Department of Health and Human Services April 27, 2015 – Federal Register Recent Federal Regulation Documents
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Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Additional Request for Nominations for the Advisory Panel on Outreach and Education (APOE)
This notice requests nominations for individuals to serve on the Advisory Panel on Outreach and Education (APOE).
M8 Electronic Common Technical Document v4.0 Draft Implementation Guide v2.0; Electronic Common Technical Document v4.0 Implementation Package Draft Specification for Submission Formats v2.0; International Conference on Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``M8 Electronic Common Technical Document (eCTD) v4.0 Draft Implementation Guide v2.0'' (the M8 eCTD draft implementation guidance) and a related document entitled ``eCTD v4.0 Implementation Package Draft Specification for Submission Formats v2.0'' (the draft specifications document). The M8 eCTD draft implementation guidance and the draft specifications document were prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The M8 eCTD draft implementation guidance provides instructions for creating the eCTD v4.0 Health Level 7 Regulated Product Submission (RPS) message for Modules 2 through 5 of the eCTD. The draft specifications document provides specifications for creating files for inclusion in the eCTD. These draft documents represent major updates to the eCTD specifications.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2016
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2016 as required by the statute. We are also proposing to adopt an IRF-specific market basket that reflects the cost structures of only IRF providers, phase in the revised wage index changes, and revise and update quality measures and reporting requirements under the IRF quality reporting program (QRP).
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