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Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 1998 rates; corrections--HCFA. Final rule with comment period; correction notice.

In the August 29, 1997, issue of the Federal Register (62 FR 45966), we published a final rule with comment period revising the Medicare hospital inpatient prospective payment systems for operating costs and capital-related costs to implement necessary changes resulting from the Balanced Budget Act of 1997, Pub. L. 105-33 and changes arising from our continuing experience with the system. This document corrects technical errors made in that document.

Centers for Medicare and Medicaid Services, U.S.↗

Agency information collection activities: proposed collection; comment request--AHCPR. Notice.

This notice announces the Agency for Health Care Policy and Research's. (AHCPR) intention to request the Office of Management and Budget (OMB) to allow a proposed information collection of the "Medical Expenditure Panel Survey--Insurance Component (MEPS-IC) for 1998 and 1999." In accordance with the Paperwork Reduction Act of 1995, Pub. L. 104-13 (44 U.S.C. 3506(c)(2)(A)), AHCPR invites the public to comment on this proposed information collection.

Data Collection↗

Medicare program; revisions to payment policies and adjustments to the relative value units under the physician fee schedule, other Part B payment policies, and establishment of the clinical psychologist fee schedule for calendar year 1998; correction--HCFA. Correction of final rule with comment period.

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on October 31, 1997 entitled "Medicare Program; Revisions to Payment Policies and Adjustments to the Relative Value Units Under the Physician Fee Schedule, Other Part B Payment Policies, and Establishment of the Clinical Psychologist Fee Schedule for Calendar Year 1998.

Centers for Medicare and Medicaid Services, U.S.↗

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 1998 rates; corrections--HCFA. Final rule with comment period; correction notice.

In the August 29, 1997, issue of the Federal Register (62 FR 45966), we published a final rule with comment period revising the Medicare hospital inpatient prospective payment systems for operating costs and capital-related costs to implement necessary changes resulting from the Balanced Budget Act of 1997, Pub. L. 105-33, and changes arising from our continuing experience with the system. This document corrects errors made in that document.

Capital Expenditures↗

Medicare program; HCFA market research for providers and other partners--HCFA. General notice with comment period.

This notice seeks public comments on information needs of Medicare risk contract health maintenance organizations (HMOs) and competitive medical plans (CMPs) and communication strategies that could improve the effectiveness and efficiency of the risk contract program. Under section 4002 of the Balanced Budget Act of 1997, and with the implementation of the Medicare + Choice program, all HMOs and CMPs will contract with HCFA under requirements of the Medicare + Choice program. The information sought in this notice will facilitate future changes in the contracting program, as well as improve information needs and communication strategies under the current risk program. Respondents should prioritize issues raised in the preliminary research and identify and additional areas of information needs and best communication strategies. This initiative is one component of our overall effort to develop a comprehensive communication strategy with Medicare providers and HMOs/CMPs and to develop innovative approaches that will assist all program participants to obtain and use information in the most accessible and effective manner. Preliminary research on the information needs of Medicare risk contract HMOs and CMPs and effective communication strategies has identified a number of areas in which we could provide additional information and potential strategies for communicating that information effectively.

Aged↗

Medicare and Medicaid programs; announcement of additional application from hospital requesting waiver for organ procurement service area--HCFA. Notice with comment period.

This notice announces an additional application that HCFA has received from a hospital requesting waiver from dealing with its designated organ procurement organization (OPO) in accordance with section 1138(a)(2) of the Act. This notice requests comments from OPOs and the general public for our consideration in determining whether such a waiver should be granted.

Catchment Area, Health↗

Medicare program; definition of provider-sponsored organization and related requirements--HCFA. Interim final rule with comment period.

The Balanced Budget Act of 1997 establishes a new Medicare + Choice program that significantly expands the health care options available to Medicare beneficiaries. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plans that contract with HCFA. Among the new options available to Medicare beneficiaries is enrollment in a provider-sponsored organization (PSO). This interim final rule with comment period defines the term "provider-sponsored organization" for purposes of the Medicare program and establishes requirements related to meeting this definition. We believe that setting forth the definition of a PSO and the related requirements will facilitate the submission of applications to participate in the Medicare program as a PSO.

Aged↗

Interim rules for mental health parity--IRS, DoL, HCFA. Interim rules with request for comments.

This document contains interim rules governing parity between medical/surgical benefits and mental health benefits in group health plans and health insurance coverage offered by issuers in connection with a group health plan. The rules contained in this document implement changes made to certain provisions of the Internal Revenue Code of 1986 (Code), the Employee Retirement Income Security Act of 1974 (ERISA or Act), and the Public Health Service Act (PHS Act) enacted as part of the Mental Health Parity Act of 1996 (MHPA) and the Taxpayer Relief Act of 1997. Interested persons are invited to submit comments on the interim rules for consideration by the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (Departments) in developing final rules. The rules contained in this document are being adopted on an interim basis to ensure that sponsors and administrators of group health plans, participants and beneficiaries, States, and issuers of group health insurance coverage have timely guidance concerning compliance with the requirements of MHPA.

Centers for Medicare and Medicaid Services, U.S.↗

Medical devices; refurbishers, rebuilders, reconditioners, servicers, and "as is" remarketers of medical devices; review and revision of compliance policy guides and regulatory requirements; request for comments and information--FDA. Advance notice of proposed rulemaking.

The Food and Drug Administration (FDA) is announcing its intention to review and, as necessary, to revise or to amend its compliance policy guides and regulatory requirements relating to the remarketing of used medical devices and the persons who refurbish, recondition, rebuild, service, or remarket such devices. The agency is considering these actions because it believes evolving industry practices warrant reevaluation of current policy and the application of certain regulatory requirements in order to ensure that particular remarketed devices meet suitable performance requirements for their intended uses, and are as safe as the originally marketed finished device. FDA is soliciting comments, proposals for alternative regulatory approaches, and information on these issues. In a future issue of the Federal Register, FDA will announce an open meeting of the Good Manufacturing Practices (GMP) Advisory Committee concerning these matters.

Device Approval↗

Medicare program; waiver requirements and solvency standards for provider-sponsored organizations--HCFA. Interim final rule with comment period.

This interim final rule with a request for comments implements authority to waive, in the case of provider-sponsored organizations (PSOs) that meet certain criteria, the requirement that Medicare + Choice organizations be licensed by a State as risk-bearing entities. The waivers will be approved only under certain conditions where the State has denied or failed to act on an application for licensure. This rule also establishes solvency standards that certain entities must meet to contract as PSOs under the new Medicare + Choice program. These standards apply to PSOs that have received a waiver of the requirement that Medicare + Choice organizations be licensed by a State as risk-bearing entities.

Centers for Medicare and Medicaid Services, U.S.↗

M.D. Physicians of Southwest Louisiana, Inc.; analysis to aid public comment--FTC. Proposed consent agreement.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint that accompanies the consent agreement and the terms of the consent order--embodied in the consent agreement--that would settle these allegations.

Antitrust Laws↗

Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA); interpretation of "federal public benefit"--HHS. Notice with comment period.

This notice with comment period interprets the term "Federal public benefit" as used in Title IV of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), Pub. L. 104-193, and identifies the HHS programs that provide such benefits under this interpretation. According to section 401 if PRWORA, aliens who are not "qualified aliens" are not eligible for any "Federal public benefit," unless the "Federal public benefit" falls within a specified exception. A "Federal public benefit" includes "any grant, contract, loan, professional license, or commercial license" provided to an individual, and also "any retirement, welfare, health, disability, public or assisted housing, postsecondary education, food assistance, unemployment benefit, or any other similar benefit for which payments or assistance are provided to an individual, household, or family eligibility unit." Under section 432, providers of a non-exempt "Federal public benefit" must verify that a person applying for the benefit is a qualified alien and is eligible to receive the benefit. The HHS programs that provide "Federal public benefits" and are not otherwise excluded from the definition by the exceptions provided in section 401(b) are: Adoption Assistance Administration on Developmental Disabilities (ADD)-State Developmental Disabilities Councils (direct services only) ADD-Special Projects (direct services only) ADD-University Affiliated Programs (clinical disability assessment services only) Adult Programs/Payments to Territories Agency for Health Care Policy and Research Dissertation Grants Child Care and Development Fund Clinical Training Grant for Faculty Development in Alcohol & Drug Abuse Foster Care Health Profession Education and Training Assistance Independent Living Program Job Opportunities for Low Income Individuals (JOLI) Low Income Home Energy Assistance Program (LIHEAP) Medicare Medicaid (except assistance for an emergency medical condition) Mental Health Clinical Training Grants Native Hawaiian Loan Program Refugee Cash Assistance Refugee Medical Assistance Refugee Preventive Health Services Program Refugee Social Services Formula Program Refugee Social Services Discretionary Program Refugee Targeted Assistance Formula Program Refugee Targeted Assistance Discretionary Program Refugee Unaccompanied Minors Program Refugee Voluntary Agency Matching Grant Program Repatriation Program Residential Energy Assistance Challenge Option (REACH) Social Services Block Grant (SSBG) State Child Health Insurance Program (CHIP) Temporary Assistance for Needy Families (TANF) While all of these programs provide "Federal public benefits" this does not mean that all benefits or services provided under these programs are "Federal public benefits." As discussed in sections II and III below, some benefits or services under these programs may not be provided to an "individual, household, or family eligibility unit" and, therefore, do not constitute "Federal public benefits" as defined by PRWORA.

Eligibility Determination↗

Medicaid and Title IV-E programs; revision to the definition of an unemployed parent--Administration for Children and Families (ACF) and HCFA. Final rule with comment period.

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) transformed the nation's welfare system into one that requires work in exchange for time-limited assistance. The law eliminated the Aid to Families with Dependent Children (AFDC) program and replaced it with the Temporary Assistance for Needy Families (TANF) program. The law provides States flexibility to design their TANF programs in ways that strengthen families and promote work, responsibility, and self-sufficiency while holding them accountable for results. Many States are using this flexibility to provide welfare to work assistance to two parent families, which was more difficult to do under the old welfare rules. However, pre-existing regulations regarding the definition of "unemployed parent" prevent some States from providing intact families with health insurance to help them stay employed. This rule will eliminate this vestige of the old welfare system in order to promote work, strengthen families, and simplify State program administration. In general under PRWORA, States must ensure that families who would have qualified for Medicaid health benefits under the prior welfare law are still eligible. While under the previous law receipt of AFDC qualified families for Medicaid, the new statute does not tie receipt of TANF to Medicaid. Instead, subject to some exceptions, Medicaid eligibility for families and children now depends upon whether a family would have qualified for AFDC under the rules in effect on July 16, 1996. Similarly, Federal foster care eligibility depends on whether the child would have qualified for AFDC under the rules in effect on July 16, 1996. In order for a family to qualify for assistance under the pre-PRWORA AFDC rules, its child had to be deprived of parental support or care due to the death, absence, incapacity, or unemployment of a parent. Two parent families generally qualified only under the "unemployment" criterion which was narrowly defined in the AFDC regulations. In this final rule with comment, we are amending these regulations to provide States with additional flexibility to provide Medicaid coverage to two parent families, facilitate coordination among the TANF, Medicaid and foster care programs, increase incentives for fulltime work, and allow States to eliminate inequitable rules that are a disincentive to family unity.

Aid to Families with Dependent Children↗

Proposed vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), Varicella (chickenpox), and measles, mumps, rubella (MMR) vaccines--CDC. Notice with comment period.

Under the National Childhood Vaccine Injury Act (42 U.S.C. section 300aa-26), CDC must develop vaccine information materials that health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for hepatitis B, Haemophilus influenzae type b, and Varicella vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines.

Centers for Disease Control and Prevention, U.S.↗