Department of Health and Human Services September 18, 2008 – Federal Register Recent Federal Regulation Documents
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Label Requirement for Food That Has Been Refused Admission into the United States
The Food and Drug Administration (FDA) is issuing a proposed rule that would require owners or consignees to label imported food that is refused entry into the United States. The label would read, ``UNITED STATES: REFUSED ENTRY.'' The proposal would describe the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the reintroduction of refused food into the United States, to facilitate the examination of imported food, and to implement part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs
This interim final rule with comment period (IFC) revises the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans. This IFC makes conforming changes to the MA regulations to reflect new statutory requirements regarding special needs plans (SNP), private- fee-for-service plans (PFFS), regional preferred provider organizations (RPPO) plans, Medicare medical savings accounts (MSA) plans, and new statutory provisions governing cost-sharing for dual-eligible enrollees in the MA program prescription drug pricing, coverage, and payment processes in the Part D program. In addition, this IFC sets forth new requirements governing the marketing of Part C and Part D plans which by statute must be in place at a date specified by the Secretary, but no later than November 15, 2008. Both the conforming changes to the regulations to reflect new statutory provisions and the new marketing requirements are based on provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008.
Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions
This final rule revises the Medicare Advantage (MA) program (Part C) and Medicare Prescription Drug Benefit Program (Part D). The regulation contains new regulatory provisions regarding marketing processes for both programs. The revisions to the Part C and Part D programs are based on lessons we have learned since 2006, the initial year of the prescription drug program and the revised MA program.
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