Organ Procurement and Transplantation Network--HRSA. Final rule with comment period

This document sets forth the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), which performs a variety of functions related to organ transplantation under contract with HHS. The document also offers a 60 day period for additional public comment. The rule will become effective 30 days following the close of the comment period. If the Department believes that additional time is required to review the comments, we will consider delaying the effective date. In combination with a new National Organ and Tissue Donation Initiative, this rule is intended to improve the effectiveness and equity of the Nation's transplantation system and to further the purposes of the National Organ Transplant Act of 1984, as amended. These purposes include: encouraging organ donation; developing an organ allocation system that functions as much as technologically feasible on a nationwide basis; providing the bases for effective Federal oversight of the OPTN (as well as for implementing related provisions in the Social Security Act); and, providing better information about transplantation to patients, families and health care providers.     

Organ Procurement and Transplantation Network. Health Resources and Services Administration, HHS. Final rule

This document sets forth improvements to the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), published in 1998. It reflects the advice of a panel convened by the National Academy of Science's Institute of Medicine, as called for in the Department's appropriation act for 1999. It also reflects comments on the 1998 rule and consultation with representatives of the organ transplantation community, as recommended in the same legislation; and it summarizes new transplant data developed in the period since enactment of the appropriations act.     

Medicare program; establishment of the Medicare+Choice program--HCFA. Correction of interim final rule with comment period

On June 26, 1998, we published in the Federal Register, at 63 FR 34,968, an interim final rule with comment period that explains and implements those provisions of the Balanced Budget Act of 1997 that established the Medicare+Choice program. This notice corrects errors made in the June 26 document.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities; extension of comment period--HCFA. Notice of extension of comment period for interim final rule

This document extends the comment period for an interim final rule with comment period that was published in the Federal Register on May 12, 1998 (63 FR 26252). That interim final rule implements provisions in section 4432 of the Balanced Budget Act of 1997 related to Medicare payment for skilled nursing facility services. Those include the implementation of a Medicare prospective payment system for skilled nursing facilities, consolidated billing, and a number of related changes. The comment period is extended for 60 days.     

Medicare program; update of ambulatory surgical center payment rates--HCFA. Notice with comment period

This notice implements section 1833(i)(2)(A) of the Social Security Act, which requires that the payment rates for ambulatory surgical center (ASC) services be reviewed and updated annually, and responds to the public comments we received concerning the ASC payment rate update notice with comment published on December 31, 1991 (56 FR 67666), except for those concerning payment amounts for lithotripsy, which will be addressed in another Federal Register document. DATES: Effective date: The payment rates contained in this notice are effective for services furnished on or after October 1, 1992. Comments date: Comments will be considered if we receive them at the appropriate address, as provided below, by 5 p.m. on November 30, 1992.     

Medicare program; update of ambulatory surgical center list of covered procedures effective July 1, 2003. Final rule with comment period

This final rule with comment period will make additions to and deletions from the current list of Medicare approved ambulatory surgical center (ASCs) procedures. In addition, it responds to comments received on the June 12, 1998 proposed rule (63 FR 32290) that addressed proposed additions to and deletions from the list of ASC covered procedures. This rule also implements requirements of section 1833(i)(1) and (2) of the Social Security Act.     

Medicare program; physician financial relationships with, and referrals to, health care entities that furnish clinical laboratory services and financial relationship reporting requirements--HCFA. Final rule with comment period

This final rule with comment period provides that, if a physician or a member of a physician's immediate family has a financial relationship with an entity, the physician may not make referrals to the entity for the furnishing of clinical laboratory services under the Medicare program, except under specified circumstances. It contains revisions to our proposal of March 11, 1992, based on comments submitted by the public. Further, it incorporates the new expansions and exceptions created by the Omnibus Budget Reconciliation Act of 1993 and the amendments in the Social Security Act Amendments of 1994 (SSA '94), that are related to referrals for clinical laboratory services and have a retroactive effective date of January 1, 1992. In addition, we are responding to comments received on the interim final rule with comment period (published on December 3, 1991) that set forth Medicare reporting requirements for the submission by certain health care entities of information about their relationships with physicians. That document implemented the reporting requirements of section 1877(f) of the Social Security Act. This rule revises those requirements to incorporate the amendments to section 1877(f) made by SSA '94, to apply to any further reporting we may require.     

Medicaid program; home and community-based services and respiratory care for ventilator-dependent individuals--HCFA. Final rule with comment period

This final rule with comment period expands coverage of Medicaid home and community-based services under the waiver provisions of section 1915(c) of the Social Security Act. This final rule also adds coverage of respiratory care services as an optional benefit under State Medicaid plans. These revisions and additions incorporate changes made by the Consolidated Omnibus Budget Reconciliation Act of 1985 and the Omnibus Budget Reconciliation Act of 1986 and respond to the public comments that we received as a result of the June 1, 1988, publication of a proposed rule. This final rule with comment period also incorporates self-implementing provisions of the Omnibus Budget Reconciliation Act of 1987, the Medicare Catastrophic Coverage Act of 1988, the Technical and Miscellaneous Revenue Act of 1988, and the Omnibus Budget Reconciliation Act of 1990 concerning home and community-based services, and makes other technical changes not specifically related to these statutes.     

Medicare and Medicaid programs; requirements for physician incentive plans in prepaid health care organizations--HCFA. Final rule correction; notice of changes in compliance dates, with comment period

In the March 27, 1996, issue of the Federal Register, we published, at 61 FR 13430, a final rule with comment period that implements requirements in sections 4204(a) and 4731 of the Omnibus Budget Reconciliation Act of 1990 that concern physician incentive plans. In the preamble of that rule, we set forth dates by which prepaid health plans had to comply with certain of the rule's provisions. This document clarifies and changes some of those deadlines, and provides an opportunity for public comments on them. It does not otherwise change the requirements set forth in the rule. In addition this document corrects the March 27 rule's inadvertent reversal of the nomenclature change made by a previous final rule.     

Medicare program; update of ambulatory surgical center payment rates effective July 1, 1990--HCFA. Notice with comment period

This notice implements section 1833(i)(2(A) of the Social Security Act, which requires that the payment rates for ambulatory surgical center services be reviewed and updated annually, and responds to public comments we received concerning the ambulatory surgical center payment rate update notice published on February 8, 1990 (55 FR 4577).     

Medicare and Medicaid programs; OBRA '87 conforming amendments--HCFA. Final rule with comment period

These regulations amend certain sections of Medicare and Medicaid rules to reflect 15 self-executing provisions of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) and changes made by sections 102, 103, and 211(b) of the Medicare Catastrophic Coverage Act of 1988 (MCCA), section 608(d)(3)(G) of the Family Support Act of 1988 (Pub. L. 100-485), and sections 6113 and 6301 of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89). They also clarify related rules. The amendments are needed to make HCFA rules consistent with current provisions of law and to ensure that users of the regulations are not confused by outdated provisions or unclear language. This document also makes technical amendments, primarily to correct internal cross-references, make nomenclature changes, and revise an outdated definition.     

Rate increase disclosure and review. Final rule with comment period

This final rule with comment period implements requirements for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The final rule establishes a rate review program to ensure that all rate increases that meet or exceed a specified threshold are reviewed by a State or CMS to determine whether they are unreasonable and that certain rate information be made public.     

Medicare program: request for public comments on implementation of the Medicare+Choice program, and notice of timeframes for submission of applications for contracts--HCFA. Notice of intent to regulate; solicitation of comments

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice program. 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 us. The BBA directs the Secretary to publish by June 1, 1998, regulations establishing standards for the Medicare+Choice program. We have already received comments and inquiries from the public on a number of issues associated with the Medicare+Choice program. This document solicits further public comments on issues related to implementation of the Medicare+Choice program. We intend to consider these comments as we develop an interim final rule to implement the Medicare+Choice program. This document also includes preliminary information regarding application procedures for organizations that intend to contract with us to participate in the Medicare+Choice program. This document also informs the public of a meeting to discuss the Medicare+Choice program.     

Medicare program; Medicare coverage of and payment for bone mass measurements--HCFA. Interim final rule with comment period

This interim final rule with comment period provides for uniform coverage of, and payment for, bone mass measurements for certain Medicare beneficiaries for services furnished on or after July 1, 1998. It implements provisions in section 4106(a) of the Balanced Budget Act of 1997.     

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.     

Medicaid program; Medicaid managed care. Withdrawal of final rule with comment period

This document withdraws all provisions of the final rule with comment period on Medicaid managed care that we published in the Federal Register on January 19, 2001 (66 FR 6228) with an initial effective date of April 19, 2001. This January 19, 2001 final rule, which has never taken effect, would have combined Medicaid managed care regulations in a new part 438, implemented Medicaid managed care requirements of the Balanced Budget Act of 1997 (Pub. L. 105-33), and imposed new requirements on entities currently regulated as "prepaid health plans' (PHPs). The regulations set forth in the final rule being withdrawn have been superseded by regulations promulgated in a subsequent rulemaking initiated on August 20, 2001 (66 FR 43613). In addition, this document addresses comments received in response to an interim final rule with comment period that we published on August 17, 2001 in the Federal Register (66 FR 43090) that further delayed, until August 16, 2002, the effective date of the January 19, 2001 final rule with comment period.     

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring; extension of comment period--FDA. Proposed rule; extension of comment period

The Food and Drug Administration (FDA) is extending to October 15, 1998, the comment period on a proposal rule that was published in the Federal Register of May 22, 1998 (63 FR 28301). The document proposed to amend the drug and biologics regulations by adding provisions that would clarify the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases. The agency is taking this action to provide interested persons additional time to submit comments to FDA on the proposed rule.     

Medicare program; update of ratesetting methodology, payment rates, payment policies, and the list of covered procedures for ambulatory surgical centers effective October 1, 1998; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on June 12, 1998 (63 FR 32290). In that rule we proposed to: Update the criteria for determining which surgical procedures can be appropriately and safely performed in an ambulatory surgical center (ASC): Make additions to and deletions from the current list of Medicare covered ASC procedures based on the revised criteria; Rebase the ASC payment rates using cost, charge, and utilization data collected by a 1994 survey of ASCs; Refine the ratesetting methodology that was implemented by a final notice published on February 8, 1990 in the Federal Register; Require that ASC payment, coverage, and wage index updates be implemented annually on January 1 rather than having these updates occur randomly throughout the year; Reduce requlatory burden; and Make several technical policy changes. This proposed rule implements requirements of section 1833(i) (1) and (2) of the Social Security Act. The comment period is extended for 30 days.