Department of Health and Human Services November 10, 2011 – Federal Register Recent Federal Regulation Documents

HHS gives notice of a determination concerning a petition to add a class of employees from the Norton Co. (or a subsequent owner), Worcester, Massachusetts, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On October 26, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical investigations in a manner that protects study subjects, FDA has developed methods to allow a clinical investigation to begin under certain circumstances, even when there are outstanding issues regarding the IDE submission. These mechanisms, including approval with conditions, staged approval or staged approval with conditions, and communication of outstanding issues related to the IDE through future considerations, are described in this guidance.

The Food and Drug Administration (FDA) is soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for early feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the approaches outlined in the draft guidance entitled ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Under the pilot program, FDA's review of IDE applications for an early feasibility study, including a first in human study, is expected to be based on less nonclinical data than would be expected for a traditional feasibility or a pivotal study. The pilot will also involve new approaches to IDE review to facilitate timely device and clinical protocol modifications during an early feasibility study.

This final rule updates and makes certain revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2012. We are also finalizing the interim final rule with comment period published on April 6, 2011, regarding the transition budget-neutrality adjustment under the ESRD PPS,. This final rule also sets forth requirements for the ESRD quality incentive program (QIP) for payment years (PYs) 2013 and 2014. In addition, this final rule revises the ambulance fee schedule regulations to conform to statutory changes. This final rule also revises the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime requirement (MLR) that must be met by an item or device in order to be considered durable for the purpose of classifying the item under the Medicare benefit category for DME. Finally, this final rule implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) Competitive Acquisition Program and responds to comments received on an interim final rule published January 16, 2009, that implemented these provisions of MIPPA effective April 18, 2009. (See the Table of Contents for a listing of the specific issues addressed in this final rule.)