclear Weapons

The International Court of Justice (ICJ) advisory opinion on the Legality of the Threat or Use of Nuclear Weapons in 1996 was a landmark case because, for the first time in history, the legal aspect of nuclear weapons was addressed. The decision has evoked controversies regarding the Court’s conclusion, the legal status of international humanitarian law in relation to nuclear weapons, and a newly introduced concept of state survival. While much legal scholarship discusses and criticizes the legal significance of the opinion, there has not been enough scholarship examining the Court’s specific choice of words and concepts that sustain its wider ideological and political position in the opinion. The paper argues that the Court’s vague and controversial logic is attributed to its confrontation with two international orders/codes: the legal order (or international law) and the political order (or state practice). The paper engages in legal semiotics as methodology to decode legal text and discover a deep structure that sustains networks of codes, according to which text is interpreted. Through the semiotic examination of three sets of key concepts (1) “permitted” and “prohibited,” (2) “threat of use” and “possession of the weapon,” and (3) “state survival,” the paper shows the ICJ’s confrontation with two orders/codes and eventual prioritization of the political order over the international legal order. The analysis of the opinion based on legal semiotics indicates an intimate and inseparable relationship between state practice and international law, which must be disentangled for the sake of the rule of law.     

Regarding/Disregarding: The Judicial Rhetoric of President Barak and the International Court of Justice's Wall Advisory Opinion

In Mara'abe v. Prime Minister of Israel (September 2005), Israel'sHigh Court addressed the effect which it should give to theInternational Court's Legal consequences of the constructionof a wall in Occupied Palestinian Territory advisory opinion.This had declared the wall illegal but, while affirming thatit shared the International Court of Justice's normative rulings,the High Court reiterated that it thought the wall a lawfulsecurity measure. Rather than dissect the substantive treatmentof the issues involved, this article examines the structureand rhetorical techniques employed by President Barak in hisleading judgment in Mara'abe. He effected a skilful practicaldisregard of the International Court's normative findings throughan elision of argument by relying on the doctrine of res judicata—aconcept that has no relevance whatsoever to advisory opinions.     

Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule

The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing advisory committees.     

Advisory committee; Medical Imaging Drugs Advisory Committee; re-establishment

The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.     

Medicare program; physicians' referrals; issuance of advisory opinions--HCFA. Final rule with comment period

This final rule with comment period incorporates into HCFA's regulations the provisions of section 1877(g)(6) of the Social Security Act (the Act), as added by section 4314 of the Balanced Budget Act of 1997. Section 1877(g)(6) requires that the Secretary issue written advisory opinions to outside parties concerning whether the referral of a Medicare patient by a physician for certain designated health services (other than clinical laboratory services) is prohibited under the physician referral provisions in section 1877 of the Act. Section 1877 not only prohibits certain referrals under the Medicare program, but also affects Federal financial participation payments to States under the Medicaid program for medical assistance consisting of designated health services furnished as the result of certain physician referrals. This final rule sets forth the specific procedures HCFA will use to issue advisory opinions.     

Advisory committee; Pediatric Advisory Committee; establishment. Final Rule

The Food and Drug Administration (FDA) is announcing the establishment of a Pediatric Advisory Committee in the Office of the Commissioner. Elsewhere in this issue of the Federal Register, FDA is publishing a document requesting nominations for the membership on this committee. This document adds the Pediatric Advisory Committee to the agency's list of standing advisory committees in 21 CFR 14.100.     

Advisory committees; OTC Drugs Advisory Committee; establishment--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the establishment by the Commissioner of Food and Drugs of the OTC Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. Elsewhere in this issue of the Federal Register, FDA is publishing a notice requesting nominations for membership on this committee. This document adds to the agency's list of standing advisory committees.     

Advisory committees; establishment and termination--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the establishment by the Commissioner of Food and Drugs of the Medical Devices Advisory Committee and the termination of the existing devices panels. This document revises the agency's list of standing advisory committees to show these actions.     

Gainsharing: a call for guidance

Gainsharing is a device by which hospitals and physicians share in the development, implementation, and proceeds resulting from the mechanisms to make the provision of healthcare more efficient and cost effective. The goal of gainsharing programs is to save hospitals money while maintaining the same or better quality of care--a goal that will ultimately result in both better care and lower expenses for payors and for society as a whole. Nevertheless, the OIG has ruled that gainsharing programs are per se illegal. This Article analyzes the reasons behind the OIG's determination and argues that, contrary to the OIG's conclusion, the advisory opinion process is legally and practically the best way to deal with the issues raised by gainsharing programs.     

Advisory committees at FDA: the Hinchey Amendment and "conflict of interest" waivers

In approving the Food and Drug Administration's (FDA) Fiscal Year 2007 budget, the House approved an amendment that would prevent the agency from using appropriated funds to waive certain conflicts of interest identified by members of its advisory committees. The amendment, introduced by Representative Hinchey and known as the Hinchey Amendment, provides that no funds may be used to: waive a conflict of interest under Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) for any voting member of an FDA advisory committee or panel; or make a certification under Section 208(b)(3) of Title 18 of the U.S. Code for any such voting member. This creates a problem, as ties to industry create the very expertise that FDA values in its outside advisors-under the Hinchey Amendment, these very ties would prevent them from serving as advisors to FDA during the drug approval process. The author opposes this change in the law and argues that the Hinchey Amendment would undermine congressional efforts in 1962 and 1989 to carefully balance the goals of attracting qualified experts and protecting agency decisionmaking. Further, the author argues, this change is unnecessary at FDA, because experts on FDA advisory committees divulge their connections to the industry, because the committees offer only advice and do not make agency decisions, and because the agency is under the watchful eye of Congress, the public, and public interest groups. The Article concludes that although FDA's advisory committee conflict-of-interest process can be improved, congressional action is unnecessary, and a change in the law through amendment to an appropriations bill that does not go through the ordinary legislative process (as an amendment to the FDCA or Title 18 would) is inappropriate. Instead, recommendations from organizations studying FDA practice, such as the OIG, GAO, and IOM, should be used to carefully and reflectively amend the process at the agency level, within the existing statutory framework.     

Work activity of persons working as members of advisory committees established under the Federal Advisory Committee Act (FACA). Final rule

We are revising our disability regulations under titles II and XVI of the Social Security Act to establish a new, special rule that affects individuals who are receiving payments or providing services as members or consultants of a committee, board, commission, council or similar group established under the Federal Advisory Committee Act (FACA). Under this special rule, we will not count any earnings an individual is receiving from serving as a member or consultant of a FACA advisory committee when we determine if the individual is engaging in substantial gainful activity under titles II and XVI of the Social Security Act (the Act). In addition, we will not evaluate any of the services the individual is providing as a member or consultant of the FACA advisory committee when determining if the individual has engaged in substantial gainful activity under titles II and XVI of the Act. Based on our experience with FACA advisory committees and the frequency and level of activity required by these committees, we believe that performance of activity on these committees does not demonstrate the ability to perform substantial gainful activity. We believe this to be consistent with Congress's view, as it has recognized in creating the Ticket to Work advisory committee, for example, that current disability beneficiaries should be considered for membership. This also will encourage individuals with disabilities to serve on FACA advisory committees, thereby providing the benefit of their unique perspective on policies and programs to the Federal Government.     

Medicare program; hospice wage index--HCFA. Notice

This notice announces the annual update to the hospice wage index as required by 42 CFR 418,306(c). This update is effective October 1, 1998. The wage index is used to reflect local differences in wage levels. The hospice wage index methodology and values are based on recommendations of a negotiated rulemaking advisory committee and were originally published in the Federal Register on August 8, 1997. This update is the second year of a 3-year transition period. The second transition year begins October 1, 1998 and ends September 30, 1999.