Clinical studies of safety and effectiveness of orphan products; availability of grants; request for applications--FDA. Notice

The Food and Drug Administration (FDA) is announcing changes to its Orphan Products Development (OPD) grant program for fiscal year (FY) 1999. The previous announcement of this program, which was published in the Federal Register of July 9, 1997, is superseded by this announcement. In the future, a new announcement will be published annually.     

Dipping and coating operations. Occupational Safety and Health Administration (OSHA), Labor. Final rule

OSHA's standards for dipping and coating operations, codified at sections 1910.108 and 1910.94(d), are designed to protect employees from fire, explosion, and other hazards associated with these operations. On April 7, 1998 (63 FR 16918), OSHA published proposed revisions to these standards in the Federal Register. The Federal Register announcement requested comments on the proposed rule, as well as on three major issues identified by OSHA. Based on these comments and other considerations, the Agency has developed the final standard to accomplish several goals: To rewrite the former standards in plain language; to consolidate the former requirements in sequential sections (sections 1910.122 through 1910.126 in subpart H of part 1910); and to update the former standards to increase the compliance options available to employers. In addition to achieving these goals, OSHA concludes that the final rule being published today will enhance employee protection by making it more understandable and useful to employers and employees and more flexible and performance-oriented than the former rules. The final rule accomplishes these goals without increasing the regulatory burden of employers or reducing employee protection.     

Medicare program; solvency standards for provider-sponsored organizations. Health Care Financing Administration (HCFA), HHS. Final rule

The Balanced Budget Act of 1997 established a new Medicare+Choice (M+C) program that offers eligible individuals Medicare benefits through enrollment in one of an array of private health plans that contract with us. Among the new options available to Medicare beneficiaries is enrollment in a provider-sponsored organization (PSO). This final rule revises and responds to comments on solvency standards that certain entities must meet to contract as PSOs under the new M+C program. These standards, originally established in an interim final rule published on May 7, 1998, apply to PSOs that have received a waiver of the requirement that M+C organizations must be licensed by a State as risk-bearing entities.     

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.     

Medicare program; changes to the Medicare+Choice program. Health Care Financing Administration (HCFA), HHS. Final rule

The purpose of this final rule is to set forth limited changes to the Medicare+Choice regulations published in our June 26, 1998 interim final rule (63 FR 34968). Those regulations implemented section 4001 of the Balanced Budget Act of 1997 (BBA), which established the Medicare+Choice (M+C) program. This final rule addresses selected issues raised by commenters on the June 26, 1998 interim final rule where we have identified the need for changes or where we believe that clarifications are needed as soon as possible. Among these issues are provider participation procedures, beneficiary enrollment options, and several access-related issues, including initial care assessment requirements, notification requirements when specialists are terminated from an M+C plan, and several coordination of care requirements.     

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).     

Notice of availability of funding for alternative projects, known as Wilson/Fish Projects, to implement alternative means of providing interim financial assistance, medical assistance, social services, and case management to refugees and Cuban and Haitian entrants. Office of Refugee Resettlement (ORR), ACF, DHHS

The Office of Refugee Resettlement (ORR) announces that competing applications will be accepted from public and private non-profit organizations under a standing announcement for Wilson/Fish projects which propose alternative approaches to serving refugees. The purpose of an alternative project is to provide integrated services and cash assistance to refugees in order to increase refugees' prospects for early employment and self-sufficiency, reduce their level of welfare dependence, enhance acculturation, and promote coordination among voluntary resettlement agencies and service providers. Projects will be accepted under either of two categories: (1) Projects to establish or maintain a refugee program in a State where the State is not participating in the refugee program or is dropping out of the refugee program or a portion of the program; and (2) projects to provide an alternative to the existing system of assistance and services to refugees. Funding is available to these projects under the "Wilson/Fish" authority.     

Privacy Act; implementation. Office of Inspector General (OIG), HHS. Final rule

This final rule exempts the new system of records, the Healthcare Integrity and Protection Data Bank (HIPDB), from certain provisions of the Privacy Act (5 U.S.C. 552a). The establishment of the HIPDB is required by section 1128E of the Social Security Act (the Act), as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 1128E of the Act directed the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers or practitioners, and to maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners. Regulations implementing the new HIPDB were published in the Federal Register on October 26, 1999 (64 FR 57740). The exemption being set forth in this rule applies to investigative materials compiled for law enforcement purposes.     

State child health; implementing regulations for the State Children's Health Insurance Program. Health Care Financing Administration (HCFA), HHS. Final rule

Section 4901 of the Balanced Budget Act of 1997 (BBA) amended the Social Security Act (the Act) by adding a new title XXI, the State Children's Health Insurance Program (SCHIP). Title XXI provides funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner. To be eligible for funds under this program, States must submit a State plan, which must be approved by the Secretary. This final rule implements provisions related to SCHIP including State plan requirements and plan administration, coverage and benefits, eligibility and enrollment, enrollee financial responsibility, strategic planning, substitution of coverage, program integrity, certain allowable waivers, and applicant and enrollee protections. This final rule also implements the provisions of sections 4911 and 4912 of the BBA, which amended title XIX of the Act to expand State options for coverage of children under the Medicaid program. In addition, this final rule makes technical corrections to subparts B, and F of part 457.     

Funding reductions in fiscal year 1982. Health Services Administration. Notice

This notice announces: (1) Factors that the Health Services Administration (HSA) will use in determining which Community Health Center (CHC) projects to fund, and (2) restrictions on the type of project activities that will be eligible for Federal support under the CHC program. a reduced level of authorization of appropriations for section 30 of the Public Health Service (PHS) Act in the recently enacted Omnibus Budget Reconciliation Act of 1981 (Pub. L 97-35) is the reason for the announcement of these factors and restrictions.     

Medicare program; suggestion program on methods to improve Medicare efficiency. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period establishes a program to encourage individuals to submit suggestions that could improve the efficiency of the Medicare program. The rule implements section 203(c) of the Health Insurance Portability and Accountability Act of 1996. The intent of this rule is to encourage suggestions and to award, if we deem appropriate, monetary payments to individuals for suggestions that improve efficiency and produce monetary savings to the Medicare program.     

Medicare and Medicaid programs; quarterly listing of program issuances--third quarter, 1998. Health Care Financing Administration (HCFA), HHS. Notice

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September 1998, relating to the Medicare and Medicaid programs. This notice also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that potentially may be covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.     

Health care programs: fraud and abuse; revisions to the PRO sanctions process-HHS. Correction to final regulations

This document corrects a technical error that appeared in 42 CFR part 1004 of the final rule published in the Federal Register on December 12, 1995 (60 FR 63634). The final rule was designed to revise and update the procedures governing the imposition and adjudication of program sanctions predicated on recommendations of State Utilization and Quality Control Peer Review Organizations. Specifically, this correction notice sets forth the corrected text for section 1004.110(f) which contained a typographical error in subparagraph (2).     

Occupational injury and illness recording and reporting requirements. Occupational Safety and Health Administration (OSHA), U.S. Department of Labor. Final rule

The Occupational Safety and Health Administration (OSHA) is revising its rule addressing the recording and reporting of occupational injuries and illnesses (29 CFR parts 1904 and 1952), including the forms employers use to record those injuries and illnesses. The revisions to the final rule will produce more useful injury and illness records, collect better information about the incidence of occupational injuries and illnesses on a national basis, promote improved employee awareness and involvement in the recording and reporting of job-related injuries and illnesses, simplify the injury and illness recordkeeping system for employers, and permit increased use of computers and telecommunications technology for OSHA recordkeeping purposes. This rulemaking completes a larger overall effort to revise Part 1904 of Title 29 of the Code of Federal Regulations. Two sections of Part 1904 have already been revised in earlier rulemakings. A rule titled Reporting fatalities and multiple hospitalization incidents to OSHA, became effective May 2, 1994 and has been incorporated into this final rule as Section 1904.39. A second rule entitled Annual OSHA injury and illness survey of ten or more employers became effective on March 13, 1997 and has been incorporated into this final rule as Section 1904.41. The final rule being published today also revises 29 CFR 1952.4, Injury and Illness Recording and Reporting Requirements, which prescribes the recordkeeping and reporting requirements for States that have an occupational safety and health program approved by OSHA under Section 18 of the Occupational Safety and Health Act (the "Act" or "OSH Act").     

Health care programs: fraud and abuse; technical revision to the scope and effect of the OIG exclusion regulations--HHS. Final rule

This document sets forth a technical revision to OIG regulations on program integrity for Medicare and State Health Care programs, concerning the scope and effect of the OIG's program exclusion regulations. Prior to this revision, the regulations provided that a program exclusion imposed under title XI of the Social Security Act was to affect future participation in all Federal non-procurement programs. This revision specifically amends the language in the existing regulations to clarify that the scope of an exclusion is now applicable to all Executive Branch procurement and non-procurement programs and activities. This rule is consistent with the Federal Acquisition Streamlining Act, and the Department's Common Rule on debarment and suspension which is also being amended and published elsewhere in this issue of the Federal Register.     

State child health; State Children's Health Insurance Program allotments and payments to states. Health Care Financing Administration (HCFA), HHS. Final rule

This rule sets forth the methodologies and procedures to determine the allotments of Federal funds for each Federal fiscal year (FY) available to individual States, Commonwealths and Territories under title XXI of the Social Security Act. This rule also specifies the allotment, payment, and grant award process that will be used for the States, the Commonwealths and Territories to claim and receive Federal financial participation (FFP) for expenditures under the State Children's Health Insurance Program (SCHIP) and related Medicaid program provisions. Established by section 4901 of the Balanced Budget Act of 1997 (Public Law 105-33), amended by technical amendments (made by Public Law 105-100), and most recently amended by the Medicare, Medicaid and SCHIP Balanced Budget Refinement Act (BBRA) of 1999 (Public Law 106-113, enacted November 29, 1999), the State Children's Health Insurance Program provides Federal matching funds to States to initiate and expand health insurance coverage to uninsured, low-income children. Aggregate Federal funding is limited to a fixed amount for each Federal fiscal year. This aggregate amount is divided into allotments for each State. State allotments are determined based on a statutory formula that divides the total available appropriation among all States with approved child health plans. Once determined, the amount of a State's allotment for a fiscal year is available for 3 years. We are publishing this final rule in accordance with the provisions of sections 2104 and 2105 of the Act that relate to allotments and payments to States under title XXI.     

Medicare program; recognition of the Community Health Accreditation Program, Inc. (CHAP) for hospices. Health Care Financing Administration (HCFA), HHS. Final notice

This notice recognizes the Community Health Accreditation Program, Inc. (CHAP) as a national accreditation organization for hospices that request participation in the Medicare program. We believe that accreditation of hospices by CHAP demonstrates that all Medicare hospice conditions of participation are met or exceeded. Thus, we grant deemed status to those hospices accredited by CHAP. The proposed notice included the application from the Joint Commission for Accreditation of Healthcare Organizations (JCAHO). We have separated the final notices to appropriately process each application and will issue a separate final notice containing the decision for JCAHO under HCFA-2039-FN.