Department of Health and Human Services July 7, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics.

This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective January 1, 2015. As required by the Affordable Care Act, this rule implements the second year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments and the Affordable Care Act mandated face-to-face encounter requirement. This rule also proposes: Changes to simplify the face-to- face encounter regulatory requirements; changes to the HH PPS case-mix weights; changes to the home health quality reporting program requirements; changes to simplify the therapy reassessment timeframes; a revision to the Speech-Language Pathology (SLP) personnel qualifications; minor technical regulations text changes; and limitations on the reviewability of the civil monetary penalty provisions. Finally, this proposed rule also discusses Medicare coverage of insulin injections under the HH PPS, the delay in the implementation of ICD-10-CM, and solicits comments on a HH value-based purchasing (HH VBP) model.

HRSA will be issuing non-competitive awards under the Ryan White HIV/AIDS Program, AETC/GME Program. Approximately $450,000 will be made available in the form of a grant to current grantees (listed in chart below) during the budget period of July 1, 2014, through June 30, 2015. This will: (1) Continue the current cohort and provide support for one additional cohort of graduate medical residents; (2) continue to provide workforce development that is integral to the national interest through meeting National HIV/AIDS Strategy goals, and that enhances the implementation of the Affordable Care Act; and (3) provide a more robust program evaluation that will yield sufficient data; and aid HRSA/HAB in future decisions regarding the replication and the viability of a subsequent GME competition. The scope of work does not change.