The hazardous waste management system--Environmental Protection Agency. Interim final amendments to interim final and final rules

The Resource Conservation and Recovery Act (RCRA) requires that EPA set regulatory standards for all facilities which treat, store, or dispose of hazardous waste. In partial implementation of its requirement, on January 23, 1981, EPA set regulatory standards for incinerators that burn hazardous waste. These regulations were issued as "interim final," which means that, although they were issued in final form, the Agency invited public comment on them with a view to future amendment. Today, EPA is amending, on an interim final basis, certain of its regulations applicable to hazardous waste incineration facilities. Today's amendments include revisions to: the general standards for permitting hazardous waste incinerators (Part 264, Subpart O), published in the Federal Register on January 23, 1981; the interim status standards for hazardous waste incinerators (Part 265, Subpart O), revised on January 23, 1981; and the consolidated permit requirements for incinerators (Part 122), published on May 19, 1980 and January 23, 1981.U     

Medicare program; State Health Insurance Assistance Program (SHIP). Health Care Financing Administration (HCFA), HHS. Interim final rule with comment period

This interim final rule explains the terms and conditions that apply to grants to States for counseling and assistance to Medicare beneficiaries, and makes several minor technical clarifications about program compliance. We also specify our policies regarding the treatment of funds associated with the management of this program, including user fee assessments not in effect when prior regulations were issued. This interim final rule is issued in accordance with section 4360 of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) and section 1857(e)(2) of the Social Security Act (the Act).     

Public Health Service--Health maintenance organizations; requirements for a health maintenance organization. Final regulations

This rule amends the Public Health Service regulations by setting forth revised requirements for the organization and operation of federally qualified health maintenance organizations (HMOs). These amendments are made as a result of (1) public comments on the interim regulations published on July 18, 1979, and (2) public comments on the notice of proposed rulemaking (NPRM) governing relationships between federally qualified HMOs and other parties, also published on July 18, 1979.     

Medicare program; Medicare and laboratory certification program; enforcement procedures for laboratories--HCFA. Final rule

These regulations set forth the rules for sanctions that HCFA may impose on laboratories that are found not to meet Federal requirements. These include the principal sanctions of suspending, limiting, or revoking the laboratory's certificate issued under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and cancelling the laboratory's approval to receive Medicare payment for its services, and the alternative sanctions that may be imposed instead of or before the principal sanctions. These amendments are necessary to conform HCFA regulations to changes made in the law by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and the 1988 amendments to section 353 of the Public Health Service Act (PHS Act). The latter are commonly referred to as "CLIA 88". The purpose of the amendments is to ensure that functioning laboratories are capable of providing accurate and reliable test results and that the health of individuals served by the laboratory and that of the general public is not adversely affected by laboratory operations and by testing procedures that do not meet the standards set forth in other subparts of part 493 of the HCFA regulations.     

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.     

Public Health Service--health systems agencies and state health planning and development agencies; certificate of need reviews. Notice regarding certificate of need programs

This Notice sets forth advance information regarding amendments to the regulations governing certificate of need reviews by health systems agencies and State health planning and development agencies. This Notice is intended to provide early guidance to States prior to publication of interim final regulations implementing the amendments to certificate of need provisions of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub. L 96-79). This early guidance will assist the States in beginning to revise their certificate of need laws. Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. The Secretary intends to publish these interim final regulations within a few weeks. Following consideration of comments which will be solicited with regard to the interim regulations, the Secretary will publish an analysis of the comments and will revise those regulations as appropriate.     

Medicare program; coverage of epoetin (EPO) used by competent home dialysis patients--HCFA. Final rule

This final rule adopts as final the interim final rule that provided for Medicare coverage of EPO used by ESRD beneficiaries who dialyze at home and are competent to use the drug without medical or other supervision and established criteria for selection of patients that can be considered "competent" and for monitoring of the patients who are selected. It also makes minor changes in response to public comments on the interim rule. The interim rule was necessary to implement section 4201(d)(1) of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90). The purpose of the amendments is to facilitate use of EPO at home, while ensuring that such use of the drug is safe.     

Failure by certain charitable organizations to meet certain qualification requirements; taxes on excess benefit transactions--IRS. Notice of proposed rulemaking

This document contains proposed regulations relating to the excise taxes on excess benefit transactions under section 4958 of the Internal Revenue Code (Code), as well as certain amendments and additions to existing Income Tax Regulations affected by section 4958. Section 4958 was enacted in section 1311 of the Taxpayer Bill of Rights 2. Section 4958 generally is effective for transactions occurring on or after September 14, 1995. Section 4958 imposes excise taxes on transactions that provide excess economic benefits to disqualified persons of public charities and social welfare organizations. The proposed regulations clarify certain definitions and rules contained in section 4958.     

Medicare program; payment for preadmission services--HCFA. Final rule

This final rule responds to public comments on the January 12, 1994, interim final rule with comment period that provided that inpatient hospital operating costs include certain preadmission services furnished by the hospital (or by an entity that is wholly owned or operated by the hospital) to the patient up to 3 days before the date of the patient's admission to that hospital. These provisions implement amendments made to section 1886(a)(4) of the Social Security Act by section 4003 of the Omnibus Budget Reconciliation Act of 1990.     

Tribal child welfare. Interim final rule

The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.     

Group health plans and health insurance issuers: rules relating to internal claims and appeals and external review processes. Amendment to interim final rules with request for comments

This document contains amendments to interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under provisions of the Affordable Care Act. These rules are intended to respond to feedback from a wide range of stakeholders on the interim final regulations and to assist plans and issuers in coming into full compliance with the law through an orderly and expeditious implementation process.     

Medicaid program; freedom of choice waiver; conforming changes--HCFA. Interim final rule with comment period

This interim final rule amends existing Medicaid regulations on freedom of choice waivers granted under section 1915(b) of the Social Security Act (the Act) to conform them to the amendments made to the Act by sections 4604 and 4742 of the Omnibus Budget Reconciliation Act of 1990. This rule: Specifies that the Secretary may not waive the requirement that the State plan provide for adjustments in payment for inpatient hospital services furnished to infants under one year of age, or to children under 6 years of age who receive these services in disproportionate share hospitals. Extends to any provider participating under a section 1915(b)(4) waiver the same prompt payment standards that apply to all other health care practitioners furnishing Medicaid services. This rule also makes technical changes in the regulations relating to a recipient's free choice of providers of family planning services and cost-sharing requirements under waivers.     

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.     

Group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act. Interim final rules with request for comments

This document contains amendments to the interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding preventive health services.     

Medicare program; Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period responds to comments on the June 26, 1998 interim final rule that implemented the Medicare+Choice (M+C) program and makes revisions to those regulations where warranted. We also are making revisions to the regulations that are necessary to reflect the changes to the M+C program resulting from the Balanced Budget Refinement Act of 1999 (BBRA). Revisions to the regulations reflecting changes in the law made by the BBRA are subject to public comment. Issues discussed in this rule include eligibility, election, and enrollment policies; marketing requirements; access requirements; service area and benefit policy; quality improvement standards; payment rates, risk adjustment methodology, and encounter data submission; provider participation rules; beneficiary appeals and grievances; contractual requirements; and preemption of State law by Federal law. This final rule also addresses comments on the interim final rule published on December 2, 1997, which implemented user fees for section 1876 risk contractors for 1998, and formed the basis for the M+C user fee provisions in the June 26, 1998 interim final rule, and the provider-sponsored organization (PSO) interim final rule published April 14, 1998.     

Exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the interim final rule that issued regulations permitting FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). FDA is taking this action to complete the rulemaking initiated with the interim final rule.     

Control of communicable diseases. Interim final rule with comment period

The Public Health Service Act authorizes the Secretary, in consultation with the Surgeon General, to make and enforce regulations as are necessary to prevent the introduction, transmission or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. The existing regulations are outdated and do not address communicable diseases that currently pose a substantial public health threat. As of April 2, 2003, the World Health Organization (WHO) has reported 2236 cases and 78 deaths related to outbreaks of a severe form of pneumonia of unknown origin in Hong Kong SAR, Vietnam, Guangdong province in southern China, Canada, Singapore, and Thailand, which appears to have spread rapidly. For this reason, the Director General of the World Health Organization (WHO) issued a global alert about cases of atypical pneumonia and recommended that travelers with atypical pneumonia who may be related to these outbreaks be placed into isolation and assessed by quarantine officials. The Centers for Disease Control and Prevention (CDC) is currently investigating 85 suspected cases of the disease in the United States. This is being issued as an interim final rule because this newly-detected disease is likely spread in person-to-person fashion and may have an adverse public health impact if further introduced into the United States.     

Supplemental Security Income: determining disability for a child under age 18. Social Security Administration. Final rules

On February 11, 1997, we published interim final rules with a request for comments to implement the Supplemental Security Income (SSI) childhood disability provisions of sections 211 and 212 of Public Law (Pub. L.) 104-193, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. We are now publishing revised final rules in response to public comments. We are also conforming our rules to amendments to Public Law 104-193 made by the Balanced Budget Act of 1997, Public Law 105-33. Finally, we are simplifying and clarifying some rules in keeping with the President's goal of using plain language in regulations.     

The legal effect of EU Regulations

The EU institutions are increasingly addressing harmonisation by means of regulation rather than the traditional use of directives. This is particularly impacting areas such as data protection, financial services regulation and European standardisation in Information and Communications Technology. More broadly, using directly applicable regulations which may have horizontal and vertical direct effect rather than directives has important administrative and constitutional implications for their application in national law and impacts on Member States' discretion to implement supplementary legislation which falls within the remit of the regulation in question. This is of particular concern where governments implement policies which might be in contravention of these rules. This may be the case in relation to the UK government's public procurement policy which mandates royalty free standards rather than royalty bearing standards with the option for the licence holder to licence royalty free.     

Accounting for long-term contract--Internal Revenue Service. Notice of proposed rulemaking

This document contains proposed amendments to regulations under sections 446, 451 and 471 of the Internal Revenue Code relating to accounting for long-term contracts. The proposed amendments would conform the regulations to section 229 of the Tax Equity and Fiscal Responsibility Act of 1982 and would affect taxpayers who have long-term contracts whether or not they use a long-term contract method of accounting for such contracts.