Federal register
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This final rule revises existing regulations that govern coverage and payment for hospice care under the Medicare program. These revisions reflect the statutory changes required by the Balanced Budget Act of 1997 (BBA), the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). ⋯ This final rule does not address the requirement for hospice data collection, the changes to the limitation of liability rules, or the changes to the hospice conditions of participation that were included in the BBA. The intent of this final rule is to expand the hospice benefit periods, improve documentation requirements to support certification and recertification of terminal illness, provide guidance on hospice admission procedures, clarify hospice discharge procedures, update coverage and payment requirements, and address the changing needs of beneficiaries, suppliers, and the Medicare program.
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This rule partially implements the TRICARE "sub-acute and long-term care program reform" enacted by Congress in the National Defense Authorization Act for Fiscal Year 2002, specifically: Establishment of "an effective, efficient, and integrated sub-acute care benefits program," with skilled nursing facility (SNF) and home health care benefits modeled after those of the Medicare program; adoption of Medicare payment methods for skilled nursing facility, home health care, and certain other institutional health care providers; adoption of Medicare rules on balance billing of beneficiaries, prohibiting it by institutional providers and limiting it by non-institutional providers; and change in the statutory exclusion of coverage for custodial and domiciliary care.
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The Food and Drug Administration (FDA) is amending its combination product regulations to define "mode of action'' (MOA) and "primary mode of action" (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.
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The Bureau of Prisons (Bureau) finalizes rules describing procedures we will follow for charging inmates fees for certain kinds of health services, as required under the Federal Prisoner Health Care Copayment Act of 2000 (Pub. L. 106-294, October 12, 2000, 114 Stat 1038, codified at 18 U. S. C. 4048).
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We are publishing final rules that amend the rules for the continuation of disability benefit payments under titles II and XVI of the Social Security Act (the Act) to certain individuals who recover medically while participating in an appropriate vocational rehabilitation (VR) program with a State vocational rehabilitation agency. We are amending these rules to conform with statutory amendments that extend eligibility for these continued benefit payments to certain individuals who recover medically while participating in an appropriate program of services. ⋯ We are also extending eligibility for these continued benefit payments to students age 18 through 21 who recover medically, or whose disability is determined to have ended as a result of an age-18 redetermination, while participating in an individualized education program developed under the Individuals with Disabilities Education Act with an appropriate provider of services. Providers of services we may approve include a public or private organization with expertise in the delivery or coordination of vocational rehabilitation services, employment services, or other support services; or a public, private or parochial school that provides or coordinates a program of vocational rehabilitation services, employment services, or other support services carried out under an individualized program or plan.