Medicare program; coverage and administrative policies for clinical diagnostic laboratory tests; intent to form Negotiated Rulemaking Committee--HCFA. Notice of intent to form Negotiated Rulemaking Committee and notice of meetings

The Balanced Budget Act of 1997 requires the Secretary to establish a Negotiated Rulemaking Committee under the Negotiated Rulemaking Act and the Federal Advisory Committee Act. The Negotiated Rulemaking Committee's (the Committee) purpose will be to negotiate national coverage and administrative policies for clinical diagnostic laboratory tests under Part B of the Medicare program as required by the Balanced Budget Act of 1997 (BBA). The Committee will consist of representatives of interested parties that are likely to be significantly affected by the proposed rule. The Committee will be assisted by a neutral facilitator. The BBA outlines the scope of issues to be negotiated by the Committee. We specifically request public comment as to whether we have identified the interests that will be affected by key issues listed below.     

Medicare program; fee schedule for payment of ambulance services and revisions to the physician certification requirements for coverage of nonemergency ambulance services. Final rule with comment period

This final rule establishes a fee schedule for the payment of ambulance services under the Medicare program, implementing section 1834(l) of the Social Security Act. As required by that section, the proposed rule on which this final fee schedule for ambulance services is based was the product of a negotiated rulemaking process that was carried out consistent with the Federal Advisory Committee Act and the Negotiated Rulemaking Act of 1990. The fee schedule described in this final rule will replace the current retrospective reasonable cost payment system for providers and the reasonable charge system for suppliers of ambulance services. In addition, this final rule requires that ambulance suppliers accept Medicare assignment; codifies the establishment of new Health Care Common Procedure Coding System (HCPCS) codes to be reported on claims for ambulance services; establishes increased payment under the fee schedule for ambulance services furnished in rural areas based on the location of the beneficiary at the time the beneficiary is placed on board the ambulance; and revises the certification requirements for coverage of nonemergency ambulance services.     

Plans established or maintained pursuant to collective bargaining agreements under section 3(40)(A)--Pension and Welfare Benefits Administration. Notice of intent to form a negotiated rulemaking advisory committee

The Department of Labor (Department) intends to form a Negotiated Rulemaking Advisory Committee (Committee) in accordance with the Negotiated Rulemaking Act of 1990 and the Federal Advisory Committee Act. The Committee will negotiate the development of a proposed rule implementing the Employee Retirement Income Security Act of 1974, as amended, 29 U.S.C. 1001-1461 (ERISA). The purpose of the proposed rule is to establish a process and criteria for a finding by the Secretary of Labor that an agreement is a collective bargaining agreement for purposes of section 3(40) of ERISA. The proposed rule will also provide guidance for determining when an employee benefit plan is established or maintained under or pursuant to such an agreement. Employee benefit plans that are established or maintained for the purpose of providing benefits to the employees of more than one employer are "multiple employer welfare arrangements" under section 3(40) of ERISA, and therefore are subject to certain state regulations, unless they meet one of the exceptions set forth in section 3(40)(A). At issue in this regulation is the exception for plans or arrangements that are established or maintained under one or more agreements which the Secretary finds to be collective bargaining agreements. If adopted, the proposed rule would affect employee welfare benefit plans, their sponsors, participants and beneficiaries, as well as service providers to plans. It may also affect plan fiduciaries, unions, employer organizations, the insurance industry, and state insurance regulators.     

Medicare program; hospice wage index--HCFA. Final rule

This final rule establishes a methodology to update the wage index used to adjust Medicare payment rates for hospice care. It also includes the new wage index, to be effective October 1, 1997. The wage index is used to reflect local differences in wage levels. A new wage index is needed because the index currently applied is based on 1981 wage and employment data and has not been updated since 1983. The methodology is based on the recommendations of a negotiated rulemaking advisory committee comprised of persons who represent interests affected by the hospice rules.     

Social Security benefits and supplemental security income; disability termination hearings at the reconsideration level--SSA. Notice of proposed rulemaking

We are proposing regulatory changes to carry out a requirement of Pub. L. 97-455 (enacted on January 12, 1983). That legislation requires several changes in the procedures used by the Social Security Administration (SSA) to conduct periodic reviews of disability cases for continuing eligibility. The proposed regulations would implement Sections 4 and 5 of the new law, which require SSA to make a face-to-face evidentiary hearing available in connection with the reconsideration of any initial determination that an individual receiving disability benefits under title II of the Social Security Act (the Act) is not now disabled. We also propose to make the new reconsideration procedure available in blindness and disability termination cases in the Supplemental Security Income (SSI) program under title XVI of the Act, pursuant to the Secretary's broad rulemaking authority in the SSI program. Although Congress has not specifically required that we do so, it is customary to extend legislative improvements in the title II disability program to comparable SSI cases, since the medical eligibility requirements in both programs are quite similar. Moreover, the proposed inclusion of SSI blindness and disability termination cases would promote effective program administration by providing a uniform appeal procedure in the two programs. We believe that this new procedure will make the reconsideration level more meaningful in blindness and disability termination cases, that beneficiaries affected by these termination decisions will be better served and that the overall quality of the decisionmaking process will also be improved.     

Medicare and state health care programs: fraud and abuse; safe harbors for protecting health plans--Office of Inspector General, HHS. Final rule

In accordance with section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, this final rule sets forth various standards and guidelines for safe harbor provisions designed to protect certain health care plans, such as health maintenance organizations and preferred provider organizations, under the Medicare and State health care programs' anti-kickback statute. These safe harbor provisions were originally published in the Federal Register on November 5, 1992 in interim final form. In response to the various public comments received, this final rule revises and clarifies various aspects of that earlier rulemaking.     

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.     

Health care programs: fraud and abuse; revised OIG sanction authorities resulting from Public Law 105-33--OIG. Notice of proposed rulemaking

This rulemaking proposes revisions to the OIG's exclusion and civil money penalty authorities set forth in 42 CFR parts 1001, 1002 and 1003, resulting from the Balanced Budget Act of 1997, Public Law 105-33. These proposed revisions are intended to protect and strengthen Medicare and State health care programs by increasing the OIG's anti-fraud and abuse authority through new or revised exclusion and civil money penalty provisions.     

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 and state health care programs: fraud and abuse; safe harbors for protecting health plans--HHS. Interim final rule with request for comment

In accordance with section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, this interim final rule establishes two new safe harbors and amends one existing safe harbor to provide protection for certain health care plans, such as health maintenance organizations and preferred provider organizations. The first new provision protects certain incentives to enrollees (including waiver of coinsurance and deductible amounts) paid by health care plans. The second new provision protects certain negotiated price reduction agreements between health care plans and contract health care providers. Finally, an existing safe harbor has been amended to protect certain agreements entered into between hospitals and Medicare SELECT insurers. These safe harbors specifically set forth various standards and guidelines that, if met, will result in the particular arrangement being protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.     

Medicare program; physicians' referrals to health care entities with which they have financial relationships (Phase II). Interim final rule with comment period

This interim final rule with comment period (Phase II of this rulemaking) incorporates into regulations the provisions concerning ownership and investment exceptions in paragraphs (c) and (d) and the compensation exceptions in paragraph (e) of section 1877 of the Social Security Act (the Act). Phase II also addresses comments concerning the reporting requirements in section 1877(f) of the Act. Phase I (as defined below) addressed the majority of issues in implementing section 1877 of the Act. Phase II both addresses the remaining issues not addressed in Phase I and responds to public comments. In general, in response to public comments, the Department has attempted to reduce regulatory burden by broadening exceptions using the Secretary's discretionary authority under the statute to create exceptions that pose no risk of fraud or abuse. For the convenience of affected parties, we have set out the entire rule as previously promulgated, including the changes made by this rulemaking.     

Medicare Program; establishment of the Medicare+Choice Program--HCFA. Interim final rule with comment period

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice (M+C) 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 plan choices beyond the original Medicare program or the plans now available through managed care organizations under section 1876 of the Social Security Act. Among the alternatives that will be available to Medicare beneficiaries are M+C coordinated care plans (including plans offered by health maintenance organizations, preferred provider organizations, and provider-sponsored organizations), M+C "MSA" plans, that is, a combination of a high deductible M+C health insurance plan and a contribution to an M+C medical savings account (MSA), and M+C private fee-for-service plans. The introduction of the M+C program will have a profound effect on Medicare beneficiaries and on the health plans and providers that furnish care. The new provisions of the Medicare statute, set forth as Part C of title XVIII of the Social Security Act, address a wide range of areas, including eligibility and enrollment, benefits and beneficiary protections, quality assurance, participating providers, payments to M+C organizations, premiums, appeals and grievances, and contracting rules. This interim final rule explains and implements these provisions. In addition, we are soliciting letters of intent from organizations that intend to offer M+C MSA plans to Medicare beneficiaries and/or to serve as M+C MSA trustees.     

Availability of information and records to the public; fees for providing information and records; procedures and appeals--SSA. Notice of proposed rulemaking

The Social Security Administration (SSA) announces proposed changes in the fees it charges for providing records from its files and record related services. These proposed changes will conform SSA's fee schedule to that recently published by the Department of Health and Human Services (HHS). The proposed rules also implement the discretion given the Secretary of Health and Human Services by section 2207 of the Omnibus Budget Reconciliation Act of 1981 to charge the full cost of providing certain information and records. The proposed rules do not change SSA's longstanding policy of generally not charging an individual for information needed to assure that our records concerning her or him are correct. In preparing these amendments, we deleted from SSA's rules several provisions concerning Medicare information. The Health Care Financing Administration (HCFA) has published separate regulations governing the availability of Medicare information and records. We have also clarified the rules for handling requests for information about individuals under the Privacy Act and the Freedom of Information Act (FOIA) and incorporated HHS' recent rules on who has authority to release or deny records in this revised material.     

Health care programs: fraud and abuse; revised OIG exclusion authorities resulting from Public Law 104-191--HHS. Notice of proposed rulemaking

This rulemaking addresses proposed revisions to the OIG's sanction authorities in conjunction with sections 211, 212 and 213 of the Health Insurance Portability and Accountability Act of 1996, along with other technical and conforming changes to the OIG exclusion authorities set forth in 42 CFR parts 1000, 1001, 1002 and 1005. These proposed revisions are specifically designed to expand the protection of certain basic fraud authorities, and revise and strengthen the current legal authorities pertaining to exclusions from the Medicare and State health care programs.     

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.     

Occupational exposure to ethylene oxide; Occupational Safety and Health Administration. Advance notice of proposed rulemaking

Notice is given that OSHA is undertaking, through rulemaking procedures under section 6(b) of the Occupational Safety and Health Act of 1970 (the Act), 29 U.S.C. 655(b), a reevaluation of the current occupational health standard regulating employee exposure to ethylene oxide (EtO), 29 CFR 1910.1000, Table Z-1. This notice summarizes the information currently available to OSHA concerning the production and use of EtO, estimates of employee exposure, and the potential health effects of employee exposure to EtO. The notice also invites interested parties to submit data, views and comments regarding the development of a new standard for EtO and the appropriate scope of coverage.     

Medical use of byproduct material; public meetings--NRC. Notice of public meetings

The Nuclear Regulatory Commission has developed a proposed rulemaking for a comprehensive revision of its regulations governing the medical use of byproduct material in 10 CFR Part 35, "Medical Use of Byproduct Material," and a proposed revision of its 1979 Medical Use Policy Statement (MPS). Throughout the development of the proposed rule and MPS, the Commission solicited input from the various interests that may be affected by these proposed revisions. The Commission now plans to solicit comments on the proposed rule and MPS through two mechanisms--publishing the documents in the Federal Register for public comment (scheduled for August 1998); and convening three facilitated public meetings, during the public comment period, to discuss the Commission's proposed resolution of the major issues. The public meetings will be held in San Francisco, California, on August 19-20, 1998; in Kansas City, Missouri, on September 16-17, 1998; and in Rockville, Maryland, on October 21-22, 1998. All meetings will be open to the public. Francis X. Cameron, Special Counsel for Public Liaison, in the Commission's Office of the General Counsel, will be the convener and facilitator for the meetings.     

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.